VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1332392
Sex: F
Age: 84
State: CA

Vax Date: 02/24/2021
Onset Date: 03/09/2021
Rec V Date: 05/19/2021
Hospital:

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

Lab Data: ZZCULTURE, Fungus (Other, Non Blood/Skin

Allergies: No

Symptom List: Dysphagia, Epiglottitis

Symptoms: After receiving my second vaccination of Pfizer-BionTech Covid 19 injection, I have the following side effect. 1.Burning of the Tongue and mouth, Sluffing of the mouth skin, and Flim over Teeth, and Dry Mouth.

Other Meds:

Current Illness: No

ID: 1332393
Sex: F
Age: 16
State: CA

Vax Date: 04/09/2021
Onset Date: 04/27/2021
Rec V Date: 05/19/2021
Hospital: Y

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

Lab Data:

Allergies: none

Symptom List: Anxiety, Dyspnoea

Symptoms: see prior

Other Meds: aspirin 81mg

Current Illness: Patient was admitted on 3/30-3/31/21. To briefly summarize her prior hospital course, she was first evaluated at hospital for RUE numbness, RUE/RLE weakness and garbled speech. NIHSS 5, CT head and CTA/CTV head and neck was normal with no evidence of infarct or vessel abnormality. She was started on aspirin 81mg daily

ID: 1332394
Sex: M
Age: 27
State: CA

Vax Date: 05/17/2021
Onset Date: 05/18/2021
Rec V Date: 05/19/2021
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: None

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

Symptoms: Pooping 5 times per day (not diarrhea), fatigue, weakness, chills, intense muscle aches and intense headache.

Other Meds: Multivitamin, calcium supplement, magnesium supplement, zinc supplement, joint supplement, vitamin D3 supplement

Current Illness: Hayfever

ID: 1332395
Sex: M
Age: 19
State: CA

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 05/19/2021
Hospital:

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

Lab Data:

Allergies: No

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Injection site pain, headache, fatigue, muscle pain.

Other Meds: No

Current Illness: No

ID: 1332396
Sex: M
Age: 47
State: NJ

Vax Date: 05/11/2021
Onset Date: 05/12/2021
Rec V Date: 05/19/2021
Hospital:

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

Lab Data: Extreme Tinnitus

Allergies: None

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

Symptoms: Extreme Tinnitus

Other Meds: None

Current Illness: Slight Tinnitus

ID: 1332398
Sex: M
Age: 33
State: CA

Vax Date: 05/01/2021
Onset Date: 05/09/2021
Rec V Date: 05/19/2021
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: I have tinnitus in both ears. I keep hearing loud, very high pitched ring.

Other Meds:

Current Illness:

ID: 1332399
Sex: M
Age: 44
State: TX

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 05/19/2021
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: Dizziness

Other Meds:

Current Illness:

ID: 1332400
Sex: M
Age: 59
State: OR

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 05/19/2021
Hospital:

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

Lab Data: UNKNOWN

Allergies: none known

Symptom List: Pharyngeal swelling

Symptoms: SON OF PATIENT CALLED TO CANCEL 2ND DOSE APPOINTMENT STATING PATIENT HAD STRANGE FEELING FROM HIS SHOULDER TO HIS HAND IMMEDIATELY AFTER VACCINE, THEN 13 MINUTES LATER HAD TINGLING IN HIS FACE AND NUMBNESS IN HIS TONGUE. HE WAS TAKEN TO THE EMERGENCY ROOM WHERE HE WAS UNABLE TO CONSUME WATER BECAUSE OF ADVERSE EFFECTS

Other Meds: unknown

Current Illness: none known

ID: 1332401
Sex: F
Age: 39
State: CA

Vax Date: 04/09/2021
Onset Date: 04/11/2021
Rec V Date: 05/19/2021
Hospital:

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

Lab Data: extensive bloodwork (CBC + electrolytes +??)

Allergies: allergic to tetracyclines (have DRESS, drug-related eisinophilic with systemic symptoms syndrome induced by tetracyclines)

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Exact same symptoms as with DRESS syndrome - swollen, itchy eyes; red, burning sensation on skin on face

Other Meds: multivitamin, vitamin c, calcium, glucosamine chondroitin, vitamin d, ashwaghanda, turmeric, finacea, topical steroid (acne)

Current Illness: NONE

ID: 1385555
Sex: F
Age: 52
State: IN

Vax Date: 05/16/2021
Onset Date: 05/16/2021
Rec V Date: 05/19/2021
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: pt arm very sore/swollen @ inj. site. Pt taking around the clock ibuprofen for past 2days & massaged area. Also altern w/hot & cold compress.

Other Meds:

Current Illness:

ID: 1407280
Sex: M
Age: 34
State: CA

Vax Date: 05/14/2021
Onset Date:
Rec V Date: 05/19/2021
Hospital:

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

Lab Data: N/A

Allergies: NKDA

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

Symptoms: NON. INTRACTABLE HEAD ACHE MYALGIA NAUSEA CHILLS REPORTED 4 DAYS POST VACCINE

Other Meds: NONE

Current Illness: NONE

ID: 1407292
Sex: M
Age: 60
State:

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 05/19/2021
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: PATIENT HAD BEEN SHOPPING IN THE STORE AND WAS IN AND OUT OF CONSCIOUSNESS WHEN I WAS CALLED OVER FROM THE PHARMACY TO CHECK ON HIM. PT ALSO USES OXYGEN AT HOME AND DID NOT BRING WITH HIM. BLOOD SUGAR WAS HIGH (>220) AND PARAMETICS ARRIVED ON SCENE AND TOOK HIM INTO AMBULANCE TO BE EVALUATED. THEY WERE NOTIFIED THAT HE RECEIVED VACCINE APPROXIMATELY 1 HOUR BEFORE EVENT.

Other Meds:

Current Illness:

ID: 1407321
Sex: M
Age: 25
State: PA

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 05/19/2021
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: Patient passed out around 5 minutes after receiving the second dose of the Moderna vaccine. He hit his head hard on the ground and felt dizzy and lightheaded for about 15 minutes after the fall.

Other Meds:

Current Illness:

ID: 1409931
Sex: F
Age: 12
State: OH

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 05/19/2021
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: n/a

Allergies:

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

Symptoms: About 5 mins after vaccine administration patient passed out. She came back to a few seconds later. 911 called EMS examined her & she went home

Other Meds: n/a

Current Illness: n/a

ID: 1332321
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lichen Sclerosus; spinal stenosis; trigger finger on the right hand; difficulty waking; dry mouth; My arm was sore after the pneumonia vaccine and the flu shot; This spontaneous report was received from a 86-year-old female patient via company, who was reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, and concomitant therapies was not provided. On an unknown date in 2020 (reported as "last year"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (formulation, dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). Additionally, it was reported that her arm was sore after the pneumonia vaccine and the influenza vaccine (reported as "flu shot ") (pain in extremity). On an unknown date in 2020, the patient had Lichen Sclerosus, spinal stenosis, trigger finger on the right hand, difficulty waking (somnolence), and dry mouth, which started after the vaccination. The patient did not take any prescription medications. Additionally, it was reported that the patient was allergic to an antibiotic that starts with an "e" and it caused her to have a severe long lasting headache but she cannot recall the name of the medication (class of product), but it was not reported if this happened before or after the vaccination. The outcome of the events lichen sclerosus, pain in extremity, dry mouth, somnolence, trigger finger and spinal stenosis, and the causal relationship between the above-mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza vaccine were not provided.

Other Meds:

Current Illness:

ID: 1332322
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: One of the patients was 5-year-old received a GARDASIL vaccine and meningococcal conjugate vaccine along with a DTAP; This spontaneous report has been received from unspecified reporter via company representative concerning a 5-year-old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included meningococcal vaccine conj and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP). On an unknown date, the patient was incorrectly vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The reporter stated that they did not realize that the patient had received the wrong vaccine until the patient's mother had already left (product administered to patient of inappropriate age).

Other Meds:

Current Illness:

ID: 1332323
Sex: F
Age:
State:

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 05/20/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Took expired Vivotif; Spontaneous report received on 11MAY2021. A female consumer reported that she "took expired Vivotif" (PT: Expired product administered). The consumer was receiving oral Vivotif capsules (expiry date: Nov 2020) for typhoid. On 07MAY2021, she took expired Vivotif. She confirmed that she did not experience any reaction after taking Vivotif. She reported that she was on her dietary supplements along with Vivotif capsules. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Medical history was reported was as none. Company comment: It was reported that a consumer took a dose of expired Vivotif (expired product administered) and did not experience any reaction. Vivotif was expired a few months before she took it. Considering the nature of the event, the causality of expired product administered is not applicable with vivotif.; Sender's Comments: It was reported that a consumer took a dose of expired Vivotif (expired product administered) and did not experience any reaction. Vivotif was expired a few months before she took it. Considering the nature of the event, the causality of expired product administered is not applicable with vivotif.

Other Meds:

Current Illness:

ID: 1332324
Sex: M
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Dose was given at age 11 in error/ not give the second dose at age 11; This case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a 11-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Bexsero (received 1st dose on an unknown date when he was 11 years old). On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 age at vaccination was not applicable for this report. The patient was given the 1st dose of Bexsero vaccine at the age of 11 by error. The health care provider had planned to give two doses when the patient would turn 16. The patient did not receive the 2nd dose of Bexsero vaccine till the time of reporting, which led to incomplete course of vaccination. The patient received the 1st dose within the age range of the label; however, it was clear the vaccine was given to the patient in error by the provider's Medical Assistant. The physician did not consent to follow up.

Other Meds:

Current Illness:

ID: 1332325
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received shingrix and experienced hives. The reporter reported to always check out the side effects before getting any vaccine.

Other Meds:

Current Illness:

ID: 1332326
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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: minor side effects with the second one / side effect / was / shivering; uncontrolled shaking of hands; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering and tremor of hands. On an unknown date, the outcome of the shivering and tremor of hands were recovered/resolved. It was unknown if the reporter considered the shivering and tremor of hands to be related to Shingrix. Additional details were provided as follows: The reporter had reported for himself/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had shivering. The patient stated that, he/she would not call it that because shivering would seem to have something to do with being cold. It was uncontrolled shaking of hands. The patient was trying to text and could not. The patient went to bed and he/she was fine the next day. The patient stated that, good thing about the vaccine was, it stayed protective above 85 percent for 4 years.

Other Meds:

Current Illness:

ID: 1332327
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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: got the shot and got it anyway/suspected vaccination failure; got the shot and got it anyway; Hope she is getting better with it now.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling unwell. On an unknown date, the outcome of the vaccination failure, shingles and feeling unwell were unknown. It was unknown if the reporter considered the vaccination failure, shingles and feeling unwell to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingles shot and got it Shingles anyways. The reporter hoped that she was getting better with it till the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1332328
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (for 25 years on head, eyes and throughout my body) and general body pain (for 25 years on head, eyes and throughout my body). On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had shingles and the pain for 25 years which was on head, eyes and throughout body. It was considered chronic case. The patient stated that the shots didn't do anything but make the patient sick for three days. The patient advised to consult with doctor. For tolerance of 2nd dose refer case US2021AMR104369.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104369:1st dose ,same patient,same event,same SP,Same reporter

Other Meds:

Current Illness:

ID: 1332329
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (for 25 years on head, eyes and body) and pain (for 25 years). Previously administered products included Shingrix with an associated reaction of illness (1st dose received on an unknown date and experienced sickness refer case US2021AMR104366). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient said that Shingles shot did not do a thing for his/her but made sick for 3 days. The follow up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104366:1st dose ,same patient,same event,same SP,Same reporter

Other Meds:

Current Illness:

ID: 1332330
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2020
Rec V Date: 05/20/2021
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: I had the shot when it first. Amen out. I now need it again,because I got them Aug 26 of last yr./ suspected vaccination failure; I had the shot when it first. Amen out. I now need it again,because I got them Aug 26 of last yr./ suspected vaccination failure; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In August 2020, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient said he/she needed the vaccine again, because patient got Shingles on 26th August 2020. No vacation or nothing along with the epidemic of covid. The patient was stuck in the house ,like a house plant. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case has been linked with US2021AMR104380 and US2021AMR104377, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104377:same reporter (1st folks case) US-GLAXOSMITHKLINE-US2021AMR104380:same repoter (2nd folks case)

Other Meds:

Current Illness:

ID: 1332331
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: suspected Vaccination failure; had both doses of the vaccine two years ago - and the shingles last month; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less 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 provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had both doses of the vaccine two years ago and the shingles last month. The patient experienced shingles 3rd time. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles not provided.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR088540:

Other Meds:

Current Illness:

ID: 1332332
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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: Suspected vaccination failure; pretty bad case of them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that his friend that has a pretty bad case of them even though he was vaccinated previously. This case was considered as suspected vaccination failure since the details dose number, time to onset and regarding laboratory confirmation of shingles not provided.

Other Meds:

Current Illness:

ID: 1332333
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Suspected vaccination failure; I had the shot and still got Shingles.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, it was horrible. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1332334
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: I got the vaccine and for two or three days had very tiny; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced blister. On an unknown date, the outcome of the blister was recovered/resolved. It was unknown if the reporter considered the blister to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient for herself. The age at vaccination was not reported. The patient currently was in her 80's and still did not had shingles. The patient's husband and aunt had shingles badly. The patient got the Shingles vaccine and for 2 or 3 days she had very tiny blisters here and there on her body. The patient felt glad to take the vaccine because she probably would have them as bad as others as she got older. The follow-up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104871:Same reporter. Invalid-Hearsay case.

Other Meds:

Current Illness:

ID: 1332335
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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: sore throat; This case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 48 hrs after receiving Shingrix, the patient experienced sore throat. On an unknown date, the outcome of the sore throat was unknown. It was unknown if the reporter considered the sore throat to be related to Shingrix. Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingrix and had some strong (unspecified) side effects for about 30 hours and then he/she got a sore throat about 48 hours after the dose. The reporter asked was that a possible side effect. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1332336
Sex: M
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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: neurological event; had hard time walking; This case was reported by a physician via sales rep and described the occurrence of neurological symptom in a male 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 neurological symptom and walking difficulty. On an unknown date, the outcome of the neurological symptom and walking difficulty were unknown. It was unknown if the reporter considered the neurological symptom and walking difficulty to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a neurological event. The patient had hard time walking. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1332337
Sex: F
Age:
State:

Vax Date: 08/13/2020
Onset Date: 09/01/2020
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Guillain Barre Syndrome; paralysis of her feet up to her waist; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis. On 13th August 2020, the patient received Shingrix (intramuscular). On 1st September 2020, 19 days after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant). On 2nd September 2020, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown. It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Shingrix. Additional detail: The patient received her Shingrix vaccine on 13 August 2020. By 01 September 2020 she developed paralysis of her feet up to her waist and lost the ability to walk. She also lost control of her bowel and bladder; she was terrified. She was rushed to the hospital on her island where they performed a lumbar puncture and then emergency airlifted her from that hospital she was admitted for a week. She has required extensive treatment and physical therapy for her injury of Guillain Barre Syndrome on 02 September 2020.

Other Meds:

Current Illness:

ID: 1332338
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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: she was anaphylactic / ER Visit Required; difficulty breathing and she was rushed to the hospital / ER Visit Required; swollen arm at the vaccination site; This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), difficulty breathing (serious criteria other: Serious as per reporter) and swelling arm (serious criteria other: Serious as per reporter). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis, difficulty breathing and swelling arm were recovered/resolved. It was unknown if the reporter considered the anaphylaxis, difficulty breathing and swelling arm to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient had a swollen arm at the vaccination site and a week later she had difficulty breathing and she was rushed to the hospital. The patient visited the emergency room. They gave the patient massive amounts of Benadryl and it took a full month for her to fully recover. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1332339
Sex: F
Age: 11
State: NY

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: administered the liquid conjugate only (without the lyophilized portion); administered the liquid conjugate only (without the lyophilized portion); This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA391A, expiry date 20th July 2022) for prophylaxis. On 13th May 2021, the patient received Menveo. On 13th May 2021, unknown after receiving Menveo, 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 nurse practitioner administered only liquid conjugate of Menveo (without lyophilized portion) to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reported batch number AMXA391A was not found in sales data sheet, hence was updated to AMVA391A. No symptoms were reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1332340
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: fever; chills; body aches; developed a sore throat; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills, general body pain and sore throat. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved and the outcome of the sore throat was not recovered/not resolved. It was unknown if the reporter considered the fever, chills, general body pain and sore throat to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient recently received Shingrix vaccine in her left arm. After getting the injection she developed the fever, chills and body aches. Those symptoms have resolved and afterwards she developed the sore throat and had not resolved till the time of reporting. The reporter declined to gave the health care professional information. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1332341
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: received first dose / on 08/29/2019 and was unaware about getting 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 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 29th August 2019 intramuscularly in left deltoid). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix , which led to incomplete course of vaccination. The patient was unaware about getting the second dose. The patient inquired whether she should get a second dose or restart the vaccine. The reporter did not had full mailing address, name of the facility, email address to HCP. The reporter did not had lot number or expiration date. The reporter mentioned that, patient received the vaccine from pharmacy intramuscularly in left deltoid. The patient consented to follow up.

Other Meds:

Current Illness:

ID: 1332342
Sex: F
Age: 55
State: CT

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swollen lymph node on the left side of her neck (the size as that of a baseball); swelling and pain at the injection site; swelling and pain at the injection site; muscle aches; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 14th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th May 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, muscle pain and fatigue. On 15th May 2021, the patient experienced lymphadenopathy. On an unknown date, the outcome of the injection site pain, injection site swelling, muscle pain and fatigue were recovering/resolving and the outcome of the lymphadenopathy was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, muscle pain, fatigue and lymphadenopathy to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient herself. The patient received the Shingrix and that evening, reported muscle aches and fatigue, as well as swelling and pain at the injection site. The next day of vaccination, the patient continued to experience fatigue and muscle aches and noted the swollen lymph node on the left side of her neck. The patient described the size as that of the baseball. Till the time of reporting, the events were improving, but not resolved. The lymph node swelling, however only reduced in size very small amount. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1332343
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had pain from her first Shingrix shot; This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient had pain after receiving her first Shingrix shot (date of first shot was unknown). No lot or expiry date was available. The patient was offered Shingrix Product Information. The reporter consented to follow-up and recommended follow-up with her health care professional. For tolerance to the 2nd dose of Shingrix, refer case US2021AMR104820.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR104820:Same reporter, same suspect, same patient (2nd dose)

Other Meds:

Current Illness:

ID: 1332344
Sex: F
Age: 1
State: TX

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 05/20/2021
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: kinrix given to a 19 month old; was due for 3rd dose of ipv and dtap / Kinrix was administered on 3/4/2021 as a 3rd dose in the series; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number yz97n, expiry date 26th August 2022) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included DTPa-IPV vaccine (Received 2nd dose on March 2020.). On 4th March 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 4th March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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 follow: The patient received 3rd dose of Kinrix at 19 months of age which leads to inappropriate age at vaccination and inappropriate schedule of vaccine administered. Medical administrator called to inquire how should they continue with vaccination. Forget to ask for follow up, , however did collect contact information if necessary.

Other Meds:

Current Illness:

ID: 1332345
Sex: M
Age: 68
State: IL

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/20/2021
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: 2nd Shingrix vaccine administered 4 weeks after 1st Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 5th May 2021, the patient received the 2nd dose of Shingrix. On 5th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: Pharmacist reported 2nd Shingrix vaccine administered 4 weeks after 1st Shingrix vaccine which led to shortening of vaccination schedule. The reporter consented to follow up.

Other Meds: Shingrix

Current Illness:

ID: 1332346
Sex: F
Age: 54
State:

Vax Date: 10/02/2020
Onset Date:
Rec V Date: 05/20/2021
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: soreness / at the injection site; swelling / at the injection site; redness / at the injection site; "baseball sized" knot at the injection site; first dose of Shingrix on 10/2/2020; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 2nd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site mass and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and injection site mass were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site mass to be related to Shingrix. Additional details were provided as follows: This case was reported by pharmacist on behalf of the patient. The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix in right deltoid and experienced redness, swelling, soreness, and a baseball sized knot at the injection site. The reporter was unaware of how long after receiving the 1st dose that these symptoms began and lasted. Reporter stated all symptoms had resolved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1332347
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: first dose on 27Feb2020 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 27th February 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first dose and missed 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. VAERS details reported for 1st dose of shingrix. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1332348
Sex: F
Age: 65
State: NJ

Vax Date: 11/13/2020
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had severe shoulder pain after the first dose; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included frozen shoulder and hashimoto's disease. On 13th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the shoulder pain to be related to Shingrix. Additional details were provided as follow: The case was reported by the patient herself. Concomitant products included Steroid Injection. The patient received 1st dose of Shingrix in right deltoid, more than 6 months before the date of reporting and experienced severe shoulder pain. Till the time of reporting, the patient did not receive 2nd dose. No primary care physician information given. The reporter consented to follow up.

Other Meds:

Current Illness: Frozen shoulder; Hashimoto's disease

ID: 1332349
Sex: F
Age:
State: DE

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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: First / on 11-3-2020 / scheduled / second / on 5-24-2021, 21 days late / due to Covid-19; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 3rd November 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The patient had reported for herself. The age at vaccination was not applicable for this report. The patient received 1st dose and scheduled to receive her second Shingrix dose on 24th May 2021, 21 days late. The patient scheduled the second dose later due to Covid-19 and her availability to receive the second Shingrix vaccine. The patient confirmed that she did not ever got Covid-19 infection. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1332350
Sex: F
Age: 53
State: NJ

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient was given the second dose / reconstituted with sterile water; Patient was given the second dose / reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number P2J7E, expiry date unknown) for prophylaxis. On 17th May 2021, the patient received the 2nd dose of Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The patient received the 2nd dose of Shingrix reconstituted with sterile water instead of the ASO1B approved diluent,which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1332351
Sex: U
Age:
State: OK

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 05/20/2021
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: Reconstituted Shingrix lyophilized powder with sterile water / and administered to a patient; Reconstituted Shingrix lyophilized powder with sterile water / and administered to a patient; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 14th May 2021, the patient received Shingrix. On 14th May 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient was administered reconstituted Shingrix lyophilized powder with sterile water instead of with the adjuvant suspension component (AS01b), which led to wrong solution used for drug reconstitution and inappropriate dose of vaccine administered. The reporter was unable to provide any vaccine or patient details at the time of reporting. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1332352
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
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: first dose received 2 years ago / delayed second dose of shingrix / asymptomatic; 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 2 years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of shingrix which led to Incomplete course of vaccination. The reporter inquired about what to do in terms of delayed 2nd dose of shingrix whether to restart or continue the series and when. The reporter was unwilling to share patient information and simply wanted to know what to do in these types of situation, would not want to be contacted about adverse event. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1332353
Sex: F
Age: 28
State: TN

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 05/20/2021
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: received dose 1 of Twinrix on 11/18/2020 and 2nd dose on 01/20/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 28-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included HAB (Twinrix). On 20th January 2021, the patient received the 2nd dose of Twinrix. On an unknown date, the patient started Twinrix Pre-Filled Syringe Device. On 20th January 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received 1st dose of Twinrix on 18th November 2020. The patient received 2nd dose twinrix more than recommended interval, which led to lengthening of vaccination schedule. The reporter wanted to know when the patient could receive 3rd dose. The batch number and expiration date were asked but were not available. No further clarifications were performed. The reporter did not consent to follow-up.

Other Meds: Twinrix

Current Illness:

ID: 1332354
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/20/2021
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: Test Date: 20210313; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Date: 20210317; Test Name: COVID-19 virus test; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: CONFIRMED COVID-19 INFECTION; BAD SINUS HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical condition. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-MAR-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 MAR-2021, the subject experienced confirmed covid-19 infection. On MAR-2021, the subject experienced bad sinus headache. On 13-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 17-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of the confirmed covid-19 infection and bad sinus headache was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be it was confirmed that no pqc was identified within the reported complaint and this was a duplicate case to pqms 90000178956. voided based on the pqc evaluation. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210517426. This report was associated with product quality complaint: 90000178962 The suspected product quality complaint has been confirmed to be voided as it was confirmed that no PQC was identified within the reported complaint and this was a duplicate case to PQMS 90000178956. Voided based on the PQC evaluation.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1332357
Sex: F
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: EEG; Result Unstructured Data: Not reported; Test Date: 2021; Test Name: Thyroid function test; Result Unstructured Data: Levels had dropped.; Test Date: 2021; Test Name: Thyroid function test; Result Unstructured Data: High (hyperthyroid).; Test Date: 202103; Test Name: Weight; Result Unstructured Data: Dropped 15 pounds in one month

Allergies:

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

Symptoms: CONVULSIONS/SEIZURES; HYPERTHYROIDISM; DRUG INTERACTION; FLUCTUATING HEART RATE; NUMBNESS DOWN FACE; NUMBNESS AND TINGLING IN ARM; ABNORMAL VISION; SKIPPED DOSES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included neurological issues related to covid, and seizures. On 19-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency once total, administered for prophylactic vaccination. The patient received Topiramate (capsule, hard, oral, batch number was not reported) 100 mg, 1 time every 1 day, from OCT-2020, 100 mg, 1 time every 1 day, from 08-MAY-2021, and 200 mg, frequency, and therapy dates were not reported for neurological issues related to covid. The batch number was not reported and has been requested. Concomitant medications included thyroid. On an unspecified date in 2021, the patient experienced hyperthyroidism, and was hospitalized (date unspecified) and experienced convulsions/seizures, numbness down face, abnormal vision, fluctuating heart rate, numbness and tingling in arm and had skipped doses (coded as drug dose omission). Patient went to the hospital where she had stopped Topamax for 6 days to check whether electroencephalogram (EEG) would show up, and thyroid function test (NR: not provided) high (hyperthyroid). levels had dropped. The hospital ultimately could not found anything. But she went back to a different hospital for more neurological testing and was taken off of Topamax again. She had another thyroid test and her levels had dropped. On, 07-May-2021, the patient was discharged and started taking it again from the night of 08-May-2021.The numbness had came back. She saw online that Topamax and Armour Thyroid should not be combined. She mentioned that at some point her dose was increased to 200 mg a day and she had experienced more seizures. On an unspecified date in 2021, the patient experienced drug interaction The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Topiramate was not reported. The patient recovered from hyperthyroidism, had not recovered from numbness down face, and abnormal vision, convulsions/seizures, fluctuating heart rate and numbness drug interaction and tingling in arm was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000179114.; Sender's Comments: V0. 20210522141-COVID-19 VACCINE AD26.COV2.S -Convulsions/Seizures, Hyperthyroidism, Drug interaction. 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). 20210522141-TOPOMAX-Convulsions/Seizures. This event(s) is labeled per RSI and is therefore considered potentially related. 20210522141-TOPOMAX-Hyperthyroidism, Drug interaction. 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: TOPAMAX; ARMOUR THYROID

Current Illness: Nervous system disorder; Seizures

ID: 1332358
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data: Test Date: 20210506; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Name: COVID-19 virus test; Result Unstructured Data: Negative

Allergies:

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

Symptoms: COVID-19 INFECTION (FLU LIKE SYMPTOMS/COUGH); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-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 06-MAY-2021, the subject experienced covid-19 infection (flu like symptoms/cough). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The outcome of covid-19 infection (flu like symptoms/cough) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am