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: 1556888
Sex: F
Age: 67
State: TX

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/14/2021
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: Received second vaccine outside dosing interval day 43; Redness and swelling at injection site (left) arm; Redness and swelling at injection site (left) arm; A spontaneous report was received from a consumer (patient's husband), concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and received second vaccine outside dosing interval day 43 (Inappropriate schedule of vaccine administered), experienced redness and swelling at injection site (left) arm (Vaccination site erythema), redness and swelling at injection site (left) arm (Vaccination site swelling). The patient's medical history included liver transplant. Current condition included autoimmune disorder. No concomitant medications were reported. On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) and on 24 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced redness and swelling at injection site (left) arm. The patient received second vaccine outside dosing interval day 43. The patient also had possible polyethylene glycol (PEG) reaction from Moderna vaccine ingredient. Treatment information for the events was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the event(s) is not applicable. The events of redness and swelling at injection site (left) arm (Vaccination site erythema), redness and swelling at injection site (left) arm (Vaccination site swelling) resolved on 19 Jan 2021 while the event of received second vaccine outside dosing interval day 43 (Inappropriate schedule of vaccine administered) was considered resolved on an unknown date. The reporter did not provide an assessment for the events redness and swelling at injection site (left) arm (Vaccination site erythema), redness and swelling at injection site (left) arm (Vaccination site swelling) and received second vaccine outside dosing interval day 43 (Inappropriate schedule of vaccine administered).; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (Lot #: 041L20A). Based on the current available information and temporal association between the use of the product and the start date of the events other events (Vaccination site erythema and Vaccination site swelling), a causal relationship cannot be excluded.

Other Meds:

Current Illness: Autoimmune disorder

ID: 1556889
Sex: F
Age: 42
State:

Vax Date: 01/18/2021
Onset Date: 02/15/2021
Rec V Date: 08/14/2021
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: dry tongue; white spots in the tongue; burning, tingling sensation in the tongue; burning, tingling sensation in the tongue; swelling of the tongue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TONGUE DISCOMFORT (burning, tingling sensation in the tongue), PARAESTHESIA ORAL (burning, tingling sensation in the tongue), SWOLLEN TONGUE (swelling of the tongue), TONGUE DISCOLOURATION (white spots in the tongue) and TONGUE DRY (dry tongue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination. Medical history was not provided by the reporter. The patient's past medical history included No adverse event. Concomitant products included LORATADINE (CLARITINE), LEVOTHYROXINE and VITAMINS NOS for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced TONGUE DISCOMFORT (burning, tingling sensation in the tongue), PARAESTHESIA ORAL (burning, tingling sensation in the tongue) and SWOLLEN TONGUE (swelling of the tongue). On 21-Feb-2021, the patient experienced TONGUE DISCOLOURATION (white spots in the tongue). On 25-Feb-2021, the patient experienced TONGUE DRY (dry tongue). At the time of the report, TONGUE DISCOMFORT (burning, tingling sensation in the tongue), PARAESTHESIA ORAL (burning, tingling sensation in the tongue), SWOLLEN TONGUE (swelling of the tongue), TONGUE DISCOLOURATION (white spots in the tongue) and TONGUE DRY (dry tongue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: CLARITINE; LEVOTHYROXINE; VITAMINS NOS

Current Illness:

ID: 1556890
Sex: F
Age:
State: MI

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/14/2021
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: light headedness; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events light headedness/dizziness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in unknown for prophylaxis of COVID-19 infection. On 4 Feb 2021, the patient experienced the event light headedness. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 8 Feb 2021, the outcome of event light headedness was unknown.

Other Meds:

Current Illness:

ID: 1556891
Sex: F
Age: 42
State: NY

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/14/2021
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: Chills; Fever; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concomitant products included NAPROXEN SODIUM (ALEVE) 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 CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: ALEVE

Current Illness:

ID: 1556892
Sex: F
Age:
State:

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/14/2021
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: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556893
Sex: F
Age: 33
State: CA

Vax Date: 02/21/2021
Onset Date:
Rec V Date: 08/14/2021
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: Right arm huritng; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm huritng) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right arm huritng). At the time of the report, PAIN IN EXTREMITY (Right arm huritng) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Non-significant follow-up

Other Meds:

Current Illness:

ID: 1556894
Sex: F
Age: 53
State: CA

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 08/14/2021
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: Patient has not received 2nd dose of Moderna vaccine; Perpetual need to cough; Like having a bunch of cotton balls or socks on their throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Perpetual need to cough), OROPHARYNGEAL DISCOMFORT (Like having a bunch of cotton balls or socks on their throat) and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of Moderna vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE and VITAMINS NOS 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 21-Jan-2021, the patient experienced COUGH (Perpetual need to cough) and OROPHARYNGEAL DISCOMFORT (Like having a bunch of cotton balls or socks on their throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of Moderna vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cough, at an unspecified dose and frequency. On 21-Jan-2021, COUGH (Perpetual need to cough) and OROPHARYNGEAL DISCOMFORT (Like having a bunch of cotton balls or socks on their throat) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of Moderna vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information reported On 16-Jun-2021: Reporter contact details and event information updated

Other Meds: ESTROGEN; PROGESTERONE; VITAMINS NOS

Current Illness:

ID: 1556895
Sex: M
Age: 83
State: SC

Vax Date: 01/08/2021
Onset Date: 01/30/2021
Rec V Date: 08/14/2021
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: Contracted COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID after first dose) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COVID-19 (Contracted COVID after first dose). At the time of the report, COVID-19 (Contracted COVID after first dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Coronavirus test: (Inconclusive) Covid. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556896
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Cold; Loss of Appetite; Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), DECREASED APPETITE (Loss of Appetite), PAIN (Soreness) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), DECREASED APPETITE (Loss of Appetite), PAIN (Soreness) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (Cold), DECREASED APPETITE (Loss of Appetite), PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556897
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: No energy; Little nauseated; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), NAUSEA (Little nauseated) and PAIN IN EXTREMITY (Sore 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (No energy), NAUSEA (Little nauseated) and PAIN IN EXTREMITY (Sore arm). At the time of the report, ASTHENIA (No energy), NAUSEA (Little nauseated) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556898
Sex: F
Age: 59
State: CA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
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: 2 full periods after being menopause for 9 years; migraines; tingling pain all over the body; Headache; face completely numb; neck pain; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (2 full periods after being menopause for 9 years), MIGRAINE (migraines) and PARAESTHESIA (tingling pain all over the body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. Concurrent medical conditions included Hay fever, Drug allergy (reacted to a sulfa drug) and Menopause. Concomitant products included LEVOTHYROXINE for Thyroid disorder. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (2 full periods after being menopause for 9 years), MIGRAINE (migraines) and PARAESTHESIA (tingling pain all over the body). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (2 full periods after being menopause for 9 years), MIGRAINE (migraines) and PARAESTHESIA (tingling pain all over the body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional events and outcome updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: LEVOTHYROXINE

Current Illness: Drug allergy (reacted to a sulfa drug); Hay fever; Menopause

ID: 1556899
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I have developed an itching, rashy kind of thing on various parts of my body) and RASH in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 PRURITUS (I have developed an itching, rash kind of thing on various parts of my body) and RASH. At the time of the report, PRURITUS and RASH outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment was provided.

Other Meds:

Current Illness:

ID: 1556900
Sex: F
Age: 49
State: MI

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 08/14/2021
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: Feeling crappy; Tiredness; Fatigue; Headache; Fever of 102 degrees; A spontaneous report was received from a consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tiredness, fatigue, headache, fever of 102 degrees and feeling bad. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 02M20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Feb 2021, the patient experienced the event(s) tiredness, fatigue, headache, fever of 102 degrees, feeling bad. Treatment details included tylenol, motrin. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), tiredness, fatigue, headache, fever of 102 degrees, feeling bad was unknown.

Other Meds:

Current Illness:

ID: 1556901
Sex: M
Age:
State: CA

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: Sore arm; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head ache) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head ache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head ache) 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. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-026644 (E2B Linked Report).; Sender's Comments: MOD-2021-026644:Crosslinked to MOD21-038768, Same reporter

Other Meds:

Current Illness:

ID: 1556902
Sex: M
Age: 76
State: CA

Vax Date: 01/19/2021
Onset Date: 01/24/2021
Rec V Date: 08/14/2021
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: Shingles; A spontaneous report was received from a Nurse concerning a 76-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shingles. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 24 Jan 2021, the patient experienced the event shingles. Treatment details included Anti shingles medication. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, shingles was unknown.

Other Meds:

Current Illness:

ID: 1556903
Sex: F
Age: 69
State: TX

Vax Date: 01/15/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
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: The patient's past medical history included Rash (Reaction occurred after administration of shingles vaccine). Previously administered products included for an unreported indication: SHINGRIX (Shingles vaccine) on 28-Jan-2013. Concurrent medical conditions included Drug allergy (Macrobid-dizzy). On 15-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Huge rash (3-4inches)/rash:pimply & ring shaped), VACCINATION SITE PRURITUS (Itching/ pruritis) and VACCINATION SITE ERYTHEMA (Redness/ erythema). The patient was treated with CORTISONE (topical) for Itching, at a dose of 1 dosage form. On 05-Feb-2021, VACCINATION SITE RASH (Huge rash (3-4inches)/rash:pimply & ring shaped), VACCINATION SITE PRURITUS (Itching/ pruritis) and VACCINATION SITE ERYTHEMA (Redness/ erythema) had resolved. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up report attached on 06-05-2021 which updated Event details, second dose details,medical history details and patient details.

Other Meds:

Current Illness: Drug allergy (Macrobid-dizzy)

ID: 1556904
Sex: F
Age: 73
State: IN

Vax Date: 02/09/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
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: delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of a rash on the arm of the shot that itches; delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of a rash on the arm of the shot that itches; A spontaneous report was received from a healthcare professional concerning a 73 years old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events delayed subcutaneous hypersensitivity reaction, otherwise called covid arm, which consists of a rash on the arm of the shot that itches/ type IV hypersensitivity reaction and rash pruritic The patient's medical history was not provided. Concomitant medications reported were vitamins, calcium, biotin, levothyroxine, escitalopram, atorvastatin, alendronate sodium, omega 3, antihistamine tablet, probiotic for drug use for unknown indication. On 9 Feb 2021,approximately 9 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced the event(s) delayed subcutaneous hypersensitivity reaction, otherwise called covid arm, which consists of.a rash on the arm of the shot that itches. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), delayed subcutaneous hypersensitivity reaction, otherwise called covid arm, which consists of was unknown.

Other Meds: VITAMINS NOS; CALCIUM; BIOTIN; LEVOTHYROXINE; ESCITALOPRAM; ATORVASTATIN; ALENDRONATE SODIUM; OMEGA 3 [FISH OIL]; PROBIOTICS NOS

Current Illness:

ID: 1556905
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Light headache; dizziness; Fever off and on; Sore arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events light headache, fever off and on, sore 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 first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) Light headache, Fever off and on, Sore arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), light headache, fever off and on, sore arm was unknown.

Other Meds:

Current Illness:

ID: 1556906
Sex: M
Age: 69
State: NY

Vax Date: 01/18/2021
Onset Date: 01/26/2021
Rec V Date: 08/14/2021
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: Tested positive for COVID-19; A spontaneous report was received from a consumer concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for COVID-19. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced the event tested positive for COVID-19. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 9 Feb 2021, the outcome of event tested positive for COVID-19 was unknown.

Other Meds:

Current Illness:

ID: 1556907
Sex: F
Age:
State: TX

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/14/2021
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: dizziness; Fever off and on; bad nausea; light headache; Sore arm; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events light headache, fever off and on, sore 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 first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced fever 99.8F coming and going, bad nausea, a light headache, dizziness, and an annoying sore arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), light headache, fever off and on, sore arm was unknown.

Other Meds:

Current Illness:

ID: 1556908
Sex: F
Age:
State:

Vax Date: 02/24/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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: Realy sore arms; injection site is hard, raised and red; injection site is hard, raised and red; injection site is hard, raised and red; allergic reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really sore arms /pain in extremity, injection site is hard /injection site induration, raised /injection site swelling and red /injection site erythema, looks like an allergic reaction /hypersensitivity. The patient's medical history was not provided. No relevant concomitant medications were reported. On 24 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 Feb 2021, the patient experienced the event(s) Really sore arms, Injection site is hard, raised and red, Looks like an allergic reaction. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), really sore arms, injection site is hard, raised and red, looks like an allergic reaction was unknown.

Other Meds:

Current Illness:

ID: 1556909
Sex: F
Age: 65
State: PA

Vax Date: 02/25/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: vision had like patch pink; little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision had like patch pink) and PAIN IN EXTREMITY (little sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and High cholesterol. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VISUAL IMPAIRMENT (vision had like patch pink) and PAIN IN EXTREMITY (little sore arm). On 25-Feb-2021, VISUAL IMPAIRMENT (vision had like patch pink) had resolved. At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. 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.; 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: Blood pressure; High cholesterol

ID: 1556910
Sex: F
Age: 67
State: CT

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
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: her arm started bothering again; warm; bump; red; it itches; it hurt; her arm a little bit swollen; Tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (bump), VACCINATION SITE SWELLING (her arm a little bit swollen) and VACCINATION SITE PAIN (Tender) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided by the reporter. On 17-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 VACCINATION SITE SWELLING (her arm a little bit swollen), VACCINATION SITE PAIN (Tender) and VACCINATION SITE PAIN (it hurt). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (it itches). 24-Feb-2021, the patient experienced VACCINATION SITE INDURATION (bump). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (her arm started bothering again), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (bump), VACCINATION SITE SWELLING (her arm a little bit swollen), VACCINATION SITE PAIN (Tender), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (it hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1556911
Sex: F
Age: 75
State: DC

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/14/2021
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: Itching at injection site; Wide swelling at injection site; Red swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE SWELLING (Wide swelling at injection site) and INJECTION SITE ERYTHEMA (Red swelling at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-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 23-Feb-2021, the patient experienced INJECTION SITE SWELLING (Wide swelling at injection site) and INJECTION SITE ERYTHEMA (Red swelling at injection site). On 26-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching at injection site). At the time of the report, INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE SWELLING (Wide swelling at injection site) and INJECTION SITE ERYTHEMA (Red swelling at injection site) outcome was unknown. No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information received on 14 Jul 2021 contains non significant information

Other Meds:

Current Illness:

ID: 1556912
Sex: F
Age: 73
State: IN

Vax Date: 02/09/2021
Onset Date: 02/17/2021
Rec V Date: 08/14/2021
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: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), CALCIUM, BIOTIN, LEVOTHYROXINE, ESCITALOPRAM, ATORVASTATIN, ALENDRONATE SODIUM, CARBINOXAMINE MALEATE (OMEGA 3), DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) and PROBIOTIC 10 for an unknown indication. On 09-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 VACCINATION SITE REACTION (delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of). At the time of the report, VACCINATION SITE REACTION (delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of) outcome was unknown. 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. There is no information about treatment medications.

Other Meds: VITAMINS A & D; CALCIUM; BIOTIN; LEVOTHYROXINE; ESCITALOPRAM; ATORVASTATIN; ALENDRONATE SODIUM; OMEGA 3; ANTIHISTAMINE ALLERGY RELIEF; PROBIOTIC 10

Current Illness:

ID: 1556913
Sex: F
Age:
State:

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/14/2021
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: major drop in blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (major drop in blood pressure) 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-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 HYPOTENSION (major drop in blood pressure). On 18-Feb-2021, HYPOTENSION (major drop in blood pressure) had 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: 1556914
Sex: F
Age:
State: TX

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Sore throat; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (Body aches) 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: 1556915
Sex: F
Age: 84
State: FL

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
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; chills; A spontaneous report was received from a consumer concerning a 84-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, chills. The patient's medical history was not provided. Concomitant medications reported were Inderal for drug use for unknown indication. On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 12M20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient developed fever between 99-99.9 Degrees Fahrenheit, as well as chills. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, fever and chills was not reported.; Reporter's Comments: This case concerns an 84-year-old female with NS expected events of fever and chills. Event onset occurred on Day 2 after the second dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: INDERAL

Current Illness:

ID: 1556916
Sex: F
Age: 44
State: PA

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: Her "face hurt"; Sweating; Blurred vision; rash; Muscle aches; Achy joints; Vomiting; Chills; Headaches; High fever of 103.8 F; General tiredness; hives; A spontaneous report was received from a consumer concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever. The patient's medical history was not provided. Concomitant medications reported were Hailey 24 FE (birth control), Singulair, Zyrtec, Red Yeast Rice for drug use for unknown indication. On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 3 Feb 2021, the patient experienced the events rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt, low-grade fever. Treatment details included Tylenol and Excedrin. Action taken with mRNA-1273 in response to the events was not reported. On 8 Feb 2021 the outcome of events, rash, hives, high fever of 103.8 f, vomiting, headaches, muscle aches, achy joints, sweating, chills, blurred vision, general tiredness, face hurt was resolved. On7 Feb 2021 the outcome of events, low-grade fever was resolved.

Other Meds: HAILEY 1.5/30; SINGULAIR; ZYRTEC ALLERGY; RED YEAST RICE WITH PLANT STEROLS

Current Illness:

ID: 1556917
Sex: F
Age: 64
State: NJ

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/14/2021
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: rash; injection site itching; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site itching, rash. 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: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced the event(s) injection site itching. On an unknown date, the patient experienced the event(s) Rash. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), injection site itching, rash was unknown.

Other Meds:

Current Illness:

ID: 1556918
Sex: F
Age:
State: MI

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: 3 of 10 pain/hardness at the injection site; low grade fever; nausea; vomiting; exhausted; 3 of 10 pain/hardness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (exhausted). On an unknown date, the patient experienced VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site). At the time of the report, VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (exhausted) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1556919
Sex: M
Age: 92
State: TX

Vax Date: 01/26/2021
Onset Date: 02/02/2021
Rec V Date: 08/14/2021
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: Redness; Pain at injection site; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Itching) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Itching). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Itching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1556920
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: blinking uncontrollably; A spontaneous report was received from a consumer concerning a 42-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blinking uncontrollably. 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: 032L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event blinking uncontrollably. Treatment details included antihistamines.. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, blinking uncontrollably was unknown.

Other Meds:

Current Illness:

ID: 1556921
Sex: F
Age: 80
State: AR

Vax Date: 02/10/2021
Onset Date: 02/18/2021
Rec V Date: 08/14/2021
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: itching the place on their arm where they had the shot; real red on arm; arm where they had the shot was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching the place on their arm where they had the shot), VACCINATION SITE ERYTHEMA (real red on arm) and VACCINATION SITE PAIN (arm where they had the shot was sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ04) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching the place on their arm where they had the shot), VACCINATION SITE ERYTHEMA (real red on arm) and VACCINATION SITE PAIN (arm where they had the shot was sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching the place on their arm where they had the shot), VACCINATION SITE ERYTHEMA (real red on arm) and VACCINATION SITE PAIN (arm where they had the shot was sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1556922
Sex: F
Age: 80
State: TX

Vax Date: 01/25/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: Fever - Temperature of 99.7F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever - Temperature of 99.7F) in an 80-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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Fever - Temperature of 99.7F). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever - Temperature of 99.7F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 99.7 f (High) 99.7. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1556923
Sex: F
Age: 74
State: HI

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/14/2021
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: rash; round circle which was swollen, around the injection site; arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm soreness), RASH (rash) and VACCINATION SITE SWELLING (round circle which was swollen, around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication. 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 PAIN IN EXTREMITY (arm soreness). On 24-Feb-2021, the patient experienced RASH (rash) and VACCINATION SITE SWELLING (round circle which was swollen, around the injection site). On 13-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, RASH (rash) and VACCINATION SITE SWELLING (round circle which was swollen, around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was prescribed antibiotics by her HCP but she did not take it.

Other Meds: LEVOTHYROXINE; AMBIEN

Current Illness:

ID: 1556924
Sex: F
Age: 52
State: MA

Vax Date: 01/28/2021
Onset Date: 01/20/2021
Rec V Date: 08/14/2021
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: lots of itching; who instructed her not to receive a second dose of the vaccine. And she has not received the second dose; Headache; Felt tired; Feeling like she was coming down with the flu or something; Hives; some diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (some diarrhea), PRURITUS (lots of itching), URTICARIA (Hives), VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something) and OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy (Unspecified allergies). On 28-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 DIARRHOEA (some diarrhea). On 28-Jan-2021, the patient experienced URTICARIA (Hives). On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something), HEADACHE (Headache) and FATIGUE (Felt tired). On an unknown date, the patient experienced PRURITUS (lots of itching) and OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose). On 28-Jan-2021, URTICARIA (Hives) had resolved. At the time of the report, DIARRHOEA (some diarrhea), PRURITUS (lots of itching), VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something), OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose), HEADACHE (Headache) and FATIGUE (Felt tired) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information included Allergy medicine and Aspirin. Allergist advised not to take Second dose of Vaccine. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Batch number added, New events added, Onset dates updated, Outcome of the event Hives updated to recovered, Treatment information updated.

Other Meds:

Current Illness: Allergy (Unspecified allergies)

ID: 1556925
Sex: F
Age: 80
State: PA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
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: Tingling of the Lips; dizziness; Pain in Sinuses; Nausea; Headache; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, headache, pain in sinuses, tingling of the lips/paresthesia oral, dizziness. 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 their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, immediately after receiving the vaccine the patient experienced the events nausea, headache, pain in sinuses, tingling of the lips, dizziness. Treatment details included diphenhydramine. Action taken with mRNA-1273 in response to the events was not reported. On 8 Feb 2021 the outcome of events, nausea, headache, pain in sinuses, tingling of the lips, dizziness was resolved.

Other Meds:

Current Illness:

ID: 1556926
Sex: F
Age: 67
State: NJ

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
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: Loose stools; difficulty breathing; congestion; dry cough; dark red,itchy, rash at injection site; injection site that was hard and painful; dark red,itchy, rash at injection site; shivers (chills); dark red,itchy, rash at injection site; injection site that was hard and painful; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stools), DYSPNOEA (difficulty breathing), NASAL CONGESTION (congestion), COUGH (dry cough) and VACCINATION SITE RASH (dark red,itchy, rash at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seasonal allergy (took nasal spray) since 2000, Hypertension (High Blood Pressure) since 2004, Hyperthyroidism, Arthritis, Heartburn and Obesity. Concomitant products included NAPROXEN for Arthritis, OMEPRAZOLE for Heartburn, LOSARTAN for Hypertension, LEVOTHYROXINE for Hyperthyroidism, LORATADINE (CLARITINE) for Seasonal allergy. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced DIARRHOEA (Loose stools), DYSPNOEA (difficulty breathing), NASAL CONGESTION (congestion), COUGH (dry cough), VACCINATION SITE RASH (dark red,itchy, rash at injection site), VACCINATION SITE PAIN (injection site that was hard and painful), VACCINATION SITE ERYTHEMA (dark red,itchy, rash at injection site), CHILLS (shivers (chills)), VACCINATION SITE PRURITUS (dark red,itchy, rash at injection site), VACCINATION SITE INDURATION (injection site that was hard and painful) and HEADACHE (headache). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. On 12-Feb-2021, DIARRHOEA (Loose stools), DYSPNOEA (difficulty breathing), NASAL CONGESTION (congestion), COUGH (dry cough), VACCINATION SITE RASH (dark red,itchy, rash at injection site), VACCINATION SITE PAIN (injection site that was hard and painful), VACCINATION SITE ERYTHEMA (dark red,itchy, rash at injection site), CHILLS (shivers (chills)), VACCINATION SITE PRURITUS (dark red,itchy, rash at injection site), VACCINATION SITE INDURATION (injection site that was hard and painful) and HEADACHE (headache) 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 considered DIARRHOEA (Loose stools), DYSPNOEA (difficulty breathing), NASAL CONGESTION (congestion), COUGH (dry cough), VACCINATION SITE RASH (dark red,itchy, rash at injection site), VACCINATION SITE PAIN (injection site that was hard and painful), VACCINATION SITE ERYTHEMA (dark red,itchy, rash at injection site), CHILLS (shivers (chills)), VACCINATION SITE PRURITUS (dark red,itchy, rash at injection site), VACCINATION SITE INDURATION (injection site that was hard and painful) and HEADACHE (headache) to be possibly related. Treatment medications included allergy nasal spray. This case was linked to MOD-2021-169064 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Reporter contact details updated. On 25-May-2021: No new information reported On 27-Jul-2021: Significant follow up appended. patient demography added. Medical history high blood pressure, Arthritis ,heartburn and seasonal allergy added. Concomitant medication Losartan, levothyroxine, omeprazole, naproxen, claritine added. outcome of events recovered/resolved added.

Other Meds: LOSARTAN; LEVOTHYROXINE; OMEPRAZOLE; NAPROXEN; CLARITINE

Current Illness: Arthritis; Heartburn; Hypertension (High Blood Pressure); Hyperthyroidism; Obesity; Seasonal allergy (took nasal spray)

ID: 1556927
Sex: F
Age: 71
State: OH

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: Lethargy; Soreness at the injection site; Shaking; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of LETHARGY (Lethargy), TREMOR (Shaking), CHILLS (Chills) and INJECTION SITE PAIN (Soreness at the injection site) in a 71-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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced TREMOR (Shaking) and CHILLS (Chills). On 04-Feb-2021, the patient experienced LETHARGY (Lethargy) and INJECTION SITE PAIN (Soreness at the injection site). At the time of the report, LETHARGY (Lethargy), TREMOR (Shaking), CHILLS (Chills) and INJECTION SITE PAIN (Soreness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No new Information

Other Meds:

Current Illness:

ID: 1556928
Sex: M
Age: 73
State: IA

Vax Date: 01/31/2021
Onset Date:
Rec V Date: 08/14/2021
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: cough; throat hoarse; voice box hoarse; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), DYSPHONIA (throat hoarse) and DYSPHONIA (voice box hoarse) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 31-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 COUGH (cough), DYSPHONIA (throat hoarse) and DYSPHONIA (voice box hoarse). At the time of the report, COUGH (cough), DYSPHONIA (throat hoarse) and DYSPHONIA (voice box hoarse) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included On antibiotic for throat. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), throat hoarse, voice box hoarse, cough was unknown.

Other Meds:

Current Illness: COPD

ID: 1556929
Sex: F
Age:
State:

Vax Date: 02/12/2021
Onset Date: 02/20/2021
Rec V Date: 08/14/2021
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: A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on her arm /rash. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, approximately 9 days 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 20 Feb 2021, the patient experienced the event(s) rash on her arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), rash on her arm was unknown.

Other Meds:

Current Illness:

ID: 1556930
Sex: F
Age:
State:

Vax Date: 01/25/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
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: Rash (around the injection site); Swelling (around the injection site); Redness (around the injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash (around the injection site)), VACCINATION SITE SWELLING (Swelling (around the injection site)) and VACCINATION SITE ERYTHEMA (Redness (around the injection site)) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash (around the injection site)), VACCINATION SITE SWELLING (Swelling (around the injection site)) and VACCINATION SITE ERYTHEMA (Redness (around the injection site)). At the time of the report, VACCINATION SITE RASH (Rash (around the injection site)), VACCINATION SITE SWELLING (Swelling (around the injection site)) and VACCINATION SITE ERYTHEMA (Redness (around the injection site)) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant details were provided No treatment details were 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: 1556931
Sex: F
Age: 80
State: AL

Vax Date: 01/21/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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: A spontaneous report was received from a consumer concerning a 80 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore /pain, itched really bad /pruritus, bothered her more at night /anxiety. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L2OA) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M2OA) via unknown route in the left arm for prophylaxis of COVID-19 infection. On Feb 2021, the patient experienced the event(s) sore, itched really bad, bothered her more at night. Treatment details included used vinegar in the bath water, acetaminophen and aspirin. 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 event(s), sore, itched really bad, bothered her more at night was unknown.

Other Meds:

Current Illness:

ID: 1556932
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Burns like a sunburn; Aches; Redness at the injection site; Pain at the injection site that is increasing; Swelling at the injection site; Fever; Headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 45-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 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 SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator o No treatment medications provided by the reporter

Other Meds:

Current Illness:

ID: 1556933
Sex: M
Age: 77
State: CA

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 08/14/2021
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: Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FATIGUE (Fatigue). On 21-Feb-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) and PYREXIA (Fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1556934
Sex: M
Age: 78
State: NJ

Vax Date: 01/22/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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: Itchiness; Rash; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), RASH (Rash) and VACCINATION SITE SWELLING (Swelling at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (Itchiness), RASH (Rash) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, PRURITUS (Itchiness), RASH (Rash) and VACCINATION SITE SWELLING (Swelling at injection site) 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 medication was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-APR-2021 updated contact details.

Other Meds:

Current Illness:

ID: 1556935
Sex: M
Age: 63
State: CA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
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: Felt dizzy again; Dizziness walking around the house; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness walking around the house) and DIZZINESS (Felt dizzy again) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 001A21A) 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 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Feb-2021, the patient experienced DIZZINESS (Dizziness walking around the house). On 22-Feb-2021, the patient experienced DIZZINESS (Felt dizzy again). On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 08-Feb-2021, DIZZINESS (Dizziness walking around the house) had resolved. At the time of the report, DIZZINESS (Felt dizzy again) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment drugs were reported. This case was linked to MOD-2021-026385, MOD-2021-026385 (Patient Link).

Other Meds: MULTI VITAMIN & MINERAL; VITAMIN D [VITAMIN D NOS]; VITAMIN B12 NOS

Current Illness:

ID: 1556936
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Redness; quite a bit of puffiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) and SKIN SWELLING (quite a bit of puffiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 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 ERYTHEMA (Redness) and SKIN SWELLING (quite a bit of puffiness). At the time of the report, ERYTHEMA (Redness) and SKIN SWELLING (quite a bit of puffiness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1556937
Sex: F
Age:
State:

Vax Date:
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
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: A rash that I've got all over my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash that I've got all over my body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced RASH (A rash that I've got all over my body). On 25-Feb-2021, RASH (A rash that I've got all over my body) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm