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: 1725227
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: got shingles after the shot / 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingles after, getting the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.

Other Meds:

Current Illness:

ID: 1725228
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: neuropathy; This case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a female 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 neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy was unknown. The reporter considered the neuropathy to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter knew the patient who had terrible reactions to the shingles shot. The reporter stated that the shots had metal in them and caused neuropathy. One of the patient's friend sued and won her case. It took 2 years to receive the settlement. This case has been linked with US2021AMR199718, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR199718:Same reporter

Other Meds:

Current Illness:

ID: 1725229
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: has been on med protocol for MS; This case was reported by a consumer via interactive digital media and described the occurrence of multiple sclerosis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Family History) (patient's brother had shingles and lasted for a few months). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced multiple sclerosis (serious criteria GSK medically significant). On an unknown date, the outcome of the multiple sclerosis was unknown. It was unknown if the reporter considered the multiple sclerosis to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by the patient's sibling. The age at vaccination was not reported. The patient took the Shingles vaccine and she was fine although she had been on med protocol for MS (Multiple sclerosis). The reporter stated that everyone would be different and needed to make their own decisions. The follow-up would not possible as no contact details were available. This case was linked with US2021AMR199698 and US2021AMR199709, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR199698:Same reporter US-GLAXOSMITHKLINE-US2021AMR199709:Same reporter

Other Meds:

Current Illness:

ID: 1725230
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/07/2021
Rec V Date: 09/23/2021
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: after both doses got shingles\ suspected vaccination failure; Shingles; Rash on right side of stomach front to back and is currently spreading down leg,; Burning rash; Itching rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. Previously administered products included Zostavax and COVID-19 VACCINE (received both vaccines approximately 6 months ago). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 7th September 2021, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, generalized rash, burning sensation and itchy rash. The patient was treated with valaciclovir (Valacyclovir) and FLUCONAZOLE (FLUCONAZOLE CREAM). On 15th September 2021, the outcome of the shingles, generalized rash, burning sensation and itchy rash were recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown. It was unknown if the reporter considered the vaccination failure, shingles, generalized rash, burning sensation and itchy rash to be related to Shingrix and Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter states that previously has shingles as a child and received Zostavax vaccine as well. The reporter states received both COVID vaccines approximately 6 months ago. The patient received both doses of Shingrix and now has shingles. The reporter states shingles started with rash on right side of stomach front to back and was currently spreading down leg, complaints of itching and burning with rash. The medical care sought and valacyclovir and fluconazole cream prescribed, and rash was fading away. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1725231
Sex: M
Age: 3
State: NC

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 09/23/2021
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: not sure how much the patient got; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 3-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number Z3Mk7, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 14th September 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On 14th September 2021, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered 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 patient received Flulaval quadrivalent in left thigh. The licensed practical nurse called in to reported that, they administered Flulaval to a 3 year old patient getting a booster for new flu season. The reporter ststed tah, the patient moved during administration of vaccine and they were not sure how much of the vaccine the patient got. It leaked out due to patient moving and jerking leg, not due to syringe, which led to incomplete dose administered. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1725232
Sex: M
Age:
State: MO

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 09/23/2021
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: given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 542NY, expiry date 30th June 2021) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 13th September 2021, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 nurse reported that, a patient had been given an expired dose of Flulaval, which led to expired vaccine used. The reporter mentioned that, the patient was male but seemed to be trans so upon follow-up the gender of the patient might change. The reporter consented to follow up by email.

Other Meds:

Current Illness:

ID: 1725233
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: 1st dose of Shingrix on March 2020; This case was reported by a pharmacist via call center representative 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 in March 2020). 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. The registered pharmacist reported that, till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter also reported that this patient was vaccinated at another pharmacy so she did not have any demographic details from patient neither details from 1st dose. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1725234
Sex: M
Age: 72
State: TN

Vax Date: 07/23/2021
Onset Date: 07/01/2021
Rec V Date: 09/23/2021
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: Shingles worse than ever; This case was reported by a consumer and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had multiple cases of reoccurring shingles). Previously administered products included Zostavax (had been previously vaccinated with Zostavax). On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were reported as follows: This case was reported by the patient for himself. The patient received Shingrix vaccine and mentioned that in July and in August 2021 he broke out with shingles all over including the lower back, hair line, and head. The stated that this episode was worse than ever. The patient inquired if it was safe for him to receive second dose of Shingrix and if it would have any benefit. The reporter consented to follow up with him and with his health care professional (pharmacist).

Other Meds:

Current Illness:

ID: 1725235
Sex: F
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: 1st shot 2019, is now here for 2nd shot; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 20th December 2019). 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: 1725237
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: first dose years ago, second dose not received; This case was reported by a physician 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 (received 1st Shingrix dose at pharmacy 4 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. At the time of the reporting, it was unknown if the patient received the second dose, which led to incomplete course of vaccination. The reporter was inquiring about administering 2nd dose of Shingrix to patient or restarting series. The reporter consented to follow up. No additional details were available from reporter.

Other Meds:

Current Illness:

ID: 1725238
Sex: F
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: first dose 2019, never got second dose; This case was reported by a nurse and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 30th August 2019, batch number:BX25K, expiry date: 19th November 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. The patient was not immunocompromised and never received second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1725239
Sex: F
Age: 61
State: AR

Vax Date: 09/08/2021
Onset Date: 09/01/2021
Rec V Date: 09/23/2021
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: dry skin on her forehead, which spread to cheeks, eyes, ears, and neck; "very bad" sore throat; skin started to flake "badly"; her face started itching; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 8th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2021, 1 days after receiving Shingrix, the patient experienced dry skin. In September 2021, the patient experienced sore throat, flaking skin, and pruritus facial. On an unknown date, the outcome of the sore throat, flaking skin, pruritus facial, and dry skin were not recovered/not resolved. It was unknown if the reporter considered the sore throat, flaking skin, pruritus facial, and dry skin to be related to Shingrix. Additional details were provided are the case was reported by patient herself. The patient received a dose of Shingrix in right deltoid and next morning, she experienced dry skin on her forehead, which spread to cheeks, eyes, ears, and neck. A couple of days or a day later, her face started itching. She used a moisturizer, but no other new cleansing or moisturizing products. Less than 2 weeks after vaccination, the dry skin got worse, and her skin started to flake badly and also reported a very bad sore throat. These events had not currently resolved. The reporter was unable to provide lot or expiration of product. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1725240
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: Severe pain where first dose was given; This case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included anemia, diabetes and hypertension. Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix and had severe pain in his right arm where the vaccine was administered. The patient stated that he also received pneumonia vaccine in his left arm on the same day as the Shingrix vaccine and did not had pain in his left arm and the patient did not know the name of the pneumonia vaccine. The arm pain was resolved without intervention. The patient declined to provide health care professional information. The reporter did not consent to follow up.

Other Meds: PNEUMONIA VACCINE

Current Illness: Anemia; Diabetes; Hypertension

ID: 1725241
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: Incomplete Course of Vaccination; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 23rd September 2020, by intramuscular in left deltoid). 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 reporter was the patient. 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 inquired if he could get his second dose or if he needed to restart the series of vaccination all over. The VAERS details were reported for 1st dose of Shingrix.

Other Meds:

Current Illness:

ID: 1725242
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: first dose about a year ago, have not received second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received about a year 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 patients (about 10 to 15) did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not have specific patient identifiers. The reporter did not consent to follow up. The details were reported for 1st dose of Shingrix.

Other Meds:

Current Illness:

ID: 1725243
Sex: F
Age: 48
State: MT

Vax Date: 09/16/2021
Onset Date:
Rec V Date: 09/23/2021
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: exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 16th September 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. The MI agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter

Other Meds:

Current Illness:

ID: 1725244
Sex: F
Age: 60
State: MT

Vax Date: 09/16/2021
Onset Date:
Rec V Date: 09/23/2021
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: exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 60-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 16th September 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. The MI agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter

Other Meds:

Current Illness:

ID: 1725245
Sex: F
Age: 31
State: MT

Vax Date: 09/16/2021
Onset Date:
Rec V Date: 09/23/2021
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: exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 31-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 16th September 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. The agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter

Other Meds:

Current Illness:

ID: 1725246
Sex: F
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: didn't receive second shot; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received 10 months 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 did not consent to follow up.

Other Meds:

Current Illness:

ID: 1725248
Sex: F
Age:
State: NV

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/23/2021
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: received 3 doses of Shingrix; This case was reported by a pharmacist and described the occurrence of extra dose administered in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in September 2020) and Shingrix (received 2nd dose in November 2020). In March 2021, the patient received the 3rd dose of Shingrix. In March 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details provided were as follows: Age at vaccination was not reported but the patient was over 60 years at the time of reporting. The pharmacist was looking for guidance because the patient received 3rd dose of Shingrix vaccine which led to extra dose administered. No information was provided about lot number or expiration date. Patient was not immunocompromised. Pharmacist mentioned that this situation was already reported. The reported did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1725249
Sex: U
Age:
State: MI

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 09/23/2021
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: liquid antigen vial of without reconstitution with the lyophilized powder; was given the liquid antigen vial of without reconstitution; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th September 2021, the patient received Shingrix. On 20th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: The age at vaccination was not reported. A patient was given the liquid antigen vial of Shingrix without reconstitution with the lyophilized powder vial which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1725250
Sex: M
Age: 53
State:

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/23/2021
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: fever; nerve pain, head, ear, throat; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of no adverse event the patient never had any symptoms with flu shot and the patient gets it every year. In September 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. In September 2021, 10 hours after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever and nerve pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the nerve pain was not recovered/not resolved. The reporter considered the fever and nerve pain to be possibly related to Shingrix. It was unknown if the reporter considered the fever and nerve pain to be related to Influenza vaccine Quadrivalent 2020-2021 season. Additional details were provided as the patient self-reported the case. The patient received Shingrix vaccine in right arm and the flu shot in left arm (did not know which one) 2 and a half weeks ago from reporting date (did not remember exact date). The patient believed he had a reaction to Shingrix. About 10 hours after getting vaccines he reported a fever and nerve pain on the top, left side of head (scalp) that radiates down to his left ear and left side of throat. The fever went away after a day, but the nerve pain remains after 2 and a half weeks. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1725251
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: administered only the liquid adjuvant; administered only the liquid adjuvant; This case was reported by a pharmacist via a representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as the age at vaccination was not reported. The pharmacist reported that a nurse in a neighboring facility administered only the liquid adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1725252
Sex: F
Age:
State: NJ

Vax Date: 01/16/2021
Onset Date: 09/10/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: High

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Started to feel very weak; Can barely move the body; Almost can not walk; 100.2? fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Started to feel very weak), MOBILITY DECREASED (Can barely move the body), GAIT DISTURBANCE (Almost can not walk) and PYREXIA (100.2? fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21O, 021M20A and 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced ASTHENIA (Started to feel very weak), MOBILITY DECREASED (Can barely move the body), GAIT DISTURBANCE (Almost can not walk) and PYREXIA (100.2? fever). At the time of the report, ASTHENIA (Started to feel very weak), MOBILITY DECREASED (Can barely move the body), GAIT DISTURBANCE (Almost can not walk) and PYREXIA (100.2? fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 100.2 (High) High. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received contain no new information. On 12-Sep-2021: Follow up received contain updated event out case as recovered/resolved.

Other Meds:

Current Illness:

ID: 1725254
Sex: F
Age:
State: AR

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 20210901; Test Name: Body temperature; Result Unstructured Data: 101 F, ranging from 100-100.5 on average; Test Date: 20210902; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BRAIN FOG; FATIGUE; STABBY BONE PAIN IN HER ARMS AND LEGS; MUSCLE WEAKNESS IN THE ARMS AND LEGS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height and weight were not reported. The patient experienced drug allergy when treated with ciprofloxacin/fluoroquinolones and levaquin (levofloxacin). She had stabby bone pain in her arms and legs when she took ciprofloxacin/fluoroquinolones. She had lost a tendon 10 years ago in the back of her calf muscle (she believed it was her left leg). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 and expiry: unknown) dose was not reported, frequency time 1 total administered on 23-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient experienced muscle weakness in the arms and legs. On 07-APR-2021, she experienced a lot of stabby bone pain in her arms and legs. On 10-APR-2021, she experienced fatigue. On 29-AUG-2021, she experienced brain fog and began having symptoms such as a pain in her right sinus and felt sweaty. She thought that, she had a sinus infection. Eventually, on 01-SEP-2021 (Wednesday), she had fever of 101 F (fahrenheit) (ranging from 100-100.5 on average). On 02-Sep-2021 (Thursday), she also had a severe headache. She went through Rapid Covid-19 test and the results were positive for Covid-19. The above symptoms were diagnosed as part of being the break through covid-19 infection (suspected covid-19 infection and suspected clinical vaccination failure). She treated her own symptoms with sinus medication and Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabby bone pain in her arms and legs, and fatigue on 15-MAY-2021, and muscle weakness in the arms and legs on 10-APR-2021, was recovering from suspected covid-19 infection, had not recovered from brain fog, 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: 90000193677.; Sender's Comments: V0:20210932343 - 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: 1725255
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: negative

Allergies:

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

Symptoms: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned 4 patients of unspecified age, sex, race and ethnicity. 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, expiry: unknown) dose, start therapy date were not reported, 1 total, administered 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. On an unspecified date, 4 patients experienced suspected immunological vaccine failure. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) negative. As per reporter "4 out of 5 patients who received the Janssen COVID-19 vaccine tested negative for antibodies in a small study group. Reporter complained about the vaccine stating that they do not believe in its efficacy. Since the reporter had a perceived lack of effect (LOE) based on their expectation from the product and the timing is unclear (no information on when the antibody test was done after the vaccine administration)". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193783.; Sender's Comments: V0: 20210934975-COVID-19 VACCINE AD26.COV2.S - Suspected immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

Date Died: 08/01/2021

ID: 1725256
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: DEATH; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a consumer (patient's friend) via a company representative through social media concerned a 55 year old patient of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient had no underlying issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose and start therapy date were not reported, 1 total, administered 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 covid-19 (suspected covid-19 and suspected clinical vaccination failure). On an unspecified date, in AUG-2021, the patient died from an unknown cause. It was unknown if an autopsy was performed. As per the reporter, ''Unfortunately I have a 55 year old friend who died last month with Covid no underlying issues, Vaccinated with J and J.'' The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of death was reported as fatal, suspected covid-19 was not recovered, and the outcome of suspected clinical vaccination failure was not reported at the time of death. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000193814.; Sender's Comments: V0: 20210935156-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210935156-Covid-19 vaccine ad26.cov2.s-Suspcted 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1725257
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 08/26/2021
Rec V Date: 09/23/2021
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: VOMITING; BLURRY VISION; DIZZINESS; NOT FEELING WELL; FEVER; HEADACHE/MIGRAINE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid 19, and headache, and concurrent conditions included: non alcoholic, non smoker, and azithromycin allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 26-AUG-2021 14:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient experienced headache/migraine. On 27-AUG-2021, the patient experienced not feeling well. On 27-AUG-2021, the patient experienced fever. On 01-SEP-2021, the patient experienced blurry vision. On 01-SEP-2021, the patient experienced dizziness. On 09-SEP-2021, treatment medications included: sumatriptan. On 12-SEP-2021, the patient experienced vomiting. Additional treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine was not applicable. The patient recovered from blurry vision, dizziness, and vomiting on SEP-2021, not feeling well, and fever, and headache/migraine on 12-SEP-2021. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergy to antibiotic; Non-smoker

ID: 1725260
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: More than 12 AU; Test Name: ANCA; Result Unstructured Data: proteinase 30.8 u/mL; Test Name: Proteinuria; Result Unstructured Data: 91 mg; Test Name: Estimated GFR; Result Unstructured Data: 68 mL/min(1.73 x m2

Allergies:

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

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; MEDICATION ERROR; This spontaneous report was received from literature. This report concerned a 67 year old male of unspecified ethnicity. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: microscopic polyangiitis phenotype, and anca (anti-neutrophil cytoplasmic antibody) vasculitis. The patient was previously (4 month before vaccine first dose) treated with steroids for microscopic polyangiitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported , expiry: unknown) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included rituximab for microscopic polyangiitis, and bnt (pfizer vaccine)162 for prophylactic vaccination.. On an unspecified date, the patient experienced confirmed immunological vaccination failure, and medication error. Laboratory data (dates unspecified) included: ANCA (NR: not provided) proteinase 30.8 u/mL, Estimated GFR (NR: not provided) 68 mL/min (1.73 x m2, Proteinuria (NR: not provided) 91 mg, and SARS-CoV-2 IgG antibody test (NR: not provided) More than 12 AU. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccination failure and medication error was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20210927182. This case associated with product quality complaint.; Sender's Comments: V0: 20210935336-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS, CONMEDS-OTHER SUSPECT DRUGS

Other Meds: BNT 162; RITUXIMAB

Current Illness: Anti-neutrophil cytoplasmic antibody positive vasculitis; Microscopic polyangiitis

ID: 1725261
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 09/14/2021
Rec V Date: 09/23/2021
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: 20210914; Test Name: White cells; Result Unstructured Data: low; Test Date: 20210914; Test Name: Antibody test; Result Unstructured Data: Negative; Test Date: 20210914; Test Name: Viral load; Result Unstructured Data: waiting

Allergies:

Symptom List: Nausea

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DROP IN ALL WHITE CELLS T'S AND LYMPH; This spontaneous report received from a patient concerned a female of unspecified age of unknown race and ethnicity. 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) 1 total, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The concomitant medication included Symtuza and the patient was taking it for 3 years. As of 14-SEP-2021, The patient experienced drop in all white cells, t's and lymph, it had never been this low and the antibodies showed up negative (confirmed Immunological Vaccine Failure).Laboratory data included: Viral load (NR: not provided) waiting, and White cells (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drop in all white cells t's and lymph and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210400184.; Sender's Comments: V0-20210936273-Covid-19 vaccine ad26.cov2.s- Confirmed immunological Vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: SYMTUZA

Current Illness:

Date Died:

ID: 1725262
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: DEATHS; This spontaneous report received from a consumer via a company representative concerned 3 patients of unspecified sex, age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown expiry: unknown) dose, start therapy date were not reported 1 total administered 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. "It was reported that, on an unknown date, JNJ vaccine caused 3 known deaths". The patients died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event death was fatal This report was serious (Death).; Sender's Comments: V0: 20210936591-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1725263
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SEVERE REACTIONS; This spontaneous report received from a patient via a company representative concerned 29 patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 and has been requested. No concomitant medications were reported. "It was reported that, on an unknown date, the patients experienced severe reactions". The action taken with covid-19 vaccine was not applicable. The outcome of severe reactions was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725264
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 09/20/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned an 8 decade 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: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725265
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (social media article) via a company representative concerned a 56 year old male of unknown race and ethnicity. 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 expiry: unknown) dose, start therapy date were not reported, frequency 1 total, administered 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 19-SEP-2021, As per the patient, " I was sick with Covid-19 after a breakthrough infection". The patient did not elaborate symptoms, and got Covid despite being fully vaccinated. On an unspecified date, the patient experienced suspected covid-19 infection, and suspected clinical vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000194012.; Sender's Comments: V0: 20210938864-COVID-19 VACCINE AD26.COV2.S-Suspected Clinical vaccine 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: 1725266
Sex: M
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: ACHY; COUGH; FEEL LIKE CRAP; CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced achy, cough, feel like crap, chills, tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, achy, chills, cough, headache and feel like crap was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725267
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 08/05/2021
Rec V Date: 09/23/2021
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: Test Date: 20210919; Test Name: Blood pressure; Result Unstructured Data: Not reported

Allergies:

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

Symptoms: EXHAUSTED; FELT PAIN ON THE FRONT UPPER CHEST OF THE LEFT SIDE BELOW THE SHOULDER AREA; UNUSUAL BRUISING IN DIFFERENT PLACES; DOUBLE DOSE SHOT OF THE VACCINE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: Patient did not have medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced double dose shot of the vaccine. On 18-AUG-2021, the patient experienced bruising in different places. On 19-SEP-2021, the patient experienced felt pain on the front upper chest of the left side below the shoulder area. On an unspecified date, the patient experienced exhausted. Laboratory data included: Blood pressure (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising in different places, and the outcome of double dose shot of the vaccine and felt pain on the front upper chest of the left side below the shoulder area was not reported. This report was non-serious.

Other Meds:

Current Illness: Penicillin allergy

ID: 1725268
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a health care professional and concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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. On an unspecified date, the patient experienced inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725269
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: FELT DOWN DUE TO HIGH FEVER; This spontaneous report received from a consumer 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 (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt down due to high fever. The action taken with covid-19 vaccine was not applicable. The outcome of felt down due to high fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725270
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 08/30/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 20210910; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210910; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Date: 20210913; Test Name: CAT scan; Result Unstructured Data: Normal; Test Date: 20210913; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210913; Test Name: Electrocardiogram; Result Unstructured Data: Normal

Allergies:

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

Symptoms: NUMBNESS IN TOES AND BOTH FEET; ZERO ENERGY; LOST SENSE OF TASTE; FACIAL NUMBNESS IN LIPS NOSE AND REST OF FACE; UPPER BACK PAIN/BACK PAIN/MUSCLE ACHES; PAIN IN BACK MOVED TO SPINE; SKIN IS ON FIRE MOSTLY FELT ON ARMS BUT ALSO ENTIRE BODY LIKE EVERY NERVE ENDING ON MY SKIN IS ON FIRE AND EXTREMELY SENSITIVE TO TOUCH HOT WATER AND COLD WATER; NOT BEEN ABLE TO SLEEP; DEEP MUSCLE PAIN IN THE ENTIRE BACK MUSCLES/DULL MUSCLE ACHE IN THE LOWER BACK/ THROBBING BACK PAIN; This spontaneous report received from a patient concerned a 64 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 (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water. On 30-AUG-2021, the patient experienced not been able to sleep. On 30-AUG-2021, the patient experienced deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain. On SEP-2021, the patient experienced upper back pain/back pain/muscle aches. On SEP-2021, the patient experienced pain in back moved to spine. On 10-SEP-2021, the patient experienced facial numbness in lips nose and rest of face. Laboratory data included: Blood test (NR: not provided) Normal, and COVID-19 virus test (NR: not provided) Negative. On 12-SEP-2021, the patient experienced lost sense of taste. On 13-SEP-2021, Laboratory data included: Blood test (NR: not provided) Normal, CAT scan (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced numbness in toes and both feet. On 18-SEP-2021, the patient experienced zero energy. Treatment medications (dates unspecified) included: naproxen, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient was recovering from deep muscle pain in the entire back muscles/dull muscle ache in the lower back/ throbbing back pain, not been able to sleep, facial numbness in lips nose and rest of face, zero energy, and pain in back moved to spine, and had not recovered from skin is on fire mostly felt on arms but also entire body like every nerve ending on my skin is on fire and extremely sensitive to touch hot water and cold water, numbness in toes and both feet, lost sense of taste, and upper back pain/back pain/muscle aches. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725271
Sex: M
Age:
State: KY

Vax Date:
Onset Date: 09/20/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTRATION OF AN OPENED VILE OF THE JNJ COVID19 VACCINE WHICH WAS LEFT OPEN AT ROOMS TEMPERATURE FOR 6 HOURS; This spontaneous report received from a health care professional concerned a 54 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and none medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced administration of an opened vile of the JNJ covid19 vaccine which was left open at rooms temperature for 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an opened vile of the JNJ covid19 vaccine which was left open at rooms temperature for 6 hours was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725272
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: GOT COVID-19 AFTER VACCINATION; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced got covid-19 after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid-19 after vaccination was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725273
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: NO PERIOD SINCE COVID-19 VACCINATION; This spontaneous report received from a consumer and concerned an adult female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: autism. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced no period since covid-19 vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no period since covid-19 vaccination. This report was non-serious.

Other Meds:

Current Illness: Autism

ID: 1725274
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SLEPT FOR LIKE 16 HOURS THE FIRST DAY; SORE ARM; FATIGUED; SLIGHT FEVER; This spontaneous report received from a patient 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: 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 slept for like 16 hours the first day, sore arm, fatigued, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for like 16 hours the first day, sore arm, fatigued, and slight fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725275
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: REALLY TIRED; FATIGUE LIKE WALKING FOR A MILE; SWEATY FOR 20 MINUTES AFTER THEN HE WAS FINE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 9320) dose was not reported, administered on 07-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced sweaty for 20 minutes after then he was fine. On 08-APR-2021, the patient experienced really tired. On 08-APR-2021, the patient experienced fatigue like walking for a mile. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty for 20 minutes after then he was fine on 07-APR-2021, and really tired, and fatigue like walking for a mile on 09-APR-2021. This report was non-serious.

Other Meds:

Current Illness: Penicillin allergy

ID: 1725276
Sex: U
Age:
State: GA

Vax Date:
Onset Date: 08/27/2021
Rec V Date: 09/23/2021
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: NAUSEA; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported. On 27-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The outcome of nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941047.

Other Meds:

Current Illness:

ID: 1725277
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: TOOK A THIRD PFIZER AND A SHOT OF JANSSEN COVID-19 VACCINE; CHEST PAIN; This spontaneous report received from a patient 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced took a third pfizer and a shot of janssen covid-19 vaccine, and chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and the outcome of took a third pfizer and a shot of janssen covid-19 vaccine was not reported. This report was non-serious.

Other Meds: BNT 162

Current Illness:

ID: 1725278
Sex: U
Age:
State: NY

Vax Date:
Onset Date: 08/23/2021
Rec V Date: 09/23/2021
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: OUT OF SPECIFICATION PRODUCT USE; TEMPERATURE EXCURSION (EXPOSED TO 27F DEGREES FOR 44 MIN); This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-AUG-2021, the patient experienced temperature excursion (exposed to 27f degrees for 44 min). On an unspecified date, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the temperature excursion (exposed to 27f degrees for 44 min) and out of specification product use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725279
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 09/21/2021
Rec V Date: 09/23/2021
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: OFF-LABEL USE; RECEIVED 0.3 ML OF THE JANSSEN COVID-19 VACCINE INSTEAD OF 0.5 ML; RECEIVED 0.3 ML OF JANSSEN COVID-19 VACCINE TODAY INSTEAD OF SECOND DOSE OF PFIZER COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 21 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: 30130BA and expiry: 30-NOV-2021) .3 ml, administered on 21-SEP-2021 for prophylactic vaccination. Concomitant medications included BNT 162 for prophylactic vaccination. On 21-SEP-2021, the patient experienced off-label use. On 21-SEP-2021, the patient experienced received 0.3 ml of the janssen covid-19 vaccine instead of 0.5 ml. On 21-SEP-2021, the patient experienced received 0.3 ml of janssen covid-19 vaccine today instead of second dose of pfizer covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use, received 0.3 ml of janssen covid-19 vaccine today instead of second dose of pfizer covid-19 vaccine and received 0.3 ml of the janssen covid-19 vaccine instead of 0.5 ml was not reported. This report was non-serious.

Other Meds: BNT 162

Current Illness:

ID: 1725280
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BRONCHITIS (FEVER AGAIN, SEVERE HEADACHE, CHILLS, SEVERE COUGH); DIZZINESS; COULD NOT WORK ONE WEEK AFTER SHOT; NAUSEA; 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 (suspension for injection, route of admin not reported, batch number: Unk) 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 bronchitis (fever again, severe headache, chills, severe cough), dizziness, could not work one week after shot, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from bronchitis (fever again, severe headache, chills, severe cough), dizziness, could not work one week after shot, and nausea. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725281
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
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: PAIN IN ARM; ARM FELT FULL LIKE SOMETHING IN THERE; This spontaneous report received from a consumer 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 (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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced pain in arm, and arm felt full like something in there. The action taken with covid-19 vaccine was not applicable. The outcome of the pain in arm and arm felt full like something in there was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941324.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am