VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1626986
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: burning sensation on skin; red spots; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (burning sensation on skin) and RASH ERYTHEMATOUS (red spots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 SKIN BURNING SENSATION (burning sensation on skin) and RASH ERYTHEMATOUS (red spots). At the time of the report, SKIN BURNING SENSATION (burning sensation on skin) outcome was unknown and RASH ERYTHEMATOUS (red spots) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that patient took "some unidentified text" and it cleared up. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1626987
Sex: F
Age:
State: FL

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Date: 20210406; Test Name: Blood work; Result Unstructured Data: Normal

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B821A and 044A21A) for COVID-19 vaccination. The patient's past medical history included Lupus erythematosus (Tested highly positive for lupus) in April 2020. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). 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 06-Apr-2021, Blood test: normal (normal) Normal. Concomitant medications also included unspecified cultural pre and probiotic. No treatment medication was reported. This case was linked to MOD-2021-215806, MOD-2021-215806 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received provided patient details, medical hsitory and concomitant medications.

Other Meds: SYNTHROID; TYLENOL

Current Illness:

ID: 1626988
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: feeling dizziness; allergy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizziness) and HYPERSENSITIVITY (allergy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 DIZZINESS (feeling dizziness) and HYPERSENSITIVITY (allergy). At the time of the report, DIZZINESS (feeling dizziness) and HYPERSENSITIVITY (allergy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication use was provided by the reporter. No treatment of events was reported.

Other Meds:

Current Illness:

ID: 1626989
Sex: F
Age: 34
State: NY

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPOSURE VIA EYE CONTACT (A vaccine spilled in the eye while taking second dose of Moderna Covid-19 Vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050c21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPOSURE VIA EYE CONTACT (A vaccine spilled in the eye while taking second dose of Moderna Covid-19 Vaccine). At the time of the report, EXPOSURE VIA EYE CONTACT (A vaccine spilled in the eye while taking second dose of Moderna Covid-19 Vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1626990
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: can the moderna vaccine effect my heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (can the moderna vaccine effect my heart) in a 66-year-old patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (can the moderna vaccine effect my heart). At the time of the report, CARDIAC DISORDER (can the moderna vaccine effect my heart) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1626991
Sex: F
Age: 63
State: NC

Vax Date: 05/13/2021
Onset Date: 06/10/2021
Rec V Date: 08/24/2021
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: patient receiving a vaccine from a vial that has been punctured for 22 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine from a vial that has been punctured for 22 hours) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine from a vial that has been punctured for 22 hours). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine from a vial that has been punctured for 22 hours) had resolved. 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. ? No treatment information was provided. ? 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.

Other Meds:

Current Illness:

ID: 1626992
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Diarrhea after First Vaccine; Stools have changed color after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after First Vaccine) and FAECES DISCOLOURED (Stools have changed color after First Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 DIARRHOEA (Diarrhea after First Vaccine) and FAECES DISCOLOURED (Stools have changed color after First Vaccine). At the time of the report, DIARRHOEA (Diarrhea after First Vaccine) and FAECES DISCOLOURED (Stools have changed color after First Vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1626993
Sex: F
Age: 43
State: FL

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 08/24/2021
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: forgot about the scheduled second dose appointment on 25May2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (forgot about the scheduled second dose appointment on 25May2021) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Apr-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 PRODUCT DOSE OMISSION ISSUE (forgot about the scheduled second dose appointment on 25May2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (forgot about the scheduled second dose appointment on 25May2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1626994
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Still has headache 15 days later; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Still has headache 15 days later) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, the patient experienced HEADACHE (Still has headache 15 days later). At the time of the report, HEADACHE (Still has headache 15 days later) outcome was unknown. No Concomitant and treatment medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1626995
Sex: F
Age: 45
State: MD

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: Vaccine dose was administered from the vial punctured for > 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not reported. HCP stated that Moderna COVID-19 vaccine was given to 4 patients yesterday (9Jun2021) from the vial which was punctured for more than 12 hours Treatment information were not reported.

Other Meds:

Current Illness:

ID: 1626996
Sex: M
Age: 55
State: AR

Vax Date: 06/08/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: slept all day and night; was feeling pretty bad/still don't feel good; bodyaches / feels like he got punched in the arm; nausea / still have nausea; headache / still have headache; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), SOMNOLENCE (slept all day and night), MALAISE (was feeling pretty bad/still don't feel good), MYALGIA (bodyaches / feels like he got punched in the arm) and NAUSEA (nausea / still have nausea) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced ILLNESS (sick), MYALGIA (bodyaches / feels like he got punched in the arm), NAUSEA (nausea / still have nausea) and HEADACHE (headache / still have headache). On an unknown date, the patient experienced SOMNOLENCE (slept all day and night) and MALAISE (was feeling pretty bad/still don't feel good). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) ongoing since an unknown date for Headache, at a dose of 1 dosage form and NAPROXEN ongoing since an unknown date for Headache, at a dose of 1 dosage form. At the time of the report, ILLNESS (sick), SOMNOLENCE (slept all day and night), MALAISE (was feeling pretty bad/still don't feel good), MYALGIA (bodyaches / feels like he got punched in the arm), NAUSEA (nausea / still have nausea) and HEADACHE (headache / still have headache) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medicines were not reported Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Updated Reporter details, Patient demographics, Added vaccination details , Treatment medications, Added new event Somnolence

Other Meds:

Current Illness:

ID: 1626997
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain; my shoulder has been killing me,My shoulder aches to touch it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain) and ARTHRALGIA (my shoulder has been killing me,My shoulder aches to touch it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 PAIN (couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain) and ARTHRALGIA (my shoulder has been killing me,My shoulder aches to touch it). At the time of the report, PAIN (couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain) and ARTHRALGIA (my shoulder has been killing me,My shoulder aches to touch it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1626998
Sex: U
Age:
State:

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: sore arm; my energy is low; feeling dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jun-2021 and was forwarded to Moderna on 10-Jun-2021. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), ASTHENIA (my energy is low) and DIZZINESS (feeling dizzy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. N Medical History was reported. Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced VACCINATION SITE PAIN (sore arm), ASTHENIA (my energy is low) and DIZZINESS (feeling dizzy). At the time of the report, VACCINATION SITE PAIN (sore arm), ASTHENIA (my energy is low) and DIZZINESS (feeling dizzy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Treatment Medicines were reported

Other Meds: ESTROGEN

Current Illness:

ID: 1626999
Sex: F
Age: 51
State: FL

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 08/24/2021
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: Throat is swollen, seemed to partially block her throat; Tongue felt bigger and seemed to partially block throat; Ulcer in mouth between her teeth and gums; Little rashes on chin and arms that were very itchy,itchy rash; Horrible sinus; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums), RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) and SINUS DISORDER (Horrible sinus) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PYREXIA (Fever). On 17-May-2021, the patient experienced PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums), RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) and SINUS DISORDER (Horrible sinus). The patient was treated with PARACETAMOL (TYLENOL) in May 2021 for Fever, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) in May 2021 for Sinus disorder, at an unspecified dose and frequency. On 17-May-2021, PYREXIA (Fever) had resolved. On 29-May-2021, SINUS DISORDER (Horrible sinus) had resolved. At the time of the report, PHARYNGEAL SWELLING (Throat is swollen, seemed to partially block her throat), PARAESTHESIA ORAL (Tongue felt bigger and seemed to partially block throat), MOUTH ULCERATION (Ulcer in mouth between her teeth and gums) and RASH PRURITIC (Little rashes on chin and arms that were very itchy,itchy rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided. The treatment information was reported as some unknown antibiotic cream.

Other Meds:

Current Illness:

ID: 1627000
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: covid-19 disease after 1st vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid-19 disease after 1st vaccine) in a 66-year-old female patient 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 COVID-19 (covid-19 disease after 1st vaccine). At the time of the report, COVID-19 (covid-19 disease after 1st vaccine) 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 concomitant medications were provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627001
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: facial swelling; redness; hot red rash at injection site spreading around top part of arm; headache; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), ERYTHEMA (redness), VACCINATION SITE RASH (hot red rash at injection site spreading around top part of arm), HEADACHE (headache) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (facial swelling), ERYTHEMA (redness), VACCINATION SITE RASH (hot red rash at injection site spreading around top part of arm), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, SWELLING FACE (facial swelling), ERYTHEMA (redness), VACCINATION SITE RASH (hot red rash at injection site spreading around top part of arm), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Treatment medication was not provided.

Other Meds:

Current Illness:

ID: 1627002
Sex: F
Age: 74
State: TN

Vax Date: 12/23/2020
Onset Date: 01/20/2021
Rec V Date: 08/24/2021
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: she can't even move; neck pain is unbearable; has diarrhea since January started as every 10 to 15 minutes but now happen occasionally; shoulder pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (she can't even move), NECK PAIN (neck pain is unbearable), DIARRHOEA (has diarrhea since January started as every 10 to 15 minutes but now happen occasionally) and ARTHRALGIA (shoulder pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced NECK PAIN (neck pain is unbearable), DIARRHOEA (has diarrhea since January started as every 10 to 15 minutes but now happen occasionally) and ARTHRALGIA (shoulder pain). On 10-Jun-2021, the patient experienced MOBILITY DECREASED (she can't even move). The patient was treated with OMEPRAZOLE ongoing since an unknown date at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (she can't even move), NECK PAIN (neck pain is unbearable), DIARRHOEA (has diarrhea since January started as every 10 to 15 minutes but now happen occasionally) and ARTHRALGIA (shoulder pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up information received on 10-JUN-2021 contains Significant information: Events, Concomitant and Treatment medications and Vaccine Doses updated

Other Meds: PEPCID [FAMOTIDINE]

Current Illness:

ID: 1627003
Sex: F
Age: 72
State: TX

Vax Date: 06/01/2021
Onset Date: 06/02/2021
Rec V Date: 08/24/2021
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: diarrhea; chest pain; nightmares; Difficulty sleeping; body pain; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping) and PAIN (body pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stent placement (cardiac stents), Pacemaker insertion (cardiac) (pacemaker) and Defibrillator/pacemaker insertion. Concurrent medical conditions included Diabetes. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping), PAIN (body pain), MYALGIA (body ache) and NAUSEA (nausea). The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) ongoing since an unknown date for Chest pain, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (diarrhea), CHEST PAIN (chest pain), NIGHTMARE (nightmares), INSOMNIA (Difficulty sleeping), PAIN (body pain), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. No treatment was reported. Patient has 8 cardiac stents and a pacemaker. Patient reported allergic to about a dozen prescription drugs.

Other Meds:

Current Illness: Diabetes

ID: 1627004
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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 reported by a consumer, describes the occurrence of vaccination complication (vaccination adverse reaction) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (vaccination adverse reaction). At the time of the report, vaccination complication (vaccination adverse reaction) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.

Other Meds:

Current Illness:

ID: 1627005
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Tingling on left side of face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling on left side of face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PARAESTHESIA (tingling on left side of face). At the time of the report, PARAESTHESIA (tingling on left side of face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications was provided by the reporter. No concomitant medications was reported by the reporter.

Other Meds:

Current Illness:

ID: 1627006
Sex: M
Age:
State: MN

Vax Date: 05/19/2021
Onset Date:
Rec V Date: 08/24/2021
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: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative.

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of fatigue and pyrexia (fever) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On May 19, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced fatigue and pyrexia (fever). At the time of the report, fatigue and pyrexia (fever) outcome: unknown. Diagnostic results: On an unknown date, SARS-CoV-2 test: Negative. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use and treatment information not provided.

Other Meds:

Current Illness:

ID: 1627007
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: This spontaneous case reported by a physician, describes the occurrence of increased appetite (strong appetite the next day after second Moderna shot) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced increased appetite (strong appetite the next day after second Moderna shot). At the time of the report, increased appetite (strong appetite the next day after second Moderna shot) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.

Other Meds:

Current Illness:

ID: 1627008
Sex: U
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048c21a) 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 PRODUCT STORAGE ERROR (Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Nurse stated the 20 patient received the Moderna vaccine from the temperature excursion) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided No Treatment information provided

Other Meds:

Current Illness:

ID: 1627009
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 PRODUCT DOSE OMISSION ISSUE (I got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my vaccine like a month or two ago and I was supposes to get the second one but I was not able to go) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1627010
Sex: U
Age:
State:

Vax Date: 05/07/2021
Onset Date:
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Date: 20210507; Test Name: COVID-19 rapid POC test; Test Result: Positive ; Result Unstructured Data: Patient received 1st Moderna vaccine on 5/7 just had rapid test and it was positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Severe reaction to vaccine at both injection site; Body aches; Extreme fatigue / Unable to function for 4 days then another 5 days to feel normal; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Severe reaction to vaccine at both injection site), MYALGIA (Body aches) and FATIGUE (Extreme fatigue / Unable to function for 4 days then another 5 days to feel normal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 07-May-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 REACTION (Severe reaction to vaccine at both injection site), MYALGIA (Body aches) and FATIGUE (Extreme fatigue / Unable to function for 4 days then another 5 days to feel normal). At the time of the report, VACCINATION SITE REACTION (Severe reaction to vaccine at both injection site), MYALGIA (Body aches) and FATIGUE (Extreme fatigue / Unable to function for 4 days then another 5 days to feel normal) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, SARS-CoV-2 test: positive (Positive) Patient received 1st Moderna vaccine on 5/7 just had rapid test and it was positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had COVID in the late December early January. No concomitant products were reported by reporter. No treatment medication provided by the reporter.

Other Meds:

Current Illness:

ID: 1627011
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: No energy; Arm is sore; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), MYALGIA (Arm is sore) and ARTHRALGIA (Shoulder pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (No energy), MYALGIA (Arm is sore) and ARTHRALGIA (Shoulder pain). At the time of the report, ASTHENIA (No energy), MYALGIA (Arm is sore) and ARTHRALGIA (Shoulder pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant products were reported by reporter. No treatment medication provided by the reporter.

Other Meds:

Current Illness:

ID: 1627012
Sex: M
Age: 61
State: IL

Vax Date: 05/13/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: Swollen ankles; in a lot of pain; sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks), JOINT SWELLING (Swollen ankles) and MYALGIA (in a lot of pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B217) for COVID-19 vaccination. Concurrent medical conditions included Foot drop (Left foot drop- started years ago) and Ankle instability (Ankle pops in and out). Concomitant products included TOFACITINIB CITRATE (XELJANZ XR), SERTRALINE HYDROCHLORIDE (SERTRALINE [SERTRALINE HYDROCHLORIDE]), SIMVASTATIN, CYCLOBENZAPRINE, DICLOFENAC SODIUM, LISINOPRIL, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), GABAPENTIN and METFORMIN HYDROCHLORIDE (METFORMIN ER) for an unknown indication. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced LIGAMENT SPRAIN (sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks). On 10-Jun-2021, the patient experienced JOINT SWELLING (Swollen ankles) and MYALGIA (in a lot of pain). At the time of the report, LIGAMENT SPRAIN (sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks), JOINT SWELLING (Swollen ankles) and MYALGIA (in a lot of pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: XELJANZ XR; SERTRALINE [SERTRALINE HYDROCHLORIDE]; SIMVASTATIN; CYCLOBENZAPRINE; DICLOFENAC SODIUM; LISINOPRIL; HYDROCODONE/ACETAMINOPHEN; GABAPENTIN; METFORMIN ER

Current Illness: Ankle instability (Ankle pops in and out); Foot drop (Left foot drop- started years ago)

ID: 1627013
Sex: F
Age: 59
State: MT

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 08/24/2021
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: Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The patient's past medical history included Sinusitis from 17-May-2021 to 27-May-2021 and Bronchitis from 17-May-2021 to 27-May-2021. Concurrent medical conditions included Allergy to arthropod sting, Latex allergy (allergy to Latex and Doxycycline), Drug allergy (Allergy to Biaxin), Hypertension since 04-Jun-2018, Depression since 04-Dec-2017 and Hyperlipidemia since 04-Dec-2017. Concomitant products included DICLOFENAC from 03-Mar-2019 to an unknown date for Chronic pain, SIMVASTATIN from 04-Dec-2017 to an unknown date and ATORVASTATIN CALCIUM (LIPITOR) from 01-Mar-2020 to an unknown date for Hyperlipidemia, METOPROLOL from 01-Mar-2020 to an unknown date for Hypertension, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) from 04-Dec-2017 to an unknown date for an unknown indication. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open) 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. Patient reported that she is allergic to TD and viozz. No treatment details were provided. Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up received on 30 Jul 2021 contains patient demographics added, medical history, concomitant medication were added.

Other Meds: SIMVASTATIN; METOPROLOL; LIPITOR; ALBUTEROL [SALBUTAMOL SULFATE]; DICLOFENAC

Current Illness: Allergy to arthropod sting; Depression; Drug allergy (Allergy to Biaxin); Hyperlipidemia; Hypertension; Latex allergy (allergy to Latex and Doxycycline)

ID: 1627014
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: bad taste in my mouth; sense of numbness in the left side of my mouth; Sense of coldness in the left side of my mouth; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (bad taste in my mouth), HYPOAESTHESIA ORAL (sense of numbness in the left side of my mouth) and FEELING COLD (Sense of coldness in the left side of my mouth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 TASTE DISORDER (bad taste in my mouth), HYPOAESTHESIA ORAL (sense of numbness in the left side of my mouth) and FEELING COLD (Sense of coldness in the left side of my mouth). At the time of the report, TASTE DISORDER (bad taste in my mouth), HYPOAESTHESIA ORAL (sense of numbness in the left side of my mouth) and FEELING COLD (Sense of coldness in the left side of my mouth) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1627015
Sex: F
Age: 56
State: FL

Vax Date: 01/20/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: She received her 1st dose back in January on 20JAN2021; Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand); itchiness all over my body; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 1st dose back in January on 20JAN2021), SKIN FISSURES (Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand)) and PRURITUS (itchiness all over my body) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. No medical history was provided. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 1st dose back in January on 20JAN2021). 09-Jun-2021, the patient experienced SKIN FISSURES (Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand)) and PRURITUS (itchiness all over my body). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 1st dose back in January on 20JAN2021) had resolved. On 10-Jun-2021, PRURITUS (itchiness all over my body) had resolved. At the time of the report, SKIN FISSURES (Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand)) had not resolved. Concomitant product use was not reported. It was reported that the patient took an anti-histamine for treatment (not further specified) and the itching improved however, the chaffing is continuing. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.

Other Meds:

Current Illness:

ID: 1627016
Sex: F
Age: 56
State: IL

Vax Date: 03/25/2021
Onset Date: 04/22/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data: Test Name: Platelet Count; Test Result: Inconclusive ; Result Unstructured Data: 322,000; Test Date: 20210410; Test Name: Platelet count decreased; Result Unstructured Data: 12000

Allergies:

Symptom List: Injection site pain

Symptoms: did notget the second shot of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did notget the second shot of the Moderna COVID-19 vaccine) in a 57-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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did notget the second shot of the Moderna COVID-19 vaccine). The patient was treated with PREDNISONE ongoing from 10-Apr-2021 for Platelet count, at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (did notget the second shot of the Moderna COVID-19 vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Platelet count decreased: 12000 (Low) 12000. On an unknown date, Platelet count: 322,000 (Inconclusive) 322,000. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided.

Other Meds:

Current Illness:

ID: 1627017
Sex: F
Age: 68
State: SC

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 08/24/2021
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: red pigmented lesion ,first started at the injection arm( left arm); red pigmented lesion spread to the legs; red pigmented lesion spread to the other arm(right arm); This spontaneous case was reported by a non-health professional and describes the occurrence of SKIN LESION (red pigmented lesion ,first started at the injection arm( left arm)), RASH ERYTHEMATOUS (red pigmented lesion spread to the legs) and RASH MACULAR (red pigmented lesion spread to the other arm(right arm)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014MZ0A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-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 an unknown date, the patient experienced SKIN LESION (red pigmented lesion ,first started at the injection arm( left arm)), RASH ERYTHEMATOUS (red pigmented lesion spread to the legs) and RASH MACULAR (red pigmented lesion spread to the other arm(right arm)). At the time of the report, SKIN LESION (red pigmented lesion ,first started at the injection arm( left arm)), RASH ERYTHEMATOUS (red pigmented lesion spread to the legs) and RASH MACULAR (red pigmented lesion spread to the other arm(right arm)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment details were reported. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non-Significant Follow Up Appended. Added batch number. Patient route of administration updated. On 30-Jun-2021: Follow up received and contains No New Information.

Other Meds:

Current Illness:

ID: 1627018
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Real bad headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Real bad headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 HEADACHE (Real bad headache). At the time of the report, HEADACHE (Real bad headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication- (not clear) for headache was reported. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1627019
Sex: F
Age: 18
State: FL

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 08/24/2021
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: Missed Second Dose ( Beyond 42 days); Tired; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PRODUCT DOSE OMISSION ISSUE (Missed Second Dose ( Beyond 42 days)) and FATIGUE (Tired) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced DIZZINESS (Dizzy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed Second Dose ( Beyond 42 days)) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzy), PRODUCT DOSE OMISSION ISSUE (Missed Second Dose ( Beyond 42 days)) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1627020
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Tingling sensations; Rash on back of left leg after first moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensations) and RASH (Rash on back of left leg after first moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 PARAESTHESIA (Tingling sensations) and RASH (Rash on back of left leg after first moderna shot). At the time of the report, PARAESTHESIA (Tingling sensations) and RASH (Rash on back of left leg after first moderna shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1627021
Sex: F
Age: 30
State:

Vax Date: 06/10/2021
Onset Date:
Rec V Date: 08/24/2021
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: This spontaneous case reported by a consumer, describes the occurrence of malaise (not feeling good), abdominal pain upper (cramps in stomach), bloody urine (blood in urine) and chills in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 10, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced malaise (not feeling good), abdominal pain upper (cramps in stomach), bloody urine (blood in urine) and chills. At the time of the report, malaise (not feeling good), abdominal pain upper (cramps in stomach), bloody urine (blood in urine) and chills outcome: unknown. Concomitant product use and treatment information not provided.

Other Meds:

Current Illness:

ID: 1627022
Sex: M
Age:
State: NY

Vax Date: 02/15/2021
Onset Date: 04/02/2021
Rec V Date: 08/24/2021
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: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 012A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (omprezole). Concomitant products included LEVOTHYROXINE for Hypothyroidism, BUPROPION for Mood disorder NOS, TESTOSTERONE, BECLOMETASONE DIPROPIONATE (QNASL) and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication. On 15-Feb-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. Cause of tinnitus provided as minor hearing loss. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 19-JUL-2021 and contains patient demographics added, relevant history updated, suspect drug details and lot number added, concomitant drugs added, adverse event details updated On 29-Jul-2021: Contained no new information.

Other Meds: LEVOTHYROXINE; BUPROPION; TESTOSTERONE; QNASL; BREO ELLIPTA

Current Illness: Drug allergy (omprezole)

ID: 1627023
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: aggravate allodynia; bones hurting; This spontaneous case was reported by a consumer and describes the occurrence of ALLODYNIA (aggravate allodynia) and BONE PAIN (bones hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALLODYNIA (aggravate allodynia) and BONE PAIN (bones hurting). At the time of the report, ALLODYNIA (aggravate allodynia) and BONE PAIN (bones hurting) outcome was unknown. No concomitant medication was reported. Treatment medication was not provided.

Other Meds:

Current Illness:

ID: 1627024
Sex: F
Age: 72
State: NY

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/24/2021
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: I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now; unexpected beneficiary effect/Herpes Simplex outbreaks disappeared; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now) and THERAPEUTIC RESPONSE UNEXPECTED (unexpected beneficiary effect/Herpes Simplex outbreaks disappeared) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Antidepressant discontinuation syndrome, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, BOTULINUM TOXIN TYPE A (BOTOX) for Vocal cord dysfunction. 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 THERAPEUTIC RESPONSE UNEXPECTED (unexpected beneficiary effect/Herpes Simplex outbreaks disappeared). On 12-Jul-2021, the patient experienced HERPES VIRUS INFECTION (I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now). On 13-Jul-2021, HERPES VIRUS INFECTION (I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (unexpected beneficiary effect/Herpes Simplex outbreaks disappeared) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. She went 6 months herpes outbreak free but yesterday she had an out break she was so excited and now disappointed. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received on 13-Jul-2021. New event Herpes NOS added.

Other Meds: BOTOX; SYNTHROID; LEXAPRO

Current Illness:

ID: 1627025
Sex: U
Age:
State:

Vax Date: 03/28/2021
Onset Date:
Rec V Date: 08/24/2021
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: lups (lips) tingling; Sick with fever; Itching all over; Severe reaction of extreme pain/aches/pains; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lups (lips) tingling), VACCINATION COMPLICATION (Sick with fever), PRURITUS (Itching all over), MYALGIA (severe reaction of extreme pain/aches/pains) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (lups (lips) tingling), VACCINATION COMPLICATION (Sick with fever), PRURITUS (Itching all over), MYALGIA (severe reaction of extreme pain/aches/pains) and PYREXIA (Fever). At the time of the report, PARAESTHESIA ORAL (lups (lips) tingling), VACCINATION COMPLICATION (Sick with fever), PRURITUS (Itching all over), MYALGIA (severe reaction of extreme pain/aches/pains) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment information was reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627026
Sex: M
Age: 60
State: WA

Vax Date: 04/21/2021
Onset Date: 04/28/2021
Rec V Date: 08/24/2021
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: Abrupt onset cough; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Abrupt onset cough) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included ATORVASTATIN and SILDENAFIL CITRATE (VIAGRA) for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced COUGH (Abrupt onset cough). At the time of the report, COUGH (Abrupt onset cough) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications provided by the reporter. This case was linked to MOD-2021-216078 (Patient Link).

Other Meds: ATORVASTATIN; VIAGRA

Current Illness:

ID: 1627027
Sex: U
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 CHILLS (chills) and VOMITING (vomiting). At the time of the report, CHILLS (chills) and VOMITING (vomiting) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1627028
Sex: F
Age:
State: NE

Vax Date:
Onset Date: 06/10/2021
Rec V Date: 08/24/2021
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: dose adminstered that was not stored properly; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (dose adminstered that was not stored properly) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) 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) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (dose adminstered that was not stored properly). At the time of the report, PRODUCT STORAGE ERROR (dose adminstered that was not stored properly) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was unknown Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up was received on 15-JUN-2021. Reporter information was updated.

Other Meds:

Current Illness:

ID: 1627029
Sex: F
Age: 45
State: CA

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 08/24/2021
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: second dose is schedualed >35 after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose is schedualed >35 after the first dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No medical history was provided by reporter. No concomitant medication reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose is schedualed >35 after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose is schedualed >35 after the first dose) 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. Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Contact information updated

Other Meds:

Current Illness:

ID: 1627030
Sex: F
Age: 55
State: TX

Vax Date: 02/28/2021
Onset Date:
Rec V Date: 08/24/2021
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: Soreness of the right arm after the first dose; Missed Second dose ( Beyond 42 days); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the right arm after the first dose) and PRODUCT DOSE OMISSION ISSUE (Missed Second dose ( Beyond 42 days)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. Concomitant products included OLMESARTAN MEDOXOMIL for an unknown indication. On 28-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 PAIN IN EXTREMITY (Soreness of the right arm after the first dose) and PRODUCT DOSE OMISSION ISSUE (Missed Second dose ( Beyond 42 days)). At the time of the report, PAIN IN EXTREMITY (Soreness of the right arm after the first dose) and PRODUCT DOSE OMISSION ISSUE (Missed Second dose ( Beyond 42 days)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds: OLMESARTAN MEDOXOMIL

Current Illness:

ID: 1627031
Sex: M
Age: 58
State: WA

Vax Date: 04/18/2021
Onset Date: 05/15/2021
Rec V Date: 08/24/2021
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: rapid heart rate; feverish; body aches; chills; could not eat drink; brain fog; shaky; breathing issues; could not walk to his truck; Could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues) and GAIT DISTURBANCE (could not walk to his truck) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues), GAIT DISTURBANCE (could not walk to his truck), INSOMNIA (Could not sleep), PYREXIA (feverish), MYALGIA (body aches) and CHILLS (chills). On an unknown date, the patient experienced TACHYCARDIA (rapid heart rate). On 17-May-2021, EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues), GAIT DISTURBANCE (could not walk to his truck), INSOMNIA (Could not sleep), PYREXIA (feverish), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, TACHYCARDIA (rapid heart rate) outcome was unknown. No concomitant medications are provided. No treatment drug details was included. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.

Other Meds:

Current Illness:

ID: 1627032
Sex: F
Age: 77
State: PA

Vax Date: 05/20/2021
Onset Date: 05/25/2021
Rec V Date: 08/24/2021
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: Not feeling well; she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose; Really small red itchy rash marks underneath the skin; Really small red itchy rash marks underneath the skin; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Really small red itchy rash marks underneath the skin), RASH ERYTHEMATOUS (Really small red itchy rash marks underneath the skin), VACCINATION COMPLICATION (Not feeling well) and PRODUCT DOSE OMISSION ISSUE (she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C214) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included ASA for Anticoagulant therapy, SIMVASTATIN for Blood cholesterol abnormal, AMLODIPINE for Blood pressure abnormal. On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced RASH PRURITIC (Really small red itchy rash marks underneath the skin) and RASH ERYTHEMATOUS (Really small red itchy rash marks underneath the skin). On an unknown date, the patient experienced VACCINATION COMPLICATION (Not feeling well) and PRODUCT DOSE OMISSION ISSUE (she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in May 2021 for Rash pruritic and Rash erythematous, at an unspecified dose and frequency. On 30-May-2021, RASH PRURITIC (Really small red itchy rash marks underneath the skin) and RASH ERYTHEMATOUS (Really small red itchy rash marks underneath the skin) had resolved. At the time of the report, VACCINATION COMPLICATION (Not feeling well) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 25-May-2021, the itchy rash started out from the left arm, then further 1/2 the way from the shoulder (6-7 inches down the arm), and 1/2 the way from the upper chest. The patient reported treatment with diphenhydramine (BENADRYL) cream did not help. 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 02-Jul-2021: Additional information received on 02-07-2021 contains significant information. New events are updated.

Other Meds: SIMVASTATIN; AMLODIPINE; ASA

Current Illness: Blood pressure; Cholesterol

ID: 1627033
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: I am swollen; Swollen gland; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (I am swollen) and LYMPHADENOPATHY (Swollen gland) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (I am swollen) and LYMPHADENOPATHY (Swollen gland). At the time of the report, SWELLING (I am swollen) and LYMPHADENOPATHY (Swollen gland) outcome was unknown.

Other Meds:

Current Illness:

ID: 1627034
Sex: M
Age: 66
State: NY

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/24/2021
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: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History was provided by the reporter. Concurrent medical conditions included Type 2 diabetes mellitus. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (tired). The patient was treated with IBUPROFEN (ADVIL ARTHRITIS PAIN) ongoing since an unknown date for Pain, at a dose of 1 dosage form; PREDNISONE ongoing since an unknown date for Pain, at a dose of 1 dosage form and HYDROXYCHLOROQUINE ongoing since an unknown date for Pain, at a dose of 1 dosage form. On 16-Jan-2021, FATIGUE (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. It was reported that patient treated pain with heat & ice packs, then was put on steroid. Concomitant product use was not provided by the reporter. This case was linked to MOD-2021-102973 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-significant follow up & added reporters address only

Other Meds:

Current Illness: Type 2 diabetes mellitus

ID: 1627035
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: first dose is over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose is over 42 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 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 PRODUCT DOSE OMISSION ISSUE (first dose is over 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose is over 42 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was unknown. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received contains non new information.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am