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**
PLEASE CHECK BACK SOON
Download the files above while you wait.






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: 1560491
Sex: M
Age:
State:

Vax Date:
Onset Date:
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: swelling in the nose; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (swelling in the nose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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 an unknown date, the patient experienced SWELLING (swelling in the nose). At the time of the report, SWELLING (swelling in the nose) outcome 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. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560492
Sex: F
Age: 62
State: AZ

Vax Date: 02/13/2021
Onset Date: 02/13/2021
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: Face Swelling; Eye felt weird; Soreness behind left ear; Stomach felt like "Someone punched her"; Achy Bones; Tightness on right side of body; Sore arm; Rash on Cheeks and Neck; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her") and BONE PAIN (Achy Bones) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her"), BONE PAIN (Achy Bones), MUSCLE TIGHTNESS (Tightness on right side of body), PAIN IN EXTREMITY (Sore arm), RASH (Rash on Cheeks and Neck), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her"), BONE PAIN (Achy Bones), MUSCLE TIGHTNESS (Tightness on right side of body), PAIN IN EXTREMITY (Sore arm), RASH (Rash on Cheeks and Neck), HEADACHE (Headache) and CHILLS (Chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included Xanax. Treatment medication included Ibuprofen. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received on 14-JUL-2021 contains non significant information. The primary reporter contact details were updated.

Other Meds: XANAX

Current Illness:

ID: 1560493
Sex: F
Age: 54
State: MO

Vax Date: 02/11/2021
Onset Date: 02/11/2021
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: Dizzy/lightheaded; Legs also hurt when she bends; Arms hurt from the shot; chills; body aches; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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-Feb-2021, the patient experienced DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560494
Sex: M
Age: 71
State: NC

Vax Date: 01/29/2021
Onset Date: 02/06/2021
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: injection site is still a big square of red; At the injection site, there's extreme swelling, rash, and extreme itching; At the injection site, there's extreme swelling, rash, and extreme itching; At the injection site, there's extreme swelling, rash, and extreme itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (At the injection site, there's extreme swelling, rash, and extreme itching), VACCINATION SITE SWELLING (At the injection site, there's extreme swelling, rash, and extreme itching), VACCINATION SITE RASH (At the injection site, there's extreme swelling, rash, and extreme itching) and VACCINATION SITE ERYTHEMA (injection site is still a big square of red) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (At the injection site, there's extreme swelling, rash, and extreme itching), VACCINATION SITE SWELLING (At the injection site, there's extreme swelling, rash, and extreme itching) and VACCINATION SITE RASH (At the injection site, there's extreme swelling, rash, and extreme itching). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site is still a big square of red). At the time of the report, VACCINATION SITE PRURITUS (At the injection site, there's extreme swelling, rash, and extreme itching) and VACCINATION SITE SWELLING (At the injection site, there's extreme swelling, rash, and extreme itching) outcome was unknown, VACCINATION SITE RASH (At the injection site, there's extreme swelling, rash, and extreme itching) was resolving and VACCINATION SITE ERYTHEMA (injection site is still a big square of red) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient has been self-treating with an unspecified topical medication for the last 3 days and reports that it seems to be helping the rash. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1560495
Sex: F
Age:
State: TN

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: My arm got little sore; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events my arm got little sore. The patient's medical history was not provided. Concomitant medications reported were Propranolol 10mg, Methimazole 5mg for drug use for unknown indication. On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 9 Feb 2021, the patient experienced the event(s) my arm got little sore. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.

Other Meds: PROPRANOLOL; METHIMAZOLE

Current Illness:

ID: 1560496
Sex: M
Age: 87
State: FL

Vax Date: 01/28/2021
Onset Date: 01/28/2021
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: tender arm but was still able to do her daily activities with no issues; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tender arm but was still able to do her daily activities with no issues) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (tender arm but was still able to do her daily activities with no issues). At the time of the report, VACCINATION SITE PAIN (tender arm but was still able to do her daily activities with no issues) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs were reported. No treatment drugs were reported.

Other Meds:

Current Illness:

ID: 1560497
Sex: M
Age: 57
State: PA

Vax Date: 01/22/2021
Onset Date: 02/08/2021
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: Arm was sore; Red blotch 4 inch long and 6 inch wide at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red blotch 4 inch long and 6 inch wide at injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red blotch 4 inch long and 6 inch wide at injection site). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red blotch 4 inch long and 6 inch wide at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment details included ice patch and hot compress.

Other Meds:

Current Illness:

ID: 1560498
Sex: M
Age:
State: FL

Vax Date: 02/16/2021
Onset Date: 02/17/2021
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: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: can barely get up; no appetite; weakness; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (can barely get up), DECREASED APPETITE (no appetite), ASTHENIA (weakness) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-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 17-Feb-2021, the patient experienced DECREASED APPETITE (no appetite), ASTHENIA (weakness) and PYREXIA (fever). On an unknown date, the patient experienced SOMNOLENCE (can barely get up). At the time of the report, SOMNOLENCE (can barely get up), DECREASED APPETITE (no appetite), ASTHENIA (weakness) and PYREXIA (fever) outcome was unknown. Treatment Drugs: Tylenol No concomitant drugs are provided. Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1560499
Sex: F
Age: 76
State: TX

Vax Date: 01/29/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Bruise on the arm at the injection site after second dose; Itching at the injection site after the second dose; Pain at the injection site after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Bruise on the arm at the injection site after second dose), INJECTION SITE PRURITUS (Itching at the injection site after the second dose) and INJECTION SITE PAIN (Pain at the injection site after the second dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INJECTION SITE BRUISING (Bruise on the arm at the injection site after second dose), INJECTION SITE PRURITUS (Itching at the injection site after the second dose) and INJECTION SITE PAIN (Pain at the injection site after the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] for Itching and Pain, at a dose of 1 g. At the time of the report, INJECTION SITE BRUISING (Bruise on the arm at the injection site after second dose), INJECTION SITE PRURITUS (Itching at the injection site after the second dose) and INJECTION SITE PAIN (Pain at the injection site after the second dose) outcome was unknown. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not Applicable. This case was linked to MOD-2021-029506 (Patient Link).

Other Meds:

Current Illness:

ID: 1560500
Sex: F
Age:
State: NE

Vax Date: 01/26/2021
Onset Date:
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: Heart rate was higher than normal; Sore arm; Low grade fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart rate was higher than normal), VACCINATION SITE PAIN (Sore arm), PYREXIA (Low grade fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History was provided by the reporter. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate was higher than normal), VACCINATION SITE PAIN (Sore arm), PYREXIA (Low grade fever) and CHILLS (Chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Heart rate was higher than normal), VACCINATION SITE PAIN (Sore arm), PYREXIA (Low grade fever) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 81-100-132 (High) Patient's heart rate was 81 while sleeping and 100 while awake but no exercising. On one of the night, heart rate was 132. On an unknown date, Oxygen saturation: normal normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1560501
Sex: F
Age: 71
State: CA

Vax Date: 02/16/2021
Onset Date: 02/26/2021
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: may have been sweating in the night but she has no fever.; experienced hoarseness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (experienced hoarseness) and HYPERHIDROSIS (may have been sweating in the night but she has no fever.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSPHONIA (experienced hoarseness). On 01-Mar-2021, the patient experienced HYPERHIDROSIS (may have been sweating in the night but she has no fever.). At the time of the report, DYSPHONIA (experienced hoarseness) and HYPERHIDROSIS (may have been sweating in the night but she has no fever.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560502
Sex: F
Age: 78
State: NC

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Pain in arm; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011C20A) for COVID-19 vaccination. Co-suspect product included non-company product ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication. The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included QUINAPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) (unknown route) at an unspecified dose. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Treatment information included Ice pack. Action taken with mRNA-1273 in response to the event was not applicable Reporter did not allow further contact

Other Meds: QUINAPRIL; ASPIRIN (E.C.)

Current Illness:

ID: 1560503
Sex: M
Age: 56
State: OR

Vax Date: 01/20/2021
Onset Date: 01/20/2021
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: headache; feeling like finger prick in his right hand; woke up in the middle of the night perspiring; his right fingers are purple every time; Strong pain on his right fingers; chest pain; difficulty breathing; red spot in his finger; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feeling like finger prick in his right hand), NIGHT SWEATS (woke up in the middle of the night perspiring), SKIN DISCOLOURATION (his right fingers are purple every time), PAIN IN EXTREMITY (Strong pain on his right fingers) and CHEST PAIN (chest pain) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Scleroderma (Diagnosed with scleroderma five years ago.) since an unknown date. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), AMLODIPINE and OMEPRAZOLE for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PARAESTHESIA (feeling like finger prick in his right hand), NIGHT SWEATS (woke up in the middle of the night perspiring), SKIN DISCOLOURATION (his right fingers are purple every time), PAIN IN EXTREMITY (Strong pain on his right fingers), CHEST PAIN (chest pain), DYSPNOEA (difficulty breathing) and RASH MACULAR (red spot in his finger). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Headache, at an unspecified dose and frequency. On 21-Jan-2021, CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing) had resolved. On 24-Jan-2021, NIGHT SWEATS (woke up in the middle of the night perspiring) had resolved. At the time of the report, PARAESTHESIA (feeling like finger prick in his right hand), SKIN DISCOLOURATION (his right fingers are purple every time), PAIN IN EXTREMITY (Strong pain on his right fingers), RASH MACULAR (red spot in his finger) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: MYCOPHENOLATE; AMLODIPINE; OMEPRAZOLE

Current Illness: Scleroderma (Diagnosed with scleroderma five years ago.)

ID: 1560504
Sex: M
Age:
State: TX

Vax Date: 01/20/2021
Onset Date: 01/20/2021
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: Positive covid test; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive covid test), PYREXIA (Fever) and MYALGIA (Body ache) in a male 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 medical history reported). On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body ache). On 26-Jan-2021, the patient experienced COVID-19 (Positive covid test). At the time of the report, COVID-19 (Positive covid test), PYREXIA (Fever) and MYALGIA (Body ache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information was took medicine and the symptoms were gone in three days. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1560505
Sex: F
Age: 78
State: OH

Vax Date: 02/04/2021
Onset Date: 02/14/2021
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: upset stomach; fatigue; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Previously administered products included for an unreported indication: SHINGRIX on 04-Dec-2020. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) from 14-Feb-2021 to 14-Feb-2021 for Shingles. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (fatigue), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Follow up received and contains no new information

Other Meds: SHINGRIX

Current Illness:

ID: 1560506
Sex: M
Age:
State: FL

Vax Date: 02/14/2021
Onset Date: 02/15/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: got a cut; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LACERATION (got a cut) 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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced SKIN LACERATION (got a cut). The patient was treated with TETANUS VACCINE on 15-Feb-2021 at a dose of 1 dosage form. At the time of the report, SKIN LACERATION (got a cut) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant drugs were reported.

Other Meds:

Current Illness:

ID: 1560507
Sex: M
Age:
State: NV

Vax Date: 02/12/2021
Onset Date: 02/12/2021
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: Sore arm; Dizziness; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness) and FATIGUE (Extreme fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Cardiac disorder since 1975, Blood pressure high since 1975, Anxiety since 1975, Acid reflux (esophageal) and Penicillin allergy. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), PAROXETIN [PAROXETINE] for Anxiety, IRBESARTAN and EZETIMIBE for Blood pressure high, ATORVASTATIN for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness) and FATIGUE (Extreme fatigue). On 13-Feb-2021, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness) and FATIGUE (Extreme fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Completed ADR Form included updated reporter details, patient demographic details, medical history, allergic information, concomitant medication, event outcome details.

Other Meds: IRBESARTAN; EZETIMIBE; ATORVASTATIN; OMEPRAZOLE; PAROXETIN [PAROXETINE]

Current Illness: Acid reflux (esophageal); Anxiety; Blood pressure high; Cardiac disorder; Penicillin allergy

ID: 1560508
Sex: M
Age: 70
State: NJ

Vax Date: 02/10/2021
Onset Date: 02/10/2021
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: nausea; vomiting; cheeks were blushed; didn't feel good; fever; pain in arm; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE PAIN (pain in arm), MYALGIA (body aches), NAUSEA (nausea) and VOMITING (vomiting) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (pain in arm), MYALGIA (body aches) and MALAISE (didn't feel good). On 11-Feb-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and FLUSHING (cheeks were blushed). On 11-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in arm), MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting), FLUSHING (cheeks were blushed) and MALAISE (didn't feel good) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560509
Sex: F
Age: 44
State: CA

Vax Date: 02/09/2021
Onset Date: 02/16/2021
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: injection site reaction; welling on her arm, 3" or 4" in; burning; red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reaction), PERIPHERAL SWELLING (welling on her arm, 3" or 4" in), BURNING SENSATION (burning), ERYTHEMA (red) and INJECTION SITE PRURITUS (itchy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included Chicken pox (historical condition include chicken pox). On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE REACTION (injection site reaction), PERIPHERAL SWELLING (welling on her arm, 3" or 4" in), BURNING SENSATION (burning), ERYTHEMA (red) and INJECTION SITE PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (injection site reaction), PERIPHERAL SWELLING (welling on her arm, 3" or 4" in), BURNING SENSATION (burning), ERYTHEMA (red) and INJECTION SITE PRURITUS (itchy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment details included Benadryl 25mg liquid and ice pack.

Other Meds:

Current Illness:

ID: 1560510
Sex: M
Age: 77
State: OH

Vax Date: 01/27/2021
Onset Date: 01/27/2021
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: Redness at the injection site; Itchiness at the injection site; floaters in his left eye; arm muscle was swollen; A spontaneous report was received from a consumer concerning a 77-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness at the injection site, itchiness at the injection site, arm muscle was swollen, floaters in his left eye. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 27 Jan 2021, after receiving the first dose of mRNA-1273, the patient experienced arm muscle was swollen. On 28 Jan 2021, the patient experienced the event redness at the injection site, itchiness at the injection site and floaters in his left eye. The patient still experienced redness and itchiness at the injection site. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), redness at the injection site, itchiness at the injection site was not resolved. The outcome of event(s), arm muscle was swollen, floaters in his left eye was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1560511
Sex: F
Age:
State: MI

Vax Date: 02/12/2021
Onset Date: 02/12/2021
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: Hard breast; Tingling Tongue; Tingling mouth; Knee arthritis; Tingling lips; Extremely painful along with entire body; entire body inflamed with arthritis; Breast Swelling,Breast engorged , enlarged,areola very enlarged; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Breast Swelling,Breast engorged , enlarged,areola very enlarged), BREAST TENDERNESS (Hard breast), PARAESTHESIA ORAL (Tingling Tongue), PARAESTHESIA ORAL (Tingling mouth) and ARTHRITIS (Knee arthritis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast reduction (Patient had a breast reduction 32 years ago). Concurrent medical conditions included Acid reflux (esophageal), Drug allergy (Morphine), Drug allergy (Protonix) and Drug allergy (Reglan). Concomitant products included FAMOTIDINE and CALCIUM for an unknown indication. On 12-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 12-Feb-2021, the patient experienced BREAST SWELLING (Breast Swelling,Breast engorged , enlarged,areola very enlarged), PARAESTHESIA ORAL (Tingling mouth), ARTHRITIS (Knee arthritis), PARAESTHESIA ORAL (Tingling lips), MYALGIA (Extremely painful along with entire body) and ARTHRITIS (entire body inflamed with arthritis). On 13-Feb-2021, the patient experienced BREAST TENDERNESS (Hard breast) and PARAESTHESIA ORAL (Tingling Tongue). At the time of the report, BREAST SWELLING (Breast Swelling,Breast engorged , enlarged,areola very enlarged), BREAST TENDERNESS (Hard breast), PARAESTHESIA ORAL (Tingling Tongue), PARAESTHESIA ORAL (Tingling mouth), ARTHRITIS (Knee arthritis), PARAESTHESIA ORAL (Tingling lips), MYALGIA (Extremely painful along with entire body) and ARTHRITIS (entire body inflamed with arthritis) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On Saturday Patient took Famotidine and antacid tablet for 2 days. Patient feels Constantly thirsty. Patient used ice pack and heating pads for months and continues today on breast and knees No Treatment medications were provided Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Medical history updated in patient tab, New events are added in events tab. On 11-Jul-2021: Non significant follow up-adr form copies updated

Other Meds: FAMOTIDINE; CALCIUM

Current Illness: Acid reflux (esophageal); Drug allergy (Reglan); Drug allergy (Protonix); Drug allergy (Morphine)

ID: 1560512
Sex: F
Age: 68
State: MN

Vax Date: 01/29/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Burning in her mouth; Terrible mouth sores on my tongue, inner lips, and gums.; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Terrible mouth sores on my tongue, inner lips, and gums.) and ORAL DISCOMFORT (Burning in her mouth) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced ORAL PAIN (Terrible mouth sores on my tongue, inner lips, and gums.). On 02-Feb-2021, the patient experienced ORAL DISCOMFORT (Burning in her mouth). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (MAALOX ADVANCED [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE;SIMETICONE]) ongoing since an unknown date at a dose of 1 dosage form; HYDROGEN PEROXIDE ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, ORAL PAIN (Terrible mouth sores on my tongue, inner lips, and gums.) and ORAL DISCOMFORT (Burning in her mouth) was resolving. No relevant concomitant medications were reported. This case was linked to MOD-2021-256827 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up document contains No New Information.

Other Meds:

Current Illness:

ID: 1560513
Sex: M
Age: 81
State: VA

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: cough; chills; fatigue; fever of 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 99 degrees) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01M20A) for COVID-19 vaccination. no medical history reported by reporter. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced COUGH (cough), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 99 degrees). The patient was treated with DEXTROMETHORPHAN POLISTIREX (ROBITUSSIN 12 HOUR COUGH RELIEF) ongoing since an unknown date at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) ongoing since an unknown date at an unspecified dose and frequency and ZINC GLUCONATE (COLD-EEZE [ZINC GLUCONATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COUGH (cough), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 99 degrees) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Non significant follow up received on 25-MAY-2021, reporter stated that he did not reported any AE

Other Meds:

Current Illness:

ID: 1560514
Sex: F
Age: 65
State: FL

Vax Date: 01/07/2021
Onset Date: 01/07/2021
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: joint pain; body weakness; dizzy; sleepy; legs were painful; fever; soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm), ASTHENIA (body weakness), DIZZINESS (dizzy), SOMNOLENCE (sleepy) and PAIN IN EXTREMITY (legs were painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness on her arm) and PYREXIA (fever). On 05-Feb-2021, the patient experienced ASTHENIA (body weakness), DIZZINESS (dizzy), SOMNOLENCE (sleepy) and PAIN IN EXTREMITY (legs were painful). On 06-Feb-2021, the patient experienced ARTHRALGIA (joint pain). At the time of the report, PAIN IN EXTREMITY (soreness on her arm), ASTHENIA (body weakness), DIZZINESS (dizzy), SOMNOLENCE (sleepy), PAIN IN EXTREMITY (legs were painful), ARTHRALGIA (joint pain) and PYREXIA (fever) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1560515
Sex: F
Age: 70
State: OK

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Extended down into my hand and up into my shoulder; Kinda fluidy; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), ARTHRALGIA (Extended down into my hand and up into my shoulder) and FLUID RETENTION (Kinda fluidy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Pelvic fracture. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On an unknown date, the patient experienced ARTHRALGIA (Extended down into my hand and up into my shoulder) and FLUID RETENTION (Kinda fluidy). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Pelvic fracture, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Arm pain), ARTHRALGIA (Extended down into my hand and up into my shoulder) and FLUID RETENTION (Kinda fluidy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported.

Other Meds:

Current Illness: Pelvic fracture

ID: 1560516
Sex: M
Age: 78
State: MS

Vax Date: 02/09/2021
Onset Date: 02/09/2021
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: fever has gotten progressively worse all day long , fever was in the 100s; fever last night/ fever has gotten progressively worse all day long , fever was in the 100s; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever last night/ fever has gotten progressively worse all day long , fever was in the 100s) and PYREXIA (fever has gotten progressively worse all day long , fever was in the 100s) in a 78-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 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (fever last night/ fever has gotten progressively worse all day long , fever was in the 100s). On 10-Feb-2021, the patient experienced PYREXIA (fever has gotten progressively worse all day long , fever was in the 100s). At the time of the report, PYREXIA (fever last night/ fever has gotten progressively worse all day long , fever was in the 100s) and PYREXIA (fever has gotten progressively worse all day long , fever was in the 100s) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1560517
Sex: M
Age: 66
State: DC

Vax Date: 01/01/2021
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: very little reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very little reaction) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol (takes an unknown statin) and Blood pressure high. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very little reaction). At the time of the report, VACCINATION COMPLICATION (very little reaction) outcome was unknown. Treatment information was not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable as the patient received the second dose on 11 Feb 2021. This case was linked to MOD-2021-052746 (Patient Link).

Other Meds:

Current Illness: Blood pressure high; High cholesterol (takes an unknown statin)

ID: 1560518
Sex: M
Age: 38
State: OK

Vax Date: 02/09/2021
Onset Date: 02/10/2021
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: Fever; Sore; Really Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN (Sore) and FATIGUE (Really Tired) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported. On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever), PAIN (Sore) and FATIGUE (Really Tired). At the time of the report, PYREXIA (Fever), PAIN (Sore) and FATIGUE (Really Tired) outcome was unknown. Not Provided No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560519
Sex: F
Age: 66
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: she felt horrible; tired; right arm started hurting the same day; experiencing a low-grade fever (99.6 F) that is ongoing; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (she felt horrible), FATIGUE (tired), VACCINATION SITE PAIN (right arm started hurting the same day) and PYREXIA (experiencing a low-grade fever (99.6 F) that is ongoing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included Herpes simplex. Concurrent medical conditions included Penicillin allergy, Drug allergy and Food allergy (kiwi). Concomitant products included TRAMADOL, ZOLPIDEM TARTRATE (AMBIEN), ALPRAZOLAM and ACYCLOVIR [ACICLOVIR] for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm started hurting the same day) and PYREXIA (experiencing a low-grade fever (99.6 F) that is ongoing). On 06-Feb-2021, the patient experienced DISCOMFORT (she felt horrible) and FATIGUE (tired). At the time of the report, DISCOMFORT (she felt horrible), FATIGUE (tired), VACCINATION SITE PAIN (right arm started hurting the same day) and PYREXIA (experiencing a low-grade fever (99.6 F) that is ongoing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Motrin, Tylenol.

Other Meds: TRAMADOL; AMBIEN; ALPRAZOLAM; ACYCLOVIR [ACICLOVIR]

Current Illness: Drug allergy; Food allergy (kiwi); Penicillin allergy

ID: 1560520
Sex: U
Age:
State:

Vax Date: 01/26/2021
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: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: arm is still pink; arm became red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (arm is still pink) and VACCINATION SITE ERYTHEMA (arm became red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (arm is still pink) and VACCINATION SITE ERYTHEMA (arm became red). At the time of the report, VACCINATION SITE DISCOLOURATION (arm is still pink) and VACCINATION SITE ERYTHEMA (arm became red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560521
Sex: F
Age:
State: MA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Dizziness; Weakness; Chills; joint pain; muscle pain; Headache; overwhelming fatigue; brain fog; nonfunctional; debilitated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below. 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 an unknown date, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 09-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below. 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 an unknown date, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (Headache), FATIGUE (overwhelming fatigue), FEELING ABNORMAL (brain fog), FEELINGS OF WORTHLESSNESS (nonfunctional) and ASTHENIA (debilitated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided.

Other Meds:

Current Illness:

ID: 1560522
Sex: F
Age:
State: CA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
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: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Headache; So tired she could not sit-up; Heartburn (like her esophagus was burning); body pain; Fever(101.8); Shivering so bad she bit her tongue and could not control her jaw/ chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain) and PYREXIA (Fever(101.8)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (In August-September, 2020). On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain), PYREXIA (Fever(101.8)) and CHILLS (Shivering so bad she bit her tongue and could not control her jaw/ chills). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and TYLENOL at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain), PYREXIA (Fever(101.8)) and CHILLS (Shivering so bad she bit her tongue and could not control her jaw/ chills) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1560523
Sex: F
Age:
State:

Vax Date:
Onset Date: 01/13/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: body aches; muscle aches; chills; extreme fatigue; high less fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (body aches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (high less fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No medical history 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (body aches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (high less fever). On 14-Jan-2021, PAIN (body aches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (high less fever) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560524
Sex: F
Age: 48
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: slight tightness of throat; felt hot on left side of the body; knocking on left side of the head; started wheezing; itchy on my stomach; involuntary spasms; jaw went to one side and back again; toes were twitching; entire body had spasms; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing) and PRURITUS (itchy on my stomach) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL (ALBUTEROL HFA) and IBUPROFEN for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing), PRURITUS (itchy on my stomach), MUSCLE SPASMS (involuntary spasms), TRISMUS (jaw went to one side and back again), MUSCLE TWITCHING (toes were twitching) and MUSCLE SPASMS (entire body had spasms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-Jan-2021 for Adverse reaction, at an unspecified dose and frequency. On 16-Jan-2021, MUSCLE SPASMS (involuntary spasms), TRISMUS (jaw went to one side and back again), MUSCLE TWITCHING (toes were twitching) and MUSCLE SPASMS (entire body had spasms) had resolved. At the time of the report, THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing) and PRURITUS (itchy on my stomach) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: SYMBICORT; ALBUTEROL HFA; IBUPROFEN

Current Illness:

ID: 1560525
Sex: M
Age:
State: NY

Vax Date: 02/14/2021
Onset Date: 02/14/2021
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: discomfort in his arm; flu-like symptoms; fever of 101.1; weakness; chills; kind of tired; sore arm; flushing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), LIMB DISCOMFORT (discomfort in his arm) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE and ROSUVASTATIN for an unknown indication. On 14-Feb-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 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), CHILLS (chills) and FATIGUE (kind of tired). On an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in his arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever of 101.1) and ASTHENIA (weakness). At the time of the report, PAIN IN EXTREMITY (sore arm), FLUSHING (flushing), BODY TEMPERATURE FLUCTUATION (felt hot and cold), LIMB DISCOMFORT (discomfort in his arm), CHILLS (chills), FATIGUE (kind of tired), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever of 101.1) and ASTHENIA (weakness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No laboratory details were provided. Treatment medications included Tylenol and low dose Allegra. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD21-032046 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: No specific follow-up information recorded. On 10-May-2021: updated contact information

Other Meds: SYNTHROID; AMLODIPINE; ROSUVASTATIN

Current Illness:

ID: 1560526
Sex: F
Age: 65
State: GA

Vax Date: 01/25/2021
Onset Date: 02/01/2021
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: Shingles; Rash on back; Right shoulder pain; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), HERPES ZOSTER (Shingles), RASH (Rash on back) and ARTHRALGIA (Right shoulder pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D), BIOTIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced BACK PAIN (Back pain) and ARTHRALGIA (Right shoulder pain). On 02-Feb-2021, the patient experienced HERPES ZOSTER (Shingles) and RASH (Rash on back). The patient was treated with IBUPROFEN for Shingles, at a dose of 1 dosage form and ACYCLOVIR [ACICLOVIR] for Shingles, at a dose of 1 dosage form. At the time of the report, BACK PAIN (Back pain) and ARTHRALGIA (Right shoulder pain) outcome was unknown and HERPES ZOSTER (Shingles) and RASH (Rash on back) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was on High blood pressure medication, Antihyperlipidemic and Aromatase Inhibitor. Reporter did not allow further contact

Other Meds: CALCIUM + VIT D; BIOTIN; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1560527
Sex: M
Age: 65
State:

Vax Date: 01/19/2021
Onset Date: 02/16/2021
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: Arm pain; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 013C20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) 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. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: TCR information received on 28-JUN-2021 contains non-significant information.

Other Meds:

Current Illness:

ID: 1560528
Sex: F
Age: 60
State: MI

Vax Date: 01/23/2021
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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (COVID arm). At the time of the report, RASH (COVID 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 reported. No treatment medications were provided

Other Meds:

Current Illness:

ID: 1560529
Sex: F
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 02/09/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Chills; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1560530
Sex: F
Age: 62
State: NV

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

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

Lab Data:

Allergies:

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

Symptoms: injection site was sore; red area below the injection site; raised area below the injection site; diarrhea; coughing; headache; nausea; vomiting; fever of 101?F; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever of 101?F) and FATIGUE (fatigue). On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (red area below the injection site) and VACCINATION SITE SWELLING (raised area below the injection site). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLPROPANOLAMINE BITARTRATE (ALKA-SELTZER PLUS COLD & FLU MEDICINE) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) for Injection site swelling, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), COUGH (coughing), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever of 101?F) and FATIGUE (fatigue) had resolved and INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (red area below the injection site) and VACCINATION SITE SWELLING (raised area below the injection site) outcome was unknown. No concomitant medications were reported. No laboratory details were provided. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1560531
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: slight chills in both arms; uncomfortable; A spontaneous report was received from a healthcare professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slight chills in both arms, uncomfortable. The patient's medical history was not mentioned. Concomitant medications reported were metoprolol tartrate 25mg 1 4 tablet daily, levothyroxine 25mcg daily, Propranolol 10mg ? tablet daily, Vitamin C, Multivitamin for drug use for unknown indication. On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 021M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date patient experienced events as slight chills in both arms and uncomfortable. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event(s), slight chills in both arms, uncomfortable was UNKNOWN.

Other Meds: METOPROLOL TARTRATE; LEVOTHYROXINE; PROPRANOLOL; VITAMIN C & ROSEHIP; MULTIVITAMIN & MINERAL

Current Illness: Blood pressure; Thyroid disorder

ID: 1560532
Sex: F
Age: 70
State: OK

Vax Date: 02/09/2021
Onset Date: 02/10/2021
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: Sick; Weak; Really Tired; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really tired / fatigue, sick / illness and weak / asthenia. The patient's medical history included diabetes. No relevant concomitant medications were reported. On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient experienced the events, really tired, sick and weak. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, really tired, sick and weak was unknown.

Other Meds:

Current Illness: Diabetes

ID: 1560533
Sex: F
Age: 69
State: CA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ZOLEDRONIC ACID (RECLAST) and Advil for back pain? Daily for an unknown indication. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was unknown This case was linked to MOD-2021-108971. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Attached vaccine adverse event reporting form

Other Meds: VITAMIN D 2000; RECLAST; Advil for back pain? Daily

Current Illness:

ID: 1560534
Sex: M
Age: 62
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: Asked if it was cyst; Swollen lymph node; A spontaneous report was received from a consumer concerning a 62-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen lymph node, asked if it was cyst. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 31 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) Swollen lymph node, Asked if it was cyst. No treatment information provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), swollen lymph node, asked if it was cyst was unknown.

Other Meds:

Current Illness:

ID: 1560535
Sex: M
Age:
State:

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Feeling signs of vertigo; Started to feel dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Started to feel dizzy) and VERTIGO (Feeling signs of vertigo) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (Started to feel dizzy). On 08-Feb-2021, the patient experienced VERTIGO (Feeling signs of vertigo). At the time of the report, DIZZINESS (Started to feel dizzy) and VERTIGO (Feeling signs of vertigo) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1560536
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: could hardly move; body aches; rash on the lower part of her right arm; chills; arm was sore at the injection site; A spontaneous report was received from a consumer concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on the lower part of her right arm (rash), arm was sore at the injection site (vaccination site pain), body aches (Myalgia), chills, could hardly move (hypokinesia). The patient's medical history was not provided. Concomitant product use was not reported. On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, on the same day of receiving vaccine, the patient experienced rash on the lower part of her right arm, arm was sore at the injection site. She had body aches, chills and could hardly move on the morning of 13 Feb 2021. Treatment included acetaminophen and an anti-itch cream. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the events, rash on the lower part of right arm, arm was sore at the injection site, body aches, chills, and could hardly move, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1560537
Sex: F
Age: 35
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient experienced hives from below chest to knees. There were fewer spots from hips to knees

Other Meds:

Current Illness:

ID: 1560538
Sex: F
Age: 91
State: NE

Vax Date: 01/29/2021
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: Noticed a mark at injection site; It was warm and blotchy; Rash clear down her arm 6 inches long but is not bothersome; A spontaneous report was received from a consumer concerning a 90-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events noticed a mark at injection site, it was warm and blotchy, rash clear down her arm 6 inches long but is not bothersome. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 043L20A) in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events, noticed a mark at injection site, it was warm and blotchy, rash clear down her arm 6 inches long but is not bothersome.Consent to contact given. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, noticed a mark at injection site, it was warm and blotchy, rash clear down her arm 6 inches long but is not bothersome were unknown.

Other Meds:

Current Illness:

ID: 1560539
Sex: F
Age: 71
State: CA

Vax Date: 02/04/2021
Onset Date: 02/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: arm was sore for about 3-4 days; Rash got larger, redder, itchier; warm to the touch; itchy; rash; speckled red spots that were raised; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (speckled red spots that were raised), PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier), VACCINATION SITE WARMTH (warm to the touch) and PRURITUS (itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH MACULAR (speckled red spots that were raised), PRURITUS (itchy) and RASH (rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier) and VACCINATION SITE WARMTH (warm to the touch). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (speckled red spots that were raised), PAIN IN EXTREMITY (arm was sore for about 3-4 days), VACCINATION SITE REACTION (Rash got larger, redder, itchier), VACCINATION SITE WARMTH (warm to the touch), PRURITUS (itchy) and RASH (rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information also included anti-itch ointment. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up was received on 26 APR 2021 included reporter details was updated.

Other Meds:

Current Illness:

ID: 1560540
Sex: F
Age: 86
State: OH

Vax Date: 01/26/2021
Onset Date: 02/02/2021
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: Rash around the injection site; Injection site itches; A spontaneous report ) was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash around the injection site, injection site itches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 2 Feb 2021, the patient experienced the event(s) rash around the injection site, injection site itches. Treatment details included dexamethasone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), rash around the injection site, injection site itches was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm