VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1657713
Sex: U
Age: 1
State: IN

Vax Date: 05/18/2021
Onset Date: 08/04/2021
Rec V Date: 08/31/2021
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: no adverse event; second dose should have been administered after the child turns 4; This spontaneous report was received from a office manager referring to a 14 month old patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications. On18-MAY-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot S0239311, expiring on 04-DEC-2021, for prophylaxis (dose, route and site of administration were not reported). 04-AUG-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T028297, expiring on 16-FEB-2022, for prophylaxis (dose, route and site of administration were not reported). Reporter stated this second dose should had been administered after the child turned 4 (inappropriate schedule of product administration). No adverse event was reported. Lot number S0239311 is an invalid lot number for mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and does not match any Company product

Other Meds:

Current Illness:

ID: 1657714
Sex: U
Age:
State: TX

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 08/31/2021
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: small scratch; less than recommended dose given due to patient moving during administration of initial vaccine; Information has been received from a Medical Assistant reporting on a 9-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 17-AUG-2021, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis (route of administration, lot number and expiration date were not reported). Medical assistant was calling to request information on hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) revaccination, after less than recommended dose given due to patient moving during administration of initial vaccine. The patient moved during vaccination and the needle left a "small scratch" on the patient's thigh. She states the physician was aware. Medical assistant verified the vaccine has been stored at recommended temperature and that the vaccine was not expired. The outcome of scratch was unknown. The causality assessment was not provided.

Other Meds:

Current Illness:

ID: 1657715
Sex: U
Age:
State: WI

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 08/31/2021
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: No additional AE reported.; a dose of VARlVAX was administered after the expiration date.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided. On 18-AUG-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R035223 with expiration date of 04-DEC-2020 (internally verified), 0.5 ml, for prophylaxis (route of administration was not reported). Caller stated the vaccine did not experience any temperature excursions. No additional events reported. No additional information provided.

Other Meds:

Current Illness:

ID: 1657716
Sex: U
Age:
State: NY

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 08/31/2021
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: No symptoms reported; patient received 4 doses of GARDASIL 9; This spontaneous report was received from a nurse referring to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications. On 17-AUG-2021, the patient was vaccinated with a 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # T027778, expiring on 27-FEB-2023, 0.5 milliliter dose, intramuscular for prophylaxis (extra dose administered). No adverse event were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T027778; expirationdate: 27-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1657717
Sex: U
Age:
State: OR

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 08/31/2021
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: No additional adverse event reported; A 12 month old child was given PROQUAD instead of VARIVAX with the MMR II; A 12 month old child was given PROQUAD instead of VARIVAX; This spontaneous report has been received from a registered nurse concerning a 12 months old patient, gender not provided. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. On 24-AUG-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, for prophylaxis (lot number U006312 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 24-AUG-2022) instead of varicella virus vaccine live (oka/merck) (VARIVAX) (wrong product administered); on the same date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose, for prophylaxis (lot number S035355 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 05-NOV-2021) (inappropriate schedule of product administration) (strength, route of administration and anatomical location were not provided). No adverse event reported.

Other Meds:

Current Illness:

ID: 1657718
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: No additional AE reported; A consumer received the first dose of GARDASIL-9 about 3 years ago. She has not received her second dose at this time; This spontaneous report has been received from a registered nurse (inconsistent information, also reported as a consumer) referring to a female patient of unspecified age. The patient's pertinent medical history, concomitant medications, previous drug reactions, and allergies were not reported. Approximately in 2018 (reported as "about three years ago"), the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (formulation, administered dose, vaccination scheme frequency, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported). Up to 1-year period on an unspecified date in 2019 and by reporting time, the patient had not received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No additional adverse events (AE) were reported.

Other Meds:

Current Illness:

ID: 1657719
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: Itching under my skin in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of itchy skin in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (experienced shingles problem in year 2002 at the age of 57 years, it was first attack, from back of his/her head down to neck and to whole arm right side its so much pain and burning, the patient asked the best medicine and the sales lady gave cream (unspecified) but still patient felt pain so much itching but did not scratch it). On an unknown date, the patient received Shingrix. On an unknown date, more than a year after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was not recovered/not resolved. It was unknown if the reporter considered the itchy skin to be related to Shingrix. RERUN Additional details were reported as follows: This patient self reported the case. The age at vaccination was not reported. The patient received shingle shot in 2018 and since then, yearly felt itching under skin in arm just for 3 months. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR177031 and US2021AMR177044, reported by the same reporter

Other Meds:

Current Illness:

ID: 1657720
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: yearly i feel itching under my skin in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of itchy skin in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (experienced shingles problem in year 2002 at the age of 57 years, it was first attack, from back of his/her head down to neck and to whole arm right side its so much pain and burning, the patient asked the best medicine and the sales lady gave cream (unspecified) but still patient felt pain so much itching but did not scratch it). On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was not recovered/not resolved. It was unknown if the reporter considered the itchy skin to be related to Shingrix. Additional details were reported as follows: This patient self reported the case. The age at vaccination was not reported. The patient received shingle shot in 2018 and since then, yearly felt itching under skin in arm just for 3 months The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR177031 and US2021AMR177044, reported by the same reporter.

Other Meds:

Current Illness:

ID: 1657721
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: shingle shots were more painful; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included ophthalmic herpes zoster (had shingles by eye, it was very scary had to go to eye specialist 3 times, all good). Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date and experienced pain, refer case US2021AMR178265) and Covid-19 (received Covid shots on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got shingles shot and stated it was more painful than covid shots.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR178265:Same reporter

Other Meds:

Current Illness:

ID: 1657722
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: arm sore; shot burning; felt nauseous; fever; headache; felt tired; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Family History) (Family members had it and not a pretty site). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, burning sensation, nausea, fever, headache and tiredness. On an unknown date, the outcome of the pain in arm, burning sensation, nausea, fever, headache and tiredness were unknown. It was unknown if the reporter considered the pain in arm, burning sensation, nausea, fever, headache and tiredness to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient just got the 2nd shingle shot and experienced burning and arm sore felt nauseous, fever, headache and felt tired. The patient reported that it had protected him/her so it was all worth it. The patient's family members had it and it was not a pretty site.

Other Meds:

Current Illness:

ID: 1657723
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: (Test Result:102,Unit:degree F,Normal Low:,Normal High:)

Allergies:

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

Symptoms: 102 temp; felt like I had a bad flu; aches; knocked my socks off. felt terrible; This case was reported by a consumer and described the occurrence of body temperature increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced body temperature increased, influenza-like symptoms, pain and feels awful. On an unknown date, the outcome of the body temperature increased, influenza-like symptoms and pain were unknown and the outcome of the feels awful was recovered/resolved. It was unknown if the reporter considered the body temperature increased, influenza-like symptoms, pain and feels awful to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient got the 1st shingle shots and had 102 temperature and felt like bad flu, aches etc and felt terrible for 4 days. The patient did not risk the 2nd one. The patient called doctor and they said that was pretty common.

Other Meds:

Current Illness:

ID: 1657724
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: muscles are sore; nausea; Been sick; This case was reported by a consumer and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle soreness, nausea and sickness. On an unknown date, the outcome of the muscle soreness and nausea were unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the muscle soreness, nausea and sickness to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient got the 1st shingle shots and had a lot side effects, all muscles was sore, nausea and been sick for two days so far, this was awful. The patient still need to get the second vaccine

Other Meds:

Current Illness:

ID: 1657725
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: shingles; trouble breathing; didn't get 2nd dose; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, difficulty breathing and incomplete course of vaccination. On an unknown date, the outcome of the shingles, difficulty breathing and incomplete course of vaccination were unknown. It was unknown if the reporter considered the shingles and difficulty breathing to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by reporter for his/her father. The age at vaccination was not reported. The patient received dose and had adverse reaction (trouble breathing). The patient also experienced mild case of shingles. The patient didn't get the 2nd dose, which led to incomplete course of vaccination

Other Meds:

Current Illness:

ID: 1657726
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine but still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1657727
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: 2nd vaccine is 3 months overdue; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, 2nd dose was due in May 2021 (6 months), and was 3 month overdue.

Other Meds:

Current Illness:

ID: 1657728
Sex: M
Age: 2
State: WA

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 08/31/2021
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: administered Kinrix for a child aged 2yr, 5mo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Dtap+IPV (received on 10th July 2019) and Dtap+IPV (received on 16th September 2019). On 20th August 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The health care provider mistakenly administered Kinrix for a child aged 2 years and 5 months old patient, which led to inappropriate age at vaccine administration. The reporter stated that, the patient had been delayed by caregivers. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1657729
Sex: M
Age: 59
State: FL

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 08/31/2021
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: patient did not receive the full dose due to the syringe leaking; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis. On 24th August 2021, the patient received the 1st dose of Shingrix. On 24th August 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown. Additional case details were reported as follows: The pharmacist stated that she was administered the 1st dose of Shingrix to a patient and the patient did not receive the full dose due to the syringe leaking which led to accidental underdose. The reporter suspected the patient received about 90 percent of the medication. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1657730
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: administered in the hip; This case was reported by a consumer via call center representative and described the occurrence of vaccine administered at inappropriate site in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Previously administered products included Fluad with an associated reaction of tendon injury (received on 10th September 2019 (National Drug Code: 70461-0019-03)). Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown. Additional details were provided as follows: The patient reported the case for herself (reporter was a massage therapist). The patient received the Fluad 2019-2020 syringe flu shot was given at a pharmacy by a pharmacist and the patient believed that the pharmacist injected her too high on the upper arm/deltoid. This resulted in a visit to the emergency room and 7 months of severe pain and the use of prescription pain medications due to tendon damage. Since then patient had requested that all of her immunizations to be done in non-deltoid shots such as thigh or hip. The patient got a subsequent unspecified flu shot in the hip rather than the deltoid to avoid the risk of having the same shoulder tendon problem occur again, which led to vaccine administered at inappropriate site and her Covid shot(s) in the thigh. The reporter provided limited information

Other Meds: COVID VACCINE (NOS)

Current Illness:

ID: 1657731
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: on Jan 16th 2021 patient received first dose and never gets the second shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 16th January 2021). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1657732
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: first dose in 2018 and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. At the moment of the call the health care professional was not in the work facility were they could find further information on the dose that was administrated. No further events were reported. Health care professional agreed to be contacted through email or phone number to be able to inform exact date of the first dose, expiration date and lot number of the vaccine. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1657733
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: first dose of Shingrix series greater than 2 years ago / never returned for second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received greater than 2 years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient did not remember date of first dose and pharmacist unable to find it in state database. The pharmacist did not have lot number or expiration date of first dose. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1657734
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: received the 1st dose of Shingrix "5 years ago" and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 5 years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No symptoms reported. The reporter stated that, the patient did not know the extact date of 1st dose vaccination. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1657735
Sex: F
Age:
State: OR

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

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

Lab Data:

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: 1808982) dose was not reported,1 total, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient was sick with covid-19 infection (suspected covid-19 infection) (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000191144 This case, from the same reporter is linked to 20210854979 and 20210855254. Additional information was received from Central Complaint Vigilance on 27-AUG-2021. The following information was updated and incorporated into the case narrative: Updated the batch number & Product Quality number.; Sender's Comments: V1: This follow up adds Product quality number and batch no. This new information does not change prior causality assessment. 20210855235- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1657736
Sex: F
Age:
State: OK

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: BACK FEELS LIKE SANDPAPER; BACK FEELS LIKE A BAD SUNBURN; MENTALLY TIRED; STOMACH PAIN AND UP THROUGH THE NIGHT WITH IT; DIARRHEA AND UP THROUGH THE NIGHT WITH IT; SHOT HURT LIKE HELL; FEVER ON AND OFF; HEADACHE; PHYSICALLY TIRED; WORSENING NEUROPATHY OF LEFT HAND/FINGERTIPS/LEGS/KNEES/TOPS OF FEET; This spontaneous report received from a patient concerned a 62 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: systemic lupus (SLE), neuropathy on bottoms of feet, and fibromyalgia. The patient never had another vaccine in life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered in left arm on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included gabapentin for neuropathy in feet. After vaccination on an unspecified date in AUG-2021, the patient experienced constant diarrhea and up through the night with it. The patient also experienced bad and ridiculous pain in the legs and knees, which started first in knees and then spread and sometimes felt like legs would buckle due to knees. Further the patient had stomach pain and it was not relieved and up through the night with it. The patient felt like sand paper on her back and also felt like a bad sunburn, the patient lifted her shirt but nothing was visible. Initially the patient had neuropathy only in the bottom of feet but it spread to left hand and fingertips and tops of feet. The patient had severe pain and she was tired of hurting, also she had pain at the shot site and headache. The patient experienced fever on and off and took acetyl salicylic acid (ASA). The patient became mentally and physically tired due to her side effects. The patient visited MD twice for the symptoms but the doctor nothing mentioned about the shot. The patient was previously taken gabapentin (90 capsules per month) and at the time of reporting 270 capsules per month for neuropathy in feet, but it did not help patient. The patient also stated that Nurse practitioner also did not advise about the vaccine and its risks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea and up through the night with it, back feels like a bad sunburn, worsening neuropathy of left hand/fingertips/legs/knees/tops of feet, stomach pain and up through the night with it, and back feels like sandpaper, and the outcome of shot hurt like hell, fever on and off, headache, mentally tired and physically tired was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210855258-Covid-19 vaccine ad26.cov2.s-WORSENING NEUROPATHY OF LEFT HAND/FINGERTIPS/LEGS/KNEES/TOPS OF FEET. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.

Other Meds: GABAPENTIN

Current Illness: Fibromyalgia; Neuropathy peripheral; Systemic lupus erythematosus.

ID: 1657737
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/09/2021
Rec V Date: 08/31/2021
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: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 64 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. It was reported that the patient was 64 years and rarely got sick. She was previously treated with rubella vaccine for prophylactic vaccination (it did not stick with her). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total administered in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-AUG-2021, the patient developed the symptoms of Covid-19 infection for first time that included feeling aches, cough and fatigue (suspected clinical vaccination failure). The symptoms lasted for about a week or two, but she still felt fatigue at time of reporting. She did not receive medical help but had bed rest for 2 weeks. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected Covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210857250- Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1657738
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: CONSTANT PAIN IN HEART; CRAMPING IN LOWER LEGS; PRICKLY FEELING IN HEART 15 MINUTES AFTER VACCINE ADMINISTRATION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient was healthy and athlete. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter called in to inquire about an adverse event that the patient was experiencing after receiving the Janssen covid-19 vaccine. On an unspecified date in AUG-2021 (about 3 weeks ago), 15 minutes after vaccine administration, the patient experienced a prickly sensation in her heart. The patient experienced cramping in her lower legs and for the last 3 weeks has had constant pain in her heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramping in lower legs, and constant pain in heart, and the outcome of prickly feeling in heart 15 minutes after vaccine administration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210857424-covid-19 vaccine ad26.cov2.s -constant pain in heart. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Non-smoker

ID: 1657739
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: VACCINE EXPOSURE DURING 24 WEEKS OF PREGNANCY; TERRIBLY SICK/GENERALLY FEELING SICK/UNBELIEVABLY SICK; ACHES; FEVER; EXHAUSTION; WEAK; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of reporting. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during 24 weeks of pregnancy, terribly sick/generally feeling sick/unbelievably sick, aches, fever, exhaustion, and weak. The date of the patient's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, exhaustion, weak, vaccine exposure during 24 weeks of pregnancy and terribly sick/generally feeling sick/unbelievably sick was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1657740
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: DVT IN BOTH LOWER LEGS; This spontaneous report received from a patient via a company representative concerned a 40-year-old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was otherwise healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose and start therapy date (on an unspecified Friday) were not reported for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, on Monday the patient sent a photo to his doctor of what was happening with his legs (redness) and on an unspecified date (Tuesday) he was diagnosed with Deep Vein Thrombosis (DVT) in each lower leg. The patient was seen at a hospital (unknown date). The patient was being treated with Xarelto (rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of DVT in both lower legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210857658-COVID-19 VACCINE AD26.COV2.S - DVT IN BOTH LOWER LEGS. This event is considered unassessable. The event 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.

Other Meds:

Current Illness:

ID: 1657741
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 08/06/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: RIGHT HAND MIDDLE FINGER TURNING BLUE/PURPLE; 3 LITTLE ROUND DOTS/SPOTS OF BLOOD AROUND SITE OF INJECTION; LOST ALL CIRCULATION IN FINGER; TINGLING AND NUMBNESS IN RIGHT HAND MIDDLE FINGER; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: bad fall, and concurrent conditions included: high blood pressure, low thyroid, penicillin allergy, latex allergy, allergy to sulfate drugs, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient have no drug abuse or illicit drug usage. The patient takes anti-hypertensive medication to prevent stroke, no history of stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced right hand middle finger turning blue/purple. On 06-AUG-2021, the patient experienced 3 little round dots/spots of blood around site of injection. On 06-AUG-2021, the patient experienced lost all circulation in finger. On 06-AUG-2021, the patient experienced tingling and numbness in right hand middle finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand middle finger turning blue/purple, lost all circulation in finger, and tingling and numbness in right hand middle finger on 09-AUG-2021, and 3 little round dots/spots of blood around site of injection on 20-AUG-2021. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Blood pressure high (Takes antihypertensive medication to prevent stroke); Hypothyroidism (does not know thyroid medication.); Latex allergy; Non-smoker; Penicillin allergy; Sulfonamide allergy

ID: 1657742
Sex: F
Age:
State: TX

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

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

Lab Data: Test Date: 202108; Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Date: 202108; Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Date: 20210813; Test Name: Body temperature; Result Unstructured Data: not reported

Allergies:

Symptom List: Nausea

Symptoms: NAUSEA; VOMITING; EVERYTHING TASTES BAD; LOSS OF APPETITE/CAN'T REALLY EAT; CHILLS; ALL OVER WEAKNESS/FEELING WEAK/LACK OF ENERGY; FEVER; HEADACHES; JOINT PAIN; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included: aneurysm, stroke, breast cancer, and double mastectomy, and concurrent conditions included: non alcohol user, non-smoker, and pre-diabetes, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use and no known allergies. The patient is on blood thinners, cholesterol, blood pressure medications and on a pill for pre-diabetes and not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced diarrhea. On AUG-2021, the patient experienced tired. Laboratory data included: COVID-19 virus test (NR: not provided) negative, negative. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced joint pain. On 13-AUG-2021, the patient experienced all over weakness/feeling weak/lack of energy. On 13-AUG-2021, the patient experienced fever. On 13-AUG-2021, the patient experienced headaches. Laboratory data included: Body temperature (NR: not provided) not reported. On 14-AUG-2021, the patient experienced everything tastes bad. On 14-AUG-2021, the patient experienced loss of appetite/can't really eat. On 17-AUG-2021, the patient experienced vomiting. On 17-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 27-AUG-2021, vomiting, and nausea on 21-AUG-2021, and joint pain, was recovering from all over weakness/feeling weak/lack of energy, and headaches, had not recovered from everything tastes bad, diarrhea, and tired, and the outcome of loss of appetite/can't really eat was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker; Pre-diabetes

ID: 1657743
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/26/2021
Rec V Date: 08/31/2021
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: MINOR SORE ARM; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; DONT FEEL GOOD FOR 24 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included mrna 1273 for prophylactic vaccination. On 26-AUG-2021, the patient experienced dont feel good for 24 hours. On 27-AUG-2021, the patient experienced inappropriate schedule of vaccine administered. On an unspecified date, the patient experienced minor sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dont feel good for 24 hours, and the outcome of minor sore arm and inappropriate schedule of vaccine administered was not reported. This report was non-serious.

Other Meds: MRNA 1273

Current Illness:

ID: 1657744
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 99.5 temperature

Allergies:

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

Symptoms: FELT LIKE ALMOST LITERALLY BIT THE BULLET/INABILITY TO GET COMFORTABLE; UNABLE TO SLEEP; CONSTANT URGE TO STRETCH; NO APPETITE; SICK; ACHES; DISCOMFORT; UNCOMFORTABLE ACHY GUT; ENTIRE AREA WAS LIKE BAD MENSTRUAL CRAMPS; TIGHTNESS IN CHEST; MOSTLY BILE; LEGS WERE VERY WEAK; CHILLS; FEVER 99.5 TEMPERATURE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. 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) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced felt like almost literally bit the bullet/inability to get comfortable. On AUG-2021, the patient experienced unable to sleep. On AUG-2021, the patient experienced constant urge to stretch. On AUG-2021, the patient experienced no appetite. On AUG-2021, the patient experienced sick. On AUG-2021, the patient experienced aches. On AUG-2021, the patient experienced discomfort. On AUG-2021, the patient experienced uncomfortable achy gut. On AUG-2021, the patient experienced entire area was like bad menstrual cramps. On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced mostly bile. On AUG-2021, the patient experienced legs were very weak. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever 99.5 temperature. On AUG-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like almost literally bit the bullet/inability to get comfortable, unable to sleep, constant urge to stretch, discomfort, uncomfortable achy gut, entire area was like bad menstrual cramps, tightness in chest, fever 99.5 temperature, headache, legs were very weak, chills, aches, sick, no appetite and mostly bile was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1657745
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Name: Direct Coombs test; Result Unstructured Data: Antibodies, but they have attached to red cells

Allergies:

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

Symptoms: ANTIBODIES ATTACHED TO HER RED CELLS; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced antibodies attached to her red cells. Laboratory data (dates unspecified) included: Direct Coombs test (NR: not provided) Antibodies, but they have attached to red cells. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibodies attached to her red cells was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1657746
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 08/26/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Date: 20210701; Test Name: COVID-19 antibody test; Result Unstructured Data: Positive 86.9; Test Date: 202108; Test Name: CAT scan; Result Unstructured Data: Negative

Allergies:

Symptom List: Tremor

Symptoms: BLOOD IN STOOL; SHAKINESS; URINARY TRACT INFECTION (UTI) SYMPTOMS SUCH AS SEDIMENT IN URINE; BRAIN FOG; NECK PAIN; INJECTION SITE REACTION; DIARRHEA; ARMS FEEL HEAVY; HEADACHE; FATIGUED; This spontaneous report received from a patient concerned an adult female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid in JAN-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified date in 01-JUL-2021, patient had COVID-19 antibody test, and it was positive 86.9 and patient was wondered why she was being mandated to get the vaccine. On 26-AUG-2021, the patient experienced blood in stool, urinary tract infection (UTI) symptoms such as sediment in urine (kidney pain, back pain, fever), shakiness, brain fog, neck pain, injection site reaction, diarrhea, arms feel heavy, headache, and fatigued. On an unspecified date in AUG-2021, The patient went to the hospital for evaluation due to the bloody stool and kidney pain, and had computerised tomogram (CAT) scan done. The patient reported that as per health care provider (HCP), the CAT scan was clear and it was from the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shakiness, blood in stool, diarrhea, urinary tract infection (UTI) symptoms such as sediment in urine (kidney pain, back pain, fever), neck pain, headache, brain fog, injection site reaction, fatigued, and arms feel heavy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210858571-Covid-19 vaccine ad26.cov2.s-Blood in stool. This event(s) is considered unassessable. The event(s) has an 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).

Other Meds:

Current Illness:

ID: 1657747
Sex: F
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Always high

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: GUILLAIN BARRE IS BETTER; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: right breast tumour, and concurrent conditions included: no alcohol use, non-smoker, sulfa drug allergy, flu shot reaction, ovarian tumour that spread to the uterus, and guillain-barre syndrome, and other pre-existing medical conditions included: Patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced guillain barre is better. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Always high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre is better was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergy to vaccine (flu shot - bad reaction.); Guillain-Barre syndrome (Problems with her legs and arms, blood pressure was always high, urinary system was not functioning appropriately, difficulty swallowing, facial muscles were weak, couldn't even smile & people didn't understand her when she speaks.); Non-smoker; Ovarian neoplasm (tumor in the ovary that spread to her uterus); Sulfonamide allergy (Sulfa - bad reaction)

ID: 1657748
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CONGESTION THAT TAKES TOO LONG TO GET BETTER; EYE ULCER VIRUS (HERPES AND SHINGLES RELATED OF WHICH PATIENT DON'T HAVE NONE); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced congestion that takes too long to get better, and eye ulcer virus (herpes and shingles related of which patient don't have none). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from congestion that takes too long to get better, and eye ulcer virus (herpes and shingles related of which patient don't have none). This report was non-serious.

Other Meds:

Current Illness:

ID: 1657749
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 08/28/2021
Rec V Date: 08/31/2021
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: BRIGHT LIGHTS HURT EYES; PAIN INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; FELT HOT; FELT COLD; ARM STILL HURTS/PAIN IN INJECTED ARM FROM SHOULDER TO WRIST; TINGLING SENSATION INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; NUMBNESS INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; SHIVERS/CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and dye in ultrasound contrast, and other pre-existing medical conditions included: The patient was currently taking Vitamins. The patient experienced lump that has not gone in 30 years when treated with influenza vaccine for drug used for unknown indication, and drug allergy when treated with metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and rosuvastatin calcium. On 28-AUG-2021, the patient experienced bright lights hurt eyes. On 28-AUG-2021, the patient experienced pain into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced felt hot. On 28-AUG-2021, the patient experienced felt cold. On 28-AUG-2021, the patient experienced arm still hurts/pain in injected arm from shoulder to wrist. On 28-AUG-2021, the patient experienced tingling sensation into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced numbness into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced shivers/chills. On 28-AUG-2021, the patient experienced headache. On 28-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain into armpits, left breast, chest, neck and jaw, felt hot, felt cold, tingling sensation into armpits, left breast, chest, neck and jaw, numbness into armpits, left breast, chest, neck and jaw, shivers/chills, and fever on AUG-2021, and had not recovered from headache, arm still hurts/pain in injected arm from shoulder to wrist, and bright lights hurt eyes. This report was non-serious.

Other Meds: LISINOPRIL; CRESTOR

Current Illness: Asthma (Patient has asthma and so grass, mold, perfumes, colognes cause her to close up.); Contrast media reaction

ID: 1657750
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: STABBING PAIN IN THE RIGHT SIDE OF CHEST; This spontaneous report received from a patient concerned a female of unspecified age. 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the patient experienced stabbing pain in the right side of chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stabbing pain in the right side of chest was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1657751
Sex: F
Age:
State: ID

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: RUNNY NOSE; FEELING COLD; TIRED; This spontaneous report received from a health care professional concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: no smoker, and other pre-existing medical conditions included: The patient had no history of using any immunomodulatory or immunosuppressive medication or anti inflammatory drugs. The patient did not have any adverse event after any previous vaccination, no history of hospitalization in last 30 days, with cause, no Illness at the time of vaccination. The patient was not pregnant and was not breastfeeding at time of vaccination. The patient had no other suspected causes including co-administered vaccine(s)/risk factors. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) .5 ml, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced runny nose, feeling cold, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, feeling cold, and tired. This report was non-serious. This case, from the same reporter is linked to 20210846435, 20210846822 and 20210846649.

Other Meds:

Current Illness: Non-smoker

ID: 1657752
Sex: F
Age: 78
State: PA

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 08/31/2021
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: Feeling hot; Redness; Rash; muscle ache; Chills; Nausea; Vomiting; persistent cough; persistent tightness in the chest; persistent sinus headache; blowing nose; phlegm; left arm was sore; poor sleep; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm) and COUGH (persistent cough) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ROSUVASTATIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), FATIGUE (extreme fatigue) and HEADACHE (headache). On 22-Apr-2021, the patient experienced RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), CHEST DISCOMFORT (persistent tightness in the chest) and SINUS HEADACHE (persistent sinus headache). On an unknown date, the patient experienced COUGH (persistent cough), FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), MYALGIA (muscle ache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, PAIN IN EXTREMITY (left arm was sore), POOR QUALITY SLEEP (poor sleep), RHINORRHOEA (blowing nose), PRODUCTIVE COUGH (phlegm), COUGH (persistent cough), CHEST DISCOMFORT (persistent tightness in the chest), SINUS HEADACHE (persistent sinus headache), FATIGUE (extreme fatigue), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown and FEELING HOT (Feeling hot), ERYTHEMA (Redness), RASH (Rash), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No information on treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2021-027155 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: reporter contact information updated. On 12-Aug-2021: non-significant follow up On 12-Aug-2021: Significant follow-up appended. Patient demography updated. Concomitant medication updated Events updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-027155:Case for dose 1

Other Meds: ROSUVASTATIN; MULTIVITAMIN [VITAMINS NOS]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1657753
Sex: F
Age: 19
State: IA

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 08/31/2021
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: 1st dose given 29 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0788C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. The patient had no known drug allergies and no chronic or long standing health conditions. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: significant follow up : patient demographics (age, ethnicity, race) updated and narrative updated

Other Meds:

Current Illness:

ID: 1657754
Sex: F
Age: 66
State: RI

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 08/31/2021
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: Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe; Itching hives; Patient stated it felt like she was burning out her skin; Painful hives; Feeling hot; Flushing; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives) and FEELING HOT (Feeling hot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypersensitivity reaction, Drug allergy (Heart rate increase), Allergy (Once trouble waking up and another time woke up prematurely), Asthma and Hay fever. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives), FEELING HOT (Feeling hot), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, URTICARIA (Painful hives/Burning hives/Itching hives/Big hives that covered her whole body from head to toe), PRURITUS (Itching hives), SKIN BURNING SENSATION (Patient stated it felt like she was burning out her skin), PAIN (Painful hives), FEELING HOT (Feeling hot), FLUSHING (Flushing), CHILLS (Chills) and PYREXIA (Fever) had resolved. No concomitant medications were reported. Treatment details included Benadryl and Benadryl cream which did not help at all. This case was linked to MOD-2021-258907 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow-up received on 13-Aug-2021: Medical history and event outcome updated

Other Meds:

Current Illness: Allergy (Once trouble waking up and another time woke up prematurely); Asthma; Drug allergy (Heart rate increase); Hay fever; Hypersensitivity reaction

ID: 1657755
Sex: F
Age: 51
State: IL

Vax Date: 03/29/2021
Onset Date: 04/26/2021
Rec V Date: 08/31/2021
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: Mammogram; Result Unstructured Data: Found an enlarged lymph node

Allergies:

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

Symptoms: Sweats; Very swollen arm; Muscle loss; Cant sleep at night; Lump in the front part of my breast; My arm hurts/ Arm is still killing me; Burning in arm; Can not move it; Skin is hanging; Body aches/ hurts bad/ sore; Enlarged lymph node; fever; it's getting to be tiresome; chills; arm is still killing me (injection site); Stiff shoulder; Sore arm/ Can not lift arm all the way up; Swollen lymph nodes; Sore shoulder; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff shoulder), PAIN IN EXTREMITY (Sore arm/ Can not lift arm all the way up), HYPERHIDROSIS (Sweats), PERIPHERAL SWELLING (Very swollen arm) and MUSCLE ATROPHY (Muscle loss) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017821A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMIN D NOS, LEVOTHYROXINE from 01-Jan-2005 to an unknown date, LISINOPRIL from 01-Jan-2005 to an unknown date and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff shoulder), PAIN IN EXTREMITY (Sore arm/ Can not lift arm all the way up), LYMPHADENOPATHY (Swollen lymph nodes) and ARTHRALGIA (Sore shoulder). On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), PERIPHERAL SWELLING (Very swollen arm), MUSCLE ATROPHY (Muscle loss), INSOMNIA (Cant sleep at night), BREAST MASS (Lump in the front part of my breast), PAIN IN EXTREMITY (My arm hurts/ Arm is still killing me), BURNING SENSATION (Burning in arm), INJECTED LIMB MOBILITY DECREASED (Can not move it), SKIN LAXITY (Skin is hanging), MYALGIA (Body aches/ hurts bad/ sore), LYMPHADENOPATHY (Enlarged lymph node), PYREXIA (fever), FATIGUE (it's getting to be tiresome), CHILLS (chills) and VACCINATION SITE PAIN (arm is still killing me (injection site)). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff shoulder), PAIN IN EXTREMITY (Sore arm/ Can not lift arm all the way up), HYPERHIDROSIS (Sweats), PERIPHERAL SWELLING (Very swollen arm), PAIN IN EXTREMITY (My arm hurts/ Arm is still killing me), LYMPHADENOPATHY (Swollen lymph nodes), ARTHRALGIA (Sore shoulder), PYREXIA (fever), FATIGUE (it's getting to be tiresome) and CHILLS (chills) had not resolved and MUSCLE ATROPHY (Muscle loss), INSOMNIA (Cant sleep at night), BREAST MASS (Lump in the front part of my breast), BURNING SENSATION (Burning in arm), INJECTED LIMB MOBILITY DECREASED (Can not move it), SKIN LAXITY (Skin is hanging), MYALGIA (Body aches/ hurts bad/ sore), LYMPHADENOPATHY (Enlarged lymph node) and VACCINATION SITE PAIN (arm is still killing me (injection site)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) Found an enlarged lymph node. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MUSCULOSKELETAL STIFFNESS (Stiff shoulder), PAIN IN EXTREMITY (Sore arm/ Can not lift arm all the way up), LYMPHADENOPATHY (Swollen lymph nodes) and ARTHRALGIA (Sore shoulder) to be possibly related. No further causality assessments were provided for HYPERHIDROSIS (Sweats), PERIPHERAL SWELLING (Very swollen arm), MUSCLE ATROPHY (Muscle loss), INSOMNIA (Cant sleep at night), BREAST MASS (Lump in the front part of my breast), PAIN IN EXTREMITY (My arm hurts/ Arm is still killing me), BURNING SENSATION (Burning in arm), INJECTED LIMB MOBILITY DECREASED (Can not move it), SKIN LAXITY (Skin is hanging), MYALGIA (Body aches/ hurts bad/ sore), LYMPHADENOPATHY (Enlarged lymph node), PYREXIA (fever), FATIGUE (it's getting to be tiresome), CHILLS (chills) and VACCINATION SITE PAIN (arm is still killing me (injection site)). No treatment medication was taken by the patient. The patient had a lump in the front part of breast left side. The physician wants the patient to visit a breast specialist. On an unknown date, the patient had ultrasound. The patient had muscle loss. This case was linked to MOD-2021-264071 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received and contains no new information. On 15-Aug-2021: Follow up information received on 16-Aug-2021: new events were added

Other Meds: VITAMIN D NOS; LEVOTHYROXINE; LISINOPRIL; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1657756
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Date: 20210723; Test Name: RT PCR; Test Result: Positive ; Result Unstructured Data: positive (source of sample is nose)

Allergies:

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

Symptoms: COVID-19; I got the moderna vaccine April (two shots spaced apart by three weeks); Nasal congestion; Loss of taste; Loss of smell; runny nose; ache/ muscle ache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jul-2021. The most recent information was received on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received 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 COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), RHINORRHOEA (runny nose) and MYALGIA (ache/ muscle ache). At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), RHINORRHOEA (runny nose) and MYALGIA (ache/ muscle ache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) positive (source of sample is nose). No concomitant medications were provided. No treatment medication information was provided. The patient confirmed having COVID-19 after receiving MODERNA vaccine three months earlier. Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Significant Follow up appended : laboratory data added, new events of muscle aches, nasal congestion/runny nose, loss of taste loss of smell were added.

Other Meds:

Current Illness:

ID: 1657757
Sex: F
Age: 43
State: LA

Vax Date: 07/17/2021
Onset Date: 07/26/2021
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: I can tell there is fever in it just by touching it; Big knot on my left arm where I got my shot at; It itches but it hurts for me to scratch it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (I can tell there is fever in it just by touching it), VACCINATION SITE INDURATION (Big knot on my left arm where I got my shot at) and VACCINATION SITE PRURITUS (It itches but it hurts for me to scratch it) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07LB21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced VACCINATION SITE WARMTH (I can tell there is fever in it just by touching it), VACCINATION SITE INDURATION (Big knot on my left arm where I got my shot at) and VACCINATION SITE PRURITUS (It itches but it hurts for me to scratch it). At the time of the report, VACCINATION SITE WARMTH (I can tell there is fever in it just by touching it), VACCINATION SITE INDURATION (Big knot on my left arm where I got my shot at) and VACCINATION SITE PRURITUS (It itches but it hurts for me to scratch it) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment medications were not reported. This case was linked to MOD-2021-288661 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Reporter details and events outcome were updated for dose 1.

Other Meds:

Current Illness:

ID: 1657758
Sex: F
Age: 61
State: CA

Vax Date: 07/30/2021
Onset Date: 07/31/2021
Rec V Date: 08/31/2021
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: Rash on the neck and other side of neck, very red; Rash and blister on the site of injection and itchiness; Painful, difficult arm; Rash and blister on the site of injection and itchiness; Rash on the neck and other side of neck, very red; Rash and blister on the site of injection and itchiness; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), PAIN IN EXTREMITY (Painful, difficult arm), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness) and RASH (Rash on the neck and other side of neck, very red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Lidocaine). On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), PAIN IN EXTREMITY (Painful, difficult arm), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness), RASH (Rash on the neck and other side of neck, very red) and VACCINATION SITE RASH (Rash and blister on the site of injection and itchiness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form and HYDROCORTISONE for Adverse event, at a dose of UNK dosage form. On 01-Aug-2021, PAIN IN EXTREMITY (Painful, difficult arm) had resolved. On 02-Aug-2021, ERYTHEMA (Rash on the neck and other side of neck, very red), VACCINATION SITE VESICLES (Rash and blister on the site of injection and itchiness), VACCINATION SITE PRURITUS (Rash and blister on the site of injection and itchiness), RASH (Rash on the neck and other side of neck, very red) and VACCINATION SITE RASH (Rash and blister on the site of injection and itchiness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: TCR Received on 17-AUG-2021 and It included reporter contact details

Other Meds:

Current Illness: Drug allergy (Lidocaine)

ID: 1657759
Sex: F
Age: 40
State: CA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/31/2021
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: Tinnitus in her right ear/Pulsatile Tinnitus; tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.; heart rate fluctuations; hand cramps; bloody eyes; insomnia; two panic attacks due to this situation; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus in her right ear/Pulsatile Tinnitus), SLEEP DISORDER (tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.), HEART RATE IRREGULAR (heart rate fluctuations), MUSCLE SPASMS (hand cramps) and OCULAR HYPERAEMIA (bloody eyes) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seasonal allergy, Dust allergy and Allergy to plants (Allery to olive trees). Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for Birth control, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Multiple allergies, ASCORBIC ACID (VIT C), VITAMIN B NOS and MAGNESIUM for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-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 TINNITUS (Tinnitus in her right ear/Pulsatile Tinnitus), SLEEP DISORDER (tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.), HEART RATE IRREGULAR (heart rate fluctuations), MUSCLE SPASMS (hand cramps), OCULAR HYPERAEMIA (bloody eyes), INSOMNIA (insomnia) and PANIC ATTACK (two panic attacks due to this situation). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, TINNITUS (Tinnitus in her right ear/Pulsatile Tinnitus) had not resolved and SLEEP DISORDER (tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.), HEART RATE IRREGULAR (heart rate fluctuations), MUSCLE SPASMS (hand cramps), OCULAR HYPERAEMIA (bloody eyes), INSOMNIA (insomnia) and PANIC ATTACK (two panic attacks due to this situation) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TINNITUS (Tinnitus in her right ear/Pulsatile Tinnitus) to be possibly related. No further causality assessments were provided for SLEEP DISORDER (tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.), HEART RATE IRREGULAR (heart rate fluctuations), MUSCLE SPASMS (hand cramps), OCULAR HYPERAEMIA (bloody eyes), INSOMNIA (insomnia) and PANIC ATTACK (two panic attacks due to this situation). Concomitant medication included supplements. The patient visited urgent care twice, and had checked with the primary physician and ear, nose, throat specialist (ENT). The patient was prescribed with prescriptions for allergies (Zyrtec and Flunase) but it did not work. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Significant follow-up information received. Added medical history, events, concomitant medications, updated reporter causality of tinnitus

Other Meds: VIT C; VITAMIN B NOS; MAGNESIUM; FLONASE [FLUTICASONE PROPIONATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SPRINTEC

Current Illness: Allergy to plants (Allery to olive trees); Dust allergy; Seasonal allergy

ID: 1657760
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: i feel sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (i feel sick) 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 MALAISE (i feel sick). At the time of the report, MALAISE (i feel sick) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. List of concomitant medication were not given.

Other Meds:

Current Illness:

ID: 1657761
Sex: M
Age: 35
State: PA

Vax Date: 05/24/2021
Onset Date:
Rec V Date: 08/31/2021
Hospital:

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

Lab Data: Test Date: 20210811; Test Name: elevated heart rate; Result Unstructured Data: 137-154 bpm during standing and walking.

Allergies:

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

Symptoms: Sore arm in the injection arm on the first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm in the injection arm on the first dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm in the injection arm on the first dose). At the time of the report, MYALGIA (Sore arm in the injection arm on the first dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, Heart rate increased: 137-154 bpm (High) 137-154 bpm during standing and walking.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant use was reported. No treatment medication was reported. This case was linked to MOD-2021-284724 (Patient Link).

Other Meds:

Current Illness:

ID: 1657762
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/31/2021
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: Red spots on legs; Feels like needles in my veins, they sting; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red spots on legs) and PARAESTHESIA (Feels like needles in my veins, they sting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history was not provided. 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 ERYTHEMA (Red spots on legs) and PARAESTHESIA (Feels like needles in my veins, they sting). At the time of the report, ERYTHEMA (Red spots on legs) and PARAESTHESIA (Feels like needles in my veins, they sting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication information was reported. No Treatment medications were provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am