VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1548650
Sex: F
Age: 74
State: NC

Vax Date: 01/19/2021
Onset Date: 02/02/2021
Rec V Date: 08/12/2021
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: Persisting itches; Persisting redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Persisting itches) and INJECTION SITE ERYTHEMA (Persisting redness ) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Persisting itches) and INJECTION SITE ERYTHEMA (Persisting redness ). At the time of the report, INJECTION SITE PRURITUS (Persisting itches) and INJECTION SITE ERYTHEMA (Persisting redness ) 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: 1548651
Sex: F
Age: 59
State: CO

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/12/2021
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: rash on the top of her arm; rash goes under her armpit as well; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm sore), VACCINATION SITE RASH (rash on the top of her arm) and RASH (rash goes under her armpit as well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm sore). On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on the top of her arm) and RASH (rash goes under her armpit as well). The patient was treated with DIPHENHYDRAMINE ongoing from 03-Feb-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm sore), VACCINATION SITE RASH (rash on the top of her arm) and RASH (rash goes under her armpit as well) 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 relevant concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: No new information was updated.

Other Meds:

Current Illness:

ID: 1548652
Sex: M
Age: 49
State: MI

Vax Date: 01/07/2021
Onset Date: 01/14/2020
Rec V Date: 08/12/2021
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: Still battles with heat flashes and Nausea; Heat flashes all over the body; Heart Rate went up right away post vaccination; Nausea following heat flashes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Heart Rate went up right away post vaccination), HOT FLUSH (Heat flashes all over the body), VACCINATION COMPLICATION (Still battles with heat flashes and Nausea) and NAUSEA (Nausea following heat flashes) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2020, the patient experienced NAUSEA (Nausea following heat flashes). On 07-Jan-2021, the patient experienced VACCINATION COMPLICATION (Heart Rate went up right away post vaccination). On 14-Jan-2021, the patient experienced HOT FLUSH (Heat flashes all over the body). On 02-Feb-2021, the patient experienced VACCINATION COMPLICATION (Still battles with heat flashes and Nausea). On 07-Jan-2021, VACCINATION COMPLICATION (Heart Rate went up right away post vaccination) had resolved. At the time of the report, HOT FLUSH (Heat flashes all over the body), VACCINATION COMPLICATION (Still battles with heat flashes and Nausea) and NAUSEA (Nausea following heat flashes) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1548653
Sex: F
Age: 63
State: TX

Vax Date: 12/03/2020
Onset Date: 12/30/2020
Rec V Date: 08/12/2021
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: Flu like symptoms; Swollen lymph nodes left neck; Swollen left arm (Site of Injection); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph nodes left neck) and VACCINATION SITE SWELLING (Swollen left arm (Site of Injection)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20a) for COVID-19 vaccination. The patient's past medical history included SARS-CoV-2 infection in April 2019 and Flu like symptoms from 30-Dec-2020 to 07-Jan-2021. Concurrent medical conditions included Hypertension since 2010 and Swollen lymph nodes since 30-Dec-2020. Concomitant products included LOSARTAN for Hypertension, VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and ZINC for Vitamin supplementation. On 03-Dec-2020 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph nodes left neck) and VACCINATION SITE SWELLING (Swollen left arm (Site of Injection)). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE SWELLING (Swollen left arm (Site of Injection)) had resolved and LYMPHADENOPATHY (Swollen lymph nodes left neck) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were reported. The swollen lymph nodes were reported to be in th left neck and left arm (injection site). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up was received on 22-APR-2021. Patient demographics- Date of Birth, age, weight, height and race, medical history information, vaccination dose details, vaccine facility information, concomitant medications and all reported events were added.

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

Current Illness: Hypertension; Swollen lymph nodes

ID: 1548654
Sex: F
Age: 37
State: LA

Vax Date: 01/11/2021
Onset Date: 01/20/2021
Rec V Date: 08/12/2021
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: positive test for Covid, not experiencing any symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (positive test for Covid, not experiencing any symptoms) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ASYMPTOMATIC COVID-19 (positive test for Covid, not experiencing any symptoms). At the time of the report, ASYMPTOMATIC COVID-19 (positive test for Covid, not experiencing any symptoms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported No treatment medication reported

Other Meds:

Current Illness:

ID: 1548655
Sex: U
Age:
State:

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 08/12/2021
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: Had some reaction; A spontaneous report was received from a Healthcare Professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had some reactions. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date had some reactions. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events, had some reactions was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1548656
Sex: F
Age: 55
State: NY

Vax Date: 01/21/2021
Onset Date: 01/28/2021
Rec V Date: 08/12/2021
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: broke out into hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out into hives) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028220A) for COVID-19 vaccination. No Medical History information was reported. On 21-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 URTICARIA (broke out into hives). The patient was treated with FLUOCINONIDE at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out into hives) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1548657
Sex: F
Age: 83
State:

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/12/2021
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: delayed type of reaction; arm was red, itchy, and bumpy.; more like a rash; bruised and red; This spontaneous case was reported by a consumer and describes the occurrence of INFUSION SITE BRUISING (bruised and red), SKIN REACTION (delayed type of reaction), VACCINATION SITE PRURITUS (arm was red, itchy, and bumpy.) and INJECTION SITE RASH (more like a rash) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INFUSION SITE BRUISING (bruised and red). On 30-Jan-2021, the patient experienced SKIN REACTION (delayed type of reaction), VACCINATION SITE PRURITUS (arm was red, itchy, and bumpy.) and INJECTION SITE RASH (more like a rash). At the time of the report, INFUSION SITE BRUISING (bruised and red), SKIN REACTION (delayed type of reaction), VACCINATION SITE PRURITUS (arm was red, itchy, and bumpy.) and INJECTION SITE RASH (more like a rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. concomitant medication use was not provided by the reporter she applied Benadryl cream on the rash and it faded significanty. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1548658
Sex: F
Age:
State: MS

Vax Date: 01/20/2021
Onset Date: 01/31/2021
Rec V Date: 08/12/2021
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: Soreness; Itchiniess; Redness raised area on left arm; This spontaneous case was reported by a consumer and describes the occurrence of in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No relevant medical history). On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were reported.; 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: 1548659
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: allergy to vaccine; A spontaneous report was received from a Healthcare Professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection. It was reported that the patient has covid arm following first vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events, covid arm was not reported.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Covid arm is consistent with the product safety profile.

Other Meds:

Current Illness:

ID: 1548660
Sex: F
Age: 73
State:

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/12/2021
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: Fever; Sweating; nose running; sneezing; hot; cold; felt bad; headache; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), CHILLS (Had chills), HEADACHE (headache), PYREXIA (Fever) and HYPERHIDROSIS (Sweating) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced CHILLS (Had chills). On 27-Jan-2021, the patient experienced FEELING ABNORMAL (felt bad) and HEADACHE (headache). On 30-Jan-2021, the patient experienced PYREXIA (Fever), HYPERHIDROSIS (Sweating), RHINORRHOEA (nose running), SNEEZING (sneezing), FEELING HOT (hot) and FEELING COLD (cold). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt bad), CHILLS (Had chills), HEADACHE (headache), PYREXIA (Fever), HYPERHIDROSIS (Sweating), RHINORRHOEA (nose running), SNEEZING (sneezing), FEELING HOT (hot) and FEELING COLD (cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Medical History information was reported.

Other Meds:

Current Illness:

ID: 1548661
Sex: F
Age:
State: OH

Vax Date: 01/29/2021
Onset Date: 02/01/2021
Rec V Date: 08/12/2021
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: Body Aches; chills; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches), CHILLS (chills) and INJECTION SITE ERYTHEMA (injection site red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 29-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 MYALGIA (Body Aches), CHILLS (chills) and INJECTION SITE ERYTHEMA (injection site red). At the time of the report, MYALGIA (Body Aches), CHILLS (chills) and INJECTION SITE ERYTHEMA (injection site red) 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.; 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: 1548662
Sex: M
Age: 22
State: CA

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/12/2021
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: very large red area, about 2&1/2" x 2&1/2" in size; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (very large red area, about 2&1/2" x 2&1/2" in size) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy. On 19-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 INJECTION SITE RASH (very large red area, about 2&1/2" x 2&1/2" in size). At the time of the report, INJECTION SITE RASH (very large red area, about 2&1/2" x 2&1/2" in size) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 23-year-old male, with medical history of sulfa allergy, who experienced a NS expected event of injection site rash. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548663
Sex: F
Age: 75
State: MI

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/12/2021
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: Black and blue mark at the injection site; Itching at the injection site; Redness at the injection site; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), INJECTION SITE BRUISING (Black and blue mark at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (Itching). On an unknown date, the patient experienced INJECTION SITE BRUISING (Black and blue mark at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 22-Jan-2021, PRURITUS (Itching) had resolved. At the time of the report, INJECTION SITE BRUISING (Black and blue mark at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548664
Sex: F
Age: 78
State: AL

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/12/2021
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: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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 DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1548665
Sex: F
Age: 61
State: NY

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/12/2021
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: Area has Very hard lump; Area is being black and blue; itches at the area of injection; Sorenessat the area, hurts; Area is being Red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness), INJECTION SITE DISCOLOURATION (Black and Blue), VACCINATION SITE MASS (Very hard lump), INJECTION SITE ERYTHEMA (Red) and PRURITUS (itches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 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 INJECTION SITE PAIN (Soreness), INJECTION SITE DISCOLOURATION (Black and Blue), VACCINATION SITE MASS (Very hard lump), INJECTION SITE ERYTHEMA (Red) and PRURITUS (itches). At the time of the report, INJECTION SITE PAIN (Soreness), INJECTION SITE DISCOLOURATION (Black and Blue), VACCINATION SITE MASS (Very hard lump), INJECTION SITE ERYTHEMA (Red) and PRURITUS (itches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: new events coded

Other Meds:

Current Illness:

ID: 1548666
Sex: M
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: swelling; Pain in the arm; axillary pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), PAIN IN EXTREMITY (Pain in the arm), AXILLARY PAIN (axillary pain) and MYALGIA (sore arm) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SWELLING (swelling), PAIN IN EXTREMITY (Pain in the arm), AXILLARY PAIN (axillary pain) and MYALGIA (sore arm). At the time of the report, SWELLING (swelling), PAIN IN EXTREMITY (Pain in the arm), AXILLARY PAIN (axillary pain) and MYALGIA (sore arm) 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. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1548667
Sex: M
Age:
State: MA

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 08/12/2021
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: fever of 99.6?F; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.6?F) and VACCINATION SITE PAIN (pain in the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (10 days in the hospital) in April 2020. Previously administered products included for an unreported indication: SHINGRIX (Shingles shot) in January 2021. Concurrent medical conditions included Back pain (fall from horse). Concomitant products included OXYCODONE for Back pain. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (fever of 99.6?F) and VACCINATION SITE PAIN (pain in the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Vaccination site pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 99.6?F) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 108 DF (High) fever of 99.6 DF. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: OXYCODONE

Current Illness: Back pain (fall from horse)

ID: 1548668
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: Adverse reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 03-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) 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 reported medical history). 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 ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548669
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) 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 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 an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1548670
Sex: F
Age: 77
State: TX

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/12/2021
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: Lymph node pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of LYMPH NODE PAIN (Lymph node pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain). At the time of the report, LYMPH NODE PAIN (Lymph node pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. The physician told her that before receiving the second vaccine, she should take 1 tylenol, 1 pepcid, and 1 benadadryl day before the vaccination, the night of the vaccination, and the day after the vaccination.

Other Meds:

Current Illness:

ID: 1548671
Sex: M
Age: 75
State: TX

Vax Date: 01/02/2021
Onset Date: 02/01/2021
Rec V Date: 08/12/2021
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: sight tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sight tenderness at injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (sight tenderness at injection site). At the time of the report, VACCINATION SITE PAIN (sight tenderness at injection site) had resolved. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided

Other Meds:

Current Illness:

ID: 1548672
Sex: M
Age: 67
State: OK

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/12/2021
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: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN for Chills and Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Chills and Fever, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient woke up to chills and fever after 10 days. Concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1548673
Sex: F
Age: 67
State: TX

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/12/2021
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: fever of 102; Slight soreness at injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight soreness at injection site (right arm)) and PYREXIA (fever of 102) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (Slight soreness at injection site (right arm)). On 02-Feb-2021, the patient experienced PYREXIA (fever of 102). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Slight soreness at injection site (right arm)) and PYREXIA (fever of 102) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 102 (High) Fever of 102. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.; 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. Further information has been requested

Other Meds:

Current Illness:

ID: 1548674
Sex: F
Age: 70
State: CA

Vax Date: 01/20/2021
Onset Date: 01/26/2021
Rec V Date: 08/12/2021
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: bump; itching; Red spot 2 inch diameter; Left arm sore with bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red spot 2 inch diameter) and VACCINATION SITE PAIN (Left arm sore with bump) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE MASS (bump), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Left arm sore with bump). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot 2 inch diameter). At the time of the report, VACCINATION SITE MASS (bump), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red spot 2 inch diameter) and VACCINATION SITE PAIN (Left arm sore with bump) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The treatment reported was Tylenol #3.; 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: 1548675
Sex: M
Age: 76
State: FL

Vax Date: 01/12/2021
Onset Date: 01/23/2021
Rec V Date: 08/12/2021
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: Flu-like symptoms; Feeling tired; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), COVID-19 (Tested positive for COVID) and FATIGUE (Feeling tired) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) 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 23-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and FATIGUE (Feeling tired). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; COLECALCIFEROL (VITAMIN D 3) at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and COVID-19 (Tested positive for COVID) had resolved and FATIGUE (Feeling tired) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, COVID-19: positive (Positive) tested positive for COVID. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported.; Sender's Comments: This case concerns a 76-year-old, male patient, who experienced Covid-19, fatigue and influenza like illness. Even thought fatigue and influenza like illness can be experienced with Covid-19, the causal relationship with mRNA-1273 cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 , is assessed as unlikely related.

Other Meds:

Current Illness:

ID: 1548676
Sex: M
Age: 65
State: GA

Vax Date: 01/27/2021
Onset Date: 01/31/2021
Rec V Date: 08/12/2021
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: Top lip swelled up; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Top lip swelled up) in a 65-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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced LIP SWELLING (Top lip swelled up). The patient was treated with IBUPROFEN for Lip swelling, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Top lip swelled up) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548677
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: rash; Enlargement of the lymph nodes on the same arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and LYMPHADENOPATHY (Enlargement of the lymph nodes on the same arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash) and LYMPHADENOPATHY (Enlargement of the lymph nodes on the same arm). At the time of the report, RASH (rash) and LYMPHADENOPATHY (Enlargement of the lymph nodes on the same arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Case crosslinked with MOD21-019884. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1548678
Sex: F
Age: 81
State: NY

Vax Date: 01/31/2021
Onset Date: 01/31/2021
Rec V Date: 08/12/2021
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: Frequent urination; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination) and VACCINATION SITE PAIN (soreness at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 02-Feb-2021, the patient experienced POLLAKIURIA (Frequent urination). At the time of the report, POLLAKIURIA (Frequent urination) and VACCINATION SITE PAIN (soreness at the injection site) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1548679
Sex: M
Age: 65
State: GA

Vax Date: 01/27/2021
Onset Date: 01/31/2021
Rec V Date: 08/12/2021
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: Top lip swelled up; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Top lip swelled up) in a 65-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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced LIP SWELLING (Top lip swelled up). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Top lip swelled up) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Covid

Other Meds:

Current Illness:

ID: 1548680
Sex: M
Age: 73
State: TN

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 08/12/2021
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: SLIGHT HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (SLIGHT HEADACHE) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Migraine headache. Concomitant products included RIZATRIPTAN for Migraine headache. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (SLIGHT HEADACHE). At the time of the report, HEADACHE (SLIGHT HEADACHE) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not reported.

Other Meds: RIZATRIPTAN

Current Illness: Migraine headache

ID: 1548681
Sex: M
Age: 57
State: IA

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 08/12/2021
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: Swelling under his left armpit; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (Swelling under his left armpit) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swelling under his left armpit). The patient was treated with IBUPROFEN on 14-Jan-2021 at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling under his left armpit) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. The swelling was half the size it was, but still swollen at the time of report. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No new information reported

Other Meds:

Current Illness:

ID: 1548682
Sex: F
Age: 68
State: MS

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/12/2021
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: On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (few hours after the injection she had a sore arm). At the time of the report, VACCINATION SITE PAIN (few hours after the injection she had a sore arm) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1548683
Sex: M
Age: 45
State: NM

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/12/2021
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: Feeling lethargic; His mind is not working very well; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Feeling lethargic), THINKING ABNORMAL (His mind is not working very well) and FATIGUE (Feeling very tired) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced LETHARGY (Feeling lethargic), THINKING ABNORMAL (His mind is not working very well) and FATIGUE (Feeling very tired). At the time of the report, LETHARGY (Feeling lethargic), THINKING ABNORMAL (His mind is not working very well) and FATIGUE (Feeling very tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1548684
Sex: F
Age: 52
State:

Vax Date: 01/22/2021
Onset Date: 02/04/2021
Rec V Date: 08/12/2021
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: injection site is warm to the touch; Injection site itching; injection site reddness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE PRURITUS (Injection site itching ), VACCINATION SITE ERYTHEMA (injection site reddness) and VACCINATION SITE SWELLING (Injection site swelling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE PRURITUS (Injection site itching ), VACCINATION SITE ERYTHEMA (injection site reddness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE WARMTH (injection site is warm to the touch), VACCINATION SITE PRURITUS (Injection site itching ), VACCINATION SITE ERYTHEMA (injection site reddness) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient is experiencing redness swelling itching and injection site is warm to the touch 2 weeks after initial injection. Concomitant and treatment information not provided

Other Meds:

Current Illness:

ID: 1548685
Sex: F
Age: 72
State: AZ

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/12/2021
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: tenderness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness in the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (tenderness in the arm). At the time of the report, VACCINATION SITE PAIN (tenderness in the arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ATORVASTATIN

Current Illness:

ID: 1548686
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/12/2021
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: Hip pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Hip pain) 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 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 ARTHRALGIA (Hip pain). At the time of the report, ARTHRALGIA (Hip pain) 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 relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1548687
Sex: F
Age:
State: TX

Vax Date: 01/16/2021
Onset Date: 01/23/2021
Rec V Date: 08/12/2021
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: Red arm; Fever; Swollen arm; Itching; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itching), PYREXIA (Fever) and ERYTHEMA (Red arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itching) and PYREXIA (Fever). On an unknown date, the patient experienced ERYTHEMA (Red arm). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) ongoing since an unknown date for Cellulitis, at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itching), PYREXIA (Fever) and ERYTHEMA (Red arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, COVID-19: negative (Negative) Covid-19 test was negative.. On 25-Jan-2021, Pyrexia: 100.5 (Inconclusive) 100.5. 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 medications were cortisone, antibiotics. No concomitant medication was reported. This case was linked to MOD-2021-021941 (Patient Link).

Other Meds:

Current Illness:

ID: 1548688
Sex: M
Age: 50
State: CA

Vax Date: 01/23/2021
Onset Date: 01/01/2021
Rec V Date: 08/12/2021
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: congestion; achy feeling in body; Bad Headache; Got COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID after first dose), NASAL CONGESTION (congestion), MYALGIA (achy feeling in body) and HEADACHE (Bad Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced COVID-19 (Got COVID after first dose). On an unknown date, the patient experienced NASAL CONGESTION (congestion), MYALGIA (achy feeling in body) and HEADACHE (Bad Headache). At the time of the report, COVID-19 (Got COVID after first dose), NASAL CONGESTION (congestion), MYALGIA (achy feeling in body) and HEADACHE (Bad Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (abnormal) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was diagnosed with Covid-19 a week after receiving first dose of the vaccine. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1548689
Sex: M
Age: 27
State: KS

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/12/2021
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: Vertigo; Arm pain; Vomiting; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), VACCINATION SITE PAIN (Arm pain), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FATIGUE (Fatigue). On 15-Jan-2021, the patient experienced VERTIGO (Vertigo), VACCINATION SITE PAIN (Arm pain), VOMITING (Vomiting) and NAUSEA (Nausea). The patient was treated with HYDROCHLOROTHIAZIDE (MICROZIDE [HYDROCHLOROTHIAZIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo), VACCINATION SITE PAIN (Arm pain), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Consumer reported he visited an urgent care on unspecified date. He received unspecified medication to treat vertigo and nausea, and was instructed to hydrate. Consumer visited his primary care physician on 19-Jan-2021 and was again treated with unspecified medication for vertigo. Consumer reported the events fully recovered before receiving the second dose of the vaccine. This case was linked to MOD-2021-237299. Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021 included new information- patient's demographics, Events of first dose recovered prior to second dose. Additional treatment information.

Other Meds:

Current Illness:

ID: 1548690
Sex: F
Age: 85
State: OK

Vax Date: 01/19/2021
Onset Date: 01/24/2021
Rec V Date: 08/12/2021
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: itching; red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METOPROLOL, EZETIMIBE, LISINOPRIL, RIVAROXABAN (XARELTO) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication. On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red). The patient was treated with CORTISONE for Vaccination site pruritus and Vaccination site erythema, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Vaccination site pruritus and Vaccination site erythema, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red) 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.

Other Meds: METOPROLOL; EZETIMIBE; LISINOPRIL; XARELTO; VESICARE

Current Illness:

ID: 1548691
Sex: F
Age: 67
State: FL

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/12/2021
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: Swollen red spot 1 inch from vaccination site; Swollen red spot size of 50 cent piece; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen red spot 1 inch from vaccination site) and VACCINATION SITE ERYTHEMA (Swollen red spot size of 50 cent piece) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical history reported. Concomitant products included INSULIN for an unknown indication. On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen red spot 1 inch from vaccination site) and VACCINATION SITE ERYTHEMA (Swollen red spot size of 50 cent piece). At the time of the report, VACCINATION SITE SWELLING (Swollen red spot 1 inch from vaccination site) and VACCINATION SITE ERYTHEMA (Swollen red spot size of 50 cent piece) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Heart rate: increased (High) Increased. On an unknown date, Blood glucose: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's medical history was not provided. Concomitant medications reported were Insulin, medication for blood pressure, eye drops for glaucoma, medication for diabetes.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: INSULIN

Current Illness:

ID: 1548692
Sex: F
Age: 44
State: NC

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/12/2021
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: Chest tightness; small difficulty breathing; Nausea; Muscle aches; Brain fog; Tingling in lips, mouth, tongue; Mouth felt like numb; all her arm felt cold, like a funny sensation.; tingling's in mouth and tongue which also appeared and reappeared; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (Chest tightness), FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling in lips, mouth, tongue), HYPOAESTHESIA ORAL (Mouth felt like numb) and PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling in lips, mouth, tongue), HYPOAESTHESIA ORAL (Mouth felt like numb), PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.), SYMPTOM RECURRENCE (tingling's in mouth and tongue which also appeared and reappeared) and MYALGIA (Muscle aches). On 23-Jan-2021, the patient experienced NAUSEA (Nausea). On 24-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (small difficulty breathing). On 22-Jan-2021, FEELING ABNORMAL (Brain fog) and PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.) had resolved. On 23-Jan-2021, NAUSEA (Nausea) had resolved. On 24-Jan-2021, CHEST DISCOMFORT (Chest tightness), SYMPTOM RECURRENCE (tingling's in mouth and tongue which also appeared and reappeared), DYSPNOEA (small difficulty breathing) and MYALGIA (Muscle aches) had resolved. At the time of the report, PARAESTHESIA (Tingling in lips, mouth, tongue) and HYPOAESTHESIA ORAL (Mouth felt like numb) had resolved. 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 reported. Treatment medication includes inhaler for shortness of breath

Other Meds:

Current Illness:

ID: 1548693
Sex: F
Age:
State: NV

Vax Date: 01/26/2021
Onset Date: 01/29/2021
Rec V Date: 08/12/2021
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: aches; arm sore; fever; gums in mouth were swollen; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL SWELLING (gums in mouth were swollen), PAIN (aches), PAIN IN EXTREMITY (arm sore) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced GINGIVAL SWELLING (gums in mouth were swollen). On an unknown date, the patient experienced PAIN (aches), PAIN IN EXTREMITY (arm sore) and PYREXIA (fever). At the time of the report, GINGIVAL SWELLING (gums in mouth were swollen), PAIN (aches), PAIN IN EXTREMITY (arm sore) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1548694
Sex: F
Age: 81
State: TX

Vax Date: 01/21/2021
Onset Date: 01/29/2021
Rec V Date: 08/12/2021
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: Warm to touch; Angry red ring (3 by 2.5 inches); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Angry red ring (3 by 2.5 inches)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Angry red ring (3 by 2.5 inches)). At the time of the report, VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Angry red ring (3 by 2.5 inches)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment details included ice and antihistamine. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up information received on 01-JUL-2021 and it contains no new information.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Vaccination site erythema is consistent with the product safety profile.

Other Meds:

Current Illness:

ID: 1548695
Sex: F
Age: 50
State: PA

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 08/12/2021
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: Mild dizziness; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Mild dizziness), NAUSEA (Nausea) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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 29-Jan-2021, the patient experienced DIZZINESS (Mild dizziness), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Dizziness, Nausea and Headache, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, Nausea and Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Mild dizziness), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1548696
Sex: M
Age: 79
State: TX

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/12/2021
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: little soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness on his arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included Bypass surgery. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (little soreness on his arm). At the time of the report, PAIN IN EXTREMITY (little soreness on his arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-215664 (Patient Link).

Other Meds:

Current Illness:

ID: 1548697
Sex: F
Age:
State: NC

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/12/2021
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: Chills; fever; Severe headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (fever) and HEADACHE (Severe headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event (no historical conditions reported). On 22-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 CHILLS (Chills), PYREXIA (fever) and HEADACHE (Severe headache). At the time of the report, CHILLS (Chills), PYREXIA (fever) and HEADACHE (Severe headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1548698
Sex: M
Age: 66
State: FL

Vax Date: 01/31/2021
Onset Date: 01/31/2021
Rec V Date: 08/12/2021
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: has no appetite; fever up to 100.1F; headache; chills; nausea; was tired; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (has no appetite), PYREXIA (fever up to 100.1F), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Blood pressure since an unknown date. Concomitant products included VITAMINS NOS for an unknown indication. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DECREASED APPETITE (has no appetite), PYREXIA (fever up to 100.1F), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and FATIGUE (was tired). The patient was treated with PARACETAMOL (TYLENOL) on 01-Feb-2021 at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (has no appetite), PYREXIA (fever up to 100.1F), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and FATIGUE (was tired) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 100.1 (Inconclusive) fever up to 100.1F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Statins and blood pressure medication are the other concomitant medications reported by reporter.

Other Meds: VITAMINS NOS

Current Illness: Blood pressure

ID: 1548699
Sex: U
Age:
State: ME

Vax Date: 02/28/2021
Onset Date:
Rec V Date: 08/12/2021
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: We inadvertently administered doses from a vial that was in our refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of 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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-037831 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No specific follow-up information recorded.; Sender's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # unknown with no associated AEs.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm