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: 1553036
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 01/31/2021
Rec V Date: 08/13/2021
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: Some oval shaped redness in upper arm and shoulder near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Some oval shaped redness in upper arm and shoulder near injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]), SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Some oval shaped redness in upper arm and shoulder near injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Some oval shaped redness in upper arm and shoulder near injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was provided.

Other Meds: ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]; SIMVASTATIN; BABY ASPIRIN; FISH OIL; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1553037
Sex: M
Age: 74
State: NY

Vax Date: 01/17/2021
Onset Date: 02/15/2021
Rec V Date: 08/13/2021
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: achy; Temperature/ fever; Nausea/Extreme nausea; Shortness of breath; kind of achy with a little headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (achy), FATIGUE (Tired), PYREXIA (Temperature/ fever) and NAUSEA (Nausea/Extreme nausea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FATIGUE (Tired) and HEADACHE (kind of achy with a little headache). On 22-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). On 23-Feb-2021, the patient experienced PAIN (achy), PYREXIA (Temperature/ fever) and NAUSEA (Nausea/Extreme nausea). At the time of the report, DYSPNOEA (Shortness of breath), PAIN (achy), FATIGUE (Tired), PYREXIA (Temperature/ fever), NAUSEA (Nausea/Extreme nausea) and HEADACHE (kind of achy with a little headache) outcome was unknown. No concomitant products were reported. Treatment information included an inhaler, for shortness of breath. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness: Asthma

ID: 1553038
Sex: F
Age: 78
State:

Vax Date: 01/22/2021
Onset Date: 01/31/2021
Rec V Date: 08/13/2021
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: Swelling in feet; body rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in feet) and RASH (body rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120a) 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 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swelling in feet) and RASH (body rash). At the time of the report, PERIPHERAL SWELLING (Swelling in feet) and RASH (body rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment related information has been reported.

Other Meds:

Current Illness:

ID: 1553039
Sex: F
Age:
State: AL

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/13/2021
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: Pain in Injection arm; Swelling in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in Injection arm) and VACCINATION SITE SWELLING (Swelling in the injection 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in Injection arm) and VACCINATION SITE SWELLING (Swelling in the injection arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain in Injection arm) and VACCINATION SITE SWELLING (Swelling in the injection arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant 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: 1553040
Sex: F
Age:
State: SC

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/13/2021
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: Hot arm of injection site; Hard arm of injection site; Redness of the arm of injection site; Chills; Fatigue; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypothyroidism since an unknown date. Concomitant products included LEVOTHYROXINE for Hypothyroidism. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient took no treatment.; 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: LEVOTHYROXINE

Current Illness: Hypothyroidism

ID: 1553041
Sex: M
Age:
State: IL

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/13/2021
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: arms were sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arms were sore at the injection site) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (arms were sore at the injection site). On 14-Feb-2021, VACCINATION SITE PAIN (arms were sore at the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment related information has been 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: 1553042
Sex: F
Age: 65
State:

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/13/2021
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: Received possible counterfeit vaccine; A spontaneous report was received from a consumer, concerning a 65-year-old, female who received possible counterfeit vaccine. The patient's medical history was not provided. Concomitant product was not provided. On 29 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. The outcome of the event, possible counterfeit vaccine were considered resolved. Company Comments: The reported event possible counterfeit vaccine administered was not applicable to mRNA-1273.; Reporter's Comments: This report refers to a case of counterfeit product for mRNA-1273, batch number - not provided, with no associated AEs. Causality is not applicable.

Other Meds:

Current Illness:

ID: 1553043
Sex: F
Age: 63
State: NV

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 08/13/2021
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: More Inflamed all over the body; Arms Hurt from Shoulder to Elbow; Soreness on the injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (More Inflamed all over the body), MYALGIA (Arms Hurt from Shoulder to Elbow) and VACCINATION SITE PAIN (Soreness on the injection site (left arm)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Psoriatic arthritis, Seasonal allergy, Pain and Acid reflux (oesophageal) (Stomach acid reflux). Concomitant products included GABAPENTIN for Pain, ADALIMUMAB (HUMIRA) for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced INFLAMMATION (More Inflamed all over the body) and MYALGIA (Arms Hurt from Shoulder to Elbow). 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness on the injection site (left arm)). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; FAMOTIDINE (FAMOTIDIN) ongoing since an unknown date for Acid reflux (esophageal), at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, INFLAMMATION (More Inflamed all over the body) and VACCINATION SITE PAIN (Soreness on the injection site (left arm)) outcome was unknown and MYALGIA (Arms Hurt from Shoulder to Elbow) had resolved with sequelae. 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. This case was linked to MOD-2021-242466 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received contains no newinformation. On 30-Jun-2021: Significant follow up received: treatment drugs were updated, events were updated. No treatment information was 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. Additionally, concurrent Arthritis in this patient may have been a contributory factor. Additional information is requested.

Other Meds: HUMIRA; GABAPENTIN

Current Illness: Acid reflux (oesophageal) (Stomach acid reflux); Pain; Psoriatic arthritis; Seasonal allergy

ID: 1553044
Sex: F
Age:
State: WI

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (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 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. No concomitant medications were reported. No treatment related information has been 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 event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1553045
Sex: F
Age: 67
State: PA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/13/2021
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: slight allergic reaction; fluctuating blood pressure; lethargy; Tingling tongue; fever; bad taste in mouth; ear lobe turned bright red; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Tingling tongue), TASTE DISORDER (bad taste in mouth), ERYTHEMA (ear lobe turned bright red), HYPERSENSITIVITY (slight allergic reaction) and BLOOD PRESSURE FLUCTUATION (fluctuating blood pressure) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Bee sting hypersensitivity, Drug allergy (Benadryl), Allergy to antibiotic (Cipro) and Allergy to antibiotic. Concomitant products included ASCORBIC ACID (VIT C), COLECALCIFEROL (VIT D [COLECALCIFEROL]) and ESTRADIOL (VAGIFEM) for an unknown indication. 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 TASTE DISORDER (bad taste in mouth), ERYTHEMA (ear lobe turned bright red) and CHILLS (chills). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling tongue), HYPERSENSITIVITY (slight allergic reaction), BLOOD PRESSURE FLUCTUATION (fluctuating blood pressure), LETHARGY (lethargy) and PYREXIA (fever). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Tingling tongue), TASTE DISORDER (bad taste in mouth), ERYTHEMA (ear lobe turned bright red), HYPERSENSITIVITY (slight allergic reaction), BLOOD PRESSURE FLUCTUATION (fluctuating blood pressure), LETHARGY (lethargy), CHILLS (chills) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Echocardiogram: normal (normal) normal. On an unknown date, Heart rate: 140 (High) increased. On an unknown date, X-ray: normal (normal) normal. Action taken with mRNA-1273 in response to the events was not Applicable. Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Patient contact details updated. On 05-May-2021: Updated patient contact details and patient demographics, newly added relevant medical history, lab data, concomitant medications and new events

Other Meds: VIT C; VIT D [COLECALCIFEROL]; VAGIFEM

Current Illness: Allergy to antibiotic (Cipro); Allergy to antibiotic; Bee sting hypersensitivity; Drug allergy (Benadryl); Penicillin allergy

ID: 1553046
Sex: F
Age: 83
State: VA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/13/2021
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: Soreness at the vaccination site on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the vaccination site on left arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the vaccination site on left arm). At the time of the report, VACCINATION SITE PAIN (Soreness at the vaccination site on left arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant and treatment medications were reported. Patient took second dose on 21-FEB-2021. This case was linked to MOD-2021-023633.

Other Meds:

Current Illness:

ID: 1553047
Sex: F
Age: 74
State: PA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/13/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 031L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included FISH OIL, MONASCUS PURPUREUS (RED YEAST RICE), OMEGA-3 NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D NOS, CALCIUM, ESCITALOPRAM OXALATE (LEXAPRO) and ATENOLOL for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 19-Feb-2021, VACCINATION SITE PAIN (Sore arm) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. This case was linked to MOD-2021-023232 (Patient Link).; 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: FISH OIL; RED YEAST RICE; OMEGA-3 NOS; BABY ASPIRIN; VITAMIN D NOS; CALCIUM; LEXAPRO; ATENOLOL

Current Illness:

ID: 1553048
Sex: F
Age:
State: IL

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/13/2021
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: Soreness at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the site of the injection) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the site of the injection). At the time of the report, VACCINATION SITE PAIN (Soreness at the site of the injection) had resolved. No concomitant medications were reported. No treatment medications were reported Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021 contains events updated from unknown to recovered

Other Meds:

Current Illness:

ID: 1553049
Sex: F
Age:
State: MN

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 08/13/2021
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: redness in the IS; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (redness in the IS) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in the IS). At the time of the report, VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (redness in the IS) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1553050
Sex: F
Age: 66
State: TX

Vax Date: 02/21/2021
Onset Date: 02/22/2021
Rec V Date: 08/13/2021
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: welt that turned red, itched and is warm; Covid arm; right arm was little bit swollen; right arm was red; right arm was "warm to the touch"; right arm was itchy; it just looked puffy; it looked weird; there was a stripe from the shot site down my arm; headache,slight headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welt that turned red, itched and is warm), VACCINATION SITE REACTION (Covid arm), PERIPHERAL SWELLING (right arm was little bit swollen), ERYTHEMA (right arm was red) and SKIN WARM (right arm was "warm to the touch") in a 66-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. Concurrent medical conditions included Blood pressure management, Atrial fibrillation, Allergy NOS and Blood cholesterol abnormal. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, APIXABAN (ELIQUIS) for Atrial fibrillation, ATORVASTATIN for Blood cholesterol abnormal, DILTIAZEM and OLMESARTAN for Blood pressure management, VITAMIN D NOS, COENZYME Q10 [UBIDECARENONE], CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN and CALCIUM, COLECALCIFEROL (CALCIUM PLUS VITAMIN D) for an unknown indication. On 21-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. On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (right arm was little bit swollen), ERYTHEMA (right arm was red), SKIN WARM (right arm was "warm to the touch"), PRURITUS (right arm was itchy), SKIN SWELLING (it just looked puffy), FEELING ABNORMAL (it looked weird), CUTANEOUS SYMPTOM (there was a stripe from the shot site down my arm), HEADACHE (headache,slight headache) and CHILLS (chills). On 23-Feb-2021, the patient experienced URTICARIA (welt that turned red, itched and is warm) and VACCINATION SITE REACTION (Covid arm). On 22-Feb-2021, HEADACHE (headache,slight headache) had resolved. On 25-Feb-2021, PERIPHERAL SWELLING (right arm was little bit swollen), ERYTHEMA (right arm was red), SKIN WARM (right arm was "warm to the touch"), PRURITUS (right arm was itchy), SKIN SWELLING (it just looked puffy), FEELING ABNORMAL (it looked weird), CUTANEOUS SYMPTOM (there was a stripe from the shot site down my arm) and CHILLS (chills) had resolved. At the time of the report, URTICARIA (welt that turned red, itched and is warm) and VACCINATION SITE REACTION (Covid arm) outcome was unknown. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not Applicable. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Newly added the relevant history, all concomitant medications and newly added the events.

Other Meds: DILTIAZEM; ELIQUIS; OLMESARTAN; VITAMIN D NOS; COENZYME Q10 [UBIDECARENONE]; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;; CALCIUM PLUS VITAMIN D; XYZAL; ATORVASTATIN

Current Illness: Allergy NOS; Atrial fibrillation; Blood cholesterol abnormal; Blood pressure management

ID: 1553051
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 02/20/2021
Rec V Date: 08/13/2021
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: trouble breathing; trouble breathing and extremely stuffy; lower back pain; stiff neck on left side all the way up behind ear; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck on left side all the way up behind ear), BACK PAIN (lower back pain), DYSPNOEA (trouble breathing) and NASAL CONGESTION (trouble breathing and extremely stuffy) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 20-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck on left side all the way up behind ear). On 21-Feb-2021, the patient experienced BACK PAIN (lower back pain). On 23-Feb-2021, the patient experienced DYSPNOEA (trouble breathing) and NASAL CONGESTION (trouble breathing and extremely stuffy). The patient was treated with MONTELUKAST at a dose of 10 milligram; AZELASTINE at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. On 22-Feb-2021, MUSCULOSKELETAL STIFFNESS (stiff neck on left side all the way up behind ear) and BACK PAIN (lower back pain) had resolved. At the time of the report, DYSPNOEA (trouble breathing) and NASAL CONGESTION (trouble breathing and extremely stuffy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant 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: 1553052
Sex: F
Age: 61
State: MA

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 08/13/2021
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: fasting blood sugar sky rocketed to 400, but it is still 300; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (fasting blood sugar sky rocketed to 400, but it is still 300) and PAIN IN EXTREMITY (sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0260L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic, Asthma, Hypertension and Cholesterol total abnormal NOS. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (fasting blood sugar sky rocketed to 400, but it is still 300) and PAIN IN EXTREMITY (sore arm). At the time of the report, BLOOD GLUCOSE INCREASED (fasting blood sugar sky rocketed to 400, but it is still 300) had not resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitantly, patient was taking medications for asthma, hypertension, cholesterol and diabetes. No treatment related information has been reported.

Other Meds:

Current Illness: Asthma; Cholesterol total abnormal NOS; Diabetic; Hypertension

ID: 1553053
Sex: F
Age: 74
State: PA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/13/2021
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: Dizziness; Nausea; Felt like she had the flu; Felt sick; Headache; Chills; Body aches; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Felt sick), DIZZINESS (Dizziness) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included FISH OIL, MONASCUS PURPUREUS (RED YEAST RICE), OMEGA-3 NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D [VITAMIN D NOS], CALCIUM, ESCITALOPRAM OXALATE (LEXAPRO) and ATENOLOL for an unknown indication. On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Felt sick), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches). On 23-Feb-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 12-Feb-2021, INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Felt sick), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) had resolved. On 14-Feb-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) had not resolved. This case was linked to MOD-2021-023223 (Patient Link).

Other Meds: FISH OIL; RED YEAST RICE; OMEGA-3 NOS; BABY ASPIRIN; VITAMIN D [VITAMIN D NOS]; CALCIUM; LEXAPRO; ATENOLOL

Current Illness:

ID: 1553054
Sex: F
Age: 66
State: OH

Vax Date: 02/13/2021
Onset Date: 02/18/2021
Rec V Date: 08/13/2021
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: The last few days, it just gets worse and worse; Dizzy when she stands up; eyesight is weirded out; patient can't focus right.; Eyesight is weirded out, can't focus right; Hot where patient got the shot; It's hard as a rock; It started Itching where patient got the shot; Swelling where patient got the shot; Turning red where patient got the shot; Painful/real sore where patient got the shot; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy when she stands up), VISION BLURRED (eyesight is weirded out; patient can't focus right.), VISUAL IMPAIRMENT (Eyesight is weirded out, can't focus right), CONDITION AGGRAVATED (The last few days, it just gets worse and worse) and VACCINATION SITE WARMTH (Hot where patient got the shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01320A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VISUAL IMPAIRMENT (Eyesight is weirded out, can't focus right), VACCINATION SITE WARMTH (Hot where patient got the shot), VACCINATION SITE MASS (It's hard as a rock), VACCINATION SITE PRURITUS (It started Itching where patient got the shot), VACCINATION SITE SWELLING (Swelling where patient got the shot), VACCINATION SITE ERYTHEMA (Turning red where patient got the shot), VACCINATION SITE PAIN (Painful/real sore where patient got the shot) and PYREXIA (Feverish). On an unknown date, the patient experienced DIZZINESS (Dizzy when she stands up), VISION BLURRED (eyesight is weirded out; patient can't focus right.) and CONDITION AGGRAVATED (The last few days, it just gets worse and worse). At the time of the report, DIZZINESS (Dizzy when she stands up), VISION BLURRED (eyesight is weirded out; patient can't focus right.), VISUAL IMPAIRMENT (Eyesight is weirded out, can't focus right), CONDITION AGGRAVATED (The last few days, it just gets worse and worse), VACCINATION SITE WARMTH (Hot where patient got the shot), VACCINATION SITE MASS (It's hard as a rock), VACCINATION SITE PRURITUS (It started Itching where patient got the shot), VACCINATION SITE SWELLING (Swelling where patient got the shot), VACCINATION SITE ERYTHEMA (Turning red where patient got the shot), VACCINATION SITE PAIN (Painful/real sore where patient got the shot) and PYREXIA (Feverish) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient did not take anything for treatment.

Other Meds:

Current Illness:

ID: 1553055
Sex: F
Age:
State: MD

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/13/2021
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: could not sleep; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep) and PAIN IN EXTREMITY (arm hurts) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Blood sugar abnormal and High cholesterol. On 17-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INSOMNIA (could not sleep) and PAIN IN EXTREMITY (arm hurts). At the time of the report, INSOMNIA (could not sleep) and PAIN IN EXTREMITY (arm hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was concomitantly taking high blood pressure pills, blood sugar pills, and high cholesterol pills. No treatment related information has been reported. Reporter did not allow further contact

Other Meds:

Current Illness: Blood pressure high; Blood sugar abnormal; High cholesterol

ID: 1553056
Sex: F
Age: 80
State: FL

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
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: No sleep; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (No sleep) and PYREXIA (Low grade fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History was provided by the reporter. Concomitant products included LETROZOLE and HYDROXYZINE HYDROCHLORIDE (ATARAX [HYDROXYZINE HYDROCHLORIDE]) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INSOMNIA (No sleep) and PYREXIA (Low grade fever). At the time of the report, INSOMNIA (No sleep) and PYREXIA (Low grade fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 99.9 (High) Patient had fever of 99.9 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event outcome updated. Patient denied consent for further follow up.

Other Meds: LETROZOLE; ATARAX [HYDROXYZINE HYDROCHLORIDE]

Current Illness:

ID: 1553057
Sex: F
Age: 31
State: VA

Vax Date: 01/28/2021
Onset Date: 02/05/2021
Rec V Date: 08/13/2021
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: its a little warm but no itching at the injection site; Red circle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (its a little warm but no itching at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (its a little warm but no itching at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site). At the time of the report, VACCINATION SITE WARMTH (its a little warm but no itching at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient took no treatment.

Other Meds:

Current Illness:

ID: 1553058
Sex: F
Age: 67
State: FL

Vax Date: 01/21/2021
Onset Date: 02/05/2021
Rec V Date: 08/13/2021
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: Feeling horrific with flu-like symptoms; Feeling as if she wanted to get run over by a train; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling horrific with flu-like symptoms) and FEELING ABNORMAL (Feeling as if she wanted to get run over by a train) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History was provided by the reporter. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling horrific with flu-like symptoms) and FEELING ABNORMAL (Feeling as if she wanted to get run over by a train). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Feeling horrific with flu-like symptoms) and FEELING ABNORMAL (Feeling as if she wanted to get run over by a train) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1553059
Sex: M
Age: 65
State: CA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/13/2021
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: Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. E11A21A) 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) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Body ache). At the time of the report, PAIN (Body ache) outcome was unknown. No relevant concomitant medication was reported. Treatment information was not provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: F/U received on 29-APR-2021,TCR, added demographics. updated actions- Patient denied FU.

Other Meds:

Current Illness:

ID: 1553060
Sex: M
Age:
State: TX

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
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: He thinks he has sinus infection; Pain on the arm of injection; felt like he was coming down with something; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like he was coming down with something), SINUSITIS (He thinks he has sinus infection) and VACCINATION SITE PAIN (Pain on the arm of injection) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KZ0A) for COVID-19 vaccination. No Medical History was provided by the reporter. Concurrent medical conditions included Asthmatic. On 27-Jan-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) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FEELING ABNORMAL (felt like he was coming down with something) and VACCINATION SITE PAIN (Pain on the arm of injection). On an unknown date, the patient experienced SINUSITIS (He thinks he has sinus infection). At the time of the report, FEELING ABNORMAL (felt like he was coming down with something), SINUSITIS (He thinks he has sinus infection) and VACCINATION SITE PAIN (Pain on the arm of injection) outcome was unknown. Lately the patient had been around people who are sick with cold and allergies. He did not think the sinus infection is related to the vaccine he received. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness: Asthmatic

ID: 1553061
Sex: M
Age: 78
State: MI

Vax Date: 01/06/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
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: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. Concomitant products included LANSOPRAZOLE (PREVACID) for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds: PREVACID

Current Illness:

ID: 1553062
Sex: F
Age: 65
State: FL

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: sore arm; ear hurt; scratchy throat; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021. The most recent information was received on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), EAR PAIN (ear hurt) and OROPHARYNGEAL PAIN (scratchy throat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027A21A) for COVID-19 vaccination. No medical history was reported by reporter. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), EAR PAIN (ear hurt) and OROPHARYNGEAL PAIN (scratchy throat). At the time of the report, PAIN IN EXTREMITY (sore arm), EAR PAIN (ear hurt) and OROPHARYNGEAL PAIN (scratchy throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported. This case was linked to MOD-2021-255550 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow up, lot number added

Other Meds:

Current Illness:

ID: 1553063
Sex: M
Age: 51
State: GA

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/13/2021
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: BRUISING SINCE RECEIVING VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (BRUISING SINCE RECEIVING VACCINE) in a 51-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (BRUISING SINCE RECEIVING VACCINE). At the time of the report, CONTUSION (BRUISING SINCE RECEIVING VACCINE) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Patient was taking blood thinners.

Other Meds:

Current Illness:

ID: 1553064
Sex: F
Age: 30
State: NC

Vax Date: 01/23/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: Menstrual cycle; Cold sweats; Pain in lower abdomen; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle), COLD SWEAT (Cold sweats) and ABDOMINAL PAIN LOWER (Pain in lower abdomen) in a 30-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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MENSTRUAL DISORDER (Menstrual cycle), COLD SWEAT (Cold sweats) and ABDOMINAL PAIN LOWER (Pain in lower abdomen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid. At the time of the report, MENSTRUAL DISORDER (Menstrual cycle), COLD SWEAT (Cold sweats) and ABDOMINAL PAIN LOWER (Pain in lower abdomen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1553065
Sex: M
Age: 72
State: TN

Vax Date: 02/04/2021
Onset Date: 02/12/2021
Rec V Date: 08/13/2021
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: tested for covid and came back positive; feels kinda weak; started feeling sick; coughing; feel bad; not very good appetite,; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested for covid and came back positive), ASTHENIA (feels kinda weak), MALAISE (started feeling sick), COUGH (coughing) and FEELING ABNORMAL (feel bad) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. . Concomitant products included GABAPENTIN, METFORMIN HYDROCHLORIDE, AMLODIPINE, METOPROLOL and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ASTHENIA (feels kinda weak), MALAISE (started feeling sick), COUGH (coughing), FEELING ABNORMAL (feel bad), DECREASED APPETITE (not very good appetite,) and PYREXIA (fever). On 19-Feb-2021, the patient experienced COVID-19 (tested for covid and came back positive). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) ongoing since an unknown date at a dose of UNK, bid; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and GUAIFENESIN at an unspecified dose and frequency. At the time of the report, COVID-19 (tested for covid and came back positive), ASTHENIA (feels kinda weak), MALAISE (started feeling sick), COUGH (coughing), FEELING ABNORMAL (feel bad), DECREASED APPETITE (not very good appetite,) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 102 ?F (High) fluctuated to 100?F. On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: GABAPENTIN; METFORMIN HYDROCHLORIDE; AMLODIPINE; METOPROLOL; LEXAPRO

Current Illness:

ID: 1553066
Sex: F
Age: 78
State: MA

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/13/2021
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: Chills; Nausea; Had a fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Had a fever of 101) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19. Concurrent medical conditions included Blood pressure abnormal, Cholesterol total abnormal NOS, Thyroid disorder NOS and Heartburn. Concomitant products included CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Had a fever of 101). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Feb-2021, CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, PYREXIA (Had a fever of 101) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 101 (High) 101. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was concomitantly taking blood pressure med, cholesterol med, Thyroid med, and heartburn med.

Other Meds: CALCIUM + VIT D

Current Illness: Blood pressure abnormal; Cholesterol total abnormal NOS; Heartburn; Thyroid disorder NOS

ID: 1553067
Sex: M
Age: 73
State: FL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/13/2021
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: Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included HYDROCODONE and IBUPROFEN for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: unknown High. On 13-Jan-2021, Weight: unknown High. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14 Jun 2021 contains patient denied for further follow up.

Other Meds: HYDROCODONE; IBUPROFEN

Current Illness:

ID: 1553068
Sex: M
Age: 66
State: GA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/13/2021
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: Mouth and tongue numb; bitter taste; soreness; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Mouth and tongue numb), DYSGEUSIA (bitter taste), PAIN (soreness) and NAUSEA (nauseated) in a 66-year-old male 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 EZETIMIBE, AMLODIPINE, LISINOPRIL, GLIMEPIRIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CLOPIDOGREL BISULFATE (PLAVIX) 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 09-Feb-2021, the patient experienced PAIN (soreness) and NAUSEA (nauseated). On 12-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (Mouth and tongue numb) and DYSGEUSIA (bitter taste). On 11-Feb-2021, PAIN (soreness) had resolved. At the time of the report, HYPOAESTHESIA ORAL (Mouth and tongue numb), DYSGEUSIA (bitter taste) and NAUSEA (nauseated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient took no treatment for symptoms.

Other Meds: EZETIMIBE; AMLODIPINE; LISINOPRIL; GLIMEPIRIDE; BABY ASPIRIN; PLAVIX

Current Illness:

ID: 1553069
Sex: F
Age: 71
State: MA

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 08/13/2021
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: feels like got run over by a truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels like got run over by a truck) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced FEELING ABNORMAL (feels like got run over by a truck). At the time of the report, FEELING ABNORMAL (feels like got run over by a truck) had resolved. No concomitant medications were reported. No treatment related information has been reported. This case was linked to MOD-2021-255982, MOD-2021-255983 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Regulatory Authority report received on 14-JUL-2021 : updated patient demographics , AE outcome updated- recovered/resolved

Other Meds:

Current Illness: Fibromyalgia

ID: 1553070
Sex: F
Age: 83
State: VA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: On 27JAN injection area started to itch and kept itching throughout the night; little rash broke out around area; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (little rash broke out around area) and VACCINATION SITE PRURITUS (On 27JAN injection area started to itch and kept itching throughout the night) in an 84-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 THYROID for Thyroiditis NOS, APIXABAN (ELIQUIS) for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (little rash broke out around area). On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (On 27JAN injection area started to itch and kept itching throughout the night). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (little rash broke out around area) and VACCINATION SITE PRURITUS (On 27JAN injection area started to itch and kept itching throughout the night) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds: ELIQUIS; THYROID

Current Illness:

ID: 1553071
Sex: M
Age: 58
State: FL

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 08/13/2021
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: 102 F Fever; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 F Fever) and FATIGUE (Exhausted) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The patient's past medical history included Kidney transplant (multiple ). Concomitant products included TACROLIMUS (PROGRAF) for Immunosuppressant drug therapy. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (102 F Fever) and FATIGUE (Exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (102 F Fever) and FATIGUE (Exhausted) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 ?F (High) 102. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitantly patient is taking antibiotics and a nasal rinse.

Other Meds: PROGRAF

Current Illness:

ID: 1553072
Sex: F
Age: 74
State: CA

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 08/13/2021
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: Dizziness; tiredness; pain in her hips and knees; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (tiredness) and ARTHRALGIA (pain in her hips and knees) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. Concurrent medical conditions included Shaking of hands. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), FATIGUE (tiredness) and ARTHRALGIA (pain in her hips and knees). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), FATIGUE (tiredness) and ARTHRALGIA (pain in her hips and knees) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitantly patient was taking medication for shaking hand along with supplements.

Other Meds:

Current Illness: Shaking of hands

ID: 1553073
Sex: U
Age:
State:

Vax Date: 01/17/2021
Onset Date: 01/25/2021
Rec V Date: 08/13/2021
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: Inch and a half of erythema spreading on the deltoid area; Some adenopathy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE ERYTHEMA (Inch and a half of erythema spreading on the deltoid area) and LYMPHADENOPATHY (Some adenopathy) 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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Inch and a half of erythema spreading on the deltoid area) and LYMPHADENOPATHY (Some adenopathy). At the time of the report, INJECTION SITE ERYTHEMA (Inch and a half of erythema spreading on the deltoid area) and LYMPHADENOPATHY (Some adenopathy) 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 information was provided. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI - Reporter denied further contact.

Other Meds:

Current Illness:

ID: 1553074
Sex: F
Age: 58
State: TN

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

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

Lab Data:

Allergies:

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

Symptoms: felt like sinus symptoms and congested; respiratory symptoms; puffy nose; left wrist feels like broken and can't even lift things; area beneath pinky is very sore; Itching; Vaccination site erythema; headache; left wrist feels like broken and can't even lift things; felt a scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose) and MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medication history information was reported. Concomitant products included AMLODIPINE BESILATE (LODOPIN [AMLODIPINE BESILATE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (felt a scratchy throat). On an unknown date, the patient experienced SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things). The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication were provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Dose 2 details added, event added-itching, vaccination site erythema for 1st dose.

Other Meds: LODOPIN [AMLODIPINE BESILATE]; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1553075
Sex: F
Age:
State: CA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 08/13/2021
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: Hair was falling and thinning, have bald spots; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair was falling and thinning, have bald spots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21 and 42L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergic reaction to antibiotics (augmentin caused lips swollen.) and Allergic reaction to antibiotics (Levaquin caused lips swollen). Concomitant products included LOSARTAN, METOPROLOL, BUPROPION, ALENDRONATE SODIUM (ALENDRONATE) and OXYBUTYNIN for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair was falling and thinning, have bald spots). At the time of the report, ALOPECIA (Hair was falling and thinning, have bald spots) outcome was unknown. Treatment medications included antihistamines. Action taken with mRNA-1273 in response to the events was not Applicable. This case was linked to MOD-2021-023307 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated patient demographics, medical history ,concomitant medications Events information is updated.

Other Meds: LOSARTAN; METOPROLOL; BUPROPION; ALENDRONATE; OXYBUTYNIN

Current Illness: Allergic reaction to antibiotics (Levaquin caused lips swollen); Allergic reaction to antibiotics (augmentin caused lips swollen.)

ID: 1553076
Sex: F
Age: 80
State: CA

Vax Date: 02/18/2021
Onset Date: 02/20/2021
Rec V Date: 08/13/2021
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: pain has gone up back, into neck; Back Pain; Little Bug; pain has gone up back, into shoulders; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain has gone up back, into neck), BACK PAIN (Back Pain), DISCOMFORT (Little Bug) and ARTHRALGIA (pain has gone up back, into shoulders) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced NECK PAIN (pain has gone up back, into neck), BACK PAIN (Back Pain), DISCOMFORT (Little Bug) and ARTHRALGIA (pain has gone up back, into shoulders). At the time of the report, NECK PAIN (pain has gone up back, into neck), BACK PAIN (Back Pain), DISCOMFORT (Little Bug) and ARTHRALGIA (pain has gone up back, into shoulders) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.

Other Meds:

Current Illness:

ID: 1553077
Sex: F
Age: 67
State: FL

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 08/13/2021
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: Really jittery; Really nervous; Didn't sleep well Saturday night due to pain; Pain in her shoulder at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Didn't sleep well Saturday night due to pain), FEELING JITTERY (Really jittery), NERVOUSNESS (Really nervous) and VACCINATION SITE PAIN (Pain in her shoulder at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05m20a) for COVID-19 vaccination. Concurrent medical conditions included Anxiety and Blood pressure high. On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in her shoulder at the injection site). On 21-Feb-2021, the patient experienced INSOMNIA (Didn't sleep well Saturday night due to pain). On 22-Feb-2021, the patient experienced FEELING JITTERY (Really jittery) and NERVOUSNESS (Really nervous). At the time of the report, INSOMNIA (Didn't sleep well Saturday night due to pain), FEELING JITTERY (Really jittery), NERVOUSNESS (Really nervous) and VACCINATION SITE PAIN (Pain in her shoulder at the injection site) outcome was unknown. Concomitant medications reported were anxiety, blood pressure and stomach medications. Treatment information was not reported.

Other Meds:

Current Illness: Anxiety; Blood pressure high

ID: 1553078
Sex: F
Age: 68
State: TN

Vax Date: 02/04/2021
Onset Date: 02/12/2021
Rec V Date: 08/13/2021
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: started feeling sick; Coughing; Flu like symptoms; aching; Fever; Headache; Freezing; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling sick), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aching) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included SERTRALINE HCL, OMEPRAZOLE, CLOPIDOGREL, METOPROLOL and SIMVASTATIN for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MALAISE (started feeling sick), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aching), PYREXIA (Fever), HEADACHE (Headache), FEELING COLD (Freezing) and CHILLS (chills). At the time of the report, MALAISE (started feeling sick), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aching), HEADACHE (Headache), FEELING COLD (Freezing) and CHILLS (chills) outcome was unknown and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 23-Feb-2021, the patient tested negative for covid-19. Treatment information included dextromethorphan (16 mg), guaifenesin 1200 mg 2/day, and at the time of the report she was still taking ibuprofen and paracetamol.

Other Meds: SERTRALINE HCL; OMEPRAZOLE; CLOPIDOGREL; METOPROLOL; SIMVASTATIN

Current Illness:

ID: 1553079
Sex: M
Age:
State: FL

Vax Date: 02/10/2021
Onset Date: 02/20/2021
Rec V Date: 08/13/2021
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: Exposed to someone with Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to someone with Covid-19) 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 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to someone with Covid-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to someone with Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Antibody IgG test-positive. Lab data included Rapid antigen test-negative, antibody IgG test-positive, swab test-awaiting results. Concomitant product use was not provided by the reporter. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1553080
Sex: F
Age: 69
State: NC

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/13/2021
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: Really bad body aches; Shivering from cold chills; Fatigue and less energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Really bad body aches), NASOPHARYNGITIS (Shivering from cold chills) and FATIGUE (Fatigue and less energy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Really bad body aches), NASOPHARYNGITIS (Shivering from cold chills) and FATIGUE (Fatigue and less energy). At the time of the report, PAIN (Really bad body aches), NASOPHARYNGITIS (Shivering from cold chills) and FATIGUE (Fatigue and less energy) 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: 1553081
Sex: F
Age:
State: MA

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/13/2021
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: Dry mouth; Body aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (Dry mouth), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DRY MOUTH (Dry mouth), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1553082
Sex: F
Age:
State: WA

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/13/2021
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: She could not walk; feet were hurting; Extremelly ill; fever (unknown); chills; Severe body pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)) and CHILLS (chills) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)), CHILLS (chills) and MYALGIA (Severe body pain). At the time of the report, GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)), CHILLS (chills) and MYALGIA (Severe body pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient stated that he side effects of the vaccine were worst than the Covid-19 disease. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1553083
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Fatigue for a week; Vomiting for 24 hours; Nausea for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea for 24 hours), FATIGUE (Fatigue for a week) and VOMITING (Vomiting for 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea for 24 hours), FATIGUE (Fatigue for a week) and VOMITING (Vomiting for 24 hours). At the time of the report, NAUSEA (Nausea for 24 hours) and VOMITING (Vomiting for 24 hours) had resolved and FATIGUE (Fatigue for a week) 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 reported.

Other Meds:

Current Illness:

ID: 1553084
Sex: F
Age: 35
State: VA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/13/2021
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: started breathing really hard; got dizzy; body was tingling; side of face was itchy; almost passed out; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (started breathing really hard), DIZZINESS (got dizzy), PARAESTHESIA (body was tingling), URTICARIA (side of face was itchy) and PRESYNCOPE (almost passed out) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DYSPNOEA (started breathing really hard), DIZZINESS (got dizzy), PARAESTHESIA (body was tingling), URTICARIA (side of face was itchy) and PRESYNCOPE (almost passed out). At the time of the report, DYSPNOEA (started breathing really hard), DIZZINESS (got dizzy), PARAESTHESIA (body was tingling), URTICARIA (side of face was itchy) and PRESYNCOPE (almost passed out) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. The patient received antihistamines as face was getting itchy.

Other Meds:

Current Illness:

ID: 1553085
Sex: F
Age: 54
State: NC

Vax Date: 01/15/2021
Onset Date: 02/11/2021
Rec V Date: 08/13/2021
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: weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling; weird sensation which started in her throat, then tongue and came to her lips, it was like numb; weird sensation which started in her throat, then tongue and came to her lips, it was like numb; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling), PHARYNGEAL HYPOAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) and HYPOAESTHESIA ORAL (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 013L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included IRBESARTAN, DOXYCYCLINE HYCLATE, ESTRADIOL, PROGESTERONE and GABAPENTIN for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PARAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling), PHARYNGEAL HYPOAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) and HYPOAESTHESIA ORAL (weird sensation which started in her throat, then tongue and came to her lips, it was like numb). On 12-Feb-2021, PARAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling), PHARYNGEAL HYPOAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) and HYPOAESTHESIA ORAL (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received on 13 Jul 2021 and contains no significant information

Other Meds: IRBESARTAN; DOXYCYCLINE HYCLATE; ESTRADIOL; PROGESTERONE; GABAPENTIN

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm