VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1642940
Sex: F
Age:
State: NE

Vax Date: 08/16/2021
Onset Date: 08/17/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: facial Swelling; tongue Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included autoimmune disorder. Concurrent medical conditions included food allergy. On 16th August 2021, the patient received Shingrix (intramuscular). On 17th August 2021, 1 days after receiving Shingrix, the patient experienced facial swelling and swollen tongue. The patient was treated with benadryl (nos) (Benadryl) and antihistamine (Antihistamines). On an unknown date, the outcome of the facial swelling and swollen tongue were unknown. It was unknown if the reporter considered the facial swelling and swollen tongue to be related to Shingrix. Additional details were provided as follows: Pharmacist stated patient was approximately 52 years old. The pharmacist stated that patient was administered Shingrix vaccine in left deltoid muscle and one day after the vaccination the patient had facial and tongue swelling. On 18th August 2021,the patient called to pharmacist to report events but pharmacist believed event had been progressing since 17th August 2021. The patient was being treated with benadryl and antihistamines. The Pharmacist was calling from home and did not have vaccine lot number/expiration date. The reporter consented to follow up. The HCP (Health care professional) gave permission to follow-up.

Other Meds:

Current Illness: Food allergy

ID: 1642941
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Allergic Reaction; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2013-2014) 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 an unknown date, the patient received FluLaval Tetra 2013-2014 and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving FluLaval Tetra 2013-2014 and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FluLaval Tetra 2013-2014 and Flulaval Tetra Pre-Filled Syringe Device. 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 age at vaccination was not reported. The physician reported that she had patient who had an allergic reaction to FluLaval vaccine in 2013. The reporter consented to follow up.

Other Meds: Flulaval Tetra Pre-Filled Syringe Device

Current Illness:

ID: 1642942
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received only the liquid portion / adjuvant only.; received only the liquid portion / adjuvant only.; This case was reported by a other health professional via call center 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 follows: The age at vaccination was not reported. The medical assistant stated that, the patient had received only the liquid portion of the shingrix, they did not reconstituted with the powder. which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further data reported. The the medical assistant states that a husband and wife were in the office and one of them received only a partial dose of the shingrix for dose 2 of the series. They had no way of determining which patient (the husband or wife) received the adjuvant only. They intend to revaccinate both patients in four weeks time. No further details were provided at the time of this call, and the medical assistant rushed off the line at the end of the medical discussion. No further details provided. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1642943
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: redness at the injection site; hives; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 17th August 2021, the patient received Boostrix (intramuscular) .5 ml. In August 2021, less than a week after receiving Boostrix, the patient experienced hives. On 18th August 2021, the patient experienced injection site erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema and hives were recovered/resolved. It was unknown if the reporter considered the injection site erythema and hives to be related to Boostrix. Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The reporter declined to provide demographic information and did not have many details. The patient received Boostrix on a Tuesday in unnown arm and next day after the vaccination patient had some redness at the injection site. On Friday or Saturday of the same week the patient had hives. The patient took Benadryl tablets and the hives resolved within days. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1642944
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received in 2017 the complete schedule. In 2020 had shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax with an associated reaction of herpes zoster. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the 1st case of shingles after the Zostavax vaccine. In 2017, about 4 years prior to the reporting, the patient received the complete vaccination schedule of Shingrix vaccine (the 2 doses 6 months apart) and in 2020, she had the mild case of shingles. The patient wanted to know if it was possible to get Shingrix twice in a lifetime. The different health care professionals (HCPs) told the patient different things and the last one said that it was not possible to get the Shingrix twice and refused to vaccinate the patient. The physician recommended revaccination after 5 years from the last Shingrix shot. The reporter was rushing to get off the phone and was looking for a yes or no to the question she asked about Shingrix booster dose. Upon asking the questions to document safety report, the reporter asked if she could get off the phone and thus, no vaccine information was provided at the time of the call. The reporter did not consent to follow up with the health care professional and therefore, did not collect the health care professional contact information. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1642945
Sex: F
Age: 70
State: NY

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Topical reaction. Injection site eruption; skin came off; This case was reported by a physician via call center representative and described the occurrence of injection site eruption in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st July 2021, the patient received the 1st dose of Shingrix. In July 2021, 3 days after receiving Shingrix, the patient experienced injection site eruption and skin peeling. On an unknown date, the outcome of the injection site eruption and skin peeling were unknown. It was unknown if the reporter considered the injection site eruption and skin peeling to be related to Shingrix. Additional details were provided as follows: The patient experienced minor local reaction after first dose of Shingrix. Topical reaction below the site of injection 4 inches down a little eruption, tiny and skin came off. The patient stated that it was nothing big, small area, probably from the site of injection. The patient experienced adverse event on day 3 after vaccine. The patient was not going to take 2nd vaccination. The reporter did not consent to follow-up. This case was been linked with the case US2021177362 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021177362:same reporter

Other Meds:

Current Illness:

ID: 1642946
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Boostrix to the same patient twice on the same day; Boostrix to the same patient twice on the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received the 2nd dose of Boostrix, Boostrix Pre-Filled Syringe Device, the 1st dose of Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device and not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced overdose and overdose. On an unknown date, the outcome of the overdose and overdose were 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 manager stated that a certified medical assistants gave Boostrix to the same patient twice on the same day, which led to overdose. The reporter stated that the patient had a twin and therefore the vaccine was administered to the same patient. This happened about 3 weeks ago and the child was fine. No additional patient demographics or vaccine details (lot, exp) available at time of call. The reporter consented to follow up via email.

Other Meds:

Current Illness:

ID: 1642947
Sex: M
Age:
State: OR

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: administrated Pediarix and a single dose of IPV at the same time; This case was reported by a physician via call center representative and described the occurrence of overdose in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977t, expiry date 5th September 2022) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE INACTIVATED (IPV (INACTIVATED POLIO VACCINE)) for prophylaxis. On 23rd August 2021, the patient received the 3rd dose of Pediarix, Pediarix Pre-Filled Syringe Device and IPV (INACTIVATED POLIO VACCINE). On 23rd August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 reported that 6 month old male patient was administrated Pediarix and a single dose of IPV at the same time, which led to overdose for inactivated polio component. The vaccines were administrated on the same day. The dose of Pediarix was meant to be a third dose. The injections were given each one in different legs. The HCP believed the single dose IPV was from the brand SANOFI but was not sure. No further events were reported. The reporter agreed to be contacted for follow up through email.

Other Meds:

Current Illness:

ID: 1642948
Sex: F
Age: 52
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Inappropriate age at vaccine administration; Infanrix was given to an adult patient instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 52-year-old female patient who received DTPa (Infanrix) (batch number 7ec55, expiry date unknown) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 20th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: Medical Assistant reported that a dose of Infanrix was given to an adult patient instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up via email.

Other Meds:

Current Illness:

ID: 1642949
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: receiving a third (extra) dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date). On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was recovered/resolved. Additional details were provided as follows: The pharmacist called on behalf of the patient. The reporter stated that, patient forgot they had received second dose, resulting in them receiving a third dose, which led to extra dose administered. No demographics collected. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1642950
Sex: F
Age: 94
State: FL

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: today dose is the third (3 dose); This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 94-year-old female patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date unknown) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date). On 23rd August 2021, the patient received the 3rd dose of Shingrix. On 23rd August 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 were provided as follows: The reporter called to report that, a female patient who did not record getting 2 dose of Shingrix, went to get the supposed 2 dose but got home and realized she had had the second dose, so today dose was the third (3 dose). The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1642951
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: never received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included shingrix (1st dose received in early 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 case details were reported as follows: The case was reported by the patient for herself. The age at vaccination was not applicable for this report. The patient never received the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1642952
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Second dose greater than 6 months./Second dose not yet given.; 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 13th August 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 case details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported that 2nd dose of Shingrix greater than 6 months and 2nd dose not yet given till the time of reporting which led to incomplete course of vaccination. The reporter did not consent to follow-up. The case had been linked with US2019129052 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2019129052:Same reporter

Other Meds:

Current Illness:

ID: 1642953
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center 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 follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patients information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter

Other Meds:

Current Illness:

ID: 1642954
Sex: M
Age: 43
State: PA

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: X-ray; Result Unstructured Data: Abnormal.

Allergies:

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

Symptoms: Looked like double pneumonia.; Started wheezing; Psychotic episode/psychotic episode; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Looked like double pneumonia.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PSYCHOTIC DISORDER (Psychotic episode/psychotic episode). On an unknown date, the patient experienced PNEUMONIA (Looked like double pneumonia.) (seriousness criterion medically significant) and WHEEZING (Started wheezing). The patient was treated with PREDNISONE for Adverse reaction, at an unspecified dose and frequency and SALBUTAMOL (ALBUTEROL HFA) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Looked like double pneumonia.) and WHEEZING (Started wheezing) outcome was unknown and PSYCHOTIC DISORDER (Psychotic episode/psychotic episode) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Treatment medication also included antibiotics. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-293194 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Asthma

ID: 1642955
Sex: M
Age: 40
State: MN

Vax Date: 04/08/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Other tests; Result Unstructured Data: Results were unknown

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Heart attack; Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and PERICARDITIS (Pericarditis) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant) and PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with COLCHICINE for Pericarditis, at a dose of .6 mg once a day; IBUPROFEN for Pericarditis, at an unspecified dose and frequency and GLYCERYL TRINITRATE (NITRO [GLYCERYL TRINITRATE]) for Heart attack, at a dose of 3 shots. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and PERICARDITIS (Pericarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: unknown Results were unknown. Concomitant product was not provided by the reporter. Patient reported that within 20 hours of receiving second dose of moderna vaccine he experienced pericarditis. Patient went to the emergency room (ER) because he thought he was having a heart attack, doctor thought so too hence he was given 3 shots of Nitro. He was not admitted. They ran lots of other tests. He was otherwise healthy, took no other medications. The patient went for a follow-up appointment three weeks back and still had it, and had not gone away yet. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.

Other Meds:

Current Illness:

ID: 1642956
Sex: F
Age: 72
State: NY

Vax Date: 03/09/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: Cardioverted because she was in chronic afib; Chills; Had fevers; Weak; Tired; Had no appetite; Dehydrated; Has been totally breathless, has had every listed reaction; Had hot flashes; Run down; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Cardioverted because she was in chronic afib), CHILLS (Chills), PYREXIA (Had fevers), ASTHENIA (Weak), FATIGUE (Tired), DECREASED APPETITE (Had no appetite), DEHYDRATION (Dehydrated), DYSPNOEA (Has been totally breathless, has had every listed reaction), HOT FLUSH (Had hot flashes) and FEELING ABNORMAL (Run down) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 032M20A) for COVID-19 vaccination. Concurrent medical conditions included Sickness (gone through 6 months of sickness). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 ATRIAL FIBRILLATION (Cardioverted because she was in chronic afib) (seriousness criteria hospitalization and medically significant), CHILLS (Chills) (seriousness criterion hospitalization), PYREXIA (Had fevers) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization), DECREASED APPETITE (Had no appetite) (seriousness criterion hospitalization), DEHYDRATION (Dehydrated) (seriousness criterion hospitalization), DYSPNOEA (Has been totally breathless, has had every listed reaction) (seriousness criterion hospitalization), HOT FLUSH (Had hot flashes) (seriousness criterion hospitalization) and FEELING ABNORMAL (Run down) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (Cardioverted because she was in chronic afib), CHILLS (Chills), PYREXIA (Had fevers), ASTHENIA (Weak), FATIGUE (Tired), DECREASED APPETITE (Had no appetite), DEHYDRATION (Dehydrated), DYSPNOEA (Has been totally breathless, has had every listed reaction), HOT FLUSH (Had hot flashes) and FEELING ABNORMAL (Run down) outcome was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Patient states that she was a sick patient and had gone through 6 months of sickness. Patient was hospitalized for 2.5 days until cardioverted because she was in chronic afib. Not once she had tested positive with Covid. She stated that she had been run down. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Sickness (gone through 6 months of sickness)

Date Died: 08/17/2021

ID: 1642957
Sex: M
Age:
State: MS

Vax Date:
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital: Y

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Date: 202107; Test Name: Lab test; Result Unstructured Data: Normal; Test Date: 20210801; Test Name: Platelet count; Result Unstructured Data: 4800

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: HEMORRHAGIC STROKE; MEDICATION ERROR (RECEIVED A FULL SERIES OF PFIZER FOLLOWED BY JNJ VACCINE); This spontaneous report received from a consumer via a company representative concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hemorrhagic stroke, and concurrent conditions included: controlled hypertension, hyperlipidemia, and overweight. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included bnt 162 for prophylactic vaccination. The patient received a full series of Pfizer sometime between MAR-2021 and MAY-2021. On JUL-2021, Laboratory data included: Lab tests were normal. On 01-AUG-2021, Laboratory data included: Platelet count (NR: not provided) 4800 and the patient had 3 brain bleeds. On 11-AUG-2021, the patient had medication error (received a full series of pfizer followed by JNJ vaccine). On 16-AUG-2021, the patient experienced hemorrhagic stroke and was hospitalized for one day. On 17-AUG-2021, the patient died from hemorrhagic stroke. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error (received a full series of Pfizer followed by JNJ vaccine) was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210837606 -covid-19 vaccine ad26.cov2.s- Hemorrhagic stroke. 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: Hemorrhagic stroke

Other Meds: BNT 162

Current Illness: Hyperlipidemia; Hypertension; Overweight

ID: 1642958
Sex: U
Age:
State: GA

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital: Y

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Date: 202106; Test Name: Lumbar puncture; Result Unstructured Data: unknown; Test Date: 202106; Test Name: MRI; Result Unstructured Data: unknown; Test Date: 20210616; Test Name: MRI; Result Unstructured Data: unknown; Test Date: 20210616; Test Name: CT scan; Result Unstructured Data: unknown; Test Date: 20210616; Test Name: Urinalysis; Result Unstructured Data: unknown; Test Date: 20210616; Test Name: Blood test; Result Unstructured Data: unknown; Test Date: 20210625; Test Name: Brain CT; Result Unstructured Data: Bell's Palsy and Guillain Barr? Syndrome; Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Name: HIV test; Result Unstructured Data: negative; Test Name: Magnetic resonance imaging spinal; Result Unstructured Data: unknown

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: FACIAL PALSY; RIGHT EYE HAD BLURRY VISION; URINARY RETENTION; NUMBNESS IN FEET WHICH ADVANCED TO COLLAR BONE; TINGLING IN FEET WHICH ADVANCED TO COLLAR BONE; BILTERAL WEAKNESS/BILTERAL LEG WEAKNESS; WALK WITH SUPPORT; PAIN; TWO LESIONS ON THORACIC SPINE AND ON LUMBAR; STROKE SYMPTOMS; This spontaneous report was received from a patient of unspecified age, sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use and the patient was non-smoker. The patient had no infectious illnesses nor any recent vaccinations or hospitalizations 6 weeks prior to onset of the event. The patient did not suffer from common cold, flu, or infection with epsteinBarr, herpes simplex, herpes Zoster, adenovirus infection, cytomegalovirus, respiratory syncytial virus infection, coxsackievirus, diarrhea or bloody diarrhea and lyme disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose, vaccination site, and batch number not reported), 1 total, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the patient experienced numbness and tingling in feet and urinary retention. The bowel was normal. The symptoms were started abruptly. The patient had bilateral weakness. The same day patient was referred to the ER, where blood and urine samples were taken, and multiple magnetic resonance imaging (MRIs) and computerized tomography (CT) scans were done. The ER doctor came back and said it was multiple sclerosis (MS), and patient was admitted to the hospital. An infectious disease (ID) doctor and a neurologist were assigned. Within 24 hours numbness and tingling had advance from feet to collar bone. The ID doctor prescribed treatments with unspecified intravenous anti viral and anti bacterial medications. The neurologist ordered a lumbar puncture with dozens of tests of the cerebral spinal fluid and more MRIs. Within 48 hours after receiving the anti viral patient was able to walk with support for short distances. Another 36 hours later patient could walk unassisted. After 9 days in the hospital, patient was feeling better and was released on 25-JUN-2021 and within an hour of being released, patient started having stroke symptoms and was rushed back to the ER. Brain CT scan was done, and it was determined that it was not a stroke but it was belle's palsy and guillain barr? syndrome. Symptoms and parts of the body affected were bilateral leg weakness and facial palsy. Patient was then released again for outpatient treatment. Patient immediately saw a neurologist who reviewed medical records, gave a shot of unspecified steroids, ordered more MRIs of spine, and gave an initial diagnosis of multiple sclerosis. Once he reviewed the MRIs with and without contrast he detected two lesions on thoracic spine along with lesions on lumbar spine. He then gave a diagnosis of thoracic myopathy and prescribed a five day infusion of Solu-Medrol (methylprednisolone sodium succinate). The treatment did not work, and patient was referred to the University for more research and another diagnosis. After more than two months, the patient still had no relief from pain and symptoms. The patient had difficulty in chewing and right eye had blurred vision. The patient tested negative for HIV and covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in feet which advanced to collar bone, urinary retention, stroke symptoms, two lesions on thoracic spine and on lumbar, bilteral weakness/bilteral leg weakness, facial palsy, right eye had blurry vision, walk with support, pain, and tingling in feet which advanced to collar bone. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0- 20210840901- covid-19 vaccine ad26.cov2.s - Urinary retention , Facial palsy, Right eye blurry vision, Walk with support, Pain, two lesions on thoracic spine along with lesions on lumbar spine 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). 20210840901- covid-19 vaccine ad26.cov2.s - Bilateral weakness/Bilateral leg weakness, Numbness had advance from feet to collar bone, Tingling had advance from feet to collar bone-. This event(s) is labeled and is therefore considered potentially related.

Other Meds:

Current Illness: Alcohol use; Non-smoker

ID: 1642959
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: MESSED UP / SLURRED SPEECH; HAND PAIN LIKE HITTING A NERVE; FELT TIRED; STROKE; FEELING REALLY HOT; NECK PAIN FOR 4 HOURS; This spontaneous report received from a patient concerned a 60 year old female of unspecified race and origin. 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. The patient work and exercise. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, 1 total administered, start therapy date were not reported (3 to 4 months ago) for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included covid-19 vaccine for prophylactic vaccination which the patient mentioned taking after JANSSEN Vaccine. On JUN-2021, the patient experienced stroke, feeling really hot, neck pain for 4 hours, hand pain like hitting a nerve and felt tired. The patient took medical attention for it but only they treated her hand pain and referred her to a hospital which she refused to do. On AUG-2021, the patient experienced messed up / slurred speech. The patient refused and said ,she did not want to go to a doctor or hospital because she might get more sick (she mentioned Covid in her area was bad). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling really hot, neck pain for 4 hours, and felt tired, and the outcome of messed up / slurred speech, hand pain like hitting a nerve and stroke was not reported This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210841218-covid-19 vaccine ad26.cov2.s -Stroke. 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).

Other Meds: COVID-19 VACCINE

Current Illness: Non-smoker

ID: 1642960
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: PNEUMONIA; SEPTIC; DON'T FEEL GOOD; ALLERGIES; FATIGUE; PASSED OUT; FELL; HIT HER HEAD; WASN'T GIVEN FLUIDS AFTER THEY TOOK BLOOD; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included: respiratory syncytial virus/pneumonia, delirious, short term memory loss, can no longer drive, and very severe sick period, and concurrent conditions included: urinary tract infection. 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, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number: 8053457 expiry: 31-DEC-2021, batch number: 8782351 expiry: 31-DEC-2021, batch number: 8434861 expiry: 28-FEB-2020, batch number: 1135785 expiry: 28-FEB-2023, batch number: 1135785 expiry: 28-FEB-2023, batch number: 1135784 expiry: 28-FEB-2023) 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 08-FEB-2018, 20 mg, 2 times every 1 day, from 09-FEB-2018, and 20 mg, 2 times every 1 day, from 10-FEB-2018 for polycythemia vera. No concomitant medications were reported. On an unspecified date, the patient, experienced allergies and pneumonia. The patient also missed doses (unspecified). It was reported that the patient had urinary tract infection (UTI) back in the winter that made her septic. The patient did not know what was going on. The patient did not feel good. On an unknown date in APR-2021, the patient passed out, fell, and hit her head because she was not given fluids after they took blood. The emergency medical services (EMS) transported patient to the emergency room (ER) where she was given fluids and was discharged home. On 13-AUG-2021, the patient mentioned she was now given 1000mL of saline when getting blood drawn. On an unspecified date, the patient experienced fatigue since coronavirus disease (COVID) shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with ruxolitinib phosphate was withdrawn. The outcome of the passed out, fell, hit her head, wasn't given fluids after they took blood, pneumonia, septic, fatigue, don't feel good and allergies were not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210841850 - covid-19 vaccine ad26.cov2.s -Pneumonia , Septic. 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 20210841850 - covid-19 vaccine ad26.cov2.s -Passed out , Fell ,Hit her head, Wasn't given fluids after they took blood. 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).

Other Meds: JAKAFI

Current Illness: Urinary tract infection (was hospitalized for about 6 days).

ID: 1642961
Sex: F
Age:
State: AR

Vax Date:
Onset Date: 05/16/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210820; Test Name: MRI; Result Unstructured Data: Not reported; Test Name: MRI; Result Unstructured Data: Not reported

Allergies:

Symptom List: Unevaluable event

Symptoms: SHE CAN'T CONCENTRATE NOR THINK CLEARLY; VISUAL IMPAIRMENT; BLOOD CLOTS IN SPLEEN; CUT OFF BLOOD SUPPLY TO HER BRAIN; MUSCLES DETERIORATING; NOT FEELING WELL/NOT NORMAL/FEELING SICK; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 63-year-old white female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: heart attack, and stroke. Concurrent conditions included: blood clots, cigarette smoker, marijuana use, and non-alcoholic. The patient experienced swollen throat and tongue when treated with olmesartan medoxomil (Benicar). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 15-MAY-2021 in the afternoon at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the patient experienced flu-like symptoms, achiness not feeling well and not normal. On 01-JUN-2021, the patient experienced deteriorating muscles. On 12-JUL-2021, the patient was diagnosed with blood clots in spleen which cut off blood supply to her brain and was hospitalized. On 16-JUL-2021, the patient experienced visual impairment (was not able to read questions on the questionnaire on the paper). For 5 days she was hospitalized for the same and discharged on 17-JUL-2021. On 20-AUG-2021, MRI was done, and result was not reported, on an unspecified date, the patient had another MRI scan result was not reported. On an unspecified date the patient was not able to concentrate nor think clearly. Patient has no one to take care of her and felt helpless and sick all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, blood clots in spleen, muscles deteriorating, visual impairment, not feeling well/not normal/feeling sick, cut off blood supply to her brain, and she can't concentrate nor think clearly. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210846635-COVID-19 VACCINE AD26.COV2.S - Blood Clots In Spleen, Cut Off Blood Supply To Her Brain, Visual Impairment, Flu-Like Symptoms, muscles Deteriorating, She Can't Concentrate Nor Think Clearly. 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). 20210846635-COVID-19 VACCINE AD26.COV2.S -Not Feeling Well/Not Normal/Feeling Sick. This event is labeled and is therefore considered potentially related.

Other Meds:

Current Illness: Abstains from alcohol; Cigarette smoker (less than 1 pack per day); Clot blood; Marijuana use

Date Died:

ID: 1642962
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: ENDED UP IN THE HOSPITAL; DEATH; This spontaneous report received from a consumer via a company representative from social media concerned 'multiple patients'. The patient's height, and weight were not reported. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported. On an unspecified date, the many patients got vaccinated and ended up in the hospital, and were hospitalized (date unspecified). The number of days of hospitalization were not reported. On an unspecified date, the patients died from an unknown cause of death. It was unspecified if an autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine was not applicable. The patients died of death and ended up in the hospital on an unspecified date. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210844140, 20210844317 and 20210844359.; Sender's Comments: V0-20210846858-COVID-19 VACCINE AD26.COV2.S-Death and Ended up in the Hospital(Fatal); These events are considered un-assessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1642963
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with amoxicillin, and clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry date was not reported) dose was not reported, frequency 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-AUG-2021, the patient experienced suspected covid-19 infection. On an unspecified date, the patient experienced suspected clinical vaccination failure. The patient experienced symptoms cough, sore throat, and runny nose on 21-Aug-2021. 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). This case, from the same reporter is linked to 20210846436. This report was associated with product quality complaint:90000191006; Sender's Comments: V0: 20210847490-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: 1642964
Sex: F
Age:
State: FL

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

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

Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: Negative (less than 1.00)

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma. 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 02-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient undergone laboratory test SARS-CoV-2 IgG (Immunoglobulin G) antibody (ARF COV-2 AB IGG SPIKE), semi quantitative which came negative (less than 1.00) (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190792.; Sender's Comments: V0: 20210849914-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:

Current Illness: Asthma

ID: 1642966
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SPONTANEOUS CORONARY ARTERY DISSECTION (SCAD); This spontaneous report received from a patient concerned a patient of unspecified age, sex, ethnic origin and race. The patient's height, and weight were not reported. The patient had no underlying health problems and no blockage anywhere. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-APR-2021 (reported as 11 days after vaccination), the patient had a heart attack. The patient believe that it was from the shot. After the shot, patient had heart palpitations and weird heart sensations. The patient was diagnosed with spontaneous coronary artery dissection (SCAD) after the heart attack, which was extremely rare and patient had no risk factors that are associated with this. The patient concluded that it was associated with the vaccine and the doctors could not rule that out. The patient would be on medication for the rest of life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spontaneous coronary artery dissection (SCAD) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210850480- covid-19 vaccine ad26.cov2.s-spontaneous coronary artery dissection (SCAD). 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).

Other Meds:

Current Illness:

ID: 1642967
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210817; Test Name: Diagnostic ultrasound; Result Unstructured Data: blood clot

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: NOT FEELING WELL; HEADACHE; BLOOD CLOT IN LEFT THIGH; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 170 pounds, and height was 71 inches. 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: 093A2112, and expiry: UNKNOWN) dose was not reported, 1 total administered to left deltoid on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced flu-like symptoms, chills, the night of the vaccination for about 3 days. The patient was not feeling well after the vaccination. On 04-AUG-2021, the patient noticed a lump on his left thigh. On 05-AUG-2021, patient experienced headache which still present. On 17-AUG-2021, the patient went to the emergency room, did an ultrasound, waited there for 6 hours and was told that he had a blood clot in left thigh. He was seen by his primary health care professional on reporting date and instructed to report his symptoms. The patient was started on Eliquis (apixaban) for 3 months till further assessed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 09-APR-2021, and had not recovered from blood clot in left thigh, headache, and not feeling well. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210851502-COVID-19 VACCINE AD26.COV2.S-Blood clot in left thigh. 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).

Other Meds:

Current Illness:

ID: 1642968
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 04/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202104; Test Name: Blood test; Result Unstructured Data: Not find any thing; Test Date: 202105; Test Name: X-ray; Result Unstructured Data: came well; Comments: Both hand and foot which came well, no broken bones; Test Date: 202106; Test Name: Magnetic resonance imaging; Result Unstructured Data: Inflammation; Test Date: 202106; Test Name: Antibody test; Result Unstructured Data: Negative; Test Date: 202107; Test Name: COVID-19 virus test negative; Result Unstructured Data: Negative; Test Name: Antibody test; Result Unstructured Data: Negative.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: HURTS TO WALK AND CAN NOT WALK LONG DISTANCE; PROBLEM IN HIS HIP; CAN NOT PRACTICE EXERCISE; CHANGED QUALITY OF LIFE; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INFLAMMATION; LEFT FOOT DARKER IN COLOR; LEFT FOOT AND HAND PAIN; STRANGE SWOLLEN WITH NO REASON IN LEFT HAND WITH THE FINGERS AND VISIBLY LEFT FOOT BY THE END OF THE MIDDLE AREA OF TOES; This spontaneous report received from a patient concerned a 49 year old white non Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included under weight, and concurrent conditions included hypertension, non-alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies and patient eats very health, no arthritis, no rheumatoid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total, administered on 22-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, patient had a strange swollen with no reason in his left hand with the fingers. On 28-APR-2021, the same side foot started to be swollen. His left foot (by the end of the middle area of toes) was swollen with the same pattern that happen to the hand as well. It was visibly swollen, and darker in color. The color subsided but the pain is still there. He was using cold ice and Epson salt bath. By the end of Apr-2021 it caused an alarm for him so he contacted primary care physician who ordered blood work which did not find anything. Then primary care physician referred him to see orthopedic. So between May and June, he saw two orthopedics in May-2021, the first orthopedic gave him prednisone tablets. Patient complained a week later and insisted on getting steroid injection. So the first orthopedic gave him 3 shots in both hand and foot because he was complaining of a lot of pain. The second orthopedic gave him one shot only in the foot. The first orthopedic ordered X-Ray in MAY-2021 for both hand and foot which came well, no broken bones. Also he ordered Magnetic resonance imaging(MRI) in Jun-2021 which showed inflammation so patient got cortisone 2 shots in hand and about 3 or 4 in the foot to reduce the swelling. There was a little improvement but a week later, the pain comes back so the Epson water and cortisone injection did not help. It was hurting to walk. He cannot wear close shoes. The doctor said that it was too constrictive and ordered him to wear an orthopedic open shoes which was higher in the left side than the normal shoes and asked him to stay out of his foot and it was very complicated for patient. So the doctor order a knee scoter for him but it was not comfortable so patient bought a wheelchair. He started to use crutches because he had problem in his hip as a consequence of the unbalanced it was after wearing the high orthopedic shoes in the left side. Patient cannot walk long distance and cannot practice exercise. All of that changed his quality of life. On Jun-2021, his primary care physician ordered spike protein antibody test which came negative(confirmed immunological vaccine failure). A month ago, around Jul-2021, the doctor ordered to test for Covid-19 which came negative. Also the doctor ordered again same spike protein antibody test which came again negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left foot darker in color, was recovering from strange swollen with no reason in left hand with the fingers and visibly left foot by the end of the middle area of toes, had not recovered from left foot and hand pain, and the outcome of inflammation, hurts to walk and can not walk long distance, problem in his hip, can not practice exercise, confirmed immunological vaccine failure and changed quality of life was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851513-covid-19 vaccine ad26.cov2.s- Confirmed immunological 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 20210851513- Covid-19 vaccine ad26.cov2.s- Strange swollen with no reason in left hand with the fingers and visibly left foot by the end of the middle area of toes, left foot darker in color, inflammation, hurts to walk and cannot walk long distance, problem in his hip, cannot practice exercise, changed quality of life. 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). 20210851513- Covid-19 vaccine ad26.cov2.s- Left foot and hand pain. This event(s) is labeled and is therefore considered potentially related.

Other Meds:

Current Illness: Abstains from alcohol; Hypertension; Non-smoker.

ID: 1642969
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DISABILITY; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a consumer who reported hearing a news via social media concerned a 15 year old of unspecified sex, 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, 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 of inappropriate age received vaccine and was disabled after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the disability and inappropriate age at vaccine administration was not reported. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0- 20210851614-covid-19 vaccine ad26.cov2.s. - Disability. 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).

Other Meds:

Current Illness:

ID: 1642970
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: UPTICK IN MULTIPLE SCLEROSIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 42 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: knee surgery, back surgery, gall bladder surgery, lumbar (l5) discectomy, post traumatic stress disorder, fallopian tube removal, and bladder urgency, and concurrent conditions included: depression, anxiety, muscle spasms, tremors, restless leg syndrome, low vitamin D levels, pain, sleep issues, and tactile sensation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, 1 total, 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 AUG-2021, the patient was fully vaccinated but contracted covid and experienced suspected clinical vaccination failure and on an unspecified date, the patient experienced uptick in multiple sclerosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uptick in multiple sclerosis, and the outcome of suspected clinical vaccination 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: 90000191183.; Sender's Comments: V0: 20210851690-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 20210851690-Covid-19 vaccine ad26.cov2.s-Uptick in multiple sclerosis. 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: Anxiety; Depression; Hypersensation skin; Muscle spasms; Pain; Restless leg syndrome; Sleep disorder; Tremor; Vitamin D decreased

ID: 1642971
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: 106.1 F

Allergies:

Symptom List: Injection site pain

Symptoms: WET COUGH; FELT A LITTLE OFF; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 205 pounds, and height was 71 inches. The patient's concurrent conditions included: alcohol use (once weekly), and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. No drug abuse or illicit drug usage. Patient had no past medical history and medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency one total, administered on 08-JUN-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. No concomitant medications were reported. Patient was symptom free from the 11-AUG-2021 until the 14-AUG-2021 and Laboratory data included: COVID-19 virus test (NR: not provided) Positive coded as (confirmed clinical vaccination failure and confirmed covid-19 infection). Then patient experienced fatigue, cough, headache and became symptoms free on 16-AUG-2021. On 25-AUG-2021, he got home from work and he felt a little off and developed a headache a wet cough. Laboratory data included: Body temperature (NR: not provided) 106.1 F. Patient had not mentioned to his health care professional about testing positive for COVID-19. He might be able to access his test results, and would be willing to provide. He did not have access to his vaccination card at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and wet cough, and the outcome of confirmed clinical vaccination failure and felt a little off was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191022.; Sender's Comments: V0-20210851723-COVID-19 VACCINE AD26.COV2.S-Confirmed 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: Alcohol use (Once weekly); Non-smoker

ID: 1642972
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SUDDEN HEARING LOSS ON LEFT EAR ABOUT THREE WEEKS AFTER JOHNSON AND JOHNSON VACCINE; This spontaneous report received from a patient via company representative concerned a patient of 32 year old. The patient's height, and weight were not reported. Prior to vaccination patient had not visited doctor or other healthcare professional office/clinic visit and patient was not diagnosed with COVID-19. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) 1 total dose was administered to the left arm on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included lisdexamfetamine mesilate. On 27-JUL-2021 13:00, the patient experienced sudden hearing loss on left ear about three weeks after Johnson and Johnson vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered with sequelae from sudden hearing loss on left ear about three weeks after Johnson and Johnson vaccine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851751- Covid-19 vaccine ad26.cov2.s- Sudden hearing loss on left ear. 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).

Other Meds: VYVANSE

Current Illness:

ID: 1642973
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 04/10/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210514; Test Name: Blood test; Result Unstructured Data: not provided; Test Date: 20210514; Test Name: Carotid artery ultrasound; Result Unstructured Data: Confirmed left sided brain stroke (on the front left side of brain); Test Date: 20210514; Test Name: Magnetic resonance imaging; Result Unstructured Data: Confirmed left sided brain stroke (on the front left side of brain); Test Date: 20210514; Test Name: Ultrasound scan; Result Unstructured Data: Confirmed left sided brain stroke (on the front left side of brain); Test Date: 20210514; Test Name: X-ray; Result Unstructured Data: Confirmed left sided brain stroke (on the front left side of brain)

Allergies:

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

Symptoms: LEFT SIDE BRAIN STROKE (ON THE FRONT SIDE OF BRAIN); HEADACHE (WORSE); This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: former cigarette smoker (stopped smoking after the stroke), and concurrent conditions included: pancreatitis, iodine allergy, colitis, non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient not have any drug abuse or illicit drug usage. Patient did not used her medication before 2 weeks of vaccination. The patient was previously treated with atropine sulfate/diphenoxylate hydrochloride, and promethazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported, 1 total, administered on 06-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced back to back headaches. Patient told to her husband that she was experiencing headache but both brushed it off. Patient noted on TV that ,headache was one of the side effect after vaccination. On 14-MAY-2021, 38 days after the vaccination, patient woke up with drooping right side of face and was not able to answer the phone when it was ringing. Patient was looked in the mirror and saw that her right eye and mouth were drooping on right side. Patient reported that, she experienced the left sided brain stroke while she was asleep and that was affecting the right side of her face and speech. On 14-MAY-2021, patient was admitted to the hospital. On 14-MAY-2021, Blood work, Ultrasound Scan, X-Ray, Carotid Artery Ultrasound in neck and Magnetic Resonance Imaging (MRI) were performed on patient to confirm the stroke. It was confirmed that patient had left sided brain stroke (on the front left side of her brain). On 17-MAY-2021, patient was discharged from hospital. Patient reported that, she still had headache and ongoing difficulty with speech, when nervous or too excited starts to stutter. On 23-AUG-2021, patient was seen by her Primary Care Provider (PCP) to follow up on recent episode where patient was unable to recognize where she was on Monday or Tuesday of last week. The patient nurse practitioner referred patient for another Magnetic Resonance Imaging (MRI) because of patient headache seems to be getting worse. Patient reported that, she did not want another shot due to her experience with the vaccine and fears another vaccine might do her more harm rather than good. Patient was hospitalized for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left side brain stroke (on the front side of brain) and headache (worse). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210851762- covid-19 vaccine ad26.cov2.s - Left side brain stroke (on the front side of brain). 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). 20210851762- covid-19 vaccine ad26.cov2.s - Headache (worse). This event(s) is labeled per RSI and is therefore considered potentially related.

Other Meds:

Current Illness: Abstains from alcohol; Colitis (Patient not experienced any flare ups in 5-6 years or longer.); Iodine allergy; Non-smoker; Pancreatitis (Patient not experienced any flare ups in 5-6 years or longer.)

ID: 1642974
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: positive

Allergies:

Symptom List: Tremor

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients. Initial information was processed along with the additional information received from central complaint vigilance Organization on 26-AUG-2021. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown)1 total dose was administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The consumer stated that at his work place, 25 people had tested positive for Covid-19. He stated that he was unsure who they all were due to privacy, and that he did not know if and what vaccine each of them got. However, he stated that some of those 25 individuals received the Janssen Covid-19 Vaccine and still got sick with covid- 19 (suspected covid-19 infection, suspected clinical vaccination failure). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000191131.; Sender's Comments: V0: 20210851777-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: 1642975
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative from social media (twitter) concerned a male of unspecified age, 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) 1 total administered, 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 was diagnosed with the covid-19 infection (suspected clinical vaccination failure) and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210852374. This report was associated with product quality complaint.; Sender's Comments: V0:20210851820-COVID-19 VACCINE AD26.COV2.S-Suspected COVID-19 infection. 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). 20210851820-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: 1642976
Sex: M
Age:
State: TN

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 08/28/2021
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: 202108; Test Name: SARS-CoV-2 rapid antibody test; Result Unstructured Data: Negative. results showed zero antibodies.; Test Date: 20210820; Test Name: COVID-19 antibody test; Result Unstructured Data: Negative

Allergies:

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

Symptoms: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 62 year old white male of unknown ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, 1 total administered in left arm on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in AUG-2021, 2 Weeks ago, patient did a rapid antibody test at his local pharmacy and the results showed zero antibodies. Laboratory data included: SARS-CoV-2 rapid antibody test (NR: not provided) Negative. Patient heard that these tests that you get at a local pharmacy was not always accurate so he decided to get another test done at his doctor's office. On 20-AUG-2021 he got blood drawn and today on 25-AUG-2021 the antibody test results came back as negative. Laboratory data included: Antibody test (NR: not provided) Negative and the patient experienced confirmed immunological vaccine failure. He does not know the name of the test but it's similar to the Test. His doctor was aware of his test results and told him that these tests were not recommended. He wanted to know if he was still protected in this case. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was associated with a product quality complaint: 90000191002. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210852120-Covid-19 vaccine ad26.cov2.s-Confirmed immunological 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: 1642977
Sex: U
Age:
State: WA

Vax Date:
Onset Date: 04/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202104; Test Name: Blood test; Result Unstructured Data: blood clot from the vaccine

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: BLOOD CLOT; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a unspecified age and sex and unspecified race & 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 dose was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was vaccinated on 02-APR-2021 and after many blood tests, hematologist confirmed blood clot from the vaccine. On APR-2021, Laboratory data included: Blood test (NR: not provided) blood clot from the vaccine. On 20-APR-2021, the patient experienced blood clot. On 20-APR-2021, the patient experienced deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210852202-COVID-19 VACCINE AD26.COV2.S - BLOOD CLOT, DEEP VEIN THROMBOSIS . 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).

Other Meds:

Current Illness:

ID: 1642978
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative from social media concerned a female of unspecified age, 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) 1 total administered, 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 was diagnosed with the covid-19 infection (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210851820. This report was associated with product quality complaint.; Sender's Comments: V0: 20210852374-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: 1642979
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female. Initial information was processed with the additional information received on 26-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user. The patient had no known allergies and did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient had a COVID symptoms of bowel issues and a sore throat after being exposed to a friend/coworker who tested positive on 19-AUG-2021 while on break without masks (suspected clinical vaccination failure and suspected COVID-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191140.; Sender's Comments: V0: 20210852508- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination 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: Abstains from alcohol; Non-smoker

ID: 1642980
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: MYOCARDITIS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, 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, 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 myocarditis and the patient would like to know if booster dose going to heal myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210852593- COVID-19 VACCINE AD26.COV2.S-myocarditis. 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).

Other Meds:

Current Illness:

ID: 1642981
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: Body temperature; Result Unstructured Data: 98-101; Comments: Fever of 98-101

Allergies:

Symptom List: Pain in extremity

Symptoms: BODY ACHES; DRY COUGH; FEVER OF 98 TO 101; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 230 pounds, and height was 70 inches. The patient's past medical history included: flu like symptoms, and concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient had no drug abuse or illicit drug usage. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient experienced body aches. On 23-AUG-2021, the patient experienced dry cough. On 23-AUG-2021, the patient experienced fever of 98 to 101. Laboratory data included: Body temperature (NR: not provided) 98-101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, dry cough and fever of 98 to 101 was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Occasionally); Non-smoker

ID: 1642982
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 07/15/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data: Test Date: 20210715; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: NEGATIVE.

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 58 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the patient did Sars-Cov-2 Antibody(Ab), IgGX test which was negative (confirmed immunological vaccine failure) and the patient stated that he was worried that he received a fraudulent dose of the vaccine. The patient said that he was additionally suspicious because the pharmacy was a very small facility that he found on the CDC website at a time where no other location had the Janssen Covid-19 Vaccine. The patient also said that he rebooked his original appointment to several weeks later and the facility still had a supply, during a time when other facilities were running out within days. The patient stated that he did not see the dose get drawn up in front of him from a vial and also he did not experienced any side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint:90000191025.; Sender's Comments: V0:20210852955-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:

Current Illness:

ID: 1642983
Sex: F
Age:
State: UT

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: RECEIVED FULL VIAL OF VACCINE (5 TIMES OF THE NORMAL DOSE); HYPOTENSION; CHILLS; VOMITING; FEVER; NAUSEA; This spontaneous report received from a physician 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 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-AUG-2021, the patient experienced received full vial of vaccine (5 times of the normal dose). On 25-AUG-2021, the patient experienced hypotension. On 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced vomiting. On 25-AUG-2021, the patient experienced fever. On 25-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypotension, fever, chills, nausea, and vomiting, and the outcome of received full vial of vaccine (5 times of the normal dose) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1642984
Sex: M
Age:
State: TN

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: 104.1 F

Allergies:

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

Symptoms: FEELING ACHY; FEVER; This spontaneous report received from a consumer concerned a 59 year old male. The patient's weight was 350 pounds, and height was 80 inches. The patient's concurrent conditions included: non smoker, alcohol use, blood pressure, and atrial fibrillation, and other pre-existing medical conditions included: The patient had no known allergies and did not have any drug abuse/illicit drug use. The patient had no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced feeling achy. On 25-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 104.1 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling achy, and fever. This report was non-serious.

Other Meds:

Current Illness: Alcohol use; Atrial fibrillation (taking medications (not specified)); Blood pressure (taking medications (not specified)); Non-smoker

ID: 1642985
Sex: U
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: ADMINISTERED A DOSE OF THE VACCINE 46 MINUTES AFTER THE 6 HOUR TIME FOR HOLDING; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned multiple patients. 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: 1808980 and expiry: 18-SEP-2021) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced administered a dose of the vaccine 46 minutes after the 6 hour time for holding. On 09-AUG-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered a dose of the vaccine 46 minutes after the 6 hour time for holding and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210849094.

Other Meds:

Current Illness:

ID: 1642986
Sex: U
Age:
State: WA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: BODY ACHES; CHILLS; 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: unknown) dose was not reported, administered on 01-APR-2021 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 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, and chills on 02-APR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1642987
Sex: M
Age:
State: OR

Vax Date:
Onset Date: 08/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: INADVERTENT ADMINISTRATION OF 1ML OF COVID-19 VACCINE; This spontaneous report received from a physician concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) 1 ml, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-AUG-2021, the patient experienced inadvertent administration of 1ml of covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of inadvertent administration of 1ml of covid-19 vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1642988
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: PUNCTURED VIAL STORED IN REFRIGERATION BEYOND THE RECOMMENDED 6 HOURS; ADMINISTRATION OF A DOSE OF THE VACCINE THAT WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a pharmacist concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced administration of a dose of the vaccine that was stored outside of the recommended storage conditions. On an unspecified date, the patient experienced punctured vial stored in refrigeration beyond the recommended 6 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of a dose of the vaccine that was stored outside of the recommended storage conditions and punctured vial stored in refrigeration beyond the recommended 6 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210855201 and 20210855614.

Other Meds:

Current Illness:

ID: 1642989
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HAS NOT EATEN; COULD NOT KEEP ANYTHING DOWN; SYMPTOMS LIKE THE FLU/ HEADACHE/ BODY ACHES/ GOT SICK/ FEELS AN ACHY, FLUISH FEELING; SPARKS RUNNING THROUGH JOINTS, HANDS, LOWER LEGS, FEET, TOES, WRISTS, FINGERS/LITTLE SHOCKS/NERVE SHOCKS; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was not reported and height was 64 inches. The patient's past medical history included: bilateral total knee replacement, and concurrent conditions included: alcohol consumer, non smoker, and allergy to pain medicine, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient sometimes take vitamins. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced symptoms like the flu/ headache/ body aches/ got sick/ feels an achy, fluish feeling. On 24-AUG-2021, the patient experienced sparks running through joints, hands, lower legs, feet, toes, wrists, fingers/little shocks/nerve shocks. On 25-AUG-2021, the patient experienced has not eaten. On 25-AUG-2021, the patient experienced could not keep anything down. The action taken with covid-19 vaccine was not applicable. The outcome of the symptoms like the flu/ headache/ body aches/ got sick/ feels an achy, fluish feeling, sparks running through joints, hands, lower legs, feet, toes, wrists, fingers/little shocks/nerve shocks, could not keep anything down and has not eaten was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Occasionally); Drug allergy (sleeps for 30 minutes and then is climbing the walls); Non-smoker

ID: 1642990
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: CHILLS; ARM HURTS; HEADACHE; FEVER; 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: Unknown) dose was not reported, administered on 25-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. On 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced arm hurts. On 25-AUG-2021, the patient experienced headache. On 25-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from arm hurts, headache, and fever on 25-AUG-2021, and had not recovered from chills. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am