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

Date Died: 07/01/2021

ID: 1740529
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 09/28/2021
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: BLOOD CLOTS; This spontaneous report received from a consumer (patient's niece) concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, therapy start date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021 (two months prior), the patient experienced blood clots and died. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0.20210951234-Covid-19 vaccine ad26.cov2.s -Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOTS

Other Meds:

Current Illness:

ID: 1740530
Sex: M
Age:
State: AK

Vax Date:
Onset Date: 09/27/2021
Rec V Date: 09/28/2021
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: 1 DOSE OF VACCINE ADMINISTERED 6 DAYS PAST EXPIRATION; This spontaneous report received from a health care professional concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced 1 dose of vaccine administered 6 days past expiration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 1 dose of vaccine administered 6 days past expiration was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1740531
Sex: M
Age: 74
State: AK

Vax Date: 05/02/2021
Onset Date: 05/04/2021
Rec V Date: 09/28/2021
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: Muscle soreness/muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness/muscle pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced MYALGIA (Muscle soreness/muscle pain). At the time of the report, MYALGIA (Muscle soreness/muscle pain) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The muscle pain was not severe and in about 2 weeks they were getting less painful. This case was linked to MOD-2021-259101 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received contains significant information of Patient demographics and vaccine start date were updated. Batch number, event start date, vaccination facility information were added.

Other Meds:

Current Illness:

ID: 1740532
Sex: M
Age: 69
State: FL

Vax Date: 07/19/2021
Onset Date: 07/20/2021
Rec V Date: 09/28/2021
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: A little bit of sore arm, sore only when moving and elevating it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A little bit of sore arm, sore only when moving and elevating it) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced VACCINATION SITE PAIN (A little bit of sore arm, sore only when moving and elevating it). On 20-Jul-2021, VACCINATION SITE PAIN (A little bit of sore arm, sore only when moving and elevating it) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment details not provided. Patient reported that he had virtually no reaction but did mention having a little bit of sore arm. It was after falling asleep on the side of injected arm. It was sore only when moving and elevating it. Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: FU Received on 21 Sep 2021 and contains no new information but initial version missed to capture dose number as 1 and relevant information captured in inarrative.

Other Meds:

Current Illness:

ID: 1740533
Sex: M
Age: 13
State: NJ

Vax Date: 06/30/2021
Onset Date: 06/30/2021
Rec V Date: 09/28/2021
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: Patient administered first dose of the Moderna COVID-19 vaccine at age of 13; This spontaneous case was reported by a dentist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of the Moderna COVID-19 vaccine at age of 13) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of the Moderna COVID-19 vaccine at age of 13). On 30-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of the Moderna COVID-19 vaccine at age of 13) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment was reported by the reporter. This case was linked to MOD-2021-271958 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up received on 20-Sep-2021 contains no new information , but action taken updated to not applicable single event of medication error reported.

Other Meds:

Current Illness:

ID: 1740534
Sex: M
Age:
State: AZ

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 09/28/2021
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: every part of his body hurt like he has been beaten with a bat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (every part of his body hurt like he has been beaten with a bat) in a 74-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 12-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (every part of his body hurt like he has been beaten with a bat). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 13-Feb-2021, PAIN (every part of his body hurt like he has been beaten with a bat) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications reported. This case was linked to MOD-2021-272289 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received contain no significant information but initial version missed to capture latency and onset date of event.

Other Meds:

Current Illness:

ID: 1740535
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: safe for pregnant women/ may have received the Moderna COVID-19 Vaccine while pregnant or may be planning to do so; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (safe for pregnant women/ may have received the Moderna COVID-19 Vaccine while pregnant or may be planning to do so) 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 MATERNAL EXPOSURE DURING PREGNANCY (safe for pregnant women/ may have received the Moderna COVID-19 Vaccine while pregnant or may be planning to do so). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (safe for pregnant women/ may have received the Moderna COVID-19 Vaccine while pregnant or may be planning to do so) had resolved. Concomitant product use was unknown by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns a female patient with no age and relevant medical history reported , who experienced the unexpected event of maternal exposure during pregnancy. The onset of the event from the time from the vaccination with Moderna is unknown since date of the exact event and the dates of the vaccination were not reported. The LMP and the EDD was also not reported. The benefit-risk relationship of Moderna is not affected by this report.

Other Meds:

Current Illness:

ID: 1740536
Sex: F
Age: 60
State: CA

Vax Date: 03/31/2021
Onset Date: 09/13/2021
Rec V Date: 09/28/2021
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: Body temperature; Result Unstructured Data: 102 for 6 hours which reduced to 99

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: could not sleep; loss of taste; urinate a lot for the first 24 hours; loss of sense of smell; my arm swelled up; loss of appetite; pain in arm; headache; fatigue; severe muscle pain; extreme/severe joint pain (On a scale of 9) for 16 hours, deep pain in my joints; fever temperature of 102 for 6 hours which reduced to 99, low grade fever; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), AGEUSIA (loss of taste), POLLAKIURIA (urinate a lot for the first 24 hours), ANOSMIA (loss of sense of smell) and PERIPHERAL SWELLING (my arm swelled up) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 021C21A and 016821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cellulitis from 19-Aug-2021 to 24-Aug-2021. Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic (Cipro, Augmentin), Pseudomyxoma peritonei since 28-May-2008, Lichen sclerosus since 22-Nov-2012, Laryngopharyngeal reflux since 10-May-2014, UTI since 05-Nov-1964 and Asthma. Concomitant products included ALPRAZOLAM (XANAX) for Muscle spasm, SIMETICONE (GAS X) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced INSOMNIA (could not sleep), AGEUSIA (loss of taste), POLLAKIURIA (urinate a lot for the first 24 hours), ANOSMIA (loss of sense of smell), PERIPHERAL SWELLING (my arm swelled up), DECREASED APPETITE (loss of appetite), PAIN IN EXTREMITY (pain in arm), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (severe muscle pain), ARTHRALGIA (extreme/severe joint pain (On a scale of 9) for 16 hours, deep pain in my joints), PYREXIA (fever temperature of 102 for 6 hours which reduced to 99, low grade fever), NAUSEA (nausea) and CHILLS (chills). The patient was treated with CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Pain, at an unspecified dose and frequency and ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) for Headache, at an unspecified dose and frequency. On 17-Sep-2021, INSOMNIA (could not sleep), AGEUSIA (loss of taste), POLLAKIURIA (urinate a lot for the first 24 hours), ANOSMIA (loss of sense of smell), PERIPHERAL SWELLING (my arm swelled up), DECREASED APPETITE (loss of appetite), PAIN IN EXTREMITY (pain in arm), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (severe muscle pain), ARTHRALGIA (extreme/severe joint pain (On a scale of 9) for 16 hours, deep pain in my joints), PYREXIA (fever temperature of 102 for 6 hours which reduced to 99, low grade fever), NAUSEA (nausea) and CHILLS (chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 for 6 hours which reduced to 99. Patent used treatment medications includes black elderberry for fever and fatigue. Herbal supplements did help to patient. This case was linked to MOD-2021-321288 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Added Medical history,Added dosage details, concomitant and treatment medication, Added new events and events outcome.

Other Meds: XANAX; GAS X

Current Illness: Allergy to antibiotic (Cipro, Augmentin); Asthma; Laryngopharyngeal reflux; Lichen sclerosus; Pseudomyxoma peritonei; Sulfonamide allergy; UTI

ID: 1740537
Sex: U
Age:
State: NY

Vax Date: 03/28/2021
Onset Date: 03/28/2021
Rec V Date: 09/28/2021
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: 20210328; Test Name: Covid-19 Test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Second dose to be given more than 42 days from first dose; Tested positive for Covid after getting first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST (Tested positive for Covid after getting first dose) and INCOMPLETE COURSE OF VACCINATION (Second dose to be given more than 42 days from first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced SARS-COV-2 TEST (Tested positive for Covid after getting first dose). On 18-Sep-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Second dose to be given more than 42 days from first dose). On 18-Sep-2021, INCOMPLETE COURSE OF VACCINATION (Second dose to be given more than 42 days from first dose) outcome was unknown. At the time of the report, SARS-COV-2 TEST (Tested positive for Covid after getting first dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, 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. The pharmacist reported that the patient who got the first shot on 28-Mar-2021 but was not able to get the second dose because the patient tested positive for Covid. Concomitant medications were not reported. No treatment information provided. Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender, with unknown medical history who experienced the unexpected event of SARS-CoV-2 test: positive and incomplete course of vaccination. The event SARS-CoV-2 test: positive occurred approximately 1 day after the first dose of mRNA-1273 and 5 months and 22 days after the first dose of mRNA-1273. The benefit-risk relationship of Spikevax in not affected by this report. This case has been designated as invalid due to missing identifiers.

Other Meds:

Current Illness:

ID: 1740538
Sex: U
Age:
State: CA

Vax Date: 09/17/2021
Onset Date:
Rec V Date: 09/28/2021
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: vial used, was opened more than 12 hours ago; this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial used, was opened more than 12 hours ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial used, was opened more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial used, was opened more than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment medications provided. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow Up received contains updated reporter's email address.

Other Meds:

Current Illness:

ID: 1740539
Sex: F
Age: 24
State: NY

Vax Date: 09/10/2021
Onset Date: 09/17/2021
Rec V Date: 09/28/2021
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: Rash developed on her hand and feet 2days ago; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash developed on her hand and feet 2days ago) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced RASH (Rash developed on her hand and feet 2days ago). At the time of the report, RASH (Rash developed on her hand and feet 2days ago) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. The patient took the Benadryl and hydrocortisone cream on 17-Sep-2021 as treatment.

Other Meds:

Current Illness:

ID: 1740540
Sex: F
Age: 67
State: CA

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 09/28/2021
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: Sleeping a lot more; More tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping a lot more) and FATIGUE (More tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Relapsing multiple sclerosis, Depression and Anxiety. Concomitant products included OCRELIZUMAB (OCREVUS), PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), OXAZEPAM, VITAMIN D3 and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication. In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced HYPERSOMNIA (Sleeping a lot more) and FATIGUE (More tired). At the time of the report, HYPERSOMNIA (Sleeping a lot more) and FATIGUE (More tired) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medications were reported

Other Meds: OCREVUS; PAXIL [PAROXETINE HYDROCHLORIDE]; OXAZEPAM; VITAMIN D3; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS

Current Illness: Anxiety; Depression; Relapsing multiple sclerosis

ID: 1740541
Sex: F
Age:
State: NJ

Vax Date: 07/23/2021
Onset Date: 08/01/2021
Rec V Date: 09/28/2021
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: 20200327; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Tested Positive

Allergies:

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

Symptoms: Dehydrated; Fatigue; Coughing; Excessive vomiting; Fever; Headache; Sore throat; Exteme nausea continued for 7 days; Missed two days of work; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HEADACHE (Headache), VOMITING (Excessive vomiting), PYREXIA (Fever) and OROPHARYNGEAL PAIN (Sore throat) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21 and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Acute symptoms lasted for 2.5 weeks and cough for a month) on 27-Mar-2020, Breathing difficult (Breathing issues : had follow up and testing) and Stomach upset (Long haul stomach : had follow up and testing). Concurrent medical conditions included High cholesterol, Heartburn (Reflux / heartburn), Altered smell sensation (patent was still smelling phantom smell) and Acid reflux (esophageal) (Reflux/heartburn). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), SIMVASTATIN (ZOCOR) for Cholesterol. On 23-Jul-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced IMPAIRED WORK ABILITY (Missed two days of work) and NAUSEA (Exteme nausea continued for 7 days). On 18-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 18-Aug-2021 at 3:30 PM, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). On 18-Aug-2021 at 8:00 PM, the patient experienced COUGH (Coughing) and VOMITING (Excessive vomiting). On an unknown date, the patient experienced DEHYDRATION (Dehydrated) and FATIGUE (Fatigue). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) in August 2021 for Adverse event, at an unspecified dose and frequency. In August 2021, IMPAIRED WORK ABILITY (Missed two days of work) and NAUSEA (Exteme nausea continued for 7 days) had resolved. On 19-Aug-2021 at 8:00 AM, VOMITING (Excessive vomiting) had resolved. At the time of the report, COUGH (Coughing), HEADACHE (Headache) and PYREXIA (Fever) had resolved and OROPHARYNGEAL PAIN (Sore throat), DEHYDRATION (Dehydrated) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2020, SARS-CoV-2 test: positive (Positive) Tested Positive. The treatment with Zofran did not help the patient. The patient had no allergic reaction to food, medication or other products and had no acute illness at time of vaccination and till prior to one month. The patient had COVID-19 at the beginning of lockdown. Follow up and testing with the pulmonologist, gastroenterologists for 6 months was done. The patient was still smelling phantoms but was otherwise fine. The patient woke up around 3 A.M and started vomiting again for at least 6-8 times. The patient felt going to emergency room as due to dehydration but was not able to afford the copay. This case was linked to MOD-2021-299891 (Patient Link).

Other Meds: ZOCOR; PROTONIX [OMEPRAZOLE.]

Current Illness: Acid reflux (esophageal) (Reflux/heartburn); Altered smell sensation (patent was still smelling phantom smell); Heartburn (Reflux / heartburn); High cholesterol.

ID: 1740542
Sex: M
Age:
State: TX

Vax Date: 09/19/2021
Onset Date: 09/19/2021
Rec V Date: 09/28/2021
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: gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already) 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 19-Sep-2021 at 10:00 AM, 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 19-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already). On 19-Sep-2021, EXPIRED PRODUCT ADMINISTERED (gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided by the reporter. Treatment medication was not given.

Other Meds:

Current Illness:

ID: 1740543
Sex: F
Age: 69
State: PA

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 09/28/2021
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: little redness today; little red dots about 8 inches around the injection site up to elbow; little bit of swelling/ 5 inches wide swelling, raised swelling/ there is little bit of swelling today; great deal of pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (little bit of swelling/ 5 inches wide swelling, raised swelling/ there is little bit of swelling today), PAIN (great deal of pain), ERYTHEMA (little redness today) and VACCINATION SITE ERYTHEMA (little red dots about 8 inches around the injection site up to elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 17-Sep-2021, the patient experienced SWELLING (little bit of swelling/ 5 inches wide swelling, raised swelling/ there is little bit of swelling today), PAIN (great deal of pain) and VACCINATION SITE ERYTHEMA (little red dots about 8 inches around the injection site up to elbow). On 20-Sep-2021, the patient experienced ERYTHEMA (little redness today). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (little bit of swelling/ 5 inches wide swelling, raised swelling/ there is little bit of swelling today), PAIN (great deal of pain), ERYTHEMA (little redness today) and VACCINATION SITE ERYTHEMA (little red dots about 8 inches around the injection site up to elbow) outcome was unknown.

Other Meds: PROZAC; MULTIVITAMINS [VITAMINS NOS.]

Current Illness:

ID: 1740544
Sex: M
Age:
State: GA

Vax Date: 02/12/1900
Onset Date: 03/01/2021
Rec V Date: 09/28/2021
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: Inappropriate schedule of vaccine administered; itchy hives,developed pop up hives on his thigh, back, stomach, & back end,Right now it's his eyelids; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (itchy hives,developed pop up hives on his thigh, back, stomach, & back end,Right now it's his eyelids), PYREXIA (fever), CHILLS (chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 030M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and Cholesterol. On 12-Feb-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced URTICARIA (itchy hives,developed pop up hives on his thigh, back, stomach, & back end,Right now it's his eyelids), PYREXIA (fever) and CHILLS (chills). On 23-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, URTICARIA (itchy hives,developed pop up hives on his thigh, back, stomach, & back end,Right now it's his eyelids) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported that she had treated with Zyrtec Liquid. Also stated that currently, she was on like blood thinners.

Other Meds:

Current Illness: Blood pressure high; Cholesterol.

ID: 1740545
Sex: F
Age: 70
State: CA

Vax Date: 05/05/2021
Onset Date: 08/01/2021
Rec V Date: 09/28/2021
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: Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse). The patient was treated with IBUPROFEN at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse) had not resolved. No concomitant medication reported. It was reported that in late August rash appeared everywhere in her legs and was ongoing. This case was linked to MOD-2021-324028 (Patient Link).

Other Meds:

Current Illness:

ID: 1740546
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: Reactions/Some people had dermal fillings and received the vaccine; Caused dermal fillers to swell up / Swelling in the areas of dermal fillers; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine) and SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers) 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 VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine) and SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers). At the time of the report, VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine) and SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers) 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 considered SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers) to be related. No further causality assessment was provided for VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine). No concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1740547
Sex: M
Age: 73
State: NY

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 09/28/2021
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: He felt like he was getting COVID; strong reaction to both doses; He reported that he had bearable side effects; He had fever after 1st dose; He had chills; knocked me out/ bothered me; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (He felt like he was getting COVID), VACCINATION COMPLICATION (strong reaction to both doses), FEELING ABNORMAL (knocked me out/ bothered me), ADVERSE DRUG REACTION (He reported that he had bearable side effects) and PYREXIA (He had fever after 1st dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (he had COVID-19 infection last year and became quite ill) in 2020. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced FEELING ABNORMAL (knocked me out/ bothered me). On an unknown date, the patient experienced FEELING ABNORMAL (He felt like he was getting COVID), VACCINATION COMPLICATION (strong reaction to both doses), ADVERSE DRUG REACTION (He reported that he had bearable side effects), PYREXIA (He had fever after 1st dose) and CHILLS (He had chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (He felt like he was getting COVID), VACCINATION COMPLICATION (strong reaction to both doses), FEELING ABNORMAL (knocked me out/ bothered me), ADVERSE DRUG REACTION (He reported that he had bearable side effects), PYREXIA (He had fever after 1st dose) and CHILLS (He had chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications includes BP (blood pressure) medications (unspecified). Treatment medication includes anti-histamines (unspecified). This case was linked to MOD-2021-324087 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Significant Follow-up received on 20-Sep-2021 added new events and medical history

Other Meds:

Current Illness:

ID: 1740548
Sex: F
Age:
State: OH

Vax Date: 09/09/2021
Onset Date: 09/11/2021
Rec V Date: 09/28/2021
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: Difficulties in the arm; Difficulties in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Difficulties in the arm) and MUSCULOSKELETAL DISCOMFORT (Difficulties in the shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple myeloma. On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced LIMB DISCOMFORT (Difficulties in the arm) and MUSCULOSKELETAL DISCOMFORT (Difficulties in the shoulder). At the time of the report, LIMB DISCOMFORT (Difficulties in the arm) and MUSCULOSKELETAL DISCOMFORT (Difficulties in the shoulder) outcome was unknown. No concomitant product was provided by the reporter. No adverse events after the first two vaccinations. The patient experienced "Difficulties in the arm" and "Difficulties in the shoulder" after third dose. The patient was in treatment (unspecified) for multiple myeloma.

Other Meds:

Current Illness: Multiple myeloma

ID: 1740549
Sex: M
Age: 61
State: IL

Vax Date: 05/04/2021
Onset Date: 06/25/2021
Rec V Date: 09/28/2021
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: Swollen testicles; Covid feet; Worn out by it; Edema in my upper and lower legs; Skin rash on my shins and calves in both legs/ skin rash got worse; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (Edema in my upper and lower legs), TESTICULAR SWELLING (Swollen testicles), VACCINATION COMPLICATION (Covid feet), RASH (Skin rash on my shins and calves in both legs/ skin rash got worse) and FATIGUE (Worn out by it) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 048D21A) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Skin rash on my shins and calves in both legs/ skin rash got worse). On 26-Jun-2021, the patient experienced OEDEMA PERIPHERAL (Edema in my upper and lower legs). On an unknown date, the patient experienced TESTICULAR SWELLING (Swollen testicles), VACCINATION COMPLICATION (Covid feet) and FATIGUE (Worn out by it). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (Edema in my upper and lower legs), TESTICULAR SWELLING (Swollen testicles), VACCINATION COMPLICATION (Covid feet), RASH (Skin rash on my shins and calves in both legs/ skin rash got worse) and FATIGUE (Worn out by it) had not resolved. No concomitant product information was provided. Treatment medication includes vitamins, frozen water bottles. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up document include patient ,facility related details.

Other Meds:

Current Illness:

ID: 1740550
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date";, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date") 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 EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date"). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date") had resolved. Not Provided No concomitant medication information available. No treatment medication information available.

Other Meds:

Current Illness:

ID: 1740551
Sex: M
Age:
State: MN

Vax Date: 05/01/2021
Onset Date: 05/05/2021
Rec V Date: 09/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210505; Test Name: Emergent coronary angiogram; Result Unstructured Data: showed very mild coronary artery disease; Test Date: 20210505; Test Name: Left ventriculogram; Result Unstructured Data: showed a mildly reduced ejection fraction of 40% with global hypokinesis that was most severe at the apex; Test Name: Chest X-ray; Result Unstructured Data: showed findings consistent with mild pulmonary oedema; Test Date: 20210505; Test Name: C-reactive protein; Result Unstructured Data: 63.5 mg/L (reference range: =8.0?mg/L); Test Date: 20210505; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Showed a decreased left ventricular ejection fraction. Demonstrated borderline enlarged left ventricle with an estimated ejection fraction of 40?45%, mild-moderate generalized left ventricular hypokinesis, slightly worse at the apex, borderline enlarged right ventricle with mildly-moderately decreased systolic function, and no significant valve disease.; Test Date: 20210506; Test Name: Transthoracic echocardiogram; Result Unstructured Data: Repeat Transthoracic echocardiogram showing normalization of ejection fraction, and no regional wall motion abnormalities; Test Date: 20210505; Test Name: Electrocardiogram; Result Unstructured Data: Electrocardiogram showed ST-segment elevation in the lateral limb and precordial leads; Test Date: 20210505; Test Name: Eosinophils; Result Unstructured Data: 0.04 ? 10(9)/L; Test Date: 20210505; Test Name: Left ventricular end-diastolic pressure; Result Unstructured Data: markedly elevated at 29?mmHg; Test Date: 20210505; Test Name: Cardiac magnetic resonance imaging; Result Unstructured Data: was compatible with acute myocarditis with patchy linear mid-myocardial enhancement of the septum and inferior walls at the base to mid-ventricle, sub-epicardial/mid-myocardial enhancement of the lateral wall at the mid-ventricle and apical lateral wall. There was associated myocardial oedema involving most of the myocardium and mild pericardial enhancement; Test Date: 20210505; Test Name: NT-proBNP; Result Unstructured Data: 1059 pg/mL (reference range: =51?pg/mL); Test Date: 20210505; Test Name: Physical exam; Result Unstructured Data: showed minimal lower extremity swelling; Test Date: 20210505; Test Name: Sedimentation rate; Result Unstructured Data: 12 mm/h; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative (COVID-19 nasal swab testing using polymerase chain reaction was negative); Test Date: 20210505; Test Name: Peak troponin T, 5th generation; Result Unstructured Data: 847 ng/L (reference range: =15?ng/L); Test Date: 20210506; Test Name: Peak troponin T, 5th generation; Result Unstructured Data: decreased to 675?ng/L the day after admission; Test Date: 20210505; Test Name: Vital signs; Result Unstructured Data: temperature of 36.9 degrees Celsius, heart rate of 79 beats per minute, blood pressure of 90/72, respiratory rate of 12 breaths per minute, and oxygen saturation of 95%; Test Date: 20210505; Test Name: White blood cell c

Allergies:

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

Symptoms: Acute myocarditis; Malaise; Dry cough; Myalgias; Headache; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a 44-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. LITERATURE REFERENCE: Case report: acute myocarditis following the second dose of mRNA-1273 SARS-CoV-2 vaccine. Rep. 2021;5(8):1-6 The patient's past medical history included Smoker (former smoker). Concurrent medical conditions included Obstructive sleep apnoea syndrome, Asthma and Obesity (BMI 30.9 kg/m2). Concomitant products included ALBUTEROL [SALBUTAMOL] and FLUTICASONE; SALMETEROL for an unknown indication. On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced MALAISE (Malaise), COUGH (Dry cough), MYALGIA (Myalgias) and HEADACHE (Headache). The patient was hospitalized from 05-May-2021 to 09-May-2021 due to MYOCARDITIS. The patient was treated with COLCHICINE on 06-May-2021 for Chest pain, at an unspecified dose and frequency. On 06-Jun-2021, MYOCARDITIS (Acute myocarditis) had resolved. At the time of the report, MALAISE (Malaise), COUGH (Dry cough), MYALGIA (Myalgias) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Angiocardiogram: abnormal (abnormal) showed very mild coronary artery disease. On 05-May-2021, C-reactive protein: 63.5 mg/l (High) 63.5 mg/L (reference range: =8.0?mg/L). On 05-May-2021, Cardiac ventriculogram left: 40% (abnormal) showed a mildly reduced ejection fraction of 40% with global hypokinesis that was most severe at the apex. On 05-May-2021, Echocardiogram: abnormal (abnormal) Showed a decreased left ventricular ejection fraction.Demonstrated borderline enlarged left ventricle with an estimated ejection fraction of 40?45%, mild-moderate generalized left ventricular hypokinesis, slightly worse at the apex, borderline enlarged right ventricle with mildly-moderately decreased systolic function, and no significant valve disease.. On 05-May-2021, Electrocardiogram: abnormal (abnormal) Electrocardiogram showed ST-segment elevation in the lateral limb and precordial leads. On 05-May-2021, Eosinophil count (0.03-0.48): 0.04 ? 10(9)/l (normal) 0.04 ? 10(9)/L. On 05-May-2021, Left ventricular end-diastolic pressure: 29?mmhg (High) markedly elevated at 29?mmHg. On 05-May-2021, Magnetic resonance imaging heart: acute myocarditis (abnormal) was compatible with acute myocarditis with patchy linear mid-myocardial enhancement of the septum and inferior walls at the base to mid-ventricle, sub-epicardial/mid-myocardial enhancement of the lateral wall at the mid-ventricle and apical lateral wall. There was associated myocardial oedema involving most of the myocardium and mild pericardial enhancement. On 05-May-2021, N-terminal prohormone brain natriuretic peptide: 1059 pg/ml (High) 1059 pg/mL (reference range: =51?pg/mL). On 05-May-2021, Physical examination: minimal lower extremity swelling (abnormal) showed minimal lower extremity swelling. On 05-May-2021, Red blood cell sedimentation rate (2-2): 12 mm/h (High) 12 mm/h. On 05-May-2021, Troponin T: 847 ng/l (High) 847 ng/L (reference range: =15?ng/L). On 05-May-2021, Vital signs measurement: normal (normal) temperature of 36.9 degrees Celsius, heart rate of 79 beats per minute, blood pressure of 90/72, respiratory rate of 12 breaths per minute, and oxygen saturation of 95%. On 05-May-2021, White blood cell count (3.4-9.6): 9.7 ? 10(9)/l (High) 9.7 ? 10(9)/L. On 06-May-2021, Echocardiogram: normal (normal) Repeat Transthoracic echocardiogram showing normalization of ejection fraction, and no regional wall motion abnormalities. On 06-May-2021, Troponin T: 675?ng/l (High) decreased to 675?ng/L the day after admission. On an unknown date, Chest X-ray: mild pulmonary oedema (abnormal) showed findings consistent with mild pulmonary oedema. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative (COVID-19 nasal swab testing using polymerase chain reaction was negative). For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Acute myocarditis), MALAISE (Malaise), COUGH (Dry cough), MYALGIA (Myalgias) and HEADACHE (Headache) to be possibly related. Patient was in his usual state of health prior to getting the second dose of mRNA-1273 SARS-CoV-2 Vaccine. There was no family history of cardiovascular or autoimmune disease. Endomyocardial biopsy was not performed as the patient experienced mild symptoms, had no haemodynamic or electrical instability, and responded promptly to initial management. The patient was started on supportive therapy for the symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. The patient was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4-5?days after presentation. The patient was discharged home after 5 days of monitoring without evidence of electrical or haemodynamic instability and with Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. The patient remained asymptomatic and off diuretics. This case concerns a 44-year-old male patient with a history of Obstructive sleep apnoea syndrome, Asthma and Obesity, who experienced the serious expected event Myocarditis. The event occurred approximately 4 days after the second and most recent dose of mRNA-1273 Moderna vaccine. The event was considered related to the study drug per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow up received by safety on 22-Sep-2021 included an Email with FTA received from team and does not contain any new information.; Sender's Comments: This case concerns a 44-year-old male patient with a history of Obstructive sleep apnoea syndrome, Asthma and Obesity, who experienced the serious expected event Myocarditis. The event occurred approximately 4 days after the second and most recent dose of mRNA-1273 Moderna vaccine. The event was considered related to the study drug per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.

Other Meds: Albuterol [Salbutamol]; Fluticasone; Salmeterol

Current Illness: Asthma; Obesity (BMI 30.9 kg/m2); Obstructive sleep apnoea syndrome.

ID: 1740553
Sex: F
Age: 33
State: MN

Vax Date: 02/16/2021
Onset Date: 09/24/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: 9/26 SARS/COV-2, NAAT, Positive

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Breakthrough COVID

Other Meds:

Current Illness:

ID: 1740554
Sex: F
Age: 35
State: NY

Vax Date: 09/22/2021
Onset Date: 09/23/2021
Rec V Date: 09/28/2021
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: Nausea, headache, malaise.

Other Meds:

Current Illness:

ID: 1740555
Sex: M
Age: 34
State: MN

Vax Date: 02/01/2021
Onset Date: 09/26/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: 9/26 SARS/COV-2, NAAT positive

Allergies:

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

Symptoms: Breakthrough COVID-19

Other Meds:

Current Illness:

ID: 1740556
Sex: M
Age: 66
State: NE

Vax Date: 09/24/2021
Onset Date: 09/25/2021
Rec V Date: 09/28/2021
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: none

Allergies: Tetracycline

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: vomiting, fever, chills, injection site pain

Other Meds: Benazepril HCT, Fenofibrate, Lovastatin, Allopurinol

Current Illness:

ID: 1740557
Sex: F
Age: 83
State: MD

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 09/28/2021
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: not immunocompromised; couldn't stand up; didn't want food or liquids; she still has difficulty standing; too weak to walk; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't stand up), DECREASED APPETITE (didn't want food or liquids), DYSSTASIA (she still has difficulty standing), ASTHENIA (too weak to walk) and NAUSEA (nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 032L20A and 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced NAUSEA (nauseous). In September 2021, the patient experienced DYSSTASIA (she still has difficulty standing) and ASTHENIA (too weak to walk). On 19-Sep-2021 at 2:00 AM, the patient experienced MOBILITY DECREASED (couldn't stand up) and DECREASED APPETITE (didn't want food or liquids). On an unknown date, the patient experienced OFF LABEL USE (not immunocompromised). At the time of the report, MOBILITY DECREASED (couldn't stand up), DECREASED APPETITE (didn't want food or liquids) and NAUSEA (nauseous) outcome was unknown, DYSSTASIA (she still has difficulty standing) and ASTHENIA (too weak to walk) had not resolved and OFF LABEL USE (not immunocompromised) had resolved. No concomitant medications were provided. Patient treatment include she went to the emergency room where they gave her 2 bags of IV fluids. Patient is not immunocompromised but got the shot because they heard Pfizer had authorized a third shot for people over 65. This case was linked to MOD-2021-324298 (Patient Link).

Other Meds:

Current Illness:

ID: 1740558
Sex: M
Age: 73
State: LA

Vax Date: 09/23/2021
Onset Date: 09/27/2021
Rec V Date: 09/28/2021
Hospital: Y

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

Lab Data: Potassium of 6.4 rose to 6.7 after fluid and lasix. Unclear cause of hyperkalemia. Peaked t-waves on EKG.

Allergies:

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

Symptoms: Patient presented to ER from doctors office after being found to be hyperkalemic, 4 days after COVID vaccine

Other Meds:

Current Illness:

ID: 1740559
Sex: F
Age: 58
State: MN

Vax Date: 01/29/2021
Onset Date: 09/23/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: 9/24 SARS/COV-2, Positive

Allergies:

Symptom List: Nausea

Symptoms: Breakthrough COVID

Other Meds:

Current Illness:

ID: 1740560
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: No second dose after the recommended time; 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 PRODUCT DOSE OMISSION ISSUE (No second dose after the recommended time) 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 PRODUCT DOSE OMISSION ISSUE (No second dose after the recommended time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose after the recommended time) had resolved. concomitant medications were not reported. treatment medications were not reported.

Other Meds:

Current Illness:

ID: 1740561
Sex: F
Age: 83
State: MD

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 09/28/2021
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: nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) outcome was unknown. Patient also received 3rd dose (Booster dose) No concomitant medications were reported No treatment information was provided This case was linked to MOD-2021-324183.

Other Meds:

Current Illness:

ID: 1740562
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: A patient was given an expired vaccine; , this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was given an expired 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was given an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was given an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication were not reported. Treatment details was not reported.

Other Meds:

Current Illness:

ID: 1740563
Sex: F
Age: 65
State: OK

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 09/28/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The patient's past medical history included Ringing in ears. Concurrent medical conditions included Hearing loss. On 04-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 PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications was provided by the reporter. No treatment was provided by the reporter. This case was linked to MOD-2021-324268 (Patient Link).

Other Meds:

Current Illness: Hearing loss.

ID: 1740564
Sex: M
Age: 76
State: LA

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 09/28/2021
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: Left arm and its joint still hurts; Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm and its joint still hurts), ARTHRALGIA (Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts) and FATIGUE (fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) 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) (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 an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm and its joint still hurts), ARTHRALGIA (Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (ACETAMINOFEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Left arm and its joint still hurts) and ARTHRALGIA (Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts) was resolving and FATIGUE (fatigue) outcome was unknown. No concomitant medications was given. This case was linked to MOD-2021-324333 (Patient Link).

Other Meds:

Current Illness:

ID: 1740565
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
Hospital: Y

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: Test Name: Blood pressure; Result Unstructured Data: High

Allergies:

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

Symptoms: High blood pressure; 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 BLOOD PRESSURE INCREASED (High blood pressure) 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, 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 BLOOD PRESSURE INCREASED (High blood pressure) (seriousness criterion hospitalization). At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. Concomitant medication information not provided. Treatment information not provided. Company comment: This case concerns a patient of unknown age and gender, who experienced the unexpected event of high blood pressure with seriousness criteria of hospitalization. The event occurred an unknown time after the second dose of mRNA-1273. The rechallenge was not applicable since the event occurred after the 2nd dose. It is to note that very limited information has been provided for this case report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, who experienced the unexpected event of high blood pressure with seriousness criteria of hospitalization. The event occurred an unknown time after the second dose of mRNA-1273. The rechallenge was not applicable since the event occurred after the 2nd dose. It is to note that very limited information has been provided for this case report. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1740566
Sex: F
Age: 45
State: TX

Vax Date: 09/10/2021
Onset Date: 09/14/2021
Rec V Date: 09/28/2021
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: Leg she had a small itchy rash which has since spread to her arms, torso and both legs; Swelling; Skin was tender; Skin allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Leg she had a small itchy rash which has since spread to her arms, torso and both legs), SWELLING (Swelling), PAIN OF SKIN (Skin was tender) and HYPERSENSITIVITY (Skin allergic reaction) in a 45-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 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced RASH PRURITIC (Leg she had a small itchy rash which has since spread to her arms, torso and both legs), SWELLING (Swelling), PAIN OF SKIN (Skin was tender) and HYPERSENSITIVITY (Skin allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Leg she had a small itchy rash which has since spread to her arms, torso and both legs) and PAIN OF SKIN (Skin was tender) had not resolved and SWELLING (Swelling) and HYPERSENSITIVITY (Skin allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Treatment medication was mentioned.

Other Meds:

Current Illness:

ID: 1740567
Sex: F
Age: 67
State: TX

Vax Date: 01/15/2021
Onset Date: 02/01/2021
Rec V Date: 09/28/2021
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 Name: Body temperature; Result Unstructured Data: 101.9 degree Fahrenheit; Test Date: 20210623; Test Name: ultrasound Scan; Result Unstructured Data: Report showed mild capsulitis, calcific bursitis, degenerate tearing of rotting cap with not true retraction on the left shoulder and acromioclavicular arthritis, signs of wearing of the muscle. Report showed evidence that the injection had been administered into the tendon, instead of the deltoid muscle.

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: mild capsulitis / may be close to getting a frozen shoulder; calcific bursitis; degenerate tearing of rotting cap with not true retraction on the left shoulder; acromioclavicular arthritis/sings of wearing of the muscle; not able to move their arm without excruciating pain,/not able to move their fingers without excruciating pain/is in so much pain/tremendous amount of pain; big shivers; a fever of 101.9?F; ultrasound that showed evidence that the injection had been administered into the tendon instead of the deltoid muscle; not able to lift their left arm up over their head, without help from the other arm/cannot move the left shoulder; wake up in the middle of the night with high level pain, every night; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (not able to lift their left arm up over their head, without help from the other arm/cannot move the left shoulder), INSOMNIA (wake up in the middle of the night with high level pain, every night), PERIARTHRITIS (mild capsulitis / may be close to getting a frozen shoulder), PERIARTHRITIS CALCAREA (calcific bursitis) and MUSCLE ATROPHY (degenerate tearing of rotting cap with not true retraction on the left shoulder) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Tremor. Concomitant products included PRIMIDONE for Tremor, DULOXETINE, ROSUVASTATIN, ALENDRONATE SODIUM (ALENDRONATE), MELOXICAM, CALCIUM, NICOTINIC ACID (B3 NIACIN), CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +), BIOTIN, BETA-CAROTENE, FOLIC ACID, WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) and PHYLLANTHUS EMBLICA for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced MOBILITY DECREASED (not able to lift their left arm up over their head, without help from the other arm/cannot move the left shoulder), PAIN IN EXTREMITY (not able to move their arm without excruciating pain,/not able to move their fingers without excruciating pain/is in so much pain/tremendous amount of pain), CHILLS (big shivers), PYREXIA (a fever of 101.9?F) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (ultrasound that showed evidence that the injection had been administered into the tendon instead of the deltoid muscle). In February 2021, the patient experienced INSOMNIA (wake up in the middle of the night with high level pain, every night). In June 2021, the patient experienced PERIARTHRITIS (mild capsulitis / may be close to getting a frozen shoulder), PERIARTHRITIS CALCAREA (calcific bursitis), MUSCLE ATROPHY (degenerate tearing of rotting cap with not true retraction on the left shoulder) and ARTHRITIS (acromioclavicular arthritis/sings of wearing of the muscle). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency; ACETAMINOPHEN for Fever, at an unspecified dose and frequency; IBUPROFEN for Shivers, at a dose of UNK, q6h; DICLOFENAC (transdermal) for Pain in arm, at an unspecified dose and frequency; BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE (MARCAINE E) for Pain in arm, at a dose of 5cc of 0.5% and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) for Pain in arm, at a dose of 0.5 cc 40mg/ml. On 12-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (ultrasound that showed evidence that the injection had been administered into the tendon instead of the deltoid muscle) had resolved. In February 2021, MOBILITY DECREASED (not able to lift their left arm up over their head, without help from the other arm/cannot move the left shoulder) had resolved. At the time of the report, INSOMNIA (wake up in the middle of the night with high level pain, every night), PERIARTHRITIS (mild capsulitis / may be close to getting a frozen shoulder), PERIARTHRITIS CALCAREA (calcific bursitis), MUSCLE ATROPHY (degenerate tearing of rotting cap with not true retraction on the left shoulder), ARTHRITIS (acromioclavicular arthritis/sings of wearing of the muscle), PAIN IN EXTREMITY (not able to move their arm without excruciating pain,/not able to move their fingers without excruciating pain/is in so much pain/tremendous amount of pain), CHILLS (big shivers) and PYREXIA (a fever of 101.9?F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2021, Ultrasound scan: abnormal (abnormal) Report showed mild capsulitis, calcific bursitis, degenerate tearing of rotting cap with not true retraction on the left shoulder and acromioclavicular arthritis, signs of wearing of the muscle. Report showed evidence that the injection had been administered into the tendon, instead of the deltoid muscle.. On an unknown date, Body temperature: 101.9 degree fahrenheit (High) 101.9 degree Fahrenheit. The physician recommended physical therapy to the patient. Patient would like to be part of the clinical trials for the Booster vaccine, and mentions that the patient had worked as a clinical research coordinator in the past and were aware of the compliance requirements for those, so the patient was considered to be very compliant.; Sender's Comments: This case concerns a 68-year-old, female subject with no reported relevant medical history, who experienced unexpected events of Mobility decreased, Insomnia, Periarthritis, Periarthritis calcarean, Muscle atrophy, Arthritis, Pain in extremity and expected events Chills, Pyrexia. The events occurred approximately 29 days after the first dose of Moderna COVID-19 Vaccine administration. The rechallenge was not applicable since both doses were administered according to the recommended schedule. The reporter did not provide causality assessment. The benefit-risk relationship of the study drug is not affected by this report.

Other Meds: PRIMIDONE; DULOXETINE; ROSUVASTATIN; ALENDRONATE; MELOXICAM; CALCIUM; B3 NIACIN; TURMERIC +; BIOTIN; BETA-CAROTENE; FOLIC ACID; ASHWAGANDHA [WITHANIA SOMNIFERA]; PHYLLANTHUS EMBLICA

Current Illness: Tremor

ID: 1740568
Sex: M
Age: 68
State: FL

Vax Date: 01/20/2021
Onset Date: 08/17/2021
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Date: 20210817; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Positive for Covid after vaccine; Lack of drug effect; sniffles for one week; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for Covid after vaccine), DRUG INEFFECTIVE (Lack of drug effect) and RHINORRHOEA (sniffles for one week) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced COVID-19 (Positive for Covid after vaccine). 17-Aug-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced RHINORRHOEA (sniffles for one week). At the time of the report, COVID-19 (Positive for Covid after vaccine) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and RHINORRHOEA (sniffles for one week) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. No concomitant medication was mentioned. No treatment medication was mentioned.; Sender's Comments: This case concerns a 69-years-old, male patient with no medical history, who experienced the unexpected event of Covid-19 with associated non-serious event of rhinorrhoea. Drug ineffective was also considered as an additional event since, the events occurred approximately six months after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Events were considered non-serious as per the reporter. The rechallenge was considered not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1740569
Sex: U
Age:
State: GA

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 09/28/2021
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: administration of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1740570
Sex: F
Age: 56
State: VA

Vax Date: 05/03/2021
Onset Date: 05/04/2021
Rec V Date: 09/28/2021
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: left arm is weak; weakness comes and goes; after a week or two, the dizziness was intermittent; the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way; tingling; electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling), ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day), MUSCULAR WEAKNESS (left arm is weak) and ASTHENIA (weakness comes and goes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. Concomitant products included VITAMIN D NOS for an unknown indication. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling) and ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day). On an unknown date, the patient experienced MUSCULAR WEAKNESS (left arm is weak), ASTHENIA (weakness comes and goes) and DIZZINESS (after a week or two, the dizziness was intermittent). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling), ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day), MUSCULAR WEAKNESS (left arm is weak), ASTHENIA (weakness comes and goes) and DIZZINESS (after a week or two, the dizziness was intermittent) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication includes: OTC Supplements and OTC Allergy medicine

Other Meds: VITAMIN D NOS

Current Illness:

Date Died:

ID: 1740571
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: brain aneurism; This spontaneous case was reported by an other health care professional and describes the occurrence of INTRACRANIAL ANEURYSM (brain aneurism) in an adult 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTRACRANIAL ANEURYSM (brain aneurism) (seriousness criteria death and medically significant). The reported cause of death was brain aneurism. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details were provided. It was reported that the person around it's 30's died from a brain aneurism right after receiving the Moderna Vaccine. No treatment information was mentioned. This case concerns female patient of unknown age with no relevant medical history reported, who experienced the unexpected event of intracranial aneurysm. The event occurred on an unknown number of days after the first dose of mRNA-1273 and had a fatal outcome on an unknown date. No autopsy report was provided. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns female patient of unknown age with no relevant medical history reported, who experienced the unexpected event of intracranial aneurysm. The event occurred on an unknown number of days after the first dose of mRNA-1273 and had a fatal outcome on an unknown date. No autopsy report was provided. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Reported Cause(s) of Death: brain aneurism

Other Meds:

Current Illness:

ID: 1740572
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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 Name: An excisional biopsy; Result Unstructured Data: An excisional biopsy of the left axillary lymph node was performed. The H&E sections of the enlarged lymph nodes show hyperplastic follicles and marked paracortical expansion with polymorphic lymphohistiocytic infiltrate and hypervascularity and sinus histiocytosis.; Test Name: A bone marrow biopsy; Result Unstructured Data: A bone marrow biopsy was also performed and showed a normocellular marrow with active trilineage hematopoiesis. No atypical lymphoid infiltrate or hemophagocytosis was detected. No immunophenotypical abnormality was detected.; Test Name: fever; Test Result: Inconclusive ; Result Unstructured Data: 104?F; Test Name: CT scan; Result Unstructured Data: CT scans showed left axillary lymphadenopathy, up to 2.1 cm, and multiple enlarged lymph nodes in the abdomen.; Test Name: Cytokine panel; Result Unstructured Data: Cytokine panel showed elevations in TNF alpha, interferon gamma, interleukin-5, interleukin-10, interleukin-13, and interleukin-6.; Test Name: Flow cytometry; Result Unstructured Data: Flow cytometry revealed no overt immunophenotypical aberrancy. The CD4:CD8 ratio was slightly increased (4.0:1).; Test Name: immunohistochemistry; Test Result: Inconclusive ; Result Unstructured Data: By immunohistochemistry, the lymphoid cells are mixed T-cells and B-cells with normal compartment. Marked perifollicular/interfollicular T cells hyperplasia are noted with intact T-cell antigens (positive for CD2, CD3, CD5, CD7, and mixed CD4 and CD8).

Allergies:

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

Symptoms: Acute kidney injury; axillary lymphadenopathy; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE KIDNEY INJURY (Acute kidney injury) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Eczema. Concurrent medical conditions included Asthma and Hypothyroidism. 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 ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criterion medically significant) and LYMPHADENOPATHY (axillary lymphadenopathy). The patient was treated with DEXAMETHASONE for Lymphadenopathy and Acute kidney injury, at an unspecified dose and frequency and ANAKINRA for Lymphadenopathy and Acute kidney injury, at an unspecified dose and frequency. At the time of the report, ACUTE KIDNEY INJURY (Acute kidney injury) and LYMPHADENOPATHY (axillary lymphadenopathy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: an excisional biopsy of the left axillary lymph no (abnormal) An excisional biopsy of the left axillary lymph node was performed. The H&E sections of the enlarged lymph nodes show hyperplastic follicles and marked paracortical expansion with polymorphic lymphohistiocytic infiltrate and hypervascularity and sinus histiocytosis.. On an unknown date, Biopsy bone marrow: a bone marrow biopsy was also performed and showed (abnormal) A bone marrow biopsy was also performed and showed a normocellular marrow with active trilineage hematopoiesis. No atypical lymphoid infiltrate or hemophagocytosis was detected. No immunophenotypical abnormality was detected.. On an unknown date, Body temperature: 104?f (Inconclusive) 104?F. On an unknown date, Computerised tomogram: ct scans showed left axillary lymphadenopathy, up (abnormal) CT scans showed left axillary lymphadenopathy, up to 2.1 cm, and multiple enlarged lymph nodes in the abdomen.. On an unknown date, Cytokine test: cytokine panel showed elevations in tnf alpha, (High) Cytokine panel showed elevations in TNF alpha, interferon gamma, interleukin-5, interleukin-10, interleukin-13, and interleukin-6.. On an unknown date, Flow cytometry: flow cytometry revealed no overt immunophenotypica (High) Flow cytometry revealed no overt immunophenotypical aberrancy. The CD4:CD8 ratio was slightly increased (4.0:1).. On an unknown date, Immunohistochemistry: by immunohistochemistry, the lymphoid cells are mi (Inconclusive) By immunohistochemistry, the lymphoid cells are mixed T-cells and B-cells with normal compartment. Marked perifollicular/interfollicular T cells hyperplasia are noted with intact T-cell antigens (positive for CD2, CD3, CD5, CD7, and mixed CD4 and CD8).. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE KIDNEY INJURY (Acute kidney injury) and LYMPHADENOPATHY (axillary lymphadenopathy) to be possibly related. Concomitant medication was not reported. After ruling out viral infections and hematolymphoid malignancy, a diagnosis of post-vaccination reactive lymphadenitis, with paracortical/interfollicular lymphoid, LC hyperplasia, and secondary hemophagocytosis was rendered. This case concerns a 23 year old female patient with medical history of Eczema, Asthma and Hypothyroidism, who experienced the unexpected serious event of ACUTE KIDNEY INJURY, 1 week after the second dose of mRNA-1273 vaccine. The patient also experienced non-serious event of LYMPHADENOPATHY, 1 week after the second dose of mRNA-1273 vaccine. The events were considered related to the vaccine per the reporter's assessment. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 23 year old female patient with medical history of Eczema, Asthma and Hypothyroidism, who experienced the unexpected serious event of ACUTE KIDNEY INJURY, 1 week after the second dose of mRNA-1273 vaccine. The patient also experienced non-serious event of LYMPHADENOPATHY, 1 week after the second dose of mRNA-1273 vaccine. The events were considered related to the vaccine per the reporter's assessment. The benefit-risk relationship of the vaccine is not affected by this report.

Other Meds:

Current Illness: Asthma; Hypothyroidism

ID: 1740573
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: she not applied vaccine to patient till 20 mint and the enjection in her hand; out side temperature that time 38 centi grade; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (she not applied vaccine to patient till 20 mint and the enjection in her hand) and PRODUCT TEMPERATURE EXCURSION ISSUE (out side temperature that time 38 centi grade) 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, the patient experienced PRODUCT ADMINISTRATION ERROR (she not applied vaccine to patient till 20 mint and the enjection in her hand) and PRODUCT TEMPERATURE EXCURSION ISSUE (out side temperature that time 38 centi grade). At the time of the report, PRODUCT ADMINISTRATION ERROR (she not applied vaccine to patient till 20 mint and the enjection in her hand) and PRODUCT TEMPERATURE EXCURSION ISSUE (out side temperature that time 38 centi grade) had resolved. It was reported that the patients went to hospital for moderna vaccine 2nd dose. There was one nurse, she took moderna vaccine to fill the injection. After filling injection she not applied vaccine to patient till 20 minutes and the injection in her hand ,outside temperature that time 38 centi grade. Concomitant medications were not reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1740574
Sex: M
Age: 41
State: TX

Vax Date: 07/24/2021
Onset Date:
Rec V Date: 09/28/2021
Hospital:

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

Lab Data: Test Name: Blood sugar; Result Unstructured Data: 49; Test Name: Body temperature; Result Unstructured Data: 99.1; Test Name: Body temperature; Result Unstructured Data: 94.9 degrees F

Allergies:

Symptom List: Vomiting

Symptoms: went to answer a text and never sent it because he passed out and woke 2-3 hours later and had a 94.9 degrees F core temperature; Brain fog; Shaking; headache, chills and 99.1 fever; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (went to answer a text and never sent it because he passed out and woke 2-3 hours later and had a 94.9 degrees F core temperature) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic (preexisting diabetic). Concomitant products included INSULIN for an unknown indication. On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (went to answer a text and never sent it because he passed out and woke 2-3 hours later and had a 94.9 degrees F core temperature) (seriousness criterion medically significant), FEELING ABNORMAL (Brain fog), TREMOR (Shaking), HEADACHE (headache, chills and 99.1 fever), CHILLS (chills) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (went to answer a text and never sent it because he passed out and woke 2-3 hours later and had a 94.9 degrees F core temperature) and TREMOR (Shaking) outcome was unknown, FEELING ABNORMAL (Brain fog) had not resolved and HEADACHE (headache, chills and 99.1 fever), CHILLS (chills) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 49 (Low) 49. On an unknown date, Body temperature: 99.1 (High) 99.1 and 94.9 (Low) 94.9 degrees F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The Concomitant medications include vitamin gummies. The Treatment information was not provided. Company comment: This case concerns a 48-year-old, male patient with previous relevant medical history diabetes and use of concomitant medication insulin, who experienced the unexpected loss of consciousness. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown, as the event happened after the first dose and have resolved, and no information about second dose was disclosed. The reporter assessed the events as possible. The medical history of diabetes and use of concomitant medication insulin remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 48-year-old, male patient with previous relevant medical history diabetes and use of concomitant medication insulin, who experienced the unexpected loss of consciousness. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown, as the event happened after the first dose and have resolved, and no information about second dose was disclosed. The reporter assessed the events as possible. The medical history of diabetes and use of concomitant medication insulin remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: INSULIN

Current Illness: Diabetic (preexisting diabetic)

ID: 1740575
Sex: F
Age:
State: IN

Vax Date: 12/30/2020
Onset Date: 09/17/2021
Rec V Date: 09/28/2021
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: Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 012M20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 17-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle). On 17-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments. Health care professional (HCP) nurse got two doses of moderna covid 19 vaccine 1st and 2nd dose in left upper arm deltoid muscle. On 17-Sep-2021, nurse got the booster which was her third dose, however, it was administered subcutaneously not intramuscular, in her left arm below the deltoid muscle. She stated that she read that the efficacy was different, because she got her booster vaccine subcutaneously and stated the efficacy cannot be determined since it was given in the wrong tissue. Concomitant medications were not reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1740576
Sex: F
Age: 70
State: GA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 09/28/2021
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: right arm hurt for 2.5 days after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm hurt for 2.5 days after the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The patient's past medical history included Cataracts, Carpal tunnel syndrome, Tinnitus and Ear injury (Busted ear drums (years ago)). Concurrent medical conditions included Diabetes, Inflammatory arthritis, Blood pressure high, Kidney disorder, Heart disease, unspecified, Allergy NOS and Thyroid disorder. Concomitant products included INSULIN for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm hurt for 2.5 days after the injection). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency and ALCOHOL (topical) for Vaccination site pain, at an unspecified dose and frequency. On 28-Feb-2021, VACCINATION SITE PAIN (right arm hurt for 2.5 days after the injection) 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. Historical condition included other health issues (unspecified). The right arm hurt for 2.5 days after the injection. The patient was treated with Tylenol and massaged arm with clear rubbing alcohol. The patient reported right arm hurts 90% of the time and stated it is possibly due to diabetes (onset date unknown). The patient received the flu shot yearly. She stated she takes a lot of medications daily (did not report the names of the medications), including Insulin. She stated that she doesn't consider herself immunocompromised, but stated she is high risk for COVID-19 infection. This case was linked to MOD-2021-325019 (Patient Link).

Other Meds: INSULIN

Current Illness: Allergy NOS; Blood pressure high; Diabetes; Heart disease, unspecified; Inflammatory arthritis; Kidney disorder; Thyroid disorder

ID: 1740577
Sex: F
Age: 70
State: GA

Vax Date: 02/26/2021
Onset Date: 04/02/2021
Rec V Date: 09/28/2021
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: flu-like symptoms; knocked down; no appetite; under the weather; had no motivation; fatigue; more than 35 days between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather) and APATHY (had no motivation) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Perforated eardrum (busted ear drums (years ago)), Tinnitus and Cataract. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Diabetes, Arthritis, Carpal tunnel syndrome, Hypertension, Kidney disorder, Heart disease, unspecified, Allergy NOS and Thyroid disorder. Concomitant products included INSULIN for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather), APATHY (had no motivation), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved and FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather), APATHY (had no motivation) and FATIGUE (fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. She stated she takes a lot of medications daily. She reported that she experienced flu-like symptoms that lasted three weeks after receiving the second dose. She reported she was knocked down and experienced fatigue and no appetite. She stated she was under the weather and wondered what was wrong with her. She reported she also had no motivation. She stated for treatment she took Tylenol. She stated that she did not consider herself immunocompromised, but stated she was high risk for COVID-19 infection. This case was linked to MOD-2021-325008 (Patient Link).

Other Meds: INSULIN

Current Illness: Allergy NOS; Arthritis; Carpal tunnel syndrome; Diabetes; Heart disease, unspecified; Hypertension; Kidney disorder; Thyroid disorder

ID: 1740578
Sex: F
Age: 26
State: TX

Vax Date: 08/14/2021
Onset Date: 09/18/2021
Rec V Date: 09/28/2021
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: changed her vision; having trouble focusing; doesn't have a temperature but she feels hot; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (changed her vision), DISTURBANCE IN ATTENTION (having trouble focusing) and FEELING HOT (doesn't have a temperature but she feels hot) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced VISUAL IMPAIRMENT (changed her vision), DISTURBANCE IN ATTENTION (having trouble focusing) and FEELING HOT (doesn't have a temperature but she feels hot). At the time of the report, VISUAL IMPAIRMENT (changed her vision), DISTURBANCE IN ATTENTION (having trouble focusing) and FEELING HOT (doesn't have a temperature but she feels hot) outcome was unknown. It was reported that patient had anxiety, but no Concomitant drug details provided for anxiety. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1740579
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 09/28/2021
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: heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart racing). At the time of the report, PALPITATIONS (heart racing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were unknown. Treatment information was not provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am