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: 1552586
Sex: M
Age: 40
State: UT

Vax Date: 02/17/2021
Onset Date: 02/22/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: little pinches of aches here and there on his arms and legs; little body aches; Joint pain in my knees; nauseated/nauseated a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little pinches of aches here and there on his arms and legs), PAIN (little body aches), ARTHRALGIA (Joint pain in my knees) and NAUSEA (nauseated/nauseated a little bit) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (little pinches of aches here and there on his arms and legs), PAIN (little body aches), ARTHRALGIA (Joint pain in my knees) and NAUSEA (nauseated/nauseated a little bit). At the time of the report, PAIN IN EXTREMITY (little pinches of aches here and there on his arms and legs), PAIN (little body aches), ARTHRALGIA (Joint pain in my knees) and NAUSEA (nauseated/nauseated a little bit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1552587
Sex: F
Age:
State: PA

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: COVID R arm; Sore R arm; Itchy R arm; Redness R arm; Rash over R arm; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (COVID R arm), PAIN IN EXTREMITY (Sore R arm), PRURITUS (Itchy R arm), VACCINATION SITE ERYTHEMA (Redness R arm) and RASH (Rash over R arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Allergic to atropine). Concomitant products included ATENOLOL, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and AMPICILLIN for an unknown indication. On 10-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 DERMATITIS ALLERGIC (COVID R arm), PAIN IN EXTREMITY (Sore R arm), PRURITUS (Itchy R arm), VACCINATION SITE ERYTHEMA (Redness R arm) and RASH (Rash over R arm). At the time of the report, DERMATITIS ALLERGIC (COVID R arm), PAIN IN EXTREMITY (Sore R arm), PRURITUS (Itchy R arm), VACCINATION SITE ERYTHEMA (Redness R arm) and RASH (Rash over R arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: ATENOLOL; CALCIUM; VITAMIN D 2000; AMPICILLIN

Current Illness:

ID: 1552588
Sex: F
Age: 68
State: FL

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Right ear unable to hear; Right ear loud ringing; Right side of face swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS (Right ear unable to hear), TINNITUS (Right ear loud ringing) and SWELLING FACE (Right side of face swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. Concurrent medical conditions included Urinary tract infection. Concomitant products included CIPROFLOXACIN (CIPRO CARE) from 23-Feb-2021 to an unknown date for Urinary tract infection. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPOACUSIS (Right ear unable to hear), TINNITUS (Right ear loud ringing) and SWELLING FACE (Right side of face swollen). In February 2021, HYPOACUSIS (Right ear unable to hear), TINNITUS (Right ear loud ringing) and SWELLING FACE (Right side of face swollen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: CIPRO CARE

Current Illness: Urinary tract infection

ID: 1552589
Sex: F
Age: 72
State: OH

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: warm left arm rash; Right arm is also slightly warm; sometimes itches ("comes and goes"); Swollen left arm; A little pink left arm rash; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm left arm rash), SKIN WARM (Right arm is also slightly warm), PRURITUS (sometimes itches ("comes and goes")), VACCINATION SITE SWELLING (Swollen left arm) and VACCINATION SITE RASH (A little pink left arm rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Eye injury (she has,one eye, due to injury years ago). Concurrent medical conditions included Hypertension, Hypothyroidism and Allergy to antibiotic (Certain antibiotics). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (BABY ASPIRIN) and FOLIC ACID for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm left arm rash), SKIN WARM (Right arm is also slightly warm), PRURITUS (sometimes itches ("comes and goes")), VACCINATION SITE SWELLING (Swollen left arm), VACCINATION SITE RASH (A little pink left arm rash) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (warm left arm rash), SKIN WARM (Right arm is also slightly warm), PRURITUS (sometimes itches ("comes and goes")), VACCINATION SITE SWELLING (Swollen left arm), VACCINATION SITE RASH (A little pink left arm rash) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: PLAVIX; BABY ASPIRIN; FOLIC ACID

Current Illness: Hypertension; Hypothyroidism

ID: 1552590
Sex: M
Age: 25
State: AL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Diagnosed with COVID; Aches/pains; flu like symptoms; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID), PAIN (Aches/pains), INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (sore arm) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391L20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 22-Jan-2021, the patient experienced PAIN (Aches/pains) and INFLUENZA LIKE ILLNESS (flu like symptoms). On 29-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 22-Jan-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, COVID-19 (Diagnosed with COVID), PAIN (Aches/pains) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, COVID-19: covid (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient reported that his AE lasted for about 18 hours. Treatment included Tylenol. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: fallow up received on 29-jun-2021 - outcome of the events was updated form unknown to recovered resolved

Other Meds: LIPITOR; LISINOPRIL; SINGULAIR; CLARITIN ALLERGIC

Current Illness:

ID: 1552591
Sex: F
Age:
State:

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

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Weakness; Headaches; Low grade fever - Temp 100, normally ~97.6; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEADACHE (Headaches) and PYREXIA (Low grade fever - Temp 100, normally ~97.6) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. 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 ASTHENIA (Weakness), HEADACHE (Headaches) and PYREXIA (Low grade fever - Temp 100, normally ~97.6). At the time of the report, ASTHENIA (Weakness), HEADACHE (Headaches) and PYREXIA (Low grade fever - Temp 100, normally ~97.6) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 100 (Inconclusive) 100. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1552592
Sex: F
Age:
State:

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: trouble walking.; arm at the injection site was sore and swollen; arm at the injection site was sore and swollen; fever of 100.0; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (trouble walking.), VACCINATION SITE SWELLING (arm at the injection site was sore and swollen), VACCINATION SITE PAIN (arm at the injection site was sore and swollen) and PYREXIA (fever of 100.0) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced GAIT DISTURBANCE (trouble walking.), VACCINATION SITE SWELLING (arm at the injection site was sore and swollen), VACCINATION SITE PAIN (arm at the injection site was sore and swollen) and PYREXIA (fever of 100.0). At the time of the report, GAIT DISTURBANCE (trouble walking.), VACCINATION SITE SWELLING (arm at the injection site was sore and swollen), VACCINATION SITE PAIN (arm at the injection site was sore and swollen) and PYREXIA (fever of 100.0) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: high (High) 100. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1552593
Sex: M
Age:
State: GA

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: he had temperature; slight fever; chills; body ache/muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE (he had temperature), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. 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 BODY TEMPERATURE (he had temperature), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body ache/muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE (he had temperature), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no concomitant drug was given to patient no treatment was received by the patient Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Followup received on 12-JUL-2021. It provides no new information.

Other Meds:

Current Illness:

ID: 1552594
Sex: M
Age:
State: ME

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and VOMITING (vomiting). At the time of the report, CHILLS (chills) and VOMITING (vomiting) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1552595
Sex: F
Age: 63
State: MD

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Potassium level came back high; LDL came back high; HDL came back high; Total cholesterol came back high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD POTASSIUM INCREASED (Potassium level came back high), LOW DENSITY LIPOPROTEIN INCREASED (LDL came back high), HIGH DENSITY LIPOPROTEIN INCREASED (HDL came back high) and BLOOD CHOLESTEROL INCREASED (Total cholesterol came back high) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN, DILTIAZEM, APIXABAN (ELIQUIS), LEVOTHYROXINE and LANSOPRAZOLE (PREVACID) for an unknown indication. On 08-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 BLOOD POTASSIUM INCREASED (Potassium level came back high), LOW DENSITY LIPOPROTEIN INCREASED (LDL came back high), HIGH DENSITY LIPOPROTEIN INCREASED (HDL came back high) and BLOOD CHOLESTEROL INCREASED (Total cholesterol came back high). At the time of the report, BLOOD POTASSIUM INCREASED (Potassium level came back high), LOW DENSITY LIPOPROTEIN INCREASED (LDL came back high), HIGH DENSITY LIPOPROTEIN INCREASED (HDL came back high) and BLOOD CHOLESTEROL INCREASED (Total cholesterol came back high) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received on 12 Jul 2021 contains non significant information

Other Meds: HYDROCHLOROTHIAZIDE; LOSARTAN; DILTIAZEM; ELIQUIS; LEVOTHYROXINE; PREVACID

Current Illness:

ID: 1552596
Sex: F
Age:
State: AZ

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE ERYTHEMA (Red ball), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-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 VACCINATION SITE PRURITUS (itchy left arm). On 02-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,). On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red ball). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (hard, bump,bigger ball, without heat,), VACCINATION SITE PRURITUS (itchy left arm), VACCINATION SITE ERYTHEMA (Red ball), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (Fever (100.8F)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 f (High) fever (100.8F). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1552597
Sex: F
Age: 36
State: IL

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Lingering numbness behind her left ear and left side of the neck; Feels like something is off; Soreness in the lymph node in her left arm pit; Soreness in her neck; Numbness on left side of her face from the eyebrow down to her jaw and around her lip; Tenderness where she had the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on left side of her face from the eyebrow down to her jaw and around her lip), HYPOAESTHESIA (Lingering numbness behind her left ear and left side of the neck), NECK PAIN (Soreness in her neck), FEELING ABNORMAL (Feels like something is off) and LYMPH NODE PAIN (Soreness in the lymph node in her left arm pit) in a 36-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. Concurrent medical conditions included Fracture bone (Permanent fractured sesamoid bone in left foot.) since 2009. Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL FE 1/20) for Birth control. On 28-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness where she had the vaccine). On 28-Jan-2021 at 12:20 PM, the patient experienced HYPOAESTHESIA (Numbness on left side of her face from the eyebrow down to her jaw and around her lip). On 31-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NECK PAIN (Soreness in her neck). On 03-Feb-2021, the patient experienced LYMPH NODE PAIN (Soreness in the lymph node in her left arm pit). On an unknown date, the patient experienced HYPOAESTHESIA (Lingering numbness behind her left ear and left side of the neck) and FEELING ABNORMAL (Feels like something is off). On 01-Feb-2021, HYPOAESTHESIA (Numbness on left side of her face from the eyebrow down to her jaw and around her lip) had resolved. On 18-Feb-2021, NECK PAIN (Soreness in her neck) and LYMPH NODE PAIN (Soreness in the lymph node in her left arm pit) had resolved. At the time of the report, HYPOAESTHESIA (Lingering numbness behind her left ear and left side of the neck), FEELING ABNORMAL (Feels like something is off) and VACCINATION SITE PAIN (Tenderness where she had the vaccine) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No Concomitant information provided. Treatment included Advil and warm compresses Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information was received on 28 Apr 2021. Additional information on patient details, medical history, concomitant medication, event details, action taken were added. On 25-May-2021: Follow up received on 25-may-2021 contains no new information.

Other Meds: JUNEL FE 1/20

Current Illness: Fracture bone (Permanent fractured sesamoid bone in left foot.)

ID: 1552598
Sex: M
Age: 42
State: CA

Vax Date: 12/20/2020
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Fatigue; Muscle ache; Headache; Fever; Chills; Given 1ml dose instead of .5ml; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021. This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (Given 1ml dose instead of .5ml), FATIGUE (Fatigue), MYALGIA (Muscle ache), HEADACHE (Headache) and PYREXIA (Fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 8:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 28-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Given 1ml dose instead of .5ml). On an unknown date, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle ache), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 28-Jan-2021, OVERDOSE (Given 1ml dose instead of .5ml) had resolved. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle ache), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The reporter stated that on 28-Jan-2021, one of the vaccinators reported potentially overdosing 2 individuals while giving the moderna covid vaccine. They possibly received 1ml of dosage instead of 0.5ml. The action taken with mRNA-1273 in response to the event was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-022427 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information received on 26-Apr-2021 contains information regarding patient demographics, dosing details, and additional events.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-022427:Same reporter

Other Meds:

Current Illness:

ID: 1552599
Sex: F
Age:
State: TX

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: raised bubble in the rash; itchiness; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itchiness, raised bubbles in the rash. 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 her first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced itchiness, raised bubbles in the rash.. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events itchiness, raised bubbles in the rash was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1552600
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: swelling, like a bump, redness and itchiness at the injection site; swelling, like a bump, redness and itchiness at the injection site; swelling, like a bump, redness and itchiness at the injection site; as the vaccine provider remove the needle from the arm, they felt some liquid running down their arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXTRAVASATION (as the vaccine provider remove the needle from the arm, they felt some liquid running down their arm), INJECTION SITE PRURITUS (swelling, like a bump, redness and itchiness at the injection site), INJECTION SITE SWELLING (swelling, like a bump, redness and itchiness at the injection site) and INJECTION SITE ERYTHEMA (swelling, like a bump, redness and itchiness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concomitant products included type 1 diabetes oral medication and hypothyroidism oral medication for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE EXTRAVASATION (as the vaccine provider remove the needle from the arm, they felt some liquid running down their arm). On an unknown date, the patient experienced INJECTION SITE PRURITUS (swelling, like a bump, redness and itchiness at the injection site), INJECTION SITE SWELLING (swelling, like a bump, redness and itchiness at the injection site) and INJECTION SITE ERYTHEMA (swelling, like a bump, redness and itchiness at the injection site). On 02-Feb-2021, INJECTION SITE EXTRAVASATION (as the vaccine provider remove the needle from the arm, they felt some liquid running down their arm) had resolved. At the time of the report, INJECTION SITE PRURITUS (swelling, like a bump, redness and itchiness at the injection site), INJECTION SITE SWELLING (swelling, like a bump, redness and itchiness at the injection site) and INJECTION SITE ERYTHEMA (swelling, like a bump, redness and itchiness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: type 1 diabetes oral medication; hypothyroidism oral medication

Current Illness:

ID: 1552601
Sex: M
Age: 52
State: FL

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Arm is sore; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) and FATIGUE (Little tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-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 VACCINATION SITE PAIN (Arm is sore) and FATIGUE (Little tired). At the time of the report, VACCINATION SITE PAIN (Arm is sore) and FATIGUE (Little tired) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-023993 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-023993:Crosslinked (MOD21-022232)

Other Meds:

Current Illness:

ID: 1552602
Sex: U
Age: 91
State: OK

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: feeling very weak; slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling very weak) and PAIN IN EXTREMITY (slightly sore arm) in a 91-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A-72021) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included WARFARIN, FINASTERIDE, CHLORIDE, FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K) and emuferel for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feeling very weak) and PAIN IN EXTREMITY (slightly sore arm). At the time of the report, ASTHENIA (feeling very weak) and PAIN IN EXTREMITY (slightly sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: WARFARIN; FINASTERIDE; CHLORIDE; LASIX + K; emuferel

Current Illness:

ID: 1552603
Sex: F
Age:
State: CO

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041220A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1552604
Sex: F
Age: 66
State: NJ

Vax Date: 01/27/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Warm to touch; Harder than rest of my arm; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Harder than rest of my arm) and VACCINATION SITE ERYTHEMA (Red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included HYDROCHLOROTHIAZIDE, ROSUVASTATIN and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) 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 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Harder than rest of my arm) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Harder than rest of my arm) and VACCINATION SITE ERYTHEMA (Red) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was not provided by the reporter. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant follow-up received included information about outcome of the events and was updated to recovered.

Other Meds: HYDROCHLOROTHIAZIDE; ROSUVASTATIN; BYSTOLIC

Current Illness:

ID: 1552605
Sex: F
Age:
State: PA

Vax Date: 02/02/2021
Onset Date: 02/01/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: very very itchy; red and all over; hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (very very itchy) and ERYTHEMA (red and all over) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Hives (The day before vaccination, 01Feb2021, patient had eaten a cereal and had developed hives (patient said it was itchy but in a scale 1-10 it was a 2)) since 01-Feb-2021. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced URTICARIA (hives). On 02-Feb-2021, the patient experienced PRURITUS (very very itchy) and ERYTHEMA (red and all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives), PRURITUS (very very itchy) and ERYTHEMA (red and all over) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness: Hives (The day before vaccination, 01Feb2021, patient had eaten a cereal and had developed hives (patient said it was itchy but in a scale 1-10 it was a 2))

ID: 1552606
Sex: F
Age: 70
State: KY

Vax Date: 01/15/2021
Onset Date: 02/01/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: tested positive for covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 01-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). The patient was treated with BAMLANIVIMAB for Adverse event, at a dose of UNK dosage form. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1552607
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 01/26/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Lower back ache; Coughing; Blood shot eyes; Small amount of swelling on upper arm; Running nose; Joint aches; Muscle aches; Pain around injection site; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), BACK PAIN (Lower back ache), COUGH (Coughing), OCULAR HYPERAEMIA (Blood shot eyes) and PERIPHERAL SWELLING (Small amount of swelling on upper arm) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (tested positive for COVID) on 23-Dec-2020. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and VACCINATION SITE PAIN (Pain around injection site). On 27-Jan-2021, the patient experienced BACK PAIN (Lower back ache), COUGH (Coughing), OCULAR HYPERAEMIA (Blood shot eyes), PERIPHERAL SWELLING (Small amount of swelling on upper arm), RHINORRHOEA (Running nose), ARTHRALGIA (Joint aches) and MYALGIA (Muscle aches). At the time of the report, PAIN IN EXTREMITY (Soreness in arm), BACK PAIN (Lower back ache), COUGH (Coughing), OCULAR HYPERAEMIA (Blood shot eyes), PERIPHERAL SWELLING (Small amount of swelling on upper arm), RHINORRHOEA (Running nose), ARTHRALGIA (Joint aches), MYALGIA (Muscle aches) and VACCINATION SITE PAIN (Pain around injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 test positive: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1552608
Sex: F
Age: 70
State: IL

Vax Date: 02/01/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: diarrhea; weakness; vomiting; shivering/chills 3-4 hours; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ASTHENIA (weakness), VOMITING (vomiting), CHILLS (shivering/chills 3-4 hours) and NAUSEA (nauseous) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (weakness), VOMITING (vomiting), CHILLS (shivering/chills 3-4 hours) and NAUSEA (nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ASTHENIA (weakness), VOMITING (vomiting), CHILLS (shivering/chills 3-4 hours) and NAUSEA (nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1552609
Sex: F
Age: 85
State: CA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Itching at the injection site; Reaction of a rash; Redness at the injection site; Swollen injection site; Tender to the touch injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Reaction of a rash), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Tender to the touch injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (to sulfur) and Penicillin allergy. Concomitant products included LISINOPRIL, LEVOTHYROXINE, RIVAROXABAN (XARELTO), METOPROLOL TARTRATE, VITAMIN D3 and CALCIUM 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 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE PAIN (Tender to the touch injection site). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Reaction of a rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with LORATADINE (oral) ongoing since an unknown date for Itching, at a dose of 1 dosage form every 24 hours. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) had resolved and VACCINATION SITE RASH (Reaction of a rash), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Tender to the touch injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: LISINOPRIL; LEVOTHYROXINE; XARELTO; METOPROLOL TARTRATE; VITAMIN D3; CALCIUM

Current Illness: Drug allergy (to sulfur); Penicillin allergy

ID: 1552610
Sex: M
Age: 80
State: IL

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: tiredness; tender arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender arm) and FATIGUE (tiredness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer. 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 TENDERNESS (tender arm). On an unknown date, the patient experienced FATIGUE (tiredness). On 28-Jan-2021, TENDERNESS (tender arm) had resolved. At the time of the report, FATIGUE (tiredness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-016013 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Event added , relevant history added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-016013:Crosslinked (MOD21-020670)

Other Meds:

Current Illness: Cancer

ID: 1552611
Sex: F
Age: 34
State: OH

Vax Date: 01/21/2021
Onset Date: 01/23/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: loss of smell; loss of taste; congestion; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell), AGEUSIA (loss of taste), NASAL CONGESTION (congestion) and FATIGUE (fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ANOSMIA (loss of smell), AGEUSIA (loss of taste), NASAL CONGESTION (congestion) and FATIGUE (fatigue). At the time of the report, ANOSMIA (loss of smell), AGEUSIA (loss of taste), NASAL CONGESTION (congestion) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: negative (Negative) Patient tested negative twice. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1552612
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: looks like Condyloma or inflamed taste bud; m Redness at injection site; Tiny white spot that has grown under her tongue; Soreness of arm; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of ANOGENITAL WARTS (looks like Condyloma or inflamed taste bud), TONGUE PIGMENTATION (Tiny white spot that has grown under her tongue), PAIN IN EXTREMITY (Soreness of arm), PYREXIA (pyrexia) and VACCINATION SITE ERYTHEMA (m Redness at injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (pyrexia). On 03-Feb-2021, the patient experienced TONGUE PIGMENTATION (Tiny white spot that has grown under her tongue) and PAIN IN EXTREMITY (Soreness of arm). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (m Redness at injection site). On 05-Feb-2021, the patient experienced ANOGENITAL WARTS (looks like Condyloma or inflamed taste bud). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunization, at an unspecified dose and frequency. At the time of the report, ANOGENITAL WARTS (looks like Condyloma or inflamed taste bud), TONGUE PIGMENTATION (Tiny white spot that has grown under her tongue), PAIN IN EXTREMITY (Soreness of arm), PYREXIA (pyrexia) and VACCINATION SITE ERYTHEMA (m Redness at injection site) outcome was unknown. No relevant concomitant medications were reported

Other Meds:

Current Illness:

ID: 1552613
Sex: F
Age: 48
State: CT

Vax Date: 01/11/2021
Onset Date: 01/25/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Asymptomatic Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (Asymptomatic Covid-19) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ASYMPTOMATIC COVID-19 (Asymptomatic Covid-19). At the time of the report, ASYMPTOMATIC COVID-19 (Asymptomatic Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test 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.; Sender's Comments: Based on the mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1552614
Sex: M
Age:
State: OK

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

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

Lab Data:

Allergies:

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

Symptoms: Flu like symptoms 8-9 hours after injection; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms 8-9 hours after injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. Concurrent medical conditions 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 INFLUENZA LIKE ILLNESS (Flu like symptoms 8-9 hours after injection). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms 8-9 hours after injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication list was not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1552615
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 01/23/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Little bit of itching; Bruise on the center; Lump on her skin; skin Warm; Rash grew to 3 to 4 inches and going around the arm (spreading); Little rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Little bit of itching), CONTUSION (Bruise on the center), MASS (Lump on her skin), SKIN WARM (skin Warm) and RASH (Little rash) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concomitant products included TRAMADOL for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (Little rash). On 30-Jan-2021, the patient experienced PRURITUS (Little bit of itching), CONTUSION (Bruise on the center), MASS (Lump on her skin), SKIN WARM (skin Warm) and RASH (Rash grew to 3 to 4 inches and going around the arm (spreading)). On 26-Jan-2021, RASH (Little rash) had resolved. At the time of the report, PRURITUS (Little bit of itching), CONTUSION (Bruise on the center), MASS (Lump on her skin), SKIN WARM (skin Warm) and RASH (Rash grew to 3 to 4 inches and going around the arm (spreading)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information provided included acetaminophen.

Other Meds: TRAMADOL

Current Illness:

ID: 1552616
Sex: F
Age: 31
State: WV

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy (Nitrous oxide allergy), Grass allergy, Seasonal allergy (trees allergy), Asthma (since childhood.) and Anxiety disorder since 09-Jan-2019. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, FLUOXETINE HYDROCHLORIDE (PROZAC) for Generalized anxiety disorder, DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) for Nausea, ACETYLSALICYLIC ACID (ASPIRIN 81) for Pregnancy, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), FOLIC ACID, VITAMIN B12 NOS and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 10-Jun-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2020, Pregnancy test: positive (Positive) Positive. On 25-Nov-2020, Ultrasound foetal: normal (normal) Normal. 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. Genetic testing done on 25 Nov 2020, Normal. Anatomy scan was done on 19 Jan 2021 (results not reported). Treatment medications were not reported.

Other Meds: PROZAC; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; UNISOM [DOXYLAMINE SUCCINATE]; ASPIRIN 81; FOLIC ACID; VITAMIN B12 NOS; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ALBUTEROL [SALBUTAMOL]

Current Illness: Allergy (Nitrous oxide allergy); Anxiety disorder; Asthma (since childhood.); Grass allergy; Seasonal allergy (trees allergy)

ID: 1552617
Sex: F
Age:
State: OH

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she had a terrible reaction to the 1st shot; Fever; Fatigue; Headache; Muscle pain; Chills; Vomited; Slept for 36 hrs; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for 36 hrs), VACCINATION COMPLICATION (she had a terrible reaction to the 1st shot), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache) in a 76-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. Concurrent medical conditions included Immunoglobulins decreased (Immunoglobulins deficiency). Concomitant products included IMMUNOGLOBULIN G HUMAN (IGG) 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 27-Jan-2021, the patient experienced HYPERSOMNIA (Slept for 36 hrs), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and VOMITING (Vomited). On an unknown date, the patient experienced VACCINATION COMPLICATION (she had a terrible reaction to the 1st shot). At the time of the report, HYPERSOMNIA (Slept for 36 hrs), VACCINATION COMPLICATION (she had a terrible reaction to the 1st shot), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and VOMITING (Vomited) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication reported was Tylenol, but patient was unsure if she actually took it. PCP advised that she should be woken up frequently to drink water. This case was linked to MOD-2021-250729 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Updated information of one new adverse event, medical history and reporter contact details are added.

Other Meds: IGG

Current Illness: Immunoglobulins decreased (Immunoglobulins deficiency)

ID: 1552618
Sex: F
Age: 69
State: MI

Vax Date: 01/26/2021
Onset Date: 02/01/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: rash spread the right wrist and began to blister; Rash spots were very itchy; rash spread to under breast about 2x2 inches/under right wrist; Raised bump on back/under armpit; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Raised bump on back/under armpit), BLISTER (rash spread the right wrist and began to blister), RASH PRURITIC (Rash spots were very itchy) and RASH (rash spread to under breast about 2x2 inches/under right wrist) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M204) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MASS (Raised bump on back/under armpit). On 02-Feb-2021, the patient experienced RASH (rash spread to under breast about 2x2 inches/under right wrist). On 04-Feb-2021, the patient experienced BLISTER (rash spread the right wrist and began to blister) and RASH PRURITIC (Rash spots were very itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, MASS (Raised bump on back/under armpit), BLISTER (rash spread the right wrist and began to blister), RASH PRURITIC (Rash spots were very itchy) and RASH (rash spread to under breast about 2x2 inches/under right wrist) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: 20-APR-2021:only reporter address was updated

Other Meds:

Current Illness:

ID: 1552619
Sex: F
Age: 73
State: OH

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Dizziness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The patient's past medical history included Surgery (surgery on throat) on 20-Apr-2021. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 05-Feb-2021, DIZZINESS (Dizziness) and PYREXIA (Fever) had resolved. No Concomitant medications were reported. No Treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Address of the reporter was added, patient age was added, pregnancy status was added as NO, first and second dose start date was added, Event was added with start and stop date On 12-Jul-2021: Follow-up information received on 12-JUL-2021; Events stop date and outcome updated.

Other Meds:

Current Illness:

ID: 1552620
Sex: F
Age: 64
State: CA

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: feeling cold; fever; very bad severe headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), PYREXIA (fever) and HEADACHE (very bad severe headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included VITAMINS NOS for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (fever) and HEADACHE (very bad severe headache). On 05-Feb-2021, the patient experienced FEELING COLD (feeling cold). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (feeling cold), PYREXIA (fever) and HEADACHE (very bad severe headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 07-Feb-2021, the patient reported another episode of headache.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1552621
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: SWOLLEN EYES; ITCHINESS; EDEMA of legs; RASH on face and legs; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (SWOLLEN EYES), PRURITUS (ITCHINESS), OEDEMA PERIPHERAL (EDEMA of legs) and RASH (RASH on face and legs) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced EYE SWELLING (SWOLLEN EYES), PRURITUS (ITCHINESS), OEDEMA PERIPHERAL (EDEMA of legs) and RASH (RASH on face and legs). At the time of the report, EYE SWELLING (SWOLLEN EYES), PRURITUS (ITCHINESS), OEDEMA PERIPHERAL (EDEMA of legs) and RASH (RASH on face and legs) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Patient reported using diphenhydramine for treating her symptoms.

Other Meds:

Current Illness:

ID: 1552622
Sex: F
Age:
State: MD

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

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

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sickness). At the time of the report, ILLNESS (sickness) outcome was unknown. Not Provided No relevant concomitant medications were provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1552623
Sex: F
Age: 75
State: NC

Vax Date: 01/21/2021
Onset Date: 01/31/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: tickle in the throat/couldn't talk; sneezed 2 or 4 times a day; roof of the mouth was rough and puffy; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (tickle in the throat/couldn't talk), SNEEZING (sneezed 2 or 4 times a day) and STOMATITIS (roof of the mouth was rough and puffy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 21-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 THROAT IRRITATION (tickle in the throat/couldn't talk), SNEEZING (sneezed 2 or 4 times a day) and STOMATITIS (roof of the mouth was rough and puffy). At the time of the report, THROAT IRRITATION (tickle in the throat/couldn't talk), SNEEZING (sneezed 2 or 4 times a day) and STOMATITIS (roof of the mouth was rough and puffy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant information provided. No treatment information provided.; 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: 1552624
Sex: F
Age: 43
State: PA

Vax Date: 01/20/2021
Onset Date: 01/29/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Skin is very little pinkish; Hot to touch at the site of injection; Itching; Redness; Swelling; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at the site of injection), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and SKIN DISCOLOURATION (Skin is very little pinkish) in a 43-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 Anaphylactic reaction to vaccine (to vaccine). Concomitant products included METFORMIN for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at the site of injection), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). On an unknown date, the patient experienced SKIN DISCOLOURATION (Skin is very little pinkish). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at the site of injection), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown and SKIN DISCOLOURATION (Skin is very little pinkish) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was advised diphenhydramine by her physician for itchiness, but she did not take it.

Other Meds: METFORMIN

Current Illness:

ID: 1552625
Sex: F
Age: 58
State: CA

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Tingling in the arms and fingers; Numbness; No strength in the arms; Cannot grip things; Soreness and redness in the arm; Rash at injection site; Felt like throwing up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Felt like throwing up), PARAESTHESIA (Tingling in the arms and fingers), MYALGIA (Soreness and redness in the arm), HYPOAESTHESIA (Numbness) and ASTHENIA (No strength in the arms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Felt like throwing up), PARAESTHESIA (Tingling in the arms and fingers), MYALGIA (Soreness and redness in the arm), HYPOAESTHESIA (Numbness), ASTHENIA (No strength in the arms), GRIP STRENGTH DECREASED (Cannot grip things) and INJECTION SITE RASH (Rash at injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of UNK dosage form. At the time of the report, NAUSEA (Felt like throwing up), PARAESTHESIA (Tingling in the arms and fingers), MYALGIA (Soreness and redness in the arm), HYPOAESTHESIA (Numbness), ASTHENIA (No strength in the arms), GRIP STRENGTH DECREASED (Cannot grip things) and INJECTION SITE RASH (Rash at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient received acupuncture in their arm which helped.

Other Meds:

Current Illness:

ID: 1552626
Sex: F
Age: 67
State: AZ

Vax Date: 02/02/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: panic attack; like she couldn't breathe; hyperventilating; feeling crappy; headache; sick to stomach; diarrhea; couldn't sleep; red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep), PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe) and HYPERVENTILATION (hyperventilating) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Spinal cord injury (Patient had spinal cord injury due to tumor she had 24 years ago and she often got 400units of Botox injected into her spine to stop muscle spasm..) since an unknown date, Hip fracture (patient had Hip fracture about 15 years ago.) since an unknown date and Spinal cord operation (Patient had two surgery done on her spinal code and last one was done in 2014, hence she tends to have neurological pain all the time.) since an unknown date. Concurrent medical conditions included Neurological disorder NOS (Neurological pain.). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Muscle spasm, IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Spinal cord injury. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep) and URTICARIA (red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs). On an unknown date, the patient experienced PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe), HYPERVENTILATION (hyperventilating), FEELING ABNORMAL (feeling crappy), HEADACHE (headache) and NAUSEA (sick to stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep), PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe), HYPERVENTILATION (hyperventilating), FEELING ABNORMAL (feeling crappy), URTICARIA (red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs), HEADACHE (headache) and NAUSEA (sick to stomach) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient gets IVIG once a month. Patient received botox up and down paraspinous muscle from neck to sacrum by HCP . Treatment includes Benadryl but patient had diarrhea in the night and couldn't sleep throughout the night. Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Significant FollowUp appended New events are added.

Other Meds: BOTOX; IVIGLOB-EX

Current Illness: Hip fracture (patient had Hip fracture about 15 years ago.); Neurological disorder NOS (Neurological pain.); Spinal cord injury (Patient had spinal cord injury due to tumor she had 24 years ago and she often got 400units of Botox injected into her spine to stop muscle spasm..); Spinal cord operation (Patient had two surgery done on her spinal code and last one was done in 2014, hence she tends to have neurological pain all the time.)

ID: 1552627
Sex: F
Age:
State: MI

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Difficulty when talking; Difficulty in breathing; Felt weak; Difficulty to swallow; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty to swallow), ASTHENIA (Felt weak), SPEECH DISORDER (Difficulty when talking) and DYSPNOEA (Difficulty in breathing) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPHAGIA (Difficulty to swallow). On 05-Feb-2021, the patient experienced ASTHENIA (Felt weak). On an unknown date, the patient experienced SPEECH DISORDER (Difficulty when talking) and DYSPNOEA (Difficulty in breathing). At the time of the report, DYSPHAGIA (Difficulty to swallow), ASTHENIA (Felt weak), SPEECH DISORDER (Difficulty when talking) and DYSPNOEA (Difficulty in breathing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood thinner medicine.

Other Meds:

Current Illness:

ID: 1552628
Sex: F
Age: 45
State: CA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: warm at location of shot; arm was red and warm and had the normal soreness and achiness; nausea; fatigue for 3-4 days; like I was going to pass out; light headed, dizzy; swelling in inner ear; unwell for 45 minutes to an hour; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (like I was going to pass out), DIZZINESS (light headed, dizzy), EAR SWELLING (swelling in inner ear), MALAISE (unwell for 45 minutes to an hour) and VACCINATION SITE WARMTH (warm at location of shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS (has History of allergies). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PRESYNCOPE (like I was going to pass out), DIZZINESS (light headed, dizzy), EAR SWELLING (swelling in inner ear), MALAISE (unwell for 45 minutes to an hour), NAUSEA (nausea) and FATIGUE (fatigue for 3-4 days). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm at location of shot) and ERYTHEMA (arm was red and warm and had the normal soreness and achiness). The patient was treated with CETIRIZINE for Premedication and Adverse reaction, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Premedication and Adverse reaction, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (like I was going to pass out), DIZZINESS (light headed, dizzy), EAR SWELLING (swelling in inner ear), MALAISE (unwell for 45 minutes to an hour), VACCINATION SITE WARMTH (warm at location of shot), ERYTHEMA (arm was red and warm and had the normal soreness and achiness), NAUSEA (nausea) and FATIGUE (fatigue for 3-4 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness: Allergy NOS (has History of allergies)

ID: 1552629
Sex: U
Age: 77
State: CA

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swollen lymph nodes on left side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes on left side) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Back pain. On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on left side). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes on left side) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other Medications: back pain medicine. No treatment information was provided. This case was linked to MOD-2021-034245 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Reporter's email address information added; Sender's Comments: MOD-2021-034245:

Other Meds:

Current Illness: Back pain

ID: 1552630
Sex: F
Age:
State: MS

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Chills; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-017817, US-MODERNATX, INC.-MOD-2021-010482, US-MODERNATX, INC.-MOD-2021-017800, US-MODERNATX, INC.-MOD-2021-017750, US-MODERNATX, INC.-MOD-2021-010477, US-MODERNATX, INC.-MOD-2021-017674, US-MODERNATX, INC.-MOD-2021-019767, US-MODERNATX, INC.-MOD-2021-019740, US-MODERNATX, INC.-MOD-2021-019718, US-MODERNATX, INC.-MOD-2021-017795, US-MODERNATX, INC.-MOD-2021-028790, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-017817:Crosslinked (MOD21-018034) US-MODERNATX, INC.-MOD-2021-010482:Crosslinked (MOD21-018048) US-MODERNATX, INC.-MOD-2021-017800:Crosslinked (MOD21-018071) US-MODERNATX, INC.-MOD-2021-017750:Crosslinked (MOD21-018080) US-MODERNATX, INC.-MOD-2021-010477:Crosslinked (MOD21-018089) US-MODERNATX, INC.-MOD-2021-017674:Crosslinked (MOD21-018092) US-MODERNATX, INC.-MOD-2021-019767:Crosslinked (MOD21-018097) US-MODERNATX, INC.-MOD-2021-019740:Crosslinked (MOD21-018102) US-MODERNATX, INC.-MOD-2021-019718:Crosslinked (MOD21-018111) US-MODERNATX, INC.-MOD-2021-017795:Crosslinked (MOD21-018119) US-MODERNATX, INC.-MOD-2021-028790:Crosslinked (MOD21-018124) US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018126)

Other Meds:

Current Illness:

ID: 1552631
Sex: M
Age: 77
State: OH

Vax Date: 01/26/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Little warmer at injection site; Solid at injection site; red rash the size of a silver dollar and solid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Little warmer at injection site), VACCINATION SITE INDURATION (Solid at injection site) and VACCINATION SITE RASH (red rash the size of a silver dollar and solid) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20) for COVID-19 vaccination. Concomitant products included Blood pressure meds for Blood pressure management, Thyroid meds for Thyroid disorder, PANTOPRAZOLE SODIUM 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 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Little warmer at injection site), VACCINATION SITE INDURATION (Solid at injection site) and VACCINATION SITE RASH (red rash the size of a silver dollar and solid). At the time of the report, VACCINATION SITE WARMTH (Little warmer at injection site), VACCINATION SITE INDURATION (Solid at injection site) and VACCINATION SITE RASH (red rash the size of a silver dollar and solid) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: follow up received on 20-JUN-2021 and contains no new information.

Other Meds: PANTOPRAZOLE SODIUM

Current Illness:

ID: 1552632
Sex: M
Age: 67
State: FL

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Outbreak of cold sore on lips; Body aches; Nausea; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Outbreak of cold sore on lips), PAIN (Body aches), NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Body aches), NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Fatigue). On 04-Feb-2021, the patient experienced ORAL HERPES (Outbreak of cold sore on lips). The patient was treated with ACETAMINOPHEN for Adverse event following immunisation, at an unspecified dose and frequency and DOCOSANOL (ABREVA) for Cold sores lip, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Outbreak of cold sore on lips), PAIN (Body aches), NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1552633
Sex: M
Age: 87
State: TX

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: General Confusion; Aphasia; Difficulty Talking Coherently, difficult time remembering wife and son's names; Intermittent Sharp Headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included Lumbar myelography (patient had a somewhat similar response several years ack to a lumbar myelogram. The fluid that is introduced called isovue which has iodine possibly aused the response.). On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches). On 31-Jan-2021, CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Computerised tomogram: (Inconclusive) Neither a CT Scan nor a MRI showed acute occurrence of bleed or blockage. On 30-Jan-2021, Magnetic resonance imaging: (Inconclusive) Neither a CT Scan nor a MRI showed acute occurrence of bleed or blockage. 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.

Other Meds:

Current Illness:

ID: 1552634
Sex: M
Age: 70
State: CA

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: flu like symptoms; extreme lethargic; delayed reaction; headache; severe muscle ache; fatigue; sever chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache) and MYALGIA (severe muscle ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache), MYALGIA (severe muscle ache), FATIGUE (fatigue) and CHILLS (sever chills). The patient was treated with IBUPROFEN ongoing since an unknown date for Fatigue and Chills, at a dose of 200 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache), MYALGIA (severe muscle ache), FATIGUE (fatigue) and CHILLS (sever chills) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products included Over the counter Prilosec: 20 milligram once a day.

Other Meds:

Current Illness:

ID: 1552635
Sex: F
Age: 72
State: IL

Vax Date: 01/26/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Injection site was itchy; Injection site was red; Injection site was swollen; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and MYALGIA (Body ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and MYALGIA (Body ache). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and MYALGIA (Body ache) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. The action taken with the drug was Not applicable.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm