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: 1432710
Sex: U
Age: 1
State: NY

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 06/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: no other adverse events; temperature excursion/ administered; This spontaneous report was received from a pharmacist and refers to a 12-month-old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-JUN-2021, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) dose reported as 1 time dosage, lot # T022312, expiration date 30-JUN-2022) (route of administration was not reported) for prophylaxis. No signs or symptoms was reported. On an unknown date, the temperature excursion was 15 degrees Celsius, for a time frame of 5 hours. There was no previous temperature excursion. The digital data logger was involved.

Other Meds:

Current Illness:

ID: 1432711
Sex: U
Age:
State: KS

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/29/2021
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: no other AEs reported; expired dose of proquad was inadvertantly; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided. On 10-JUN-2021, the patient was inadvertently vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 injection lot # S038145, expiration date 25-MAY-2021 (exact dose and route of administration were nor provided) for prophylaxis. The nurse requested post-expiry viability data. No further information was provided and no other adverse events (AEs) were reported. The action taken was not applicable.

Other Meds:

Current Illness:

ID: 1432712
Sex: U
Age: 4
State: NY

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 06/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: no other adverse events; temperature excursion/ 15 C; This spontaneous report was received from a pharmacist and refers to a 4-year-old patient of an unspecified gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 09-JUN-2021, the patient was vaccinated with improperly stored 1 time dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # T027114, expiration date was reported and also validated as 07-FEB-2022 (exact dose, strength, route of administration, anatomical location were not provided) for prophylaxis. The data logger registered, that the vaccine prior to administration was stored at the temperature of 15 degree Celsius (C) for 5 hours (product storage error temperature too high). No previous temperature excursion was detected. No other adverse event or product quality complaints were reported (no adverse event). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2106USA003417: US-009507513-2106USA003447: US-009507513-2106USA003425:

Other Meds:

Current Illness:

ID: 1432713
Sex: U
Age: 0
State: TX

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: no additional adverse event reported; Administration of improperly stored vaccine / temperature 47 F; This spontaneous report was received from a medical assistant and refers to a 6 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided. On 10-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) single dose unspecified, orally, lot # T033812, expiration date 29-DEC-2021 for prophylaxis. The administered dose of the vaccine was stored in a temperature of 47 degrees Fahrenheit (F) for 1 hour. There was no previous temperature excursion reported. Digital data logger was not involved. No adverse event (AE) was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2106USA003944: US-009507513-2106USA004039: US-009507513-2106USA004087: US-009507513-2106USA003971: US-009507513-2106USA004335:

Other Meds:

Current Illness:

ID: 1432714
Sex: U
Age:
State: ME

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 06/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AEs reported; temperature excursion (TE)/ administered on 07-JUN-2021; This spontaneous report was received from a medical assistant and refers to a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not provided. On 07-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA, dose: 0.5 ml, intramuscularly (IM), lot # T001212, expiration date was reported and also validated as 12-JAN-2022, for prophylaxis (strength and anatomical location were not reported) (improper storage of product in use). The digital data logger registered, that on 07-MAY-2021, unsupported temperature excursion (TE) occurred and the vaccine was stored at the temperature of 54 degree Fahrenheit (F) for 10 hours. No previous TE was detected. The vaccine was not removed from the inventory and was administered to the patient. No additional adverse event (AE) reported (no adverse event).

Other Meds:

Current Illness:

ID: 1432715
Sex: U
Age:
State: CO

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 06/29/2021
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: patient received an expired VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 15-JUN-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA), 1 ml, lot # S025258 with expiration date 05-NOV-2020 (route and anatomical location were not reported) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1432716
Sex: U
Age:
State: MO

Vax Date: 06/08/2021
Onset Date: 06/08/2021
Rec V Date: 06/29/2021
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: no additional AE; Adult patient was administered a pediatric dose; This spontaneous report as received from a registered nurse referring to a 21-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported. On 08-JUN-2021, the patient was inadvertently vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 milliliter for prophylaxis (lot# T022333 has been verified to be valid, expiration date reported and validated as 11-DEC-2021) (dose number, route of administration, anatomical location site, and vaccination scheme were not provided) (incorrect dose administered). No additional adverse event (AE) reported.

Other Meds:

Current Illness:

ID: 1432717
Sex: F
Age:
State: CO

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 06/29/2021
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: No additional AEs reported; a patient due for her second dose of VARlVAX and was accidently administered PROQUAD instead of VARlVAX; This spontaneous report was received from a medical assistant referring to a 25-year-old female. Information regarding the patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported. On 14-JUN-2021, the patient was due for her second dose of varicella virus vaccine live (Oka/Merck) (VARlVAX) for prophylaxis (dose, vaccination scheme, route of administration, anatomical injection site, lot number and expiration date not reported) and was accidently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter for prophylaxis (lot # T021301 has been verified to be valid, expiration date reported and validated as 19-DEC-2021) for prophylaxis (dose number, route of administration, anatomical injection site and vaccination scheme were not reported) instead (wrong product administered). No additional adverse events (AEs) reported.

Other Meds:

Current Illness:

ID: 1432718
Sex: U
Age:
State: MA

Vax Date: 06/15/2021
Onset Date: 04/01/2021
Rec V Date: 06/29/2021
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: No additional AEs; 5 bad doses were given and 6 potential patients were involved; 5 bad doses were given and 6 potential patients were involved; back in April we had a delivery of GARDASIL 9 that did not arrive for more than 5 days; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided. On an unspecified date in April 2021, the reporter had a delivery of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days (product distribution issue), when the product was received it was supposed to be returned to the wholesaler, instead it was placed in the refrigerator. Information about the temperature storage or a time frame was unknown by the reporter. There wasn't a previous temperature excursion. On 15-JUN-2021, the patient was vaccinated with a bad dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, 1 time dose as prophylaxis (with lot number T026168 and expiration date 04-DEC-2022, both verified as valid; vaccination scheme frequency, route and anatomical location of administration were not provided) (product storage error) (poor quality product administered). No additional adverse events occurred. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments: US-009507513-2106USA005004: US-009507513-2106USA005001: US-009507513-2106USA005150: US-009507513-2106USA005081: US-009507513-2106USA005047:

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1432719
Sex: U
Age:
State: MA

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 06/29/2021
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: No additional information was provided; back in April we had a delivery of GARDASIL 9 that did not arrive for more than 5 days, when the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. Back in April 2021 the reporter had a delivery of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days. When the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator. It was discovered on 16-JUN-2021 that 5 bad doses were given, and 6 potential patients were involved, including that on 13-MAY-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (one time dose; lot # T026168, expiration date 04-DEC-2022; route and strength unknown) for prophylaxis (product storage error). The reporter could not confirm if this was a valid dose or bad dose. No additional adverse event. The temperature and time frame of the vaccine was unknown. There was no previous temperature excursion. The call was not because of a data logger. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2106USA005004: US-009507513-2106USA005001: US-009507513-2106USA005005: US-009507513-2106USA005047: US-009507513-2106USA005150:

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1432720
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 06/15/2021
Rec V Date: 06/29/2021
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: with in several hours the patient had fever, chills, and body aches, and has resolved 48 hours later; with in several hours the patient had fever, chills, and body aches, and has resolved 48 hours later; with in several hours the patient had fever, chills, and body aches, and has resolved 48 hours later; This spontaneous report was received from a nurse via a company representative and refers to a 22-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 time dose (site and route of administration, lot# and expiration date were not reported) for prophylaxis. The same day within several hours after the vaccination, the patient experienced fever, chills and body aches. The events had resolved 48 hours later, on 17-JUN-2021. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.

Other Meds:

Current Illness:

ID: 1432721
Sex: U
Age:
State: MA

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/29/2021
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: No AE; mishandling of the product; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In April 2021, there was a delivery of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days, when the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator. On 28-MAY-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T026168, expiration date was reported as 04-DEC-2022; site and route of administration were not reported) for prophylaxis. There was no previous temperature excursion/ No digital data logger was involved. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments: US-009507513-2106USA005004: US-009507513-2106USA005005: US-009507513-2106USA005001:

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1432722
Sex: U
Age: 11
State: OR

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 06/29/2021
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: No additional AE details are available; a dose of MMR II which expired on 5/30/2021 was administered to a patient on 6/17/2021; This spontaneous report was received from a medical assistant and refers to a 11-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was not provided. On 17-JUN-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, dose: 0.5 milliliter, lot # S016676, expiration date: 30-MAY-2021 (dose number, route of administration and anatomical location were not reported) for an unknown indication established as prophylaxis. The expired dose of vaccine had no temperature excursions. No additional adverse events were reported.

Other Meds:

Current Illness:

ID: 1432723
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: a 12 month old was inadvertently administered the PNEUMOVAX 23 vaccine; No additional AE; This spontaneous report was received from a pharmacist referring to a 12-month-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided. On an unknown date, the 12-month-old patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (route and anatomical location of administration were not provided; dose, vaccination scheme frequency, lot number and expiration date were unknown by the reporter) for prophylaxis (product administered to patient of inappropriate age).

Other Meds:

Current Illness:

ID: 1432724
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: administering 2 doses of pediatric RECOMBIVAX HB to a 22 year old man for his first dose of hepatitis b, rather than giving the adult RECOMBIVAX HB.; Caller states customer is considering administering 2 doses of pediatric RECOMBIVAX HB to a 22 year old man / Doses have not yet been administered.; No additional AE; This spontaneous report was received from a healthcare office manager referring to a 22-year-old male patient. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not provided. On an unspecified date, the patient considered to get vaccinated with two doses of pediatric formulation of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (concentration, dose number, vaccination scheme frequency, route of administration, anatomical site of vaccination were not reported; lot number and expiration date were unknown by the reporter) for prophylaxis. He did not consider getting vaccinated with the adult formulation of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (circumstance or information capable of leading to medication error), (incorrect product formulation administered) since the adult formulation of the vaccine was not in stock. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1432725
Sex: F
Age: 27
State: MT

Vax Date: 06/14/2021
Onset Date:
Rec V Date: 06/29/2021
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: patient is currently pregnant at this time and received the GARDASIL 9 vaccine inadvertently today; no additional adverse events have been reported; This spontaneous prospective pregnancy report as received from a registered nurse concerning a 28-year-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 14-JUN-2021, the patient was vaccinated with a first dose reported as single dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe, lot # T026168, expiration date reported : 04-DEC-2022, dose:0 .5 milliliter, intramuscularly, for prophylaxis (anatomical location was not reported), inadvertently. On an unknown date, the patient became pregnant. At the time of vaccination the patient was currently pregnant and no additional adverse events had been reported by the patient as a result of receiving the vaccine. The mother's last menstrual period, estimated due date, prenatal tests and results were not reported.The trimester of exposure was unspecified. The pregnancy outcome was outcome pending. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1432726
Sex: M
Age: 68
State: CA

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 06/29/2021
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: no adverse events; Dose of PNEUMOVAX23 had expired on 06/12/2021 and was administered on 06/21/2021; This spontaneous report was received from a medical sassistant, referring to a 68 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 21-JUN-2021, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5ml, lot# S029916, expiration date 12-JUN-2021, for prophylaxis (strength, dose, route and frequency were not reported). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1432727
Sex: U
Age:
State: OK

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 06/29/2021
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: NO ADVERSE EVENT; PNEUMOVAX23 was administered to a patient on 16JUN2021 after experiencing a temperature excursion; This spontaneous report was received from a vaccine coordinator, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 16-JUN-2021, the patient was vaccinated with an improper stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot# T033369, expiration date 26-MAY-2022, for prophylaxis (strength, dose, route and frequency were not reported). The temperature excursion was of -40.0 Centigrade degrees (?C), during 45 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033369; expirationdate: 26-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1432728
Sex: U
Age:
State: NY

Vax Date: 06/22/2021
Onset Date: 06/22/2021
Rec V Date: 06/29/2021
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: No additional AE.; Patient was inadvertently administered expired GARDASIL 9 by unknown nurse; This spontaneous report as received from a Healthcare Business Professional, referring to a 24 year old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided. On 22-JUN-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), with lot # R028762 and expiration date on 21-JUN-2021 (route, strength, and dose were not provided) for prophylaxis. The vaccine had not been involved in any previous temperature excursion. No additional adverse events were reported.

Other Meds:

Current Illness:

ID: 1432729
Sex: M
Age:
State: IN

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 06/29/2021
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: no adverse event; administration of an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a 2 month old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1684157, expiring on 26-JUN-2021, 2 milliliter, oral, for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 8.6 degrees Celsius for 4hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.

Other Meds:

Current Illness:

ID: 1432730
Sex: U
Age: 67
State: TN

Vax Date: 10/06/2014
Onset Date:
Rec V Date: 06/29/2021
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: Other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to an elderly patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-OCT-2014, the pt was administered the zoster vaccine live (ZOSTAVAX) (route, dose, lot number and expiration date were not reported) by a healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 1432731
Sex: F
Age:
State: NY

Vax Date: 05/12/2021
Onset Date: 05/16/2021
Rec V Date: 06/29/2021
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: 20210516; Test Name: Aspiration pleural cavity; Test Result: Inconclusive ; Test Date: 20210516; Test Name: Computerised tomogram thorax; Result Unstructured Data: CT chest showed Vague ground-glass opacities left lung base possibly representing pneumonitis or atelectasis; Test Date: 20210516; Test Name: Cytology; Result Unstructured Data: cytology was significant for reactive mesothelial cells and negative for any malignancy; Test Date: 20210516; Test Name: Full blood count; Test Date: 20210516; Test Name: Metabolic function test; Test Date: 20210516; Test Name: SARS-CoV-2 test; Test Result: Negative

Allergies:

Symptom List: Unevaluable event

Symptoms: Pleural effusion; Cough; Dyspnoea; This case was received on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PLEURAL EFFUSION (Pleural effusion), LUNG OPACITY (Lung opacity), COUGH (Cough), DYSPNOEA (Dyspnoea) and HILAR LYMPHADENOPATHY (Hilar lymphadenopathy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 027C21A) for COVID-19 vaccination. The patient's past medical history included Lung cancer (relapse in 2010 tx with radiation- in remission) in 2007. Concurrent medical conditions included Diabetes mellitus (diabetes mellitus type 2), Tobacco user, Neuropathy, Hyperlipidemia and Restless leg syndrome. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), GABAPENTIN, IRBESARTAN, ROPINIROLE, INSULIN GLARGINE (LANTUS), METOPROLOL and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 12-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PLEURAL EFFUSION (Pleural effusion) (seriousness criterion hospitalization), LUNG OPACITY (Lung opacity) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization) and HILAR LYMPHADENOPATHY (Hilar lymphadenopathy) (seriousness criterion hospitalization). At the time of the report, PLEURAL EFFUSION (Pleural effusion), LUNG OPACITY (Lung opacity), COUGH (Cough), DYSPNOEA (Dyspnoea) and HILAR LYMPHADENOPATHY (Hilar lymphadenopathy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, Aspiration pleural cavity: Inconclusive. On 16-May-2021, Computerised tomogram thorax: (abnormal) CT chest showed Vague ground-glass opacities left lung base possibly representing pneumonitis or atelectasis. On 16-May-2021, Cytology: (abnormal) cytology was significant for reactive mesothelial cells and negative for any malignancy. On 16-May-2021, Full blood count: normal. On 16-May-2021, Metabolic function test: normal. On 16-May-2021, SARS-CoV-2 test: Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment product information was provided. Patient was vaccinated on 12 Apr 2021 and 12 May 2021 and presented to the emergency department on 15 May 2021 with complaint of worsening shortness of breath and cough. According to the patient her shortness of breath started couple of weeks back just after her first covid vaccine but it got worse in the last few days following her second vaccine. Imaging revealed a large R pleural effusion. A thoracentesis was done and she was sent home. She was tested and was covid negative. Cytology was significant for reactive mesothelial cells and negative for any malignancy. CT chest showed Vague ground-glass opacities left lung base possibly representing pneumonitis or atelectasis. Confluent right hilar lymphadenopathy and a large effusion was seen she was discharged home to follow up with her doctor on 17 Apr 2021.; 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. The patient's comorbidities remains as confounders.

Other Meds: LIPITOR; GABAPENTIN; IRBESARTAN; ROPINIROLE; LANTUS; METOPROLOL; SINGULAIR

Current Illness: Diabetes mellitus (diabetes mellitus type 2); Hyperlipidemia; Neuropathy; Restless leg syndrome; Tobacco user

ID: 1432732
Sex: M
Age:
State: IN

Vax Date: 05/18/2021
Onset Date: 05/19/2021
Rec V Date: 06/29/2021
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 Name: Body temperature; Result Unstructured Data: 103.2

Allergies:

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

Symptoms: Syncope; Diarrhoea; Dizziness; Fatigue; Gait inability; Pallor; Skin discolouration; Pyrexia; Vomiting; This case was received via Regulatory Authority on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), FATIGUE (Fatigue), GAIT INABILITY (Gait inability), PALLOR (Pallor), SKIN DISCOLOURATION (Skin discolouration), PYREXIA (Pyrexia) and VOMITING (Vomiting) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination. No medical history reported by the reporter. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced SYNCOPE (Syncope) (seriousness criteria medically significant and congenital anomaly), DIARRHOEA (Diarrhoea) (seriousness criterion congenital anomaly), DIZZINESS (Dizziness) (seriousness criterion congenital anomaly), FATIGUE (Fatigue) (seriousness criterion congenital anomaly), GAIT INABILITY (Gait inability) (seriousness criterion congenital anomaly), PALLOR (Pallor) (seriousness criterion congenital anomaly), SKIN DISCOLOURATION (Skin discolouration) (seriousness criterion congenital anomaly), PYREXIA (Pyrexia) (seriousness criterion congenital anomaly) and VOMITING (Vomiting) (seriousness criterion congenital anomaly). At the time of the report, SYNCOPE (Syncope), DIARRHOEA (Diarrhoea), DIZZINESS (Dizziness), FATIGUE (Fatigue), GAIT INABILITY (Gait inability), PALLOR (Pallor), SKIN DISCOLOURATION (Skin discolouration), PYREXIA (Pyrexia) and VOMITING (Vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.2 (High) 103.2. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment was reported. Action taken with the mRNA-1273 in response to the event is not applicable. 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: FLONASE [MOMETASONE FUROATE]; ALLEGRA

Current Illness:

ID: 1432733
Sex: F
Age:
State: NE

Vax Date: 04/22/2021
Onset Date: 05/18/2021
Rec V Date: 06/29/2021
Hospital: Y

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

Lab Data: Test Date: 20210518; Test Name: CT Angiogram; Result Unstructured Data: Angiogram peripheral abnormal

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Pulmonary embolism; Thrombosis; This case was received via VAERS (Reference number: 1350684) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and THROMBOSIS (Thrombosis) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The patient's past medical history included Irritable bowel syndrome and Glucose tolerance impaired. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization, medically significant and life threatening) and THROMBOSIS (Thrombosis) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and THROMBOSIS (Thrombosis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Angiogram: abnormal (abnormal) Angiogram peripheral abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the patient was seen in emergency room (ER) with left lower extremity blood clot. No treatment information provided. Action taken with mRNA-1273 was not applicable. Company comment Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

Other Meds: CLARITIN-D; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1432734
Sex: F
Age:
State:

Vax Date: 05/03/2021
Onset Date: 05/05/2021
Rec V Date: 06/29/2021
Hospital: Y

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: Confusional state; Diabetes mellitus; Facial paralysis; Hypertension; Ischaemic stroke; This case was received via VAERS (Reference number: 1358541) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (Confusional state) (seriousness criteria hospitalization and disability), DIABETES MELLITUS (Diabetes mellitus) (seriousness criteria hospitalization, disability and medically significant), FACIAL PARALYSIS (Facial paralysis) (seriousness criteria hospitalization, disability and medically significant), HYPERTENSION (Hypertension) (seriousness criteria hospitalization and disability) and ISCHAEMIC STROKE (Ischaemic stroke) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized on 05-May-2021 due to CONFUSIONAL STATE, DIABETES MELLITUS, FACIAL PARALYSIS, HYPERTENSION and ISCHAEMIC STROKE. At the time of the report, CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Patient received first dose of vaccine on 5/3/21. On 5/5, presented to urgent care clinic and was transferred to hospital with confusion, and facial droop. Patient was Diagnosed with acute ischemic stroke, new diagnosis hypertension and diabetes mellitus. 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:

Date Died: 06/02/2021

ID: 1432736
Sex: M
Age:
State: NJ

Vax Date: 06/01/2021
Onset Date: 06/02/2021
Rec V Date: 06/29/2021
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: Death; Cardiac arrest; Fatigue; This case was received on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), CARDIAC ARREST (Cardiac arrest) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hemodialysis. Concurrent medical conditions included Chronic kidney disease (On HD). On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant) and FATIGUE (Fatigue) (seriousness criterion death). The patient died on 02-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment/concomitant medications were reported. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness: Chronic kidney disease (On HD)

ID: 1432737
Sex: F
Age:
State: CA

Vax Date: 05/18/2021
Onset Date: 05/28/2021
Rec V Date: 06/29/2021
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: Bell's palsy; Lymphadenopathy; This case was received via FDA VAERS (Reference number: 1369999) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and LYMPHADENOPATHY (Lymphadenopathy). At the time of the report, BELL'S PALSY (Bell's palsy) and LYMPHADENOPATHY (Lymphadenopathy) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. The patient reported Bell's palsy was on right side of face and he was taking an oral steroid. Patient reported swollen lymph node was in left armpit and nothing had changed and he was not treating it. 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:

ID: 1432738
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: gave me fever; missed the 2nd Shingles vaccine /was supposed to take it in Jan 2021/ I put off the 2nd one.; I was ill for 12 hours; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced fever, illness and social problem. On an unknown date, the outcome of the fever and social problem were unknown and the outcome of the illness was recovered/resolved. It was unknown if the reporter considered the fever and illness to be related to Shingles vaccine. Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and experienced fever and was ill for about 12 hours. The patient missed the second dose of shingles vaccine as it was supposed to take in January 2021 and as the COVID hit the patient and needed that second vaccine.

Other Meds:

Current Illness:

ID: 1432739
Sex: M
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: administered liquid only portion of Menveo to patient/ mixed two liquid vials instead of the powder vial; administered liquid only portion of Menveo to patient/ mixed two liquid vials instead of the powder vial; liquid component contains ?MenCYW-135'; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate reconstitution technique in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique, incorrect dose administered and accidental overdose. On an unknown date, the outcome of the inappropriate reconstitution technique, incorrect dose administered and accidental overdose were unknown. Additional details were provided as follows: The age at vaccination was not reported. The nurse mistakenly administered liquid only portion of Menveo to patient. She mixed two liquid vials instead of the powder vial and the liquid vial which led to inappropriate reconstitution technique, incorrect dose administered (Men A component not received) and accidental overdose of MenCYW components. Event detected when a different patient was about to received Menveo and it was noted that the vial counts were off. There were no longer a matching number of liquid and powder vials. No known harm to the patient. The reporter did not consented to follow up.

Other Meds:

Current Illness:

ID: 1432740
Sex: U
Age:
State:

Vax Date: 10/01/2020
Onset Date: 04/19/2021
Rec V Date: 06/29/2021
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: experienced the allergic reactions; This case was reported by a consumer and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis. In October 2020, the patient received the 1st dose of Shingrix. On 19th April 2021, between 5 and 7 months after receiving Shingrix, 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 Shingrix. Additional details were provided as follows: This case was reported by the patient himself or herself. The age at vaccination was not reported. The patient had received the first shot of Shingrix and experienced the allergic reactions. This case has been linked to US2021AMR137685, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR137685:Same reporter

Other Meds:

Current Illness:

ID: 1432741
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: pain at the injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient had recently received Shingrix and had experienced pain at the injection site.

Other Meds:

Current Illness:

ID: 1432742
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis. On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown. Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR137655:Same reporter US-GLAXOSMITHKLINE-US2021AMR137642:Same reporter US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter US-GLAXOSMITHKLINE-US2021AMR137653:Same reporter

Other Meds:

Current Illness:

ID: 1432743
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis. On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown. Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR137642:Same reporter US-GLAXOSMITHKLINE-US2021AMR137654:Same reporter US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter US-GLAXOSMITHKLINE-US2021AMR137653:Same reporter

Other Meds:

Current Illness:

ID: 1432744
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: patient of mine got his first Shingrix dose 18 months ago.; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose by patient 18 months ago of reporting date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not reported. Till the time of reporting, the patient not yet received 2nd dose of Shingrix, which led to incomplete course of vaccination.

Other Meds:

Current Illness:

ID: 1432745
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: I've had/ a full round consisting of 2 shots & I still had them!/suspected vaccination failure; I've had/ a full round consisting of 2 shots & I still had them!; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had 2 shots of the old one and a full round consisting of 2 shots and still had shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.

Other Meds:

Current Illness:

ID: 1432746
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: arm hurt after the first dose / arm felt better after exercising; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The patient reported the case for himself/herself. The age at vaccination was not reported. The patient's arm hurt after the first dose of Shingrix but he/she went to the gym and exercised anyway. Then arm felt better after exercising. The patient enquired if it was ok to exercise 4 hours after Shingrix shot or he/she should have waited until the next day. Patient also questioned if exercising had effect his/her shot.

Other Meds:

Current Illness:

ID: 1432747
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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 the two shots for it, they made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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 patient reported the case for himself/herself The age at vaccination was not reported. The patient received Shingrix shot and got sick. No other information was reported. For tolerance to 2nd dose, refer case US2021AMR137806.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR137806:Same patient, Same reporter, 2nd dose

Other Meds:

Current Illness:

ID: 1432748
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: Had the two shots for it, they made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles Vaccine with an associated reaction of illness (received 1st dose on an unknown date and experienced sickness, refer case - US2021AMR137802). 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 unknown. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported the case for himself/herself The age at vaccination was not reported. The patient had received Shingrix shot and got sick. No other information was reported. For tolerance to 2nd dose, refer case US2021AMR137802.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR137802:Same patient, Same reporter, 1st dose

Other Meds:

Current Illness:

ID: 1432749
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: reconstituted lyophilized menA with normal saline and administered; reconstituted lyophilized menA with normal saline and administered; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 are as follows: The age at vaccination was not reported. The case was reported by nurse for patient. Nurse reported that the new office staff member incorrectly reconstituted lyophilized menA with normal saline and administered to patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not agree to follow up from GSK

Other Meds:

Current Illness:

ID: 1432750
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: sick with flu like symptoms; sick with migraine headache; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced influenza-like symptoms and migraine headache. On an unknown date, the outcome of the influenza-like symptoms and migraine headache were unknown. It was unknown if the reporter considered the influenza-like symptoms and migraine headache to be related to Shingles vaccine. Additional details were provided are as follows: The age at vaccination was not reported. The patient recently received 1st shot of Shingles vaccine and got sick the same night with flu like symptoms and a migraine headache and was in bed for 2 days. He/she had another shot in September, really not looking forward to it but the patient did not want the shingles either.

Other Meds:

Current Illness:

ID: 1432751
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: grabbed the wrong green box and gave flu instead; grabbed the wrong green box and gave flu instead; This case was reported by a pharmacist via sales rep and described the occurrence of wrong vaccine administered in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced wrong vaccine administered and product packaging confusion. On an unknown date, the outcome of the wrong vaccine administered and product packaging confusion were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient was due for both vaccines, but the nurse was trying to administer tdap and grabbed the wrong green box and gave flu instead, which led to wrong vaccine administered and product packaging confusion. No other information was reported.

Other Meds:

Current Illness:

Date Died:

ID: 1432752
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: heart attack caused by this vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of heart attack in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced heart attack (serious criteria death and GSK medically significant). On an unknown date, the outcome of the heart attack was fatal. The reported cause of death was heart attack. The reporter considered the heart attack to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter stated that, his or her friend died due to heart attack from the vaccine.; Reported Cause(s) of Death: Heart attack

Other Meds:

Current Illness:

ID: 1432754
Sex: F
Age: 71
State: FL

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 06/29/2021
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 the first dose of Shingrix on 2018 / have not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2018). On 23rd December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd December 2020, unknown after receiving Shingrix, 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. Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix on 2018 and came back today to receive the second one. Till the time of reporting did not received 2nd dose which led incomplete course of vaccination. Consented to follow up. This case has been linked with case US2020254932, reported by same reporter. Follow up information was received from pharmacist on 23rd June 2021: The batch number and expiry details were updated. On 23rd December 2020, the patient had received second dose of Shingrix (0.5 ml) Intramuscularly, which led to lengthening of vaccination schedule. The VAERS details were updated.; Sender's Comments: US-GLAXOSMITHKLINE-US2020254932:same reporter

Other Meds:

Current Illness:

ID: 1432755
Sex: F
Age: 52
State: MA

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 06/29/2021
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: 52 y/o adult / 2nd dose of 10mcg; 52 y/o adult / 2nd dose of 10mcg; 1st dose / on 05/25/2021 and 2nd dose / on 06/02/2021; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 52-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included HBV (Engerix B adult). On 2nd June 2021, the patient received the 2nd dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, adult product administered to child and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult product administered to child and drug dose administration interval too short 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 patient previously received 1st dose of Engerix 20 ug dose on 25th of May 2021. The pharmacist reported that, the adult patient received dose of Engerix 10 ug earlier than the recommended interval, which led to underdose, adult use of child product and shortening of the vaccine schedule. No further information was reported. The reporter consented to follow up. This case is linked US2021134490 reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021134490:same reporter

Other Meds:

Current Illness:

ID: 1432756
Sex: U
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 06/29/2021
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: received DOSE 1 of twinrix on Dec 2020 never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 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. Previously administered products included Twinrix (received first dose on December 2020). On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix 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. Till the time of reporting, patient did not received 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1432757
Sex: U
Age: 5
State: TN

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 06/29/2021
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: on Jun 18th 2021 / received Pediarix /with expiration date on Jun 14th 2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 18th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional information was provided as follows: The patient received expired Pediarix vaccine, which led to expired vaccine used. The reporter consented to follow up via email. This case was linked with US2021134505, for same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021134505:same reporter

Other Meds:

Current Illness:

ID: 1432758
Sex: F
Age: 4
State: FL

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 06/29/2021
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: An expired dose was given to patient on June 18th, 2021 / vaccine had expired on May 24th, 2021.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number K7TF9, expiry date 24th May 2021) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 18th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient had received an expired dose of Pediarix on 18th June 2021 which had already expired on 24th May 2021. The reporter consented to follow-up via email.

Other Meds:

Current Illness:

ID: 1432759
Sex: F
Age:
State: MN

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 06/29/2021
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: administration /of the Twinrix vaccine to a /17 year old patient.; 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 17-year-old female patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 2022) 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. On 17th May 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 17th May 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional case details were reported as follows: The 17 year old female patient was administered the Twinrix vaccine, which led to inappropriate age at vaccine administration. No further events were reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1432760
Sex: F
Age:
State: UT

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 06/29/2021
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: Administration of only the diluent portion of the / vaccine / on 3/20/2021; Administration of only the diluent portion of the / vaccine / on 3/20/2021; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th March 2021, the patient received Shingrix. On 20th March 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The nurse was reported that the pharmacy administration only the diluent portion of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further events were reported. The reporter consented to follow up. No further information was reported.; Sender's Comments: US-GLAXOSMITHKLINE-US2021135664:Same reporter

Other Meds:

Current Illness:

ID: 1432761
Sex: F
Age: 62
State: LA

Vax Date: 06/07/2021
Onset Date: 06/14/2021
Rec V Date: 06/29/2021
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: Swollen arm that was hurting; Swollen arm; shoulder blade and hip pain; very fatigue; Diarrhea; Difficult breathing; Headache; Stomachache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 7th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 14th June 2021, 7 days after receiving Shingrix, the patient experienced pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved and the outcome of the arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, swelling arm, arthralgia, fatigue, diarrhea, difficulty breathing, headache and stomach pain to be related to Shingrix. Additional details were reported as follows: This case was reported by the patient. The patient reported that patient received Shingrix vaccine and after one week experienced stomachache, headache, difficult breathing diarrhea and very fatigue, shoulder blade and hip pain all of which were continuing to affect her. The patient also stated that a swollen arm that was hurting at the time of these other symptoms, but has resolved at the time of the call. Consented to follow up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am