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: 1557739
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: splitting migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (splitting migraine) 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) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 7:00 AM, the patient experienced MIGRAINE (splitting migraine). The patient was treated with NAPROXEN SODIUM at an unspecified dose and frequency. At the time of the report, MIGRAINE (splitting migraine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557740
Sex: M
Age: 73
State: VA

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Dont feel good; Joints ache; Headache; Fever of 100.5F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Dont feel good), PYREXIA (Fever of 100.5F), ARTHRALGIA (Joints ache) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 22-Jan-2021. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever of 100.5F). On an unknown date, the patient experienced MALAISE (Dont feel good), ARTHRALGIA (Joints ache) and HEADACHE (Headache). At the time of the report, MALAISE (Dont feel good), PYREXIA (Fever of 100.5F), ARTHRALGIA (Joints ache) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 100.5 ?F (High) Fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1557741
Sex: F
Age:
State: NJ

Vax Date: 02/04/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Right side of her upper lip swollen/ then the upper lip; Right cheek was swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Right side of her upper lip swollen/ then the upper lip) and SWELLING FACE (Right cheek was swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), TIMOLOL, LATANOPROST, AMLODIPINE BESILATE (NORVASC) and LEVOTHYROXINE SODIUM (SYNTHROID) 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 06-Feb-2021, the patient experienced LIP SWELLING (Right side of her upper lip swollen/ then the upper lip) and SWELLING FACE (Right cheek was swollen). At the time of the report, LIP SWELLING (Right side of her upper lip swollen/ then the upper lip) and SWELLING FACE (Right cheek was swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: CRESTOR; LISINOPRIL; BABY ASPIRIN; TIMOLOL; LATANOPROST; NORVASC; SYNTHROID

Current Illness:

ID: 1557742
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Rash; Fatigue; Redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), FATIGUE (Fatigue) and ERYTHEMA (Redness) in a male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash), FATIGUE (Fatigue) and ERYTHEMA (Redness). At the time of the report, RASH (Rash), FATIGUE (Fatigue) and ERYTHEMA (Redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557743
Sex: F
Age: 50
State: OH

Vax Date: 01/26/2021
Onset Date: 02/07/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: big red bulge of 2x2 inches at the injection site; It was warm to touch; big red bulge of 2x2 inches at the injection site; It is warm to touch itchy but not painful; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE MASS (big red bulge of 2x2 inches at the injection site), VACCINATION SITE WARMTH (It was warm to touch), VACCINATION SITE ERYTHEMA (big red bulge of 2x2 inches at the injection site) and VACCINATION SITE PRURITUS (It is warm to touch itchy but not painful) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LANSOPRAZOLE (PREVACID) 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 07-Feb-2021, the patient experienced VACCINATION SITE MASS (big red bulge of 2x2 inches at the injection site), VACCINATION SITE WARMTH (It was warm to touch), VACCINATION SITE ERYTHEMA (big red bulge of 2x2 inches at the injection site) and VACCINATION SITE PRURITUS (It is warm to touch itchy but not painful). At the time of the report, VACCINATION SITE MASS (big red bulge of 2x2 inches at the injection site), VACCINATION SITE WARMTH (It was warm to touch), VACCINATION SITE ERYTHEMA (big red bulge of 2x2 inches at the injection site) and VACCINATION SITE PRURITUS (It is warm to touch itchy but not painful) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other concomitant medication reported was vitamins. Reporter did not allow further contact

Other Meds: PREVACID

Current Illness:

ID: 1557744
Sex: F
Age:
State: NY

Vax Date: 01/23/2021
Onset Date: 01/25/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swelling on the chest; swelling on shoulders; swelling of the lymph node on both side of the neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (swelling on the chest), JOINT SWELLING (swelling on shoulders) and LYMPHADENOPATHY (swelling of the lymph node on both side of the neck) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 23-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 MUSCULOSKELETAL CHEST PAIN (swelling on the chest), JOINT SWELLING (swelling on shoulders) and LYMPHADENOPATHY (swelling of the lymph node on both side of the neck). On 28-Jan-2021, MUSCULOSKELETAL CHEST PAIN (swelling on the chest), JOINT SWELLING (swelling on shoulders) and LYMPHADENOPATHY (swelling of the lymph node on both side of the neck) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness: Asthma

ID: 1557745
Sex: F
Age:
State: IL

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Fever for a few days following; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever for a few days following) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PYREXIA (Fever for a few days following). At the time of the report, PYREXIA (Fever for a few days following) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557746
Sex: F
Age: 70
State: TX

Vax Date: 02/26/2021
Onset Date: 03/14/2021
Rec V Date: 08/14/2021
Hospital: Y

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: Patient says she developed shortness of breath, leg edema, progressive chest congestion with productive cough. Progressively worse until was admitted to the hospital on March 28,2021 with 'heart inflammation" , developed arrhythmia and subsequently diagnosed w congestive heart failure.

Other Meds:

Current Illness:

ID: 1557747
Sex: F
Age: 44
State: AZ

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies: Amitriptyline

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Stomach cramping and diarrhea, vomiting, couldn't stay awake, vertigo, falling, couldn't walk. Impending doom. I really felt I was going to die. Also, nothing got rid of my migraine that lasted 10 days.

Other Meds: Emgality, Ubrevly, Botox( for migraines) xanax, zolpidem, Aspirin, tylenol

Current Illness: None. I hade Covid in January

ID: 1557748
Sex: F
Age: 39
State:

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

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

Lab Data:

Allergies: none

Symptom List: Diarrhoea, Nasal congestion

Symptoms: nausea, diziness, galbladder pain

Other Meds: none

Current Illness: none

ID: 1557749
Sex: M
Age: 18
State: MD

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

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

Lab Data:

Allergies: None

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

Symptoms: Shivering, chills, extreme headache, dizziness, motion sickness, fever, extreme sweating.

Other Meds: None

Current Illness: None

ID: 1557750
Sex: F
Age: 58
State: CA

Vax Date: 01/27/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Itchy; Arm was very red; Soreness; A spontaneous report was received from a healthcare professional concerning a 58-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness/ vaccination site pain, arm was very red/ vaccination site erythema and itchy/ vaccination site pruritus. The patient's medical history was not provided. Concomitant medications reported were aspirin, vitamin C and D, metamucil, crestor, colace for drug use for unknown indication. On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 8 Feb 2021, the patient experienced soreness at injection site. On 9 Feb 2021, the patient experienced the event arm was very red and itchy. Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events soreness, arm was very red and itchy was unknown.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN C [ASCORBIC ACID]; METAMUCIL [PLANTAGO OVATA]; CRESTOR; COLACE; VITAMIN D NOS

Current Illness:

ID: 1557751
Sex: F
Age: 45
State: TX

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/14/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
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: Red welts; Face was red; Head ache either the front or the back of her head; had hot spot all over her face (cheeks, ears) about 102 F; Lips felt numb; Flush; Numbness in the left side of the face; Brain frog; Hot spot all over her face (cheeks, ears); Numbness in the left side of body hip and buttock/Went numb from elbow to wrist; Face was hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Lips felt numb), FLUSHING (Flush), HYPOAESTHESIA (Numbness in the left side of the face), COLD-STIMULUS HEADACHE (Brain frog) and RASH MACULAR (Hot spot all over her face (cheeks, ears)) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hashimoto's disease since an unknown date, Polycystic ovarian syndrome since an unknown date, Psoriatic arthritis since an unknown date and Hypothyroidism since an unknown date. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Lips felt numb), FLUSHING (Flush), HYPOAESTHESIA (Numbness in the left side of the face), COLD-STIMULUS HEADACHE (Brain frog), RASH MACULAR (Hot spot all over her face (cheeks, ears)), HYPOAESTHESIA (Numbness in the left side of body hip and buttock/Went numb from elbow to wrist), HOT FLUSH (Face was hot to touch), ERYTHEMA (Face was red), HEADACHE (Head ache either the front or the back of her head) and PYREXIA (had hot spot all over her face (cheeks, ears) about 102 F). On 21-Jan-2021, the patient experienced URTICARIA (Red welts). At the time of the report, HYPOAESTHESIA ORAL (Lips felt numb), FLUSHING (Flush), HYPOAESTHESIA (Numbness in the left side of the face), COLD-STIMULUS HEADACHE (Brain frog), RASH MACULAR (Hot spot all over her face (cheeks, ears)), HYPOAESTHESIA (Numbness in the left side of body hip and buttock/Went numb from elbow to wrist), HOT FLUSH (Face was hot to touch), URTICARIA (Red welts), ERYTHEMA (Face was red), HEADACHE (Head ache either the front or the back of her head) and PYREXIA (had hot spot all over her face (cheeks, ears) about 102 F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 102 (High) Fahrenheit. In 2021, SARS-CoV-2 test: negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.

Other Meds:

Current Illness: Hashimoto's disease; Hypothyroidism; Polycystic ovarian syndrome; Psoriatic arthritis

ID: 1557752
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.

Other Meds:

Current Illness:

ID: 1557753
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: quite sick from the second dose; Ragging headache; fatigue; bad body ache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (quite sick from the second dose), HEADACHE (Ragging headache), FATIGUE (fatigue) and MYALGIA (bad body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 08-Feb-2021, the patient experienced ILLNESS (quite sick from the second dose), HEADACHE (Ragging headache), FATIGUE (fatigue) and MYALGIA (bad body ache). At the time of the report, ILLNESS (quite sick from the second dose), HEADACHE (Ragging headache), FATIGUE (fatigue) and MYALGIA (bad body ache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Upon in internal review on 21 May 2021, the age was corrected to unknown age. No concomitant medications were reported. No treatment related information has been reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: The outcome of events were updated to recovered. The reporter did not allow further contact.

Other Meds:

Current Illness:

ID: 1557754
Sex: F
Age:
State: GA

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm got stiff; It itches; rash all over her body/it started spreading all over her body/red spots all over her body; rash on her right arm where she received the vaccine; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm got stiff), PRURITUS (It itches), RASH (rash all over her body/it started spreading all over her body/red spots all over her body), VACCINATION SITE RASH (rash on her right arm where she received the vaccine) and VACCINATION SITE ERYTHEMA (red at the injection site) in an 87-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 Lupus erythematosus since an unknown date. Concomitant products included HYDROXYCHLOROQUINE for Lupus erythematosus, LEVOTHYROXINE for Lupus syndrome. On 21-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 MUSCULOSKELETAL STIFFNESS (Arm got stiff), PRURITUS (It itches), RASH (rash all over her body/it started spreading all over her body/red spots all over her body), VACCINATION SITE RASH (rash on her right arm where she received the vaccine) and VACCINATION SITE ERYTHEMA (red at the injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm got stiff), PRURITUS (It itches), RASH (rash all over her body/it started spreading all over her body/red spots all over her body), VACCINATION SITE RASH (rash on her right arm where she received the vaccine) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment related information has been reported.

Other Meds: HYDROXYCHLOROQUINE; LEVOTHYROXINE

Current Illness: Lupus erythematosus

ID: 1557755
Sex: M
Age: 82
State: VA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. Concomitant products included APIXABAN (ELIQUIS) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) from 06-Feb-2021 to 07-Feb-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ELIQUIS; LIPITOR

Current Illness:

ID: 1557756
Sex: F
Age: 63
State: PA

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: dizzy spells/lightheaded; headaches; arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells/lightheaded), HEADACHE (headaches) and VACCINATION SITE PAIN (arm hurt a little) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included LOSARTAN, ATORVASTATIN, VENLAFAXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced DIZZINESS (dizzy spells/lightheaded), HEADACHE (headaches) and VACCINATION SITE PAIN (arm hurt a little). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy spells/lightheaded), HEADACHE (headaches) and VACCINATION SITE PAIN (arm hurt a little) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: LOSARTAN; ATORVASTATIN; VENLAFAXINE; MULTIVITAMINS [VITAMINS NOS]

Current Illness: Blood pressure high; High cholesterol

ID: 1557757
Sex: M
Age:
State: PA

Vax Date: 02/24/2021
Onset Date: 02/26/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), NASAL CONGESTION (congestion) and PRODUCTIVE COUGH (coughing clear flehm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), NASAL CONGESTION (congestion) and PRODUCTIVE COUGH (coughing clear flehm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), NASAL CONGESTION (congestion) and PRODUCTIVE COUGH (coughing clear flehm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1557758
Sex: M
Age: 70
State: FL

Vax Date: 01/29/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Night Sweating; Chills; Constant Headache; Nausea; Body ache; Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweating), COVID-19 (Covid 19), CHILLS (Chills), HEADACHE (Constant Headache) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Covid 19). On an unknown date, the patient experienced NIGHT SWEATS (Night Sweating), CHILLS (Chills), HEADACHE (Constant Headache), NAUSEA (Nausea) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (Night Sweating), CHILLS (Chills), HEADACHE (Constant Headache), NAUSEA (Nausea) and MYALGIA (Body ache) had not resolved and COVID-19 (Covid 19) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, COVID-19: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1557759
Sex: F
Age: 28
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Slightly elevated heart rate; Weakness; Dizziness; Headache; Dizziness; chest pain; Shortness of breath; A spontaneous report was received from a consumer concerning a 28-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, chest pain, shortness of breath/dyspnoea, headache, weakness/asthenia, slightly elevated heart rate/heart rate increased. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 8 Feb 2021, thirty minutes after receiving the vaccine the patient experienced the event dizziness, chest pain, shortness of breath, headache. The patient visited emergency room on 8 Feb 2021 for the events. On 9 Feb 2021, the patient experienced the event(s) weakness, slightly elevated heart rate and dizziness worsened. Treatment details included diphenhydramine and breathing treatment. Action taken with mRNA-1273 in response to the events was not reported. On 9 Feb 2021, the outcome of events dizziness, chest pain, shortness of breath, headache, weakness, slightly elevated heart rate was unknown.

Other Meds:

Current Illness:

ID: 1557760
Sex: M
Age: 42
State: FL

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Dental abscess; Swelling of left eye; Swelling of left cheek; Headache; Muscle pain; Chills; Joint pain; Fever; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of TOOTH ABSCESS (Dental abscess), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a 42-year-old male 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. No Medical History information was reported. On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), ARTHRALGIA (Joint pain), PYREXIA (Fever) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced TOOTH ABSCESS (Dental abscess) with EYE SWELLING (Swelling of left eye) and SWELLING FACE (Swelling of left cheek). In February 2021, TOOTH ABSCESS (Dental abscess) had resolved. At the time of the report, HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint pain), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved and MYALGIA (Muscle pain) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1557761
Sex: M
Age: 62
State: TN

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Chest pain; Blood pressure fluctuating; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), BLOOD PRESSURE FLUCTUATION (Blood pressure fluctuating) and DYSPNOEA (shortness of breath) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The patient's past medical history included Foot surgery (2 weeks before vaccination). Concurrent medical conditions included Allergy NOS. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced CHEST PAIN (Chest pain), BLOOD PRESSURE FLUCTUATION (Blood pressure fluctuating) and DYSPNOEA (shortness of breath). At the time of the report, CHEST PAIN (Chest pain), BLOOD PRESSURE FLUCTUATION (Blood pressure fluctuating) and DYSPNOEA (shortness of breath) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment medication was not reported. Reporter did not allow further contact

Other Meds:

Current Illness: Allergy NOS

ID: 1557762
Sex: F
Age:
State: PA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (Tested positive for covid). On 28-Jan-2021, COVID-19 (Tested positive for covid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment related information has been reported. This case was linked to MOD-2021-052870 (Patient Link).

Other Meds:

Current Illness:

ID: 1557763
Sex: U
Age: 34
State: AZ

Vax Date: 02/05/2021
Onset Date: 02/07/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Pain in lungs; Pain at top of breath; Felt pain in back; Joint pain in right ankle; Joint pain in right wrist; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Pain in lungs), DYSPNOEA (Pain at top of breath), BACK PAIN (Felt pain in back), ARTHRALGIA (Joint pain in right ankle) and ARTHRALGIA (Joint pain in right wrist) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021 at 2:00 AM, the patient experienced PULMONARY PAIN (Pain in lungs), DYSPNOEA (Pain at top of breath), BACK PAIN (Felt pain in back), ARTHRALGIA (Joint pain in right ankle) and ARTHRALGIA (Joint pain in right wrist). The patient was treated with IBUPROFEN for Adverse event, at a dose of 800 milligram. On 08-Feb-2021, ARTHRALGIA (Joint pain in right ankle) and ARTHRALGIA (Joint pain in right wrist) had resolved. At the time of the report, PULMONARY PAIN (Pain in lungs), DYSPNOEA (Pain at top of breath) and BACK PAIN (Felt pain in back) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported.

Other Meds:

Current Illness:

ID: 1557764
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (vaccination site rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (vaccination site rash). At the time of the report, VACCINATION SITE RASH (vaccination site rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.

Other Meds:

Current Illness:

ID: 1557765
Sex: M
Age:
State: OH

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: can't shovel the snow and at night when he lays on his back, toss and turn due to the tightness; A lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (can't shovel the snow and at night when he lays on his back, toss and turn due to the tightness) and FATIGUE (A lot of fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MUSCLE TIGHTNESS (can't shovel the snow and at night when he lays on his back, toss and turn due to the tightness) and FATIGUE (A lot of fatigue). At the time of the report, MUSCLE TIGHTNESS (can't shovel the snow and at night when he lays on his back, toss and turn due to the tightness) and FATIGUE (A lot of fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported

Other Meds:

Current Illness:

ID: 1557766
Sex: F
Age: 69
State:

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Tired for a few days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired for a few days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2*A) for COVID-19 vaccination. The patient's past medical history included Anaphylactic reaction to drug (Amifostine 20 years ago). Previously administered products included for an unreported indication: AMIFOSTINE (20 years ago) since an unknown date. Concurrent medical conditions included Cancer. Concomitant products included OLAPARIB (LYNPARZA) for Cancer. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired for a few days). At the time of the report, FATIGUE (Tired for a few days) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged. Concomitant medication included additional unspecified medications. Treatment medication was not reported. This case was linked to MOD-2021-027614 (Patient Link).

Other Meds: LYNPARZA

Current Illness: Cancer

ID: 1557767
Sex: M
Age:
State: CA

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: diarrhea; constipated; No appetite, could not eat anything; stomach worrying him; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CONSTIPATION (constipated), DECREASED APPETITE (No appetite, could not eat anything) and ABDOMINAL DISCOMFORT (stomach worrying him) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Prostatic disorder NOS (Taking pressure medicine for his prostate). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 06-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 DIARRHOEA (diarrhea), CONSTIPATION (constipated), DECREASED APPETITE (No appetite, could not eat anything) and ABDOMINAL DISCOMFORT (stomach worrying him). At the time of the report, DIARRHOEA (diarrhea), CONSTIPATION (constipated), DECREASED APPETITE (No appetite, could not eat anything) and ABDOMINAL DISCOMFORT (stomach worrying him) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment related information has been reported

Other Meds: PRILOSEC [OMEPRAZOLE]; ASPIRIN 81

Current Illness:

ID: 1557768
Sex: F
Age: 71
State: WI

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: pain in my pinky finger; extremely ill; nauseous; headache; dizzy; diarrhea; sore arm; muscles started twisting in her legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (muscles started twisting in her legs), PAIN IN EXTREMITY (pain in my pinky finger), NAUSEA (nauseous) and DIZZINESS (dizzy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE, LORATADINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (muscles started twisting in her legs), NAUSEA (nauseous), DIZZINESS (dizzy), DIARRHOEA (diarrhea) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in my pinky finger) and ILLNESS (extremely ill). At the time of the report, PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (muscles started twisting in her legs), PAIN IN EXTREMITY (pain in my pinky finger), NAUSEA (nauseous), DIZZINESS (dizzy), DIARRHOEA (diarrhea), HEADACHE (headache) and ILLNESS (extremely ill) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was not reported.

Other Meds: LEVOTHYROXINE; LORATADINE; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1557769
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Some areas on my skin that are quite a little large that I have that I would like to report; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (Some areas on my skin that are quite a little large that I have that I would like to report) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN SWELLING (Some areas on my skin that are quite a little large that I have that I would like to report). At the time of the report, SKIN SWELLING (Some areas on my skin that are quite a little large that I have that I would like to report) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up information received on 05-JUN-2021 contains significant information- event outcome added. Patient stated her events resolved in 3days and she did not took any medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1557770
Sex: F
Age: 68
State: CA

Vax Date: 01/31/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm ache; Pain on the legs; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ache), PAIN IN EXTREMITY (Pain on the legs) and HEADACHE (headache) in a 68-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 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm ache), PAIN IN EXTREMITY (Pain on the legs) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Arm ache), PAIN IN EXTREMITY (Pain on the legs) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant and treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Event outcome updated

Other Meds:

Current Illness:

ID: 1557771
Sex: F
Age: 53
State: CA

Vax Date: 02/04/2021
Onset Date: 02/07/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: negative Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment or concomitant medications were reported. Experienced mild flu-like symptoms. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR Form - patient declined further follow-up, provided event outcome.

Other Meds:

Current Illness:

ID: 1557772
Sex: F
Age: 77
State: FL

Vax Date: 02/24/2021
Onset Date: 02/26/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Swelling gland under the ear; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling gland under the ear) and PAIN IN EXTREMITY (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced LYMPHADENOPATHY (Swelling gland under the ear) and PAIN IN EXTREMITY (Sore arm). At the time of the report, LYMPHADENOPATHY (Swelling gland under the ear) and PAIN IN EXTREMITY (Sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter said Everything is Fine now. Declined to share Email address

Other Meds:

Current Illness:

ID: 1557773
Sex: M
Age:
State: PA

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: He started to not feel well again today; Sunday got sicker; had diarrhea; Had a fever of 99.5; Flu like symptoms; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), ILLNESS (Sunday got sicker), DIARRHOEA (had diarrhea), MALAISE (He started to not feel well again today) and PYREXIA (Had a fever of 99.5) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Atrial fibrillation. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Had a fever of 99.5). On 07-Feb-2021, the patient experienced ILLNESS (Sunday got sicker) and DIARRHOEA (had diarrhea). On 09-Feb-2021, the patient experienced MALAISE (He started to not feel well again today). The patient was treated with LOPERAMIDE in February 2021 for Diarrhea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) 06-Feb-2021 for Fever, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ILLNESS (Sunday got sicker), DIARRHOEA (had diarrhea), MALAISE (He started to not feel well again today) and PYREXIA (Had a fever of 99.5) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557774
Sex: M
Age:
State: CA

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: little pain; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little pain) and VACCINATION SITE PAIN (Tenderness) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (little pain) and VACCINATION SITE PAIN (Tenderness). At the time of the report, VACCINATION SITE PAIN (little pain) and VACCINATION SITE PAIN (Tenderness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1557775
Sex: F
Age: 65
State: IL

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: two red circles bruised around at the injection site, each circle is like 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (two red circles bruised around at the injection site, each circle is like 3 inches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE BRUISING (two red circles bruised around at the injection site, each circle is like 3 inches). At the time of the report, VACCINATION SITE BRUISING (two red circles bruised around at the injection site, each circle is like 3 inches) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medication was not reported. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1557776
Sex: F
Age: 69
State:

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: swollen lymph node developed; Headache; I was tired; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node developed), HEADACHE (Headache) and FATIGUE (I was tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L2*A) for COVID-19 vaccination. The patient's past medical history included Anaphylactic reaction (To Amifostine 20 years ago). Previously administered products included for an unreported indication: AMIFOSTINE (20 years ago). Concurrent medical conditions included Cancer. Concomitant products included OLAPARIB (LYNPARZA) for Cancer. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node developed), HEADACHE (Headache) and FATIGUE (I was tired). At the time of the report, LYMPHADENOPATHY (swollen lymph node developed), HEADACHE (Headache) and FATIGUE (I was tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: swollen lymph node. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication was not reported.

Other Meds: LYNPARZA

Current Illness: Cancer

ID: 1557777
Sex: F
Age: 25
State: MI

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Mild Itching on the face; hives on the face; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Mild Itching on the face) and URTICARIA (hives on the face) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced RASH PRURITIC (Mild Itching on the face) and URTICARIA (hives on the face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in February 2021 for Rash and Hives, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Mild Itching on the face) and URTICARIA (hives on the face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557778
Sex: F
Age: 68
State: TX

Vax Date: 01/21/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash at injection site, spread out, has got wider; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at injection site, spread out, has got wider) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, ROSUVASTATIN, METHYLPHENIDATE HYDROCHLORIDE (CONCERTA), LEVOTHYROXINE, PROPRANOLOL, SERTRALINE, PALIPERIDONE and CLONAZEPAM for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site, spread out, has got wider). At the time of the report, VACCINATION SITE RASH (Rash at injection site, spread out, has got wider) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was not reported. Reporter did not allow further contact

Other Meds: GABAPENTIN; ROSUVASTATIN; CONCERTA; LEVOTHYROXINE; PROPRANOLOL; SERTRALINE; PALIPERIDONE; CLONAZEPAM

Current Illness:

ID: 1557779
Sex: F
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Feels sleepy; Developed itchy mark injection site; Developed red mark on injection site; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feels sleepy), VACCINATION SITE PRURITUS (Developed itchy mark injection site) and VACCINATION SITE ERYTHEMA (Developed red mark on injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SOMNOLENCE (Feels sleepy), VACCINATION SITE PRURITUS (Developed itchy mark injection site) and VACCINATION SITE ERYTHEMA (Developed red mark on injection site). At the time of the report, SOMNOLENCE (Feels sleepy), VACCINATION SITE PRURITUS (Developed itchy mark injection site) and VACCINATION SITE ERYTHEMA (Developed red mark on injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment medication was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Phone contact, patient hung up phone.

Other Meds:

Current Illness:

ID: 1557780
Sex: F
Age: 88
State: AZ

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: arthritis of the knee; Very severe pain from her knees to feet, on both legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very severe pain from her knees to feet, on both legs) and ARTHRITIS (arthritis of the knee) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very severe pain from her knees to feet, on both legs). On an unknown date, the patient experienced ARTHRITIS (arthritis of the knee). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Very severe pain from her knees to feet, on both legs) and ARTHRITIS (arthritis of the knee) outcome was unknown. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: TCR attached. Event updated.

Other Meds:

Current Illness:

ID: 1557781
Sex: F
Age: 60
State: WA

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

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

Lab Data:

Allergies:

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

Symptoms: Irritated throat; Coughing; Voice was a little gravely; clearing her throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Irritated throat), COUGH (Coughing), DYSPHONIA (Voice was a little gravely) and THROAT CLEARING (clearing her throat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Bee sting. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced THROAT IRRITATION (Irritated throat), COUGH (Coughing), DYSPHONIA (Voice was a little gravely) and THROAT CLEARING (clearing her throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in January 2021 for Adverse event, at an unspecified dose and frequency. In January 2021, THROAT IRRITATION (Irritated throat), COUGH (Coughing), DYSPHONIA (Voice was a little gravely) and THROAT CLEARING (clearing her throat) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitants were provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No new event information received. Information provided included address, email address, and correct spelling of last name.

Other Meds:

Current Illness: Bee sting

ID: 1557782
Sex: F
Age: 38
State: VA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Heart started racing; She had tachycardia; Her appetite is down; Sweating palms; nausea; Headache; Fever; Chills for 2 days; This spontaneous case was reported by a physician assistant and describes the occurrence of PALPITATIONS (Heart started racing), TACHYCARDIA (She had tachycardia), DECREASED APPETITE (Her appetite is down), HYPERHIDROSIS (Sweating palms) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FEXOFENADINE, MELATONIN and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills for 2 days). On 30-Jan-2021, the patient experienced PALPITATIONS (Heart started racing), TACHYCARDIA (She had tachycardia), DECREASED APPETITE (Her appetite is down), HYPERHIDROSIS (Sweating palms) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) on 28-Jan-2021 for Chills, Fever and Headache, at an unspecified dose and frequency. On 30-Jan-2021, HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills for 2 days) had resolved. At the time of the report, PALPITATIONS (Heart started racing), TACHYCARDIA (She had tachycardia), DECREASED APPETITE (Her appetite is down), HYPERHIDROSIS (Sweating palms) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Blood potassium: low (Low) Low. On 30-Jan-2021, Blood sodium: low (Low) Low. 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. Additional concomitant medication included unspecified birth control. Reporter did not allow further contact

Other Meds: FEXOFENADINE; MELATONIN; ALLEGRA

Current Illness:

ID: 1557783
Sex: M
Age: 75
State: DE

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Itching; Forehead Rash/Face Rash/Shoulders Rash/Chest Rash/Rash on his Bald head; prickly bumps on top of Head; Pain on Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (prickly bumps on top of Head), PRURITUS (Itching), RASH (Forehead Rash/Face Rash/Shoulders Rash/Chest Rash/Rash on his Bald head) and VACCINATION SITE PAIN (Pain on Injection Site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain on Injection Site). On 08-Feb-2021, the patient experienced SKIN DISORDER (prickly bumps on top of Head) and RASH (Forehead Rash/Face Rash/Shoulders Rash/Chest Rash/Rash on his Bald head). On 09-Feb-2021, the patient experienced PRURITUS (Itching). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Itching, at a dose of 1 dosage form. At the time of the report, SKIN DISORDER (prickly bumps on top of Head), PRURITUS (Itching), RASH (Forehead Rash/Face Rash/Shoulders Rash/Chest Rash/Rash on his Bald head) and VACCINATION SITE PAIN (Pain on Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment for the event included topical steroids began 10-FEB-2021. Patient gave consent for safety to Follow-up.

Other Meds:

Current Illness:

ID: 1557784
Sex: F
Age:
State: KS

Vax Date: 02/24/2021
Onset Date: 02/26/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 08-Feb-2021. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Coronavirus test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1557785
Sex: M
Age:
State: NM

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heartbeat is rising) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced HEART RATE INCREASED (heartbeat is rising). At the time of the report, HEART RATE INCREASED (heartbeat is rising) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment medication was not reported

Other Meds:

Current Illness:

ID: 1557786
Sex: F
Age: 27
State: KY

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Fatigue; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011KL20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site). On 16-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. On 18-Jan-2021, FATIGUE (Fatigue) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment medication was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Telephone contact in attempt to obtain email address, reporter disconnected the call.

Other Meds:

Current Illness:

ID: 1557787
Sex: F
Age: 65
State: SC

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ERYTHEMATOUS; LOCALIZED INFLAMMATION; Arm is sensitive; hot; hives; red ring going around; arm was red; arm was tender; slight headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (ERYTHEMATOUS), INFLAMMATION (LOCALIZED INFLAMMATION), SENSITIVE SKIN (Arm is sensitive), VACCINATION SITE WARMTH (hot) and VACCINATION SITE URTICARIA (hives) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZU(orV)7) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Diabetes, High cholesterol, Drug allergy (Most cholesterol medicines, hydrocodone allergy), Food allergy (scallops, clams, bass, fish) and Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 25-Feb-2021, the patient experienced SENSITIVE SKIN (Arm is sensitive), VACCINATION SITE WARMTH (hot), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (red ring going around), VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE PAIN (arm was tender) and HEADACHE (slight headache). On 26-Feb-2021, the patient experienced RASH ERYTHEMATOUS (ERYTHEMATOUS) and INFLAMMATION (LOCALIZED INFLAMMATION). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (ERYTHEMATOUS), INFLAMMATION (LOCALIZED INFLAMMATION), SENSITIVE SKIN (Arm is sensitive), VACCINATION SITE WARMTH (hot), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (red ring going around), VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE PAIN (sore arm), VACCINATION SITE PAIN (arm was tender) and HEADACHE (slight headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: ZYRTEC ALLERGY

Current Illness: Diabetes; Drug allergy (Most cholesterol medicines, hydrocodone allergy); Food allergy (scallops, clams, bass, fish); High cholesterol; Hypertension; Seasonal allergy

ID: 1557788
Sex: F
Age: 83
State: WI

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Itching at the injection site; headaches; Redness at the injection site; Swelling at the injection site; Fatigue; muscle pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), HEADACHE (headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), HEADACHE (headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), HEADACHE (headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: OMEPRAZOLE

Current Illness: Acid reflux (esophageal)

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm