VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1631618
Sex: M
Age: 75
State: TX

Vax Date: 01/29/2021
Onset Date: 03/07/2021
Rec V Date: 08/25/2021
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: Pain in arm; Headache; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination. Concurrent medical conditions included Pulmonary fibrosis, Emphysema and COPD. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Low grade fever). At the time of the report, PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Low grade fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications with H/O pulmonary fibrosis, emphysema, and COPD. Treatment details included None. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness: COPD; Emphysema; Pulmonary fibrosis

ID: 1631619
Sex: M
Age:
State: TN

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 08/25/2021
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: pain; Severe migraine; Herpes flare up; itchy; swelling; burned; blister; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine), HERPES VIRUS INFECTION (Herpes flare up), PRURITUS (itchy), SWELLING (swelling) and SKIN BURNING SENSATION (burned) in a 72-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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MIGRAINE (Severe migraine), HERPES VIRUS INFECTION (Herpes flare up), PRURITUS (itchy), SWELLING (swelling), SKIN BURNING SENSATION (burned) and BLISTER (blister). On an unknown date, the patient experienced PAIN (pain). On 27-Feb-2021, MIGRAINE (Severe migraine) had resolved. At the time of the report, HERPES VIRUS INFECTION (Herpes flare up), PRURITUS (itchy), SWELLING (swelling), SKIN BURNING SENSATION (burned) and BLISTER (blister) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Patient was prescribed phenazopyridine 200mg, acyclovir 400mg TID, and a third 'antibiotic' that, he could not recall. Patient attempted to self medicate with an anti-itch topical spray but found no, relief..

Other Meds:

Current Illness:

ID: 1631620
Sex: F
Age:
State: NY

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 08/25/2021
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: she often needs a cane to walk; slight headache; muscle pain; A SPOTANOUS report was received concerning a 92 Years old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) SECOND dose on 16-feb-2021, batch no:016M20A intramuscular route The patient's medical history was not provided Event of Problem : Patient stated that she received her 2nd dose of the Moderna COVID 19 vaccine on 16FEB2021 at pharmacy. About a week ago (unsure of the exact date), she started having slight headache and muscle pain. The muscle pain usually starts in the evening and she often times need a cane to walk. She takes Aspin to alleviate the symptoms. She has not called her doctor because she does not think it is necessary. Treatment information was ASPIRIN Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events were UNKNOWN

Other Meds:

Current Illness:

ID: 1631621
Sex: F
Age:
State: TN

Vax Date: 02/25/2021
Onset Date: 03/06/2021
Rec V Date: 08/25/2021
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: Patient says her arm hurts when she lifts it; (node)Swollen; (node)itchy; (node)red; (node)hard; (node) tender to touch; felt a nodeabout a size of a baseball at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), LIMB DISCOMFORT (Patient says her arm hurts when she lifts it), SWELLING ((node)Swollen), PRURITUS ((node)itchy) and ERYTHEMA ((node)red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included SEMAGLUTIDE (OZEMPIC) and PARACETAMOL (TYLENOL) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-2021, the patient experienced INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), SWELLING ((node)Swollen), PRURITUS ((node)itchy), ERYTHEMA ((node)red), INDURATION ((node)hard) and TENDERNESS ((node) tender to touch). On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (Patient says her arm hurts when she lifts it). At the time of the report, INJECTION SITE MASS (felt a nodeabout a size of a baseball at injection site), LIMB DISCOMFORT (Patient says her arm hurts when she lifts it), SWELLING ((node)Swollen), PRURITUS ((node)itchy), ERYTHEMA ((node)red), INDURATION ((node)hard) and TENDERNESS ((node) tender to touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication includes Blood pressure tablets, Cholesterol tablets and stomach tablets. Treatment includes Tylenol.

Other Meds: OZEMPIC; TYLENOL

Current Illness:

ID: 1631622
Sex: F
Age: 71
State: FL

Vax Date: 02/03/2021
Onset Date: 03/04/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210304; Test Name: body temerature; Result Unstructured Data: 101.9 F

Allergies:

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

Symptoms: Light colored "poop"; Stomach issues progressively increase/has a lot of gas; Severe bloating of abdomen; Got sick; Severe body aches; Felt like head was going to explode; Fever 101.9F; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), ABDOMINAL DISTENSION (Severe bloating of abdomen), FAECES PALE (Light colored "poop"), FLATULENCE (Stomach issues progressively increase/has a lot of gas) and MYALGIA (Severe body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Abdominal disorder (Issues with abdomen), Hiatal hernia, Narrowing of esophagus, Breast cancer, Surgery (32 surgeries for hiatal hernia,), Spinal fusion (Lumbar fusion and neck fusion), Cholecystectomy (Gall bladder removed) and Surgery (Component separation surgery (abdomen)). Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Drug allergy (allergic to Levaquin.), Blood pressure high and Drug allergy (allergic to cipro.). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Got sick). 04-Mar-2021, the patient experienced MYALGIA (Severe body aches), HEADACHE (Felt like head was going to explode) and PYREXIA (Fever 101.9F). On 08-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Severe bloating of abdomen). On an unknown date, the patient experienced FAECES PALE (Light colored "poop") and FLATULENCE (Stomach issues progressively increase/has a lot of gas). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Got sick), ABDOMINAL DISTENSION (Severe bloating of abdomen), FAECES PALE (Light colored "poop"), FLATULENCE (Stomach issues progressively increase/has a lot of gas), MYALGIA (Severe body aches), HEADACHE (Felt like head was going to explode) and PYREXIA (Fever 101.9F) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature increased: 101.9 (High) 101.9 F. No relevant concomitant medications were reported. .

Other Meds:

Current Illness: Blood pressure high; Drug allergy (allergic to Levaquin.); Drug allergy (allergic to cipro.); Sulfonamide allergy (Sulfa drugs allergy)

ID: 1631623
Sex: F
Age: 69
State: CO

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/25/2021
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: Bad diarrhea; Fast heartbeat; wobly; flushed; Shaking inside body; dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and HEART RATE INCREASED (Fast heartbeat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DILTIAZEM, ALPRAZOLAM, HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE), LOSARTAN, DULOXETINE and ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for an unknown indication. On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) mRNA-1273. On 25-Feb-2021, the patient experienced FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and TREMOR (wobly). On 26-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat). On 27-Feb-2021, the patient experienced DIARRHOEA (Bad diarrhea). On 01-Mar-2021, FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and DIARRHOEA (Bad diarrhea) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided. Tylenol was provided as a corrective treatment for the symptoms No treatment medication were provided. Symptoms subsided on day 5 and she felt fine. Consent obtained for safety follow up Reporter did not allow further contact

Other Meds: DILTIAZEM; ALPRAZOLAM; HYDROXIZINE; LOSARTAN; DULOXETINE; ACYCLOVIR [ACICLOVIR SODIUM]

Current Illness:

ID: 1631624
Sex: M
Age: 64
State: MA

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 08/25/2021
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: Headache; Little bit of fever; On and off chills; Felt very fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Little bit of fever), CHILLS (On and off chills) and FATIGUE (Felt very fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 HEADACHE (Headache), PYREXIA (Little bit of fever), CHILLS (On and off chills) and FATIGUE (Felt very fatigue). At the time of the report, HEADACHE (Headache), PYREXIA (Little bit of fever), CHILLS (On and off chills) and FATIGUE (Felt very fatigue) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications or treatment details provided.

Other Meds:

Current Illness:

ID: 1631625
Sex: F
Age: 71
State: NC

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 08/25/2021
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: fatigue; chills; Sore; Soreness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness) and PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness) and PRURITUS (Itchiness). On 08-Feb-2021, PAIN IN EXTREMITY (Soreness) and PRURITUS (Itchiness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information provided. This case was linked to MOD-2021-079358 (Patient Link).

Other Meds:

Current Illness:

ID: 1631626
Sex: F
Age: 81
State:

Vax Date: 03/08/2021
Onset Date: 03/10/2021
Rec V Date: 08/25/2021
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: "blurry" blisters in her mouth; This spontaneous case was reported by a health care professional and describes the occurrence of ORAL MUCOSAL BLISTERING ("blurry" blisters in her mouth) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A2A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), VITAMIN D3, LORATADINE, METFORMIN and WARFARIN for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING ("blurry" blisters in her mouth). At the time of the report, ORAL MUCOSAL BLISTERING ("blurry" blisters in her mouth) 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. Treatment information included hot water and salt. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No new information was provided.

Other Meds: STATIN EZ; VITAMIN D3; LORATADINE; METFORMIN; WARFARIN

Current Illness:

ID: 1631627
Sex: F
Age:
State: IL

Vax Date: 03/03/2021
Onset Date: 03/08/2021
Rec V Date: 08/25/2021
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: lost their smell; muscle pain; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), HEADACHE (headaches) and ANOSMIA (lost their smell) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MYALGIA (muscle pain) and HEADACHE (headaches). On 09-Mar-2021, the patient experienced ANOSMIA (lost their smell). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MYALGIA (muscle pain), HEADACHE (headaches) and ANOSMIA (lost their smell) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported.

Other Meds:

Current Illness:

ID: 1631628
Sex: M
Age:
State: CA

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 08/25/2021
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: pain in the body; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the body), PYREXIA (fever) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (pain in the body), PYREXIA (fever) and CHILLS (chills). At the time of the report, MYALGIA (pain in the body), PYREXIA (fever) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications or treatment details reported.

Other Meds:

Current Illness:

ID: 1631629
Sex: F
Age: 80
State: UT

Vax Date: 02/17/2021
Onset Date: 02/01/2021
Rec V Date: 08/25/2021
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: not getting better; no taste; she did has not received her 2nd dose until now; Weak/She was very weak; Got so deeply sick,severe illness/sick all the time/1st dose made her so sick; shortness of breath; Felt like she didn't have any blood left in her body\Everything in her body seemed strange/she didn't think she was going to live; She says that she has had a sore throat since she received the vaccine; She is now starting to forget things; she cannot do anything; Achy; muscle aches,body aches; a lot of fatigue/She says that she is so tired all the time; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got so deeply sick,severe illness/sick all the time/1st dose made her so sick), DYSPNOEA (shortness of breath), AGEUSIA (no taste), ASTHENIA (Weak/She was very weak) and MALAISE (not getting better) in an 80-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. There was no medical history reported. Concomitant products included AMLODIPINE, LEVOTHYROXINE and AMITRIPTYLINE for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ILLNESS (Got so deeply sick,severe illness/sick all the time/1st dose made her so sick), DYSPNOEA (shortness of breath), ASTHENIA (Weak/She was very weak), FEELING ABNORMAL (Felt like she didn't have any blood left in her body\Everything in her body seemed strange/she didn't think she was going to live), OROPHARYNGEAL PAIN (She says that she has had a sore throat since she received the vaccine), MEMORY IMPAIRMENT (She is now starting to forget things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she cannot do anything), PAIN (Achy), MYALGIA (muscle aches,body aches) and FATIGUE (a lot of fatigue/She says that she is so tired all the time). On an unknown date, the patient experienced AGEUSIA (no taste), MALAISE (not getting better) and PRODUCT DOSE OMISSION ISSUE (she did has not received her 2nd dose until now). At the time of the report, ILLNESS (Got so deeply sick,severe illness/sick all the time/1st dose made her so sick), DYSPNOEA (shortness of breath), AGEUSIA (no taste), ASTHENIA (Weak/She was very weak), MALAISE (not getting better), FEELING ABNORMAL (Felt like she didn't have any blood left in her body\Everything in her body seemed strange/she didn't think she was going to live), OROPHARYNGEAL PAIN (She says that she has had a sore throat since she received the vaccine), MEMORY IMPAIRMENT (She is now starting to forget things), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she cannot do anything), PAIN (Achy), MYALGIA (muscle aches,body aches) and FATIGUE (a lot of fatigue/She says that she is so tired all the time) had not resolved and PRODUCT DOSE OMISSION ISSUE (she did has not received her 2nd dose until now) 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. It was stated that after received 1st dose the patient felt like did not have any blood left in body. The patient was very weak and achy. Everything in body seemed strange. The patient stated that had a sore throat since received the vaccine. Patient now starting to forget things and was sick all the time. The patient said that she was so tired all the time that cannot do anything. The patient stated that all these issues were still going on and have not dissipated since she received the vaccine. The patient stated that the 1st dose made so sick that did not think she was going to live. That was the main reason why patient did has not received 2nd dose until now. There was no relevant treatment medication reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up was received on 29-JUN-2021 Contains significant information. New events, Ageusia, Asthenia, Malaise were added and outcome of the events Illness, Dyspnoea, fatigue, Myalgia, changed from unknown to Not recovered/Not resolved. On 19-Jul-2021: Follow-up was received on 19 Jul 2021: For moderna COVID-19 vaccine anatomical location added as right arm, For events fatigue, Illness and asthenia description as reported updated, For event asthenia start date added and new events feeling abnormal, oropharyngeal pain, oropharyngeal pain, loss of personal independence in daily activities, pain and product dose omission issue were added.

Other Meds: AMLODIPINE; LEVOTHYROXINE; AMITRIPTYLINE

Current Illness:

ID: 1631630
Sex: F
Age: 66
State: IL

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/25/2021
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: Esophageal problems; Esophageal problems/ruptured esophagus; Severe headache; Nausea; Bedridden; Dry Heaving; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETCHING (Dry Heaving), OESOPHAGEAL DISCOMFORT (Esophageal problems), DIZZINESS (Esophageal problems/ruptured esophagus), BEDRIDDEN (Bedridden) and HEADACHE (Severe headache) in a 66-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 MULTIVITAMIN [VITAMINS NOS] 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 RETCHING (Dry Heaving) and BEDRIDDEN (Bedridden). On 04-Mar-2021, the patient experienced DIZZINESS (Esophageal problems/ruptured esophagus), HEADACHE (Severe headache) and NAUSEA (Nausea). On 21-Apr-2021, the patient experienced OESOPHAGEAL DISCOMFORT (Esophageal problems). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Adverse event, at a dose of UNK dosage form. On 27-Mar-2021, RETCHING (Dry Heaving), BEDRIDDEN (Bedridden), HEADACHE (Severe headache) and NAUSEA (Nausea) had resolved. At the time of the report, OESOPHAGEAL DISCOMFORT (Esophageal problems) had not resolved and DIZZINESS (Esophageal problems/ruptured esophagus) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use included a pain killer for an unknown indication. Treatment medication included IV Benadryl for headache and nausea medicine that did not work five days after onset of symptoms. The patient was advised not to take the second dose of the Moderna COVID-19 Vaccine. The patient reported to have an appointment with a gastroenterologist for the ongoing esophageal symptoms. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Additional information added to include updated reporter information and event outcomes.

Other Meds: MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1631631
Sex: F
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: It didn't look like it has 0.5ml in it; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (It didn't look like it has 0.5ml in it) 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 INCORRECT DOSE ADMINISTERED (It didn't look like it has 0.5ml in it). At the time of the report, INCORRECT DOSE ADMINISTERED (It didn't look like it has 0.5ml in it) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Company Comment: This report refers to a case of incorrect dose administered for mRNA-1273, with no associated AEs. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-05-2021 contains non-significant information. On 25-Jun-2021: Follow up information was received from initial reporter: The reporter declined for further follow up; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, with no associated AEs.

Other Meds:

Current Illness:

ID: 1631632
Sex: F
Age: 55
State: GA

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

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

Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Unknown

Allergies:

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

Symptoms: Positive Covid-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive Covid-19 Test) in a 55-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 25-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 SARS-COV-2 TEST POSITIVE (Positive Covid-19 Test). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive Covid-19 Test) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1631633
Sex: F
Age: 72
State: MT

Vax Date: 02/14/2021
Onset Date:
Rec V Date: 08/25/2021
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: Red rash itchy with around 8 bumps; Red rash itchy with around 8 bumps; Red rash itchy with around 8 bumps; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red rash itchy with around 8 bumps), RASH (Red rash itchy with around 8 bumps), SWELLING (Red rash itchy with around 8 bumps) and PRURITUS (Itchy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included CARVEDILOL, ATORVASTATIN, HYDROCHLOROTHIAZIDE and RIVAROXABAN (XARELTO) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red rash itchy with around 8 bumps), RASH (Red rash itchy with around 8 bumps), SWELLING (Red rash itchy with around 8 bumps) and PRURITUS (Itchy). The patient was treated with ACRIVASTINE (BENADRYL [ACRIVASTINE]) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 1 dosage form and TRIAMCINOLONE at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Red rash itchy with around 8 bumps), RASH (Red rash itchy with around 8 bumps), SWELLING (Red rash itchy with around 8 bumps) and PRURITUS (Itchy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-229894 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant follow up updated on 21-Jun-2021

Other Meds: CARVEDILOL; ATORVASTATIN; HYDROCHLOROTHIAZIDE; XARELTO

Current Illness: Dust allergy; Pollen allergy

ID: 1631634
Sex: M
Age: 88
State: FL

Vax Date: 02/24/2021
Onset Date: 03/01/2021
Rec V Date: 08/25/2021
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: COVID; COVID; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of COVID-19 (COVID) and the second episode of COVID-19 (COVID) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced the first episode of COVID-19 (COVID). On 08-Mar-2021, the patient experienced the second episode of COVID-19 (COVID). On 09-Mar-2021, last episode of COVID-19 (COVID) 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 Meds:

Current Illness:

ID: 1631635
Sex: F
Age: 60
State: GA

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/25/2021
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: Fever; Nausea; Really, really bad headache/ Feels like whole head is in a vice grip; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Really, really bad headache/ Feels like whole head is in a vice grip) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00105736) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Really, really bad headache/ Feels like whole head is in a vice grip). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Really, really bad headache/ Feels like whole head is in a vice grip) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1631636
Sex: F
Age: 70
State:

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 08/25/2021
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: injection site it is very red; injection site hurts when she touches it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site it is very red) and VACCINATION SITE PAIN (injection site hurts when she touches it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site it is very red) and VACCINATION SITE PAIN (injection site hurts when she touches it). At the time of the report, VACCINATION SITE ERYTHEMA (injection site it is very red) and VACCINATION SITE PAIN (injection site hurts when she touches it) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1631637
Sex: M
Age:
State:

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/25/2021
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: Significant tinnitus in right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Significant tinnitus in right ear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TINNITUS (Significant tinnitus in right ear). At the time of the report, TINNITUS (Significant tinnitus in right ear) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.; 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. Further information has been requested

Other Meds:

Current Illness:

ID: 1631638
Sex: M
Age: 76
State:

Vax Date: 03/03/2021
Onset Date: 03/05/2021
Rec V Date: 08/25/2021
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: Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded. On 05-May-2021: Translated doc added On 18-May-2021: Translated document - moderna dosage anatomical location was specified , vaccine details was added .

Other Meds:

Current Illness:

ID: 1631639
Sex: U
Age:
State:

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 08/25/2021
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: first vaccine 1/7/21, hard time finding the 2nd dose; A spontaneous report was received from a consumer concerning a patient of unspecified age and gender, who received Moderna COVID-19 vaccine (mRNA-1273) and reported had first vaccine, hard time finding the second dose missing dose/product dose omission issue . The patient's medical history is unknown. Concomitant medication were not reported. On 07 Jan 2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (Batch no: unknown) for prophylaxis of COVID-19 infection. On an unknown date, it was reported that, hard time finding the second dose. No Laboratory details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.

Other Meds:

Current Illness:

ID: 1631640
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/25/2021
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: Pain and tenderness in forearm; Stomach Upset; chills; Typical vaccination soreness; Woozy/wobbly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woozy/wobbly), PAIN IN EXTREMITY (Pain and tenderness in forearm), ABDOMINAL DISCOMFORT (Stomach Upset), CHILLS (chills) and VACCINATION SITE PAIN (Typical vaccination soreness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (Woozy/wobbly). On 20-Jan-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (Typical vaccination soreness). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain and tenderness in forearm) and ABDOMINAL DISCOMFORT (Stomach Upset). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Woozy/wobbly), PAIN IN EXTREMITY (Pain and tenderness in forearm), ABDOMINAL DISCOMFORT (Stomach Upset), CHILLS (chills) and VACCINATION SITE PAIN (Typical vaccination soreness) 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: 1631641
Sex: F
Age: 78
State: VA

Vax Date: 03/03/2021
Onset Date: 03/09/2021
Rec V Date: 08/25/2021
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: Cramp in leg,have cramps in my back; pain in her hip and joints her leg, thigh pain; tightness thigh; pain in her hip and joints her leg; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramp in leg,have cramps in my back), PAIN IN EXTREMITY (pain in her hip and joints her leg, thigh pain), MUSCULOSKELETAL STIFFNESS (tightness thigh) and ARTHRALGIA (pain in her hip and joints her leg) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M80A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MUSCLE SPASMS (Cramp in leg,have cramps in my back), PAIN IN EXTREMITY (pain in her hip and joints her leg, thigh pain), MUSCULOSKELETAL STIFFNESS (tightness thigh) and ARTHRALGIA (pain in her hip and joints her leg). At the time of the report, MUSCLE SPASMS (Cramp in leg,have cramps in my back), PAIN IN EXTREMITY (pain in her hip and joints her leg, thigh pain), MUSCULOSKELETAL STIFFNESS (tightness thigh) and ARTHRALGIA (pain in her hip and joints her leg) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information not provided. Treatment information not provided by the reporter.

Other Meds:

Current Illness:

ID: 1631642
Sex: F
Age: 71
State: KY

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: injection site still hot; injection site still red; Soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site still hot), VACCINATION SITE ERYTHEMA (injection site still red) and VACCINATION SITE PAIN (Soreness in the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2OT) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. On 26-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 WARMTH (injection site still hot), VACCINATION SITE ERYTHEMA (injection site still red) and VACCINATION SITE PAIN (Soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site still hot), VACCINATION SITE ERYTHEMA (injection site still red) and VACCINATION SITE PAIN (Soreness in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included unspecified blood pressure medication. Treatment medication included Tylenol.

Other Meds:

Current Illness: Blood pressure high

ID: 1631643
Sex: F
Age: 80
State: MA

Vax Date: 02/06/2021
Onset Date: 02/16/2021
Rec V Date: 08/25/2021
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: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (COVID arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (COVID arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Itching, at an unspecified dose and frequency. On 20-Feb-2021, TYPE IV HYPERSENSITIVITY REACTION (COVID arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products included high blood pressure medications.

Other Meds:

Current Illness: Hypertension

ID: 1631644
Sex: F
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: have been itching constantly all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (have been itching constantly all over) 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 No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (have been itching constantly all over). At the time of the report, PRURITUS (have been itching constantly all over) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1631645
Sex: F
Age:
State: NE

Vax Date: 02/26/2021
Onset Date: 03/07/2021
Rec V Date: 08/25/2021
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: stomach cramps; diarrhea; weak; lethargic; horrible headache; has no energy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic) and HEADACHE (horrible headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic), HEADACHE (horrible headache) and FATIGUE (has no energy). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19 vaccination, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) was resolving and DIARRHOEA (diarrhea), ASTHENIA (weak), LETHARGY (lethargic), HEADACHE (horrible headache) and FATIGUE (has no energy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication reported

Other Meds:

Current Illness:

ID: 1631646
Sex: F
Age: 54
State:

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/25/2021
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: arm was super sore; had a fever; was real tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was super sore), PYREXIA (had a fever) and FATIGUE (was real tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was super sore), PYREXIA (had a fever) and FATIGUE (was real tired). On 23-Jan-2021, PAIN IN EXTREMITY (arm was super sore), PYREXIA (had a fever) and FATIGUE (was real tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment information was reported. No concomitant medication information was reported. This case was linked to MOD-2021-226959 (Patient Link).

Other Meds:

Current Illness:

ID: 1631647
Sex: M
Age: 20
State:

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/25/2021
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: Chest thightness; Lightheadedness; He became cyanotic; Nausea; Patient fell over; This spontaneous case was reported by a nurse and describes the occurrence of CHEST DISCOMFORT (Chest thightness), DIZZINESS (Lightheadedness), CYANOSIS (He became cyanotic), NAUSEA (Nausea) and FALL (Patient fell over) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014N20A) for COVID-19 vaccination. MEDICAL HISTORY (Parent): The parent's past medical history included Epilepsy and Allergy. MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest thightness), DIZZINESS (Lightheadedness), CYANOSIS (He became cyanotic), NAUSEA (Nausea) and FALL (Patient fell over). The patient was treated with NORMAL SALINE at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Chest thightness), DIZZINESS (Lightheadedness), CYANOSIS (He became cyanotic), NAUSEA (Nausea) and FALL (Patient fell over) 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. Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Follow up information was received on 10-Mar-2021Report contains no new information, however listedness added, outcome added which was missed in previous version, seriousness criteria removed as it is not given in the document

Other Meds:

Current Illness:

ID: 1631648
Sex: F
Age:
State: WA

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 08/25/2021
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: diarrhea; nauseous; joint pain; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), NAUSEA (nauseous), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (Headache) 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 Bleeding (brain bleed before the vaccine which lead to brain surgery and a long recovery) and Surgery (Brain surgery). On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nauseous), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (Headache). On 06-Mar-2021, DIARRHOEA (diarrhea), NAUSEA (nauseous), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1631649
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown. Not Provided The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1631650
Sex: F
Age:
State: MD

Vax Date: 01/12/2021
Onset Date:
Rec V Date: 08/25/2021
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: hasn't received a phone call or notification for 2nd dose; started over and received Pfizer instead; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (hasn't received a phone call or notification for 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (started over and received Pfizer instead) 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 12-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 PRODUCT ADMINISTRATION INTERRUPTED (hasn't received a phone call or notification for 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (started over and received Pfizer instead). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (hasn't received a phone call or notification for 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (started over and received Pfizer instead) 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 product use was not provided by the reporter. Patient took Pfizer as second dose vaccine. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Event added (interchange of vaccine products)

Other Meds:

Current Illness:

ID: 1631651
Sex: M
Age: 67
State: TX

Vax Date: 03/05/2021
Onset Date: 03/07/2021
Rec V Date: 08/25/2021
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: Arm was sore; Rash is on both arms, sides and back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and RASH (Rash is on both arms, sides and back) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (Rash is on both arms, sides and back). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and RASH (Rash is on both arms, sides and back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was reported. Patient had not used anything to treat his symptoms.

Other Meds:

Current Illness:

ID: 1631652
Sex: M
Age:
State: FL

Vax Date: 03/01/2021
Onset Date: 03/11/2021
Rec V Date: 08/25/2021
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: very sick; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick) and VOMITING (throwing up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history were provided. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ILLNESS (very sick) and VOMITING (throwing up). At the time of the report, ILLNESS (very sick) and VOMITING (throwing up) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitants were provided. No treatment drug was provided.

Other Meds:

Current Illness:

ID: 1631653
Sex: F
Age: 56
State: WI

Vax Date: 02/26/2021
Onset Date: 03/05/2021
Rec V Date: 08/25/2021
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: A bright red patch/spread to about inch in diameter and still has a red ring around it; Swollen; Burning; Little sleep; it began itching; Throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it began itching), PAIN (Throbbing), ERYTHEMA (A bright red patch/spread to about inch in diameter and still has a red ring around it), SWELLING (Swollen) and BURNING SENSATION (Burning) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (it began itching), PAIN (Throbbing), BURNING SENSATION (Burning) and SLEEP DEFICIT (Little sleep). On 06-Mar-2021, the patient experienced ERYTHEMA (A bright red patch/spread to about inch in diameter and still has a red ring around it) and SWELLING (Swollen). At the time of the report, PRURITUS (it began itching), PAIN (Throbbing), SWELLING (Swollen), BURNING SENSATION (Burning) and SLEEP DEFICIT (Little sleep) outcome was unknown and ERYTHEMA (A bright red patch/spread to about inch in diameter and still has a red ring around it) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1631654
Sex: F
Age: 63
State: FL

Vax Date: 03/07/2021
Onset Date: 03/07/2021
Rec V Date: 08/25/2021
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: itching on left eyelid; swelling on left eyelid; puffed up left eyelid; This spontaneous case was reported by a consumer and describes the occurrence of EYELIDS PRURITUS (itching on left eyelid), SWELLING OF EYELID (swelling on left eyelid) and PERIORBITAL SWELLING (puffed up left eyelid) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced EYELIDS PRURITUS (itching on left eyelid), SWELLING OF EYELID (swelling on left eyelid) and PERIORBITAL SWELLING (puffed up left eyelid). On 10-Mar-2021, SWELLING OF EYELID (swelling on left eyelid) had resolved. At the time of the report, EYELIDS PRURITUS (itching on left eyelid) had resolved and PERIORBITAL SWELLING (puffed up left eyelid) had not 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. No concomitant medications were provided by the reporter. Patient reporting using cold compresses, hot compresses, and taking Benadryl to treat the events.

Other Meds:

Current Illness:

ID: 1631655
Sex: F
Age: 84
State: WA

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/25/2021
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: nose felt blocked off; runny nose and eyes; sudden high fever; headache; whole right arm painful including fingers and palm; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (nose felt blocked off), PAIN IN EXTREMITY (whole right arm painful including fingers and palm), RHINORRHOEA (runny nose and eyes), HEADACHE (headache) and PYREXIA (sudden high fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation, Arthritis (arthritis in her right thumb) and Shoulder discomfort (has a shoulder problem in her right arm). On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (whole right arm painful including fingers and palm) and HEADACHE (headache). On 10-Mar-2021, the patient experienced NASAL CONGESTION (nose felt blocked off), RHINORRHOEA (runny nose and eyes) and PYREXIA (sudden high fever). On 08-Mar-2021, HEADACHE (headache) had resolved. On 09-Mar-2021, PAIN IN EXTREMITY (whole right arm painful including fingers and palm) had resolved. At the time of the report, NASAL CONGESTION (nose felt blocked off) and PYREXIA (sudden high fever) outcome was unknown and RHINORRHOEA (runny nose and eyes) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication heat applied to sore arm. No concomitant medication details was reported.

Other Meds:

Current Illness: Arthritis (arthritis in her right thumb); Atrial fibrillation; Shoulder discomfort (has a shoulder problem in her right arm)

ID: 1631656
Sex: F
Age: 67
State: TX

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 08/25/2021
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: rash inside and lower than where the injection was given; small rash 1.5 at the site of the injection; fatigue; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash inside and lower than where the injection was given), VACCINATION SITE RASH (small rash 1.5 at the site of the injection) and FATIGUE (fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The patient's past medical history included Mood disorder. Concurrent medical conditions included Asthma and Allergy (respiratory allergies). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash inside and lower than where the injection was given), VACCINATION SITE RASH (small rash 1.5 at the site of the injection) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash inside and lower than where the injection was given), VACCINATION SITE RASH (small rash 1.5 at the site of the injection) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness: Allergy (respiratory allergies); Asthma

ID: 1631657
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/09/2021
Rec V Date: 08/25/2021
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: Severe chest pain; Crazy head ache; Breathing issues; fever; 103?F fever; very weak; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), ASTHENIA (very weak), PAIN (sore), PYREXIA (103?F fever) and CHEST PAIN (Severe chest pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced ASTHENIA (very weak) and PAIN (sore). On 10-Mar-2021, the patient experienced PYREXIA (103?F fever). On 11-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced CHEST PAIN (Severe chest pain), HEADACHE (Crazy head ache) and DYSPNOEA (Breathing issues). On 10-Mar-2021, PYREXIA (103?F fever) had resolved. At the time of the report, PYREXIA (fever), ASTHENIA (very weak), PAIN (sore), CHEST PAIN (Severe chest pain), HEADACHE (Crazy head ache) and DYSPNOEA (Breathing issues) outcome was unknown. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1631658
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: wasn't up to doing anything; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (wasn't up to doing anything) 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) (unknown route) 1 dosage form. On an unknown date, 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 ASTHENIA (wasn't up to doing anything). At the time of the report, ASTHENIA (wasn't up to doing anything) outcome was unknown. Action taken with mRNA-1273 in response to the events was not applicable

Other Meds:

Current Illness:

ID: 1631659
Sex: M
Age:
State: NY

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 08/25/2021
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: Patient received a different dose; Syringe issue; Underdose; A spontaneous report was received from a pharmacist concerning a unspecified age of male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced patient received a different dose, syringe was disconnected from the needle/ syringe Issue and lost half a dose approx/ Under dose. The patient's medical history, was not provided by the reporter. Concomitant medications were not reported. On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number:032M20A) unknown route of administration in the unknown site for prophylaxis of COVID-19 infection. On the same day, prior to receiving mRNA-1273, the syringe was disconnected from the needle and lost half a dose approx. Therefore patient received a different dose. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, syringe was disconnected from the needle and the patient received half a dose approx. were considered resolved on 11 Mar 2021.; Reporter's Comments: This report refers to a case of underdose and syringe issue for mRNA-1273 (lot # unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1631660
Sex: F
Age: 67
State: CA

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20201224; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

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

Symptoms: Light body aches; tired; chills; Pain near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Light body aches), FATIGUE (tired), CHILLS (chills) and VACCINATION SITE PAIN (Pain near the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Patient's medical history included No Adverse event. Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Light body aches), FATIGUE (tired), CHILLS (chills) and VACCINATION SITE PAIN (Pain near the injection site). On 11-Mar-2021, PAIN (Light body aches) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (tired) and VACCINATION SITE PAIN (Pain near the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided

Other Meds: LOSARTAN; AMLODIPINE

Current Illness:

ID: 1631661
Sex: F
Age: 71
State: GA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/25/2021
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: Injection site redness; Injection site tenderness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tenderness) in a 72-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 01-Mar-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 ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tenderness). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tenderness) 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: 1631662
Sex: F
Age: 73
State: CT

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/25/2021
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: small rash itchy around the injection site (R arm); small rash itchy around the injection site (R arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (small rash itchy around the injection site (R arm)) and VACCINATION SITE PRURITUS (small rash itchy around the injection site (R arm)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 22-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 RASH (small rash itchy around the injection site (R arm)) and VACCINATION SITE PRURITUS (small rash itchy around the injection site (R arm)). At the time of the report, VACCINATION SITE RASH (small rash itchy around the injection site (R arm)) and VACCINATION SITE PRURITUS (small rash itchy around the injection site (R arm)) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1631663
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: A lot of itching/ Itching at the injection site; Rash/ Rash on arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (A lot of itching/ Itching at the injection site) and RASH (Rash/ Rash on arm after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (A lot of itching/ Itching at the injection site) and RASH (Rash/ Rash on arm after first dose). The patient was treated with CORTISONE for Rash and Vaccination site pruritus, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (A lot of itching/ Itching at the injection site) and RASH (Rash/ Rash on arm after first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. This case was linked to US-MODERNATX, INC.- (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23-APR-2021 contains significant information. Vaccine dose number was updated. On 24-Jun-2021: Follow up received on 24-JUN-2021 contains no new information.; Sender's Comments: US-MODERNATX, INC.-:crosslinked

Other Meds:

Current Illness:

ID: 1631664
Sex: M
Age:
State: TX

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/25/2021
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: Test Date: 20210203; Test Name: Body temperature; Result Unstructured Data: Degrees F

Allergies:

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

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 06-Jan-2021, the patient received first 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 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100 Degrees F. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1631665
Sex: F
Age:
State: OH

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/25/2021
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: Test Date: 20210307; Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 101 degrees Fahrenheit; Test Date: 20210311; Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 99.5 degrees Fahrenheit

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: fever of 101?F; Sore at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore at injection site) and PYREXIA (fever of 101?F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE PAIN (Sore at injection site). On 07-Mar-2021, the patient experienced PYREXIA (fever of 101?F). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Sore at injection site) and PYREXIA (fever of 101?F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature:. On 11-Mar-2021, Body temperature:. Treatment included acetaminophen.

Other Meds:

Current Illness:

ID: 1631666
Sex: F
Age:
State:

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 08/25/2021
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: itching at the injection site; swelling at the injection site; rash at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.Consumer stated that his wife got the 1st shot on 24Feb2021 and developed itching, swelling, and rash at the injection site. This case was linked to MOD-2021-108935 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Medical report contains information on Dose 2 and its events

Other Meds:

Current Illness:

ID: 1631667
Sex: F
Age: 47
State: PA

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/25/2021
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: small rash on neck and face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (small rash on neck and face) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 014M20A) for COVID-19 vaccination. The patient's past medical history included Seasonal allergy and Shellfish allergy. Concomitant products included TAMOXIFEN and BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced RASH (small rash on neck and face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY & SINUS) at an unspecified dose and frequency. At the time of the report, RASH (small rash on neck and face) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. This case was linked to MOD-2021-026437, MOD-2021-026437 (Patient Link).

Other Meds: TAMOXIFEN; VERTEX [BETAHISTINE HYDROCHLORIDE]

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am