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: 1594687
Sex: F
Age: 73
State: FL

Vax Date: 01/19/2021
Onset Date: 01/28/2021
Rec V Date: 08/21/2021
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: Teary eyes; Red scaly eyelids; Itchy eyelids; Injection site redness; Injection site hot; Injection site very itchy; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Teary eyes), ECZEMA EYELIDS (Red scaly eyelids), EYELIDS PRURITUS (Itchy eyelids), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE WARMTH (Injection site hot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Teary eyes, Eczema eyelids and Eyelids pruritus. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site very itchy) and VACCINATION SITE SWELLING (Injection site swelling). On an unknown date, the patient experienced LACRIMATION INCREASED (Teary eyes), ECZEMA EYELIDS (Red scaly eyelids) and EYELIDS PRURITUS (Itchy eyelids). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, LACRIMATION INCREASED (Teary eyes), ECZEMA EYELIDS (Red scaly eyelids), EYELIDS PRURITUS (Itchy eyelids), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site very itchy) and VACCINATION SITE SWELLING (Injection site swelling) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: No new information was received.

Other Meds:

Current Illness:

ID: 1594688
Sex: F
Age: 83
State: AL

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/21/2021
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: Injection site was hot to touch; Left arm swollen; rash 2.5 inches in diameter; Injection site stung; Left arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Left arm sore), PERIPHERAL SWELLING (Left arm swollen), INJECTION SITE RASH (rash 2.5 inches in diameter), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Injection site stung) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C20A) 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 PAIN (Left arm sore). On 26-Jan-2021, the patient experienced PERIPHERAL SWELLING (Left arm swollen), INJECTION SITE RASH (rash 2.5 inches in diameter), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Injection site stung). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Jan-2021, PAIN (Left arm sore) had resolved. At the time of the report, PERIPHERAL SWELLING (Left arm swollen), INJECTION SITE RASH (rash 2.5 inches in diameter), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Injection site stung) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR: Pt feels better, requesting no more follow ups

Other Meds:

Current Illness:

ID: 1594689
Sex: F
Age:
State: MI

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/21/2021
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: Feeling "clammy"; feels like crap, feeling yucky; Body ache; Low grade fever 99F; Headache; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Feeling "clammy"), FEELING ABNORMAL (feels like crap, feeling yucky), MYALGIA (Body ache), PYREXIA (Low grade fever 99F) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced COLD SWEAT (Feeling "clammy"), FEELING ABNORMAL (feels like crap, feeling yucky), MYALGIA (Body ache), PYREXIA (Low grade fever 99F), HEADACHE (Headache) and NAUSEA (Nauseated). At the time of the report, COLD SWEAT (Feeling "clammy"), FEELING ABNORMAL (feels like crap, feeling yucky), MYALGIA (Body ache), PYREXIA (Low grade fever 99F), HEADACHE (Headache) and NAUSEA (Nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 99 ?F (Low) (99F). 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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1594690
Sex: F
Age: 76
State: FL

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/21/2021
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: Warm to touch at the injection site; A very big , red area at the injection site; Injection site which is also swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (A very big , red area at the injection site) and VACCINATION SITE SWELLING (Injection site which is also swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (A very big , red area at the injection site) and VACCINATION SITE SWELLING (Injection site which is also swollen). At the time of the report, VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (A very big , red area at the injection site) and VACCINATION SITE SWELLING (Injection site which is also swollen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. There was no concomitant medication reported. There was no relevant treatment medication reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up was received on 29-JUN-2021, contain significant information. Changed the outcome of all the events,from unknown to recovered/resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1594691
Sex: F
Age:
State: CA

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 08/21/2021
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: nauseous; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and VOMITING (vomiting) in a 72-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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseous) and VOMITING (vomiting). At the time of the report, NAUSEA (nauseous) and VOMITING (vomiting) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications provided. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Updated Onset date of mRNA-1273 first dose from 02-Feb-2021 to 14-Feb-2021.

Other Meds:

Current Illness:

ID: 1594692
Sex: M
Age: 44
State:

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 08/21/2021
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: broke up in hives; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke up in hives) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25J20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (broke up in hives). At the time of the report, URTICARIA (broke up in hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 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. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1594693
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: Tested positive for Covid; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 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 SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid) 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. Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of positive for SARS-CoV-2, are assessed as unlikely related. Further information has been requested.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of positive for SARS-CoV-2, are assessed as unlikely related. Further information has been requested.

Other Meds:

Current Illness:

ID: 1594694
Sex: F
Age: 79
State: NY

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/21/2021
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: Acid reflux; Arms started feeling achy; Random chills; Headache; Mild nausea in the morning; Fatigue; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PAIN IN EXTREMITY (Arms started feeling achy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Mild nausea in the morning) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gastric irritation, Hypothyroidism and Allergy. Concurrent medical conditions included Hypertension. Concomitant products included FAMOTIDINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 18-Jan-2021, the patient experienced FATIGUE (Fatigue). On 19-Jan-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Mild nausea in the morning). On 20-Jan-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PAIN IN EXTREMITY (Arms started feeling achy) and CHILLS (Random chills). On 16-Jan-2021, VACCINATION SITE PAIN (Injection site pain) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PAIN IN EXTREMITY (Arms started feeling achy), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Mild nausea in the morning) and CHILLS (Random chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication detail was reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: The follow up document contain no new information.

Other Meds: FAMOTIDINE; BYSTOLIC; SYNTHROID; ALLEGRA

Current Illness: Hypertension

ID: 1594695
Sex: F
Age:
State: CA

Vax Date: 01/16/2021
Onset Date: 01/24/2021
Rec V Date: 08/21/2021
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: rash is raised bumps; Blister; Itches; Severe rash on both of my arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (rash is raised bumps), BLISTER (Blister), PRURITUS (Itches) and RASH (Severe rash on both of my arms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). Concomitant products included METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU MEDROL), LEVOTHYROXINE, DIPHENHYDRAMINE, ESCITALOPRAM and NIACIN for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced RASH VESICULAR (rash is raised bumps), BLISTER (Blister), PRURITUS (Itches) and RASH (Severe rash on both of my arms). At the time of the report, RASH VESICULAR (rash is raised bumps), BLISTER (Blister), PRURITUS (Itches) and RASH (Severe rash on both of my arms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: SOLU MEDROL; LEVOTHYROXINE; DIPHENHYDRAMINE; ESCITALOPRAM; NIACIN

Current Illness:

ID: 1594696
Sex: F
Age: 72
State: AZ

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 08/21/2021
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: A spontaneous report was received from a consumer, concerning his wife, a 72-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache, body ache, chills, fever, nausea, and vomiting. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) in the left arm for prophylaxis of COVID-19 infection. On 24 Jan 2021, after vaccination, the patient experienced severe headache, body ache and chills. On 26 Jan 2021, she also experienced fever of 104f. Additionally, on 27 Jan 2021 she developed severe nausea and vomiting. On an unknown date in 2021, she was bed ridden. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of event(s), severe headache, body ache, chills, fever of 104f, severe nausea, vomiting were not resolved and ongoing at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:

Other Meds:

Current Illness:

ID: 1594697
Sex: F
Age: 81
State: FL

Vax Date: 01/09/2021
Onset Date: 01/12/2021
Rec V Date: 08/21/2021
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: COVID-19; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PYREXIA (fever) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included OMEPRAZOLE, SIMVASTATIN, AMLODIPINE, DOXEPIN, HYDROCHLOROTHIAZIDE, FISH OIL, CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]), VITAMIN D3, GUAIFENESIN (MUCINEX) and MACROGOL 3350 (MIRALAX) for an unknown indication. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 14-Jan-2021, CHILLS (chills) had resolved. On 16-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, COVID-19 (COVID-19) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, COVID-19: (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included antibody infusion ER.

Other Meds: OMEPRAZOLE; SIMVASTATIN; AMLODIPINE; DOXEPIN; HYDROCHLOROTHIAZIDE; FISH OIL; CITRACAL [CALCIUM CITRATE]; VITAMIN D3; MUCINEX; MIRALAX

Current Illness:

ID: 1594698
Sex: F
Age:
State: WA

Vax Date: 01/18/2021
Onset Date: 01/28/2021
Rec V Date: 08/21/2021
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: At the injection site and it's a bit warm; At the injection site and it's a bit warm and hard; Big red circle on my arm at the injection site; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red circle on arm at the injection site (injection site redness) and it's a bit warm (injection site warmth) and hard (injection site warmth). The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of the events the patient received their dose of mRNA-1273 (Batch Number: Not provided) for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced big red circle on arm at the injection site (injection site redness) and it's a bit warm (injection site warmth) and hard (injection site induration). No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events red circle on arm at the injection site (injection site redness) and it's a bit warm (injection site warmth) and hard (injection site induration) was not reported.; Reporter's Comments: Based on the information provided and the established safety profile of mRNA-1273 vaccine, a causal association between the events reported and the product use cannot be excluded. Injection site redness and Injection site induration are consistent with the known safety profile of the vaccine

Other Meds:

Current Illness:

ID: 1594699
Sex: M
Age: 85
State: MT

Vax Date: 02/01/2021
Onset Date: 02/16/2021
Rec V Date: 08/21/2021
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: antibody assay with negative results; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST NEGATIVE (antibody assay with negative results) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 01-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 16-Feb-2021, the patient experienced ANTIBODY TEST NEGATIVE (antibody assay with negative results). At the time of the report, ANTIBODY TEST NEGATIVE (antibody assay with negative results) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Antibody test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received contains No new information

Other Meds:

Current Illness:

ID: 1594700
Sex: F
Age: 59
State: MA

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/21/2021
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: hunches over when she walks; migraine, a horrible headache; feels like a weight on her stomach; did not sleep all night because of how bad she feels; urinating but not a lot; feels so nauseous that she cannot eat anything; tired/exhausted; feverish (101?F fever); worse chills ever; This spontaneous case was reported by a nurse and describes the occurrence of GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels) and URINE OUTPUT DECREASED (urinating but not a lot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-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) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101?F fever)) and CHILLS (worse chills ever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101?F fever)) and CHILLS (worse chills ever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101 (High) 101?F. On 18-Feb-2021, Urine output: decreased (Low) Decreased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitants medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: follow up received on 13 JUL 2021 in which Contact information is updated. On 04-Aug-2021: Follow up received included laboratory data was added.

Other Meds:

Current Illness:

ID: 1594701
Sex: F
Age: 72
State: NH

Vax Date: 02/03/2021
Onset Date: 02/11/2021
Rec V Date: 08/21/2021
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: Injection site was itching; Red Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Red Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included No adverse reaction (No reported medical history). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Red Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Red Injection Site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant list is provided. No treatment is given. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No information is provided in the attached document of the additional information. On 29-Apr-2021: Additional info-2

Other Meds:

Current Illness:

ID: 1594702
Sex: M
Age: 83
State: AL

Vax Date: 01/19/2021
Onset Date: 02/18/2021
Rec V Date: 08/21/2021
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: face flushed; really fast heart rate; bad headaches; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (face flushed), HEART RATE INCREASED (really fast heart rate), HEADACHE (bad headaches) and PYREXIA (Temperature) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 04120A) 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 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FLUSHING (face flushed), HEART RATE INCREASED (really fast heart rate), HEADACHE (bad headaches) and PYREXIA (Temperature). On 18-Feb-2021, FLUSHING (face flushed) and HEART RATE INCREASED (really fast heart rate) had resolved. At the time of the report, HEADACHE (bad headaches) and PYREXIA (Temperature) outcome was unknown. No treatment medication was provided. Concomitant medications reported were Heart pills Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up report received included no new information.

Other Meds:

Current Illness:

ID: 1594703
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: Pain at the injection site; Feel fatigued; Tired; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Feel fatigued), FATIGUE (Tired) and HEADACHE (Slight 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Feel fatigued), FATIGUE (Tired) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Feel fatigued), FATIGUE (Tired) and HEADACHE (Slight headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. As per client, MO error in DOB capture

Other Meds:

Current Illness:

ID: 1594704
Sex: F
Age: 73
State:

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 08/21/2021
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: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (no other symptoms except some arm soreness/stiffness the next day) and musculoskeletal stiffness (no other symptoms except some arm soreness/stiffness the next day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 20, 2021, patient experienced pain in extremity (no other symptoms except some arm soreness/stiffness the next day) and musculoskeletal stiffness (no other symptoms except some arm soreness/stiffness the next day). At the time of the report, pain in extremity (no other symptoms except some arm soreness/stiffness the next day) and musculoskeletal stiffness (no other symptoms except some arm soreness/stiffness the next day) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported.

Other Meds:

Current Illness:

ID: 1594705
Sex: F
Age:
State: WA

Vax Date: 02/09/2021
Onset Date: 02/14/2021
Rec V Date: 08/21/2021
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: Full body hives/urticaria; itching; hot to touch; Full body rashes; low grade fever of 98-102 deg F; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Full body hives/urticaria), PRURITUS (itching), FEELING HOT (hot to touch), RASH (Full body rashes) and PYREXIA (low grade fever of 98-102 deg F) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concomitant products included PREDNISONE, CETIRIZINE and RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication. On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced URTICARIA (Full body hives/urticaria), PRURITUS (itching), FEELING HOT (hot to touch), RASH (Full body rashes) and PYREXIA (low grade fever of 98-102 deg F). At the time of the report, URTICARIA (Full body hives/urticaria), PRURITUS (itching), FEELING HOT (hot to touch), RASH (Full body rashes) and PYREXIA (low grade fever of 98-102 deg F) outcome was unknown. No treatment medication information was provided Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received on 06-jul-2021 contains non-significant information- added reporter's email and address

Other Meds: PREDNISONE; CETIRIZINE; ZANTAC

Current Illness:

ID: 1594706
Sex: U
Age: 57
State: NJ

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/21/2021
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: The swelling of cubital area of the left arm; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling of cubital area of the left arm/ vaccination site swelling.. The patient's medical history was not provided. No relevant concomitant medications were reported. On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 3 Feb 2021, the patient experienced swelling of cubital area of the left arm.Treatment details included diphenhydramine. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event swelling of cubital area of the left arm was unknown.

Other Meds:

Current Illness:

ID: 1594707
Sex: M
Age: 70
State: NY

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/21/2021
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: Fatigue; sleeps all the time; headache; muscle aches; arm soreness; warm; pinkish; Little swollen below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches) and PAIN IN EXTREMITY (arm soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CENTRUM VITAMINTS for Immune disorder (NOS), TAMSULOSIN for Prostate, GLUCOSAMINE and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (pinkish) and VACCINATION SITE SWELLING (Little swollen below the injection site). At the time of the report, FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (pinkish) and VACCINATION SITE SWELLING (Little swollen below the injection site) outcome was unknown. Treatment for the events: None.

Other Meds: CENTRUM VITAMINTS; TAMSULOSIN; GLUCOSAMINE; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1594708
Sex: M
Age: 68
State: IL

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/21/2021
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: felt some of the vaccine run down his arm; got about 90% of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (felt some of the vaccine run down his arm) and UNDERDOSE (got about 90% of the vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (felt some of the vaccine run down his arm) and UNDERDOSE (got about 90% of the vaccine). At the time of the report, VACCINATION SITE DISCHARGE (felt some of the vaccine run down his arm) and UNDERDOSE (got about 90% of the vaccine) 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. Concomitant medication was not reported. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Correspondence email attached

Other Meds:

Current Illness:

ID: 1594709
Sex: F
Age: 65
State: WA

Vax Date: 01/14/2021
Onset Date: 01/24/2021
Rec V Date: 08/21/2021
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: Huge red welt at the injection site; Arm was also very warm; Burning rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was also very warm), VACCINATION SITE RASH (Burning rash at injection site) and VACCINATION SITE ERYTHEMA (Huge red welt at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm was also very warm) and VACCINATION SITE RASH (Burning rash at injection site). On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Huge red welt at the injection site). On 30-Jan-2021, VACCINATION SITE RASH (Burning rash at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm was also very warm) and VACCINATION SITE ERYTHEMA (Huge red welt 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. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up information received captured reporter contact details. On 08-Apr-2021: Follow-up information received captured no new information.; 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: 1594710
Sex: F
Age: 66
State: NC

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/21/2021
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: feeling terrible; Loss of taste; Loss of smell; not taking the 2nd dose of the Moderna vaccine; being sick; Super rush of adrenaline; flu-like symptoms; very dehydrated; Heart felt like it was being squeezed and twisted /Myheart felt like someone had grabbed it smooshed it and put it back in my chest; drenched from head to toe (3 blanket)/fever that made her sweat through her sheets/sweats; serum noradrenaline increased / feels like adrenaline is flowing, increased metabolism; being talkative / Very talkative; weakness; extreme fatigue; fever/fever that made her sweat through her sheets / Spiked fever; Headache; muscle aches; joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERMETABOLISM (serum noradrenaline increased / feels like adrenaline is flowing, increased metabolism), LOGORRHOEA (being talkative / Very talkative), ASTHENIA (weakness), EPINEPHRINE INCREASED (Super rush of adrenaline) and HYPERHIDROSIS (drenched from head to toe (3 blanket)/fever that made her sweat through her sheets/sweats) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma and Lupus syndrome. Concomitant products included HYDROCODONE for Pain, COLECALCIFEROL (VITAMIN D 3) and ZINC for Supplementation therapy, VITAMIN C [ASCORBIC ACID], PARACETAMOL (TYLENOL) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HYPERMETABOLISM (serum noradrenaline increased / feels like adrenaline is flowing, increased metabolism), LOGORRHOEA (being talkative / Very talkative), ASTHENIA (weakness), HYPERHIDROSIS (drenched from head to toe (3 blanket)/fever that made her sweat through her sheets/sweats), CHEST DISCOMFORT (Heart felt like it was being squeezed and twisted /Myheart felt like someone had grabbed it smooshed it and put it back in my chest), FATIGUE (extreme fatigue), PYREXIA (fever/fever that made her sweat through her sheets / Spiked fever), HEADACHE (Headache), MYALGIA (muscle aches), ARTHRALGIA (joint pain) and CHILLS (chills). On 30-Jan-2021, the patient experienced DEHYDRATION (very dehydrated). On an unknown date, the patient experienced EPINEPHRINE INCREASED (Super rush of adrenaline), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (feeling terrible), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), PRODUCT DOSE OMISSION ISSUE (not taking the 2nd dose of the Moderna vaccine) and ILLNESS (being sick). On 30-Jan-2021, HYPERMETABOLISM (serum noradrenaline increased / feels like adrenaline is flowing, increased metabolism), LOGORRHOEA (being talkative / Very talkative), ASTHENIA (weakness), HYPERHIDROSIS (drenched from head to toe (3 blanket)/fever that made her sweat through her sheets/sweats), DEHYDRATION (very dehydrated), FATIGUE (extreme fatigue) and PYREXIA (fever/fever that made her sweat through her sheets / Spiked fever) had resolved, CHEST DISCOMFORT (Heart felt like it was being squeezed and twisted /Myheart felt like someone had grabbed it smooshed it and put it back in my chest), HEADACHE (Headache), MYALGIA (muscle aches), ARTHRALGIA (joint pain) and CHILLS (chills) outcome was unknown. At the time of the report, EPINEPHRINE INCREASED (Super rush of adrenaline), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (feeling terrible), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and ILLNESS (being sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not taking the 2nd dose of the Moderna vaccine) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment for the event included Zithromax for 5 days Tylenol and Aspirin,Hydrocodone 375mg 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. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Significant follow up received on 26-4-2021, Patient demographics(Weight, Race ) added. New events (Loss of taste, Loss of smell, adrenaline rush, chest discomfort, Sweaty, Talkative) were added. Treatment medications(Tylenol, Aspirin, Azithromycin) added. Action taken with drug (Withdrawn) added. On 26-Apr-2021: Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: VITAMIN D 3; ZINC; HYDROCODONE; VITAMIN C [ASCORBIC ACID]; TYLENOL; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Asthma; Lupus syndrome

ID: 1594711
Sex: F
Age:
State: MA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/21/2021
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: injection site enlarged; swelling; this real warm sensation in the chest immediately after receiving the shot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FEELING HOT (this real warm sensation in the chest immediately after receiving the shot), INJECTION SITE SWELLING (injection site enlarged) and SWELLING (swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included METOPROLOL for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced FEELING HOT (this real warm sensation in the chest immediately after receiving the shot). On an unknown date, the patient experienced INJECTION SITE SWELLING (injection site enlarged) and SWELLING (swelling). On 29-Jan-2021, FEELING HOT (this real warm sensation in the chest immediately after receiving the shot) outcome was unknown. At the time of the report, INJECTION SITE SWELLING (injection site enlarged) and SWELLING (swelling) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Treatment information was not provided. Upon internal review on 4-Aug-21, the age was corrected to 67 years.

Other Meds: METOPROLOL

Current Illness:

ID: 1594712
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/21/2021
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: Side effects from second vaccination; A spontaneous report was received from a Consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and reported the events side effects from second vaccination(vaccine complication). The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (unknown batch number) intramuscularly for prophylaxis of COVID-19 infection. No adverse events were reported to the first dose of vaccine. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (batch number provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient reported event side effects from second vaccination(vaccine complication) No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event side effects from second vaccination was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1594713
Sex: F
Age: 72
State: NY

Vax Date: 02/27/2021
Onset Date: 03/12/2021
Rec V Date: 08/21/2021
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: Slept for 12 hours; some kind of allergy/allergic reaction; Really dizzy; Vertigo; Felt like she was going to pass out; Rash at injection site; Didn't receive Moderna's second shot; Feelings of fainting; A kind of slashing, sore arm; Rash all over the body/Rash at injection site and chest area; Lymph nodes in the neck; Headaches; Abdominal pains; Fast heart beats; Poor appetite; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Feelings of fainting), PAIN IN EXTREMITY (A kind of slashing, sore arm), HYPERSOMNIA (Slept for 12 hours), ABDOMINAL PAIN (Abdominal pains) and HEART RATE INCREASED (Fast heart beats) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Eczema. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRESYNCOPE (Feelings of fainting). 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (A kind of slashing, sore arm), ABDOMINAL PAIN (Abdominal pains), HEART RATE INCREASED (Fast heart beats), DECREASED APPETITE (Poor appetite), RASH (Rash all over the body/Rash at injection site and chest area), LYMPHADENOPATHY (Lymph nodes in the neck) and HEADACHE (Headaches). On an unknown date, the patient experienced HYPERSOMNIA (Slept for 12 hours), ALLERGY TO VACCINE (some kind of allergy/allergic reaction), DIZZINESS (Really dizzy), VERTIGO (Vertigo), FEELING ABNORMAL (Felt like she was going to pass out), VACCINATION SITE RASH (Rash at injection site) and PRODUCT DOSE OMISSION ISSUE (Didn't receive Moderna's second shot). 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, PRESYNCOPE (Feelings of fainting), PAIN IN EXTREMITY (A kind of slashing, sore arm), HYPERSOMNIA (Slept for 12 hours), ABDOMINAL PAIN (Abdominal pains), HEART RATE INCREASED (Fast heart beats), DECREASED APPETITE (Poor appetite), ALLERGY TO VACCINE (some kind of allergy/allergic reaction), DIZZINESS (Really dizzy), VERTIGO (Vertigo), FEELING ABNORMAL (Felt like she was going to pass out), RASH (Rash all over the body/Rash at injection site and chest area), LYMPHADENOPATHY (Lymph nodes in the neck), HEADACHE (Headaches), VACCINATION SITE RASH (Rash at injection site) and PRODUCT DOSE OMISSION ISSUE (Didn't receive Moderna's second shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: high (High) High. On an unknown date, Antibody test: negative (Negative) Negative (didn't have COVID) and positive (Positive) positive for antibodies against the Spike Protein. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. no treatment medications were reported. After receiving Moderna's first dose in February patient developed allergic reaction and was advised not to take the second shot and was really dizzy, having vertigo and feeling like was going to pass out. Also, developed a rash that was not only at the injection site but all over chest area. Patient's waned to know did Spike protein antibodies protect against the Delta variant. Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow up received on 31 Mar 2021 included no new information. On 30-Jun-2021: Reporter Qualification was updated (from HCP to Non-HCP) and added event allergy to vaccine with outcome unknown. On 05-Aug-2021: Follow up received included reporter address, additional events really dizzy, vertigo, felt like she was going to pass out, rash at injection site and chest area, didn't receive moderna's second shot.; 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: Eczema

ID: 1594714
Sex: F
Age: 70
State: NJ

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 08/21/2021
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: Red spot on arm about 1.5 inch diameter; Sore arm after injection; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (Red spot on arm about 1.5 inch diameter) and VACCINATION SITE PAIN (Sore arm after injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced RASH MACULAR (Red spot on arm about 1.5 inch diameter) and VACCINATION SITE PAIN (Sore arm after injection). At the time of the report, RASH MACULAR (Red spot on arm about 1.5 inch diameter) and VACCINATION SITE PAIN (Sore arm after injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Reporter contact details(email address) added. Non-sig information.

Other Meds:

Current Illness:

ID: 1594715
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 08/21/2021
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: A little soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little soreness in her 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 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A little soreness in her arm). At the time of the report, PAIN IN EXTREMITY (A little soreness in her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication provided. No concomitant medication provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18 May 2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1594716
Sex: F
Age: 78
State: NM

Vax Date: 01/27/2021
Onset Date: 01/30/2021
Rec V Date: 08/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Arm sore; Back hurt; Left hip felt weird and was hardly able to stand on it.; I am not sleeping; Panic attack; Pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping) and PANIC ATTACK (Panic attack) in a 78-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. Concurrent medical conditions included Arthritis. Concomitant products included LOSARTAN and PREDNISONE for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping), PANIC ATTACK (Panic attack), PAIN (Pain) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping), PANIC ATTACK (Panic attack), PAIN (Pain) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details was not reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information received on 07-Jul-2021 and does not contain any new information

Other Meds: LOSARTAN; PREDNISONE

Current Illness: Arthritis

ID: 1594717
Sex: F
Age:
State: FL

Vax Date: 01/27/2021
Onset Date: 02/01/2021
Rec V Date: 08/21/2021
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: Pain in the neck and shoulder area; Pain in the neck and shoulder area; Diarrhea five days after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea five days after getting the vaccine), NECK PAIN (Pain in the neck and shoulder area) and ARTHRALGIA (Pain in the neck and shoulder area) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included Colonoscopy (Patient have had a problem in the past with a medication administered in a colonoscopy procedure.). Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), IRBESARTAN, PARACETAMOL (TYLENOL), MONTELUKAST SODIUM (SINGULAIR), TAMSULOSIN, GUAIFENESIN (MUCINEX), METFORMIN and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced DIARRHOEA (Diarrhea five days after getting the vaccine). On an unknown date, the patient experienced NECK PAIN (Pain in the neck and shoulder area) and ARTHRALGIA (Pain in the neck and shoulder area). At the time of the report, DIARRHOEA (Diarrhea five days after getting the vaccine), NECK PAIN (Pain in the neck and shoulder area) and ARTHRALGIA (Pain in the neck and shoulder area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No new information; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds: BYSTOLIC; IRBESARTAN; TYLENOL; SINGULAIR; TAMSULOSIN; MUCINEX; METFORMIN; ZYRTEC ALLERGY

Current Illness:

ID: 1594718
Sex: F
Age:
State: FL

Vax Date: 01/14/2021
Onset Date: 01/21/2021
Rec V Date: 08/21/2021
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: Localized rash below injection site; Rash under site of injection; This spontaneous case was reported by a physician and describes the occurrence of RASH (Localized rash below injection site) and INJECTION SITE RASH (Rash under site of injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE RASH (Rash under site of injection). On 22-Jan-2021, the patient experienced RASH (Localized rash below injection site). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. On 23-Jan-2021, INJECTION SITE RASH (Rash under site of injection) had resolved. On 24-Jan-2021, RASH (Localized rash below injection site) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Added event. Updated Address, age, route of administration, anatomical location. Added patient demographics.

Other Meds:

Current Illness:

ID: 1594719
Sex: F
Age: 78
State: CT

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/21/2021
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: pain in arm; diarrhoea; stomach pains; vomited; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 07-Dec-2020. Concomitant products included ATORVASTATIN, FLUOXETINE and AMOXICILLIN TRIHYDRATE (AMOXISOL) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm) and DIARRHOEA (diarrhoea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jan-2021, ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) and DIARRHOEA (diarrhoea) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. 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. This case was linked to MOD-2021-133408 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up information was received on 15-MAY-2021, Additional information included onset date of medical history, updated additional events.; 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: ATORVASTATIN; FLUOXETINE; AMOXISOL

Current Illness:

ID: 1594720
Sex: F
Age: 72
State: NJ

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/21/2021
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: throat felt funny,felt like she had cotton in her throat; arm was very painful; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (throat felt funny,felt like she had cotton in her throat) and PAIN IN EXTREMITY (arm was very painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. no medical history was reported. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), BUPROPION, LORAZEPAM (ATIVAN), ZOLEDRONIC ACID (RECLAST), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), COLFORSIN, CURCUMA LONGA (TURMERIC + FORSKOLIN) and FOLIC ACID (FOLATE) for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat felt funny,felt like she had cotton in her throat) and PAIN IN EXTREMITY (arm was very painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of unknown and PARACETAMOL (TYLENOL) at a dose of unknown. On 18-Jan-2021, OROPHARYNGEAL DISCOMFORT (throat felt funny,felt like she had cotton in her throat) had resolved. On 20-Jan-2021, PAIN IN EXTREMITY (arm was very painful) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ZOLOFT; BUPROPION; ATIVAN; RECLAST; VITAMIN D 2000; TURMERIC + FORSKOLIN; FOLATE

Current Illness:

ID: 1594721
Sex: F
Age: 88
State: NY

Vax Date: 01/21/2021
Onset Date: 01/30/2021
Rec V Date: 08/21/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Large red lesion (as big as a cookie) and a lengthy red lesion (same size of a mirror handle)), INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy on the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination. The patient's past medical history included UTI, Heart valve replacement in June 2020 and Pacemaker insertion (cardiac) (Had pacemaker (left)) in June 2020. Concurrent medical conditions included AFib. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, DILTIAZEM for Cardiac valve disease, FUROSEMIDE (FUROSIMIDE) for Diuretic therapy, VITAMIN D [VITAMIN D NOS] for Supplementation therapy, ASCORBIC ACID, OLIGOMERIC PROANTHOCYANIDIN, VACCINIUM MACROCARPON (CRANBERRY CHOCOLATE) for Urinary tract infection. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced SKIN LESION (Large red lesion (as big as a cookie) and a lengthy red lesion (same size of a mirror handle)), INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy on the injection site). At the time of the report, SKIN LESION (Large red lesion (as big as a cookie) and a lengthy red lesion (same size of a mirror handle)), INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy on the injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Adverse event reporting form completed. Updated the reporter details and vaccination details. On 27-Jul-2021: Non-significant follow-up received. Best doctor/HCP contact detail updated.

Other Meds: DILTIAZEM; ELIQUIS; FUROSIMIDE; VITAMIN D [VITAMIN D NOS]; CRANBERRY CHOCOLATE

Current Illness: AFib

ID: 1594722
Sex: F
Age: 69
State: NJ

Vax Date: 01/22/2021
Onset Date: 01/29/2021
Rec V Date: 08/21/2021
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: Rectangle on skin of right arm; Pain at injection site; Skin is hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Skin is hot to touch), SCAR (Rectangle on skin of right arm) and VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Skin is hot to touch) and VACCINATION SITE PAIN (Pain at injection site). On 31-Jan-2021, the patient experienced SCAR (Rectangle on skin of right arm). On 01-Feb-2021, VACCINATION SITE WARMTH (Skin is hot to touch) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, SCAR (Rectangle on skin of right arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment medications were taken by the patient. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021 does not contain any new information.

Other Meds:

Current Illness: Asthma

ID: 1594723
Sex: F
Age:
State: MI

Vax Date: 01/22/2021
Onset Date: 01/31/2021
Rec V Date: 08/21/2021
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: Red bumpy rash that was warm to the touch at the injection site; Red bumpy rash that was warm to the touch at the injection site; Red bumpy rash that was warm to the touch at the injection site; Headache; Vaccination Site Rash; Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), VACCINATION SITE WARMTH (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE PRURITUS (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (Red bumpy rash that was warm to the touch at the injection site) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (30 years ago). 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 URTICARIA (Hives). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE PRURITUS (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (Red bumpy rash that was warm to the touch at the injection site), HEADACHE (Headache) and VACCINATION SITE RASH (Vaccination Site Rash). At the time of the report, URTICARIA (Hives), VACCINATION SITE WARMTH (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE PRURITUS (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (Red bumpy rash that was warm to the touch at the injection site), HEADACHE (Headache) and VACCINATION SITE RASH (Vaccination Site Rash) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Case comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up received captured reporter email address.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Penicillin allergy (30 years ago)

ID: 1594724
Sex: F
Age: 67
State: NC

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/21/2021
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: Pain in the injection arm; Pain in the neck; Pain in the Shoulder; Numbness of the Face; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the neck), PAIN IN EXTREMITY (Pain in the Shoulder), HYPOAESTHESIA (Numbness of the Face) and INJECTION SITE PAIN (Pain in the injection arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Psoriasis. Concomitant products included VITAMINS NOS 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 26-Jan-2021, the patient experienced NECK PAIN (Pain in the neck), PAIN IN EXTREMITY (Pain in the Shoulder) and HYPOAESTHESIA (Numbness of the Face). On 02-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 26-Jan-2021, NECK PAIN (Pain in the neck), PAIN IN EXTREMITY (Pain in the Shoulder) and HYPOAESTHESIA (Numbness of the Face) had resolved. At the time of the report, INJECTION SITE PAIN (Pain in the injection arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-248297 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received and contains information about 2nd dose, Concomitant medication was added and medical history was added.

Other Meds: VITAMINS NOS

Current Illness: Asthma

ID: 1594725
Sex: F
Age: 84
State: FL

Vax Date: 01/07/2021
Onset Date: 01/10/2021
Rec V Date: 08/21/2021
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: Improper balance; Inner ear issue like improper balance; Nausea; Dizziness; Hard time moving; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Improper balance), DIZZINESS (Dizziness), HYPOKINESIA (Hard time moving), EAR DISORDER (Inner ear issue like improper balance) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Walker user (Using a walker to prevent risk of fall) and Contrast media allergy (Contrast dye). Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER), SOTALOL, WARFARIN, CALCIUM and MAGNESIUM for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced DIZZINESS (Dizziness), HYPOKINESIA (Hard time moving) and NAUSEA (Nausea). On 16-Jan-2021, the patient experienced BALANCE DISORDER (Improper balance) and EAR DISORDER (Inner ear issue like improper balance). On 16-Jan-2021, DIZZINESS (Dizziness), HYPOKINESIA (Hard time moving) and NAUSEA (Nausea) had resolved. At the time of the report, BALANCE DISORDER (Improper balance) and EAR DISORDER (Inner ear issue like improper balance) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information include OTC Meclizine 35 mg: on empty stomach in AM of 10th January then after 25 mg on empty stomach in AM (changed dosage 5 days ago) Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI

Other Meds: METFORMIN ER; SOTALOL; WARFARIN; CALCIUM; MAGNESIUM

Current Illness: Contrast media allergy (Contrast dye); Walker user (Using a walker to prevent risk of fall)

ID: 1594726
Sex: F
Age: 97
State: IL

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/21/2021
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: arm hurt; vomiting; trouble getting her throat cleared; arm was a little red; arm was swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (arm hurt), VOMITING (vomiting), THROAT IRRITATION (trouble getting her throat cleared), ERYTHEMA (arm was a little red) and PERIPHERAL SWELLING (arm was swollen) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (arm hurt), VOMITING (vomiting), THROAT IRRITATION (trouble getting her throat cleared), ERYTHEMA (arm was a little red) and PERIPHERAL SWELLING (arm was swollen). The patient was treated with ONDANSETRON (ZOFRAN MELT) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 27-Jan-2021, VOMITING (vomiting) and THROAT IRRITATION (trouble getting her throat cleared) had resolved. On 30-Jan-2021, PAIN (arm hurt), ERYTHEMA (arm was a little red) and PERIPHERAL SWELLING (arm was swollen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1594727
Sex: F
Age: 75
State:

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 08/21/2021
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: Rash; Itchy; Swollen; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1594728
Sex: M
Age: 84
State: FL

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/21/2021
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: Aches; weakness; loose stool; flu like symptoms; Not eating well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), ASTHENIA (weakness), DIARRHOEA (loose stool), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (Not eating well) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-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 PAIN (Aches), ASTHENIA (weakness), DIARRHOEA (loose stool), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (Not eating well). At the time of the report, PAIN (Aches), ASTHENIA (weakness), DIARRHOEA (loose stool), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (Not eating well) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1594729
Sex: F
Age: 76
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/21/2021
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: Dizzy; Erratic heart rate; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy) and HEART RATE ABNORMAL (Erratic heart rate) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20a) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (almost to every antibiotic). Concomitant products included B-COMPLEX + VITAMIN C for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (Dizzy) and HEART RATE ABNORMAL (Erratic heart rate). On 21-Jan-2021, DIZZINESS (Dizzy) and HEART RATE ABNORMAL (Erratic heart rate) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 110/60 (normal) 110/60 on average. On an unknown date, Heart rate: 62 (normal) resting heart rate in bed is 62 beats per minute, 72 (normal) when moving around is usually about 72 beats per minute and When it (heart rate) was erratic it ranged from 40-83 beats per minute. 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. Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Followup received on 31-mar-2021. NNI

Other Meds: B-COMPLEX + VITAMIN C

Current Illness: Drug allergy (almost to every antibiotic)

ID: 1594730
Sex: F
Age: 25
State: PA

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/21/2021
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: Tingling Sensation; Black and Blue mark; Don't feel good; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling Sensation), SKIN DISCOLOURATION (Black and Blue mark) and FEELING ABNORMAL (Don't feel good) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, VITAMINS NOS for an unknown indication. 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 PARAESTHESIA (Tingling Sensation), SKIN DISCOLOURATION (Black and Blue mark) and FEELING ABNORMAL (Don't feel good). At the time of the report, PARAESTHESIA (Tingling Sensation), SKIN DISCOLOURATION (Black and Blue mark) and FEELING ABNORMAL (Don't feel good) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Email address of reporter updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: BREO ELLIPTA; VITAMINS NOS

Current Illness: Asthma

ID: 1594731
Sex: M
Age: 84
State: TX

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/21/2021
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: Arm had welts; Arm was red; arm was itchy; arm was blotchy; My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), URTICARIA (Arm had welts), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PRURITUS (arm was itchy) and RASH MACULAR (arm was blotchy) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). On 26-Jan-2021, the patient experienced URTICARIA (Arm had welts), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PRURITUS (arm was itchy) and RASH MACULAR (arm was blotchy). At the time of the report, PAIN IN EXTREMITY (My arm was sore), URTICARIA (Arm had welts), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PRURITUS (arm was itchy) and RASH MACULAR (arm was blotchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: The followup does not contain any new information.

Other Meds:

Current Illness:

ID: 1594732
Sex: F
Age: 74
State: TX

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/21/2021
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: swelling up and down her arm; itchiness in her arm; heat in her arm; fever in her arm; moderate site reaction; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling up and down her arm), PRURITUS (itchiness in her arm), FEELING HOT (heat in her arm), VACCINATION SITE REACTION (moderate site reaction) and PYREXIA (fever in her arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE REACTION (moderate site reaction). On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling up and down her arm), PRURITUS (itchiness in her arm), FEELING HOT (heat in her arm) and PYREXIA (fever in her arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (swelling up and down her arm), PRURITUS (itchiness in her arm), FEELING HOT (heat in her arm), VACCINATION SITE REACTION (moderate site reaction) and PYREXIA (fever in her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant information was provided by the reporter Other treatment information: ice Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up document is received on 08-JUN-2021 and it is NNI

Other Meds:

Current Illness:

ID: 1594733
Sex: F
Age:
State: AZ

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/21/2021
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: got round and swollen, oval; itchy; developed big hives at the site of the injection, about a 3-inch welt; a little sore at the site when she touched it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little sore at the site when she touched it), PERIPHERAL SWELLING (got round and swollen, oval), PRURITUS (itchy) and VACCINATION SITE URTICARIA (developed big hives at the site of the injection, about a 3-inch welt) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Drug allergy (allergic to codeine). Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN and ERGOCALCIFEROL for Allergy, DESLORATADINE (CLARINEX [DESLORATADINE]), MONTELUKAST and TRIAMCINOLONE for Allergy NOS. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (a little sore at the site when she touched it). On 01-Feb-2021, the patient experienced PERIPHERAL SWELLING (got round and swollen, oval), PRURITUS (itchy) and VACCINATION SITE URTICARIA (developed big hives at the site of the injection, about a 3-inch welt). The patient was treated with DESLORATADINE (CLARINEX [DESLORATADINE]) at an unspecified dose and frequency; TRIAMCINOLONE at an unspecified dose and frequency and MONTELUKAST at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a little sore at the site when she touched it), PERIPHERAL SWELLING (got round and swollen, oval), PRURITUS (itchy) and VACCINATION SITE URTICARIA (developed big hives at the site of the injection, about a 3-inch welt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitants-Ergocalciferol, Triamcinolone Cream Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-june-2021 and does not contain any significant information

Other Meds: CLARINEX [DESLORATADINE]; MONTELUKAST; HYDROCHLOROTHIAZIDE; TELMISARTAN; ERGOCALCIFEROL; TRIAMCINOLONE

Current Illness: Penicillin allergy; Sulfonamide allergy

ID: 1594734
Sex: F
Age: 74
State: CA

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/21/2021
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: Whole Upper arm red; Whole Upper arm itching; Upper arm harden; Sore at injection site; Upper arm swollen; Left upper arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site), VACCINATION SITE SWELLING (Upper arm swollen), INJECTION SITE ERYTHEMA (Whole Upper arm red), VACCINATION SITE PRURITUS (Whole Upper arm itching) and VACCINATION SITE INDURATION (Upper arm harden) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension (Under Control) in 1975. Concurrent medical conditions included Drug allergy (Cephhalexin) since 05-Jun-2021. Concomitant products included ATENOLOL and CHLORTHALIDONE for Hypertension, OXYMETHOLONE (ANADROL) and LOSARTAN for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Upper arm swollen) and LIMB DISCOMFORT (Left upper arm sore). On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site), INJECTION SITE ERYTHEMA (Whole Upper arm red), VACCINATION SITE PRURITUS (Whole Upper arm itching) and VACCINATION SITE INDURATION (Upper arm harden). The patient was treated with SERTRALINE HYDROCHLORIDE (ZEPHYR) (oral) from 27-Jan-2021 to 31-Jan-2021 for Vaccination site erythema, at a dose of 1 dosage form, 2/days and NAPROXEN SODIUM (ALEVE) (oral) on 27-Jan-2021 for Injection site reaction, at a dose of 1 dosage form, 4 /days. At the time of the report, VACCINATION SITE PAIN (Sore at injection site), VACCINATION SITE SWELLING (Upper arm swollen), INJECTION SITE ERYTHEMA (Whole Upper arm red), VACCINATION SITE PRURITUS (Whole Upper arm itching), VACCINATION SITE INDURATION (Upper arm harden) and LIMB DISCOMFORT (Left upper arm sore) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 23 Jan 2021, left upper arm started getting sore in the afternoon. On 24 Jan 2021 the left arm sore was worsening. On 25 Jan 2021, the injection site area hardened and turned red and itchy. On 27 Jan 2021, The patient called her doctor and was advised to take Zephyr and Aleve four times a day for five days as the symptoms disappeared. Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-JUN-2021.Patient information Updated. Second dose information Updated.

Other Meds: ANADROL; LOSARTAN; ATENOLOL; CHLORTHALIDONE

Current Illness: Drug allergy (Cephhalexin)

ID: 1594735
Sex: F
Age: 80
State: FL

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/21/2021
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: chills; got hard; arm was puffy, swelled up very badly, and it got hard and red.; hurt when needle put in arm still sore; got red; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE INDURATION (got hard), VACCINATION SITE SWELLING (arm was puffy, swelled up very badly, and it got hard and red.), VACCINATION SITE PAIN (hurt when needle put in arm still sore), VACCINATION SITE ERYTHEMA (got red) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE INDURATION (got hard), VACCINATION SITE SWELLING (arm was puffy, swelled up very badly, and it got hard and red.), VACCINATION SITE PAIN (hurt when needle put in arm still sore) and VACCINATION SITE ERYTHEMA (got red). On 29-Jan-2021, the patient experienced CHILLS (chills). At the time of the report, VACCINATION SITE INDURATION (got hard), VACCINATION SITE SWELLING (arm was puffy, swelled up very badly, and it got hard and red.), VACCINATION SITE PAIN (hurt when needle put in arm still sore), VACCINATION SITE ERYTHEMA (got red) and CHILLS (chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional information received: Updated event outcome updated

Other Meds:

Current Illness:

ID: 1594736
Sex: F
Age: 32
State: DC

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/21/2021
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: This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination. The patient's past medical history included Alcohol use (1 drink/day before pregnancy) in 2008 and Marijuana use. Concomitant products included PARACETAMOL (TYLENOL) for Pain management and Headache, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 14-Oct-2020 to an unknown date and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twentieth week of the pregnancy. The delivery occurred on 08-May-2021, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. pre-eclampsia diagnosed on 07-May-2021, emergency C-section took place on 08-May-2021. On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore at injection site) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2020, Pregnancy test: positive (Positive) positive. On 15-Jan-2021, Ultrasound abdomen: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included unspecified antimalarial drugs. Obstetric panel tests (first trimester maternal sequential screening panel) were conducted on 02-Nov-2020 which showed normal pregnancy-associated plasma protein A. On 11-Jan-2021, Maternal serum alpha fetoprotein screening test showed negative. Regular ultrasounds were normal. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during this pregnancy. Number of fetuses was reported as 1. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received on 13 May 2021 added outcome of events, concomitant medications and laboratory details.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ADVIL 12 HOUR; TYLENOL; ZYRTEC ALLERGY

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm