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: 1702855
Sex: F
Age: 48
State: NC

Vax Date: 09/10/2021
Onset Date: 09/11/2021
Rec V Date: 09/16/2021
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: None

Symptom List: Dysphagia, Epiglottitis

Symptoms: Facial Paresthesia, metal taste in mouth, LUQ pain and neck swelling/discomfort, left side facial droop, eyes close bilaterally, slurred speech.

Other Meds: Adderall Amethyst

Current Illness: None

ID: 1703052
Sex: F
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/16/2021
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: Painful lump near collarbone/ swollen lymph node; Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone). The patient was treated with IBUPROFEN from August 2021 to August 2021 for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone) had not resolved. No concomitant medications were reported by the provider.

Other Meds:

Current Illness:

ID: 1703053
Sex: U
Age: 55
State: IN

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/16/2021
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: chills with hot flashes; chills with hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (chills with hot flashes) and CHILLS (chills with hot flashes) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced HOT FLUSH (chills with hot flashes) and CHILLS (chills with hot flashes). At the time of the report, HOT FLUSH (chills with hot flashes) and CHILLS (chills with hot flashes) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information were not provided by the reporter. Concomitant medications were not reported by reporter.

Other Meds:

Current Illness:

ID: 1703054
Sex: M
Age: 55
State: WA

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 09/16/2021
Hospital: Y

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: Extreme nausea; cyclic vomiting; Muscular cramps in feet, legs, torso; Combination ofsweats and chills; Renal failure; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Renal failure), NAUSEA (Extreme nausea), CYCLIC VOMITING SYNDROME (cyclic vomiting), MUSCLE SPASMS (Muscular cramps in feet, legs, torso) and COLD SWEAT (Combination ofsweats and chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Cannabinoid hyperemesis syndrome. On 27-Aug-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 27-Aug-2021, the patient experienced RENAL FAILURE (Renal failure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced NAUSEA (Extreme nausea) (seriousness criterion hospitalization), CYCLIC VOMITING SYNDROME (cyclic vomiting) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscular cramps in feet, legs, torso) (seriousness criterion hospitalization) and COLD SWEAT (Combination ofsweats and chills) (seriousness criterion hospitalization). At the time of the report, RENAL FAILURE (Renal failure) was resolving and NAUSEA (Extreme nausea), CYCLIC VOMITING SYNDROME (cyclic vomiting), MUSCLE SPASMS (Muscular cramps in feet, legs, torso) and COLD SWEAT (Combination ofsweats and chills) outcome was unknown. No concomitant medication details were reported. No treatment information was reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1703055
Sex: F
Age: 40
State: IN

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 09/16/2021
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: Weakness & inability to lift arm, fatigue, sore throat; Weakness & inability to lift arm, fatigue, sore throat; Weakness & inability to lift arm, fatigue, sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Weakness & inability to lift arm, fatigue, sore throat), MUSCULAR WEAKNESS (Weakness & inability to lift arm, fatigue, sore throat) and FATIGUE (Weakness & inability to lift arm, fatigue, sore throat) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Weakness & inability to lift arm, fatigue, sore throat), MUSCULAR WEAKNESS (Weakness & inability to lift arm, fatigue, sore throat) and FATIGUE (Weakness & inability to lift arm, fatigue, sore throat). On 04-Sep-2021, OROPHARYNGEAL PAIN (Weakness & inability to lift arm, fatigue, sore throat), MUSCULAR WEAKNESS (Weakness & inability to lift arm, fatigue, sore throat) and FATIGUE (Weakness & inability to lift arm, fatigue, sore throat) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications and Treatment informations were not provided. My arm hurt badly enough that it was difficult to use and I could barely lift over my head

Other Meds:

Current Illness:

ID: 1703056
Sex: F
Age: 67
State:

Vax Date: 08/31/2021
Onset Date: 09/03/2021
Rec V Date: 09/16/2021
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: malaise; dizziness; skin rash; Severe Vomiting; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis, Drug allergy (Multiple drug allergies), Insect sting allergy (severe reaction), Contrast media allergy (yellow dye 5) and Anaphylactic reaction. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), EZETIMIBE (ZETIA), UPADACITINIB (RINVOQ) and HYDROMORPHONE HYDROCHLORIDE (DILAUDID) for an unknown indication. On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting), PYREXIA (fever) and HEADACHE (headache). At the time of the report, MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting), PYREXIA (fever) and HEADACHE (headache) was resolving. No treatment medications were provided by reporter.

Other Meds: LIPITOR; ZETIA; RINVOQ; DILAUDID.

Current Illness: Anaphylactic reaction; Contrast media allergy (yellow dye 5); Drug allergy (Multiple drug allergies); Insect sting allergy (severe reaction); Rheumatoid arthritis.

ID: 1703245
Sex: F
Age: 38
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 09/16/2021
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: positive human papillomavims test; This spontaneous report was received from 39 years old female patient, referring to herself. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On 23-FEB-2021 and 24-MAR-2021, the patient was vaccinated with the first dose and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot# and expiry date were not reported) respectively for prophylaxis. On an unknown date in 2021, following the second dose, the patient was positive for the human papillomavims test. The outcome of positive for the human papillomavims test was unknown. The patient had not yet received a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and expected to receive a third dose 24-AUG-2021. Causality assessment was not provided.

Other Meds:

Current Illness:

ID: 1703246
Sex: M
Age:
State:

Vax Date: 12/28/2015
Onset Date: 08/04/2021
Rec V Date: 09/16/2021
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 adverse events were reported; the consumer's son received a fourth dose of GARDASIL 9; This spontaneous report has been received from a consumer referring to a 25-year-old male patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported. On 28-DEC-2015 and 15-FEB-2016, the patient was vaccinated with the first and second 0.5 milliliters (ml) doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) respectively (both with lot number L037339, which has been verified to be valid for syringe formulation, the expiration date was reported as "08-FEB-2018"; however, upon internal verification was established as 09-FEB-2018). On 29-JUL-2016, the patient received the third 0.5 ml dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number L019287 has been verified to be valid for syringe formulation, with an expiration date on 14-SEP-2017). The three doses of the vaccine were administered as prophylaxis (routes of administration and anatomical sites of vaccination were not provided). On approximately 04-AUG-2021 (reported as "a few weeks ago, maybe the 4th (AUG2021)"), the patient was vaccinated with a 0.5 ml fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (extra dose administered) (formulation, route of administration, anatomical site of vaccination, lot number, and expiration date were not provided). No additional adverse events were reported (no adverse event). 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: devicelotnumber: L037339; expirationdate: 09-FEB-2018; 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: 1703247
Sex: F
Age:
State: FL

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/16/2021
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 AE; Product administered to patient of inappropriate age; This spontaneous report as received from a health professional referring to a 7-year-old female patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported. On 19-AUG-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028583 that has been verified to be valid expiration date 04-MAR-2023, 0.5 milliliter for prophylaxis (frequency, strength, route of administration, were not reported) (product administered to patient of inappropriate age). No adverse event was 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; manufacturername: devicelotnumber: T028583; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; operatorofdevice: Unknown; 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: 1703265
Sex: U
Age:
State: NM

Vax Date: 08/29/2021
Onset Date: 08/29/2021
Rec V Date: 09/16/2021
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 AE's; A caller stated that an expired dose of GARDASIL 9; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported. On 29-AUG-2021, the patient was vaccinated with a expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 time dose, expiry date 23-JUL-2021 for prophylaxis (strength, route of administration, and lot number,were not reported). The vaccine did not experienced temperature excursion and no additional adverse events were reported.

Other Meds:

Current Illness:

ID: 1703268
Sex: U
Age:
State: NY

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 30-JUL-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of minus 40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several reports, 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: devicelotnumber: T026167; 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: 1703273
Sex: U
Age: 11
State: NY

Vax Date: 07/27/2018
Onset Date: 08/16/2019
Rec V Date: 09/16/2021
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 additional adverse event; Extra dose administered; Gardasil 9 1st dose administeren on 27-JUL-2018, 2nd on 16-AUG-2019 and 3rd on 21-AUG-2020; This spontaneous report as received from a Registered Nurse referring to a 12 year old patient (currently 14 year old) gender not reported. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 27-JUL-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 26-AUG-2019 (inappropriate schedule of product administration), 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) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 21-AUG-2020, the patient received an additional third dose (extra dose administered ) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # S020254 that expires on 09-DEC-2021, for prophylaxis (dose, route of administration and administration site date were not reported). No additional adverse event was 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: S020254; expirationdate: 08-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; 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: 1703278
Sex: U
Age:
State: NY

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 09-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703279
Sex: U
Age:
State: NY

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 09-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703280
Sex: U
Age:
State: NY

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 13-AUG-2021, the patient was vaccinated with an improperly stored GARDASIL 9 at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703281
Sex: U
Age:
State: NY

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703282
Sex: U
Age:
State: NY

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703283
Sex: U
Age:
State: NY

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703284
Sex: U
Age:
State: NY

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 09-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703285
Sex: U
Age:
State: NY

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 18-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703286
Sex: U
Age:
State: NY

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 19-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703287
Sex: U
Age:
State: NY

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 23-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703288
Sex: U
Age:
State: NY

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 23-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703289
Sex: U
Age:
State: NY

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 23-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703290
Sex: U
Age:
State: NY

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 23-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703291
Sex: U
Age:
State: NY

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 23-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703292
Sex: U
Age:
State: NY

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 13-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703293
Sex: U
Age:
State: NY

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 13-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of minus 40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703294
Sex: U
Age:
State: NY

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of minus 40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703295
Sex: U
Age:
State: NY

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 19-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703296
Sex: U
Age:
State: NY

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 19-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703297
Sex: U
Age:
State: NY

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 20-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703298
Sex: U
Age:
State: NY

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 26-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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 SYRINGE DEVICE

Current Illness:

ID: 1703299
Sex: U
Age:
State: NY

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 26-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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 SYRINGE DEVICE

Current Illness:

ID: 1703300
Sex: U
Age:
State: NY

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 26-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703301
Sex: U
Age:
State: NY

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 26-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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.; manufactureraddr; devicelotnumber: T026167; 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: 1703302
Sex: U
Age:
State: NY

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 03-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of minus 40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several reports, 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: T026167; 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: 1703303
Sex: U
Age:
State: NY

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 06-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703304
Sex: U
Age:
State: NY

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 06-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703305
Sex: U
Age:
State: NY

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 06-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703306
Sex: U
Age:
State: NY

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703307
Sex: U
Age:
State: NY

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703308
Sex: U
Age:
State: NY

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/16/2021
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: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported. On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis. The administered vaccine underwent a temperature excursion below 2 degrees Celsius (?C) of -40.0 ?C for a time frame of 15 minutes; and an excursion above 8?C of 9.6 ?C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported. This is one of several cases, 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: T026167; 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: 1703317
Sex: U
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 09/16/2021
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: 50 year old patient received 2 doses of Gardasil; This spontaneous report was received from a pharmacist referring a 50-year-old patient's gender not reported. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 2 for prophylaxis (dose, route of administration, lot number, and expiration date were not reported). The pharmacist mentioned that they discovered that the patient was 50 years old until after the second dose was administered. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1703318
Sex: F
Age: 44
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/16/2021
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: Cellulitis; cannot sleep; cannot relax; rheumatoid arthritis flare up; low grade fever; INFLAMMATION on hand; nerve pain; autoimmune disorder; intentional misuse in product use duration; rash; shingles; This spontaneous report has been received from a 43 years old female consumer via other company letter (manufacture control number#21K-163-3984635-00) (It was also reported as a solicited report, conflict information). The patient was a non-smoker, abstains from alcohol. She had stomach problems, lupus markers, preeclampsia, autoimmune condition, dilantin allergy manifested by hives, sulfa drugs allergy manifested by hives, cefdinir allergy manifested by hives, phenytoin allergy manifested by hives (it was also reported the patient had no known allergies and no relevant medical history, conflict information). On unspecified date, the patient started suspect therapy with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, unit, frequency, strength, lot# expiration date were not reported) for prophylaxis. From unspecified date in 2020, the patient started with upadacitinib (RINVOQ) 15 mg orally daily (lot#1138391) for rheumatoid arthritis. On an unknown date, the patient experienced cellulitis. In unspecified date in 2020, the patient experienced rashes and shingles. It was unknown if the patient was enrolled in a covid-19 vaccine trial. In February 2021, the patient received 1st dose of covid-19 vaccine tozinameran manufactured by Pfizer. In March 2021, the patient received the 2nd dose tozinameran. In March 2021, the patient experienced misuse/ stopped taking upadacitinib (RINVOQ) because of autoimmune condition and it was not advised by physician. The patient had taken a break from upadacitinib (RINVOQ) treatment started in March 2021 and turning at the end of June 2021. In June 2021, the patient experienced nerve pain. In June 2021, the rashes resolved. On 01-JUN-2021, the patient experienced inflammation on hands. On 30-JUN-2021, the patient experienced rheumatoid arthritis flare ups and low grade fever. In July 2021, the patient experienced cannot sleep and cannot relax. On 01-JUL-2021, the low grade fever resolved. Upadacitinib (RINVOQ) did help with her rheumatoid arthritis and with that she had returned back to treatment and was prescribed with a month long steroid pack. She was stopped taking upadacitinib (RINVOQ) because of her autoimmune condition and it was not advised by her physician. She stated she saw her physician last on 06-JUL-2021 and restarted upadacitinib (RINVOQ) again. It was also reported as intentional misuse in product use duration and autoimmune was stopped on the same day (outcome for both events was reported as unknown, conflict information). The patient was treated with fexofenadine hydrochloride (ALLEGRA), prednisone and gabapentin. Outcome of inflammation localized, difficulty sleeping, feeling anxious, nerve pain, rheumatoid arthritis flare up, shingles was reported as improved at the reporting time. Outcome of intentional misuse in product use duration, cellulitis, autoimmune disorder was reported as unknown. Action taken with upadacitinib (RINVOQ) regarding all of the events were reported as dose not changed. Action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding all of the events were reported as unknown. The reporter's causality for the event (s) of inflammation on hands, cannot sleep, cannot relax and rheumatoid arthritis flare ups with upadacitinib (RINVOQ) was a reasonable possibility. The reporter's causality for the event(s) of misuse/stopped taking upadacitinib (RINVOQ) because of autoimmune condition and it was not advised by physician onset in March 2021, rashes, nerve pain, cellulitis, low grade fever, shingles and misuse/stopped taking upadacitinib (RINVOQ) because of autoimmune condition and it was not advised by physician onset in March 2021 was not provided. Alternate etiology for cellulitis was reported as pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). Causality with other events with pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) were not reported. Upon internal review, cellulitis, rheumatoid arthritis flare up and autoimmune disorder were determined to be medically significant events.

Other Meds: RINVOQ

Current Illness: Abstains from alcohol; Drug hypersensitivity; Non-smoker; Rheumatoid arthritis

ID: 1703327
Sex: F
Age:
State: AR

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/16/2021
Hospital: Y

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: the patient began to experience weakness in her hands and legs; The patient was found to have decreased grip strength; This spontaneous report was received from a physician via company representative, referring to a 21-year-old female patient. Information regarding the patient's pertinent medical history, concomitant therapies and previous drug reactions or allergies were unknown by the reporter. On 07-SEP-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (ml) as prophylaxis (formulation, vaccination scheme frequency and anatomical location were not reported; route of administration, lot number and expiration date were unknown by the reporter). On the same date, at an unspecified time after the administration, while the patient was still in the office, the patient began to experience weakness in her hands and legs (muscular weakness) and was found to have decreased grip strength. The patient declined to remain in the office for observation and that evening the patient reported that her symptoms had not decreased. On an unknown date in September 2021, the patient was hospitalized and it was reported that she would be in the hospital for 5 days. The patient saw a neurologist who did not believe that the patient's condition was caused by the hpv rl1 6 11 16 18 31 33 45 52 58 vlp (yeast) vaccine (GARDASIL 9). According to the reporting physician, the neurologist stated that "it should not have happened that fast from the vaccine". No treatment was administered for adverse events. It is unknown if laboratory studies or diagnoses were performed. The outcome of the events muscular weakness and grip strength decreased was reported as not recovered. The reporting physician did not provide the causality assessment between the events muscular weakness and grip strength decreased and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).; Sender's Comments: US-009507513-2109USA002610:

Other Meds:

Current Illness:

ID: 1703334
Sex: F
Age: 54
State: WA

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 09/16/2021
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: Heart fluttering; Heart issue; Severe chest pain; Inappropriate route of vaccination; This case was initially received via another Manufacturer (Reference number: PVIUS2021001184) on 18-Aug-2021. The most recent information was received on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. The license partner had received the report from VAERS (Reference number: 1638756). This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9LU-18343-69467) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arrhythmia, Blood pressure high and Asthma. On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) .5 milliliter. On 29-Apr-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), CARDIAC DISORDER (Heart issue), CHEST PAIN (Severe chest pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). The patient was treated with LORAZEPAM for Adverse event, at an unspecified dose and frequency. At the time of the report, CARDIAC FLUTTER (Heart fluttering), CARDIAC DISORDER (Heart issue) and CHEST PAIN (Severe chest pain) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Cardiac flutter and non-serious events of Cardiac disorder and Chest pain, a causal relationship cannot be excluded; however case causality is confounded by the patient's known history of arrhythmia and hypertension. Causality for the event Incorrect route of product administration assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow up received included new event added. On 07-Sep-2021: The report type of this case was updated from spontaneous to regulatory authority. Event onset date for the event Heart issue and Severe chest pain were added. Outcome for the events Heart fluttering, Heart issue and Severe chest pain were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Cardiac flutter and non-serious events of Cardiac disorder and Chest pain, a causal relationship cannot be excluded; however case causality is confounded by the patient's known history of arrhythmia and hypertension. Causality for the event Incorrect route of product administration assessed as not applicable.

Other Meds:

Current Illness: Arrhythmia; Asthma; Blood pressure high

ID: 1703335
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/16/2021
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: 1st Dose Administered to a 15-year-old; Initial Report Received on 20-Jul-2021 and 23-Jul-2021 A pharmacist reported that a 15 year-old male patient (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No relevant medical history was reported. No relevant concomitant medications were reported. On an unspecified date, a 15 year-old male patient received the first dose of HEPLISAV-B (Lot # 934601, expiration date 16-Mar-2022; NDC # and serial number were not reported) injection in the left deltoid from a medical office. No adverse effects were reported. The reporter asked if the second dose of HEPLISAV-B should be given or if another vaccine should be used. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds:

Current Illness:

ID: 1703336
Sex: U
Age: 15
State: NC

Vax Date: 05/27/2021
Onset Date: 05/27/2021
Rec V Date: 09/16/2021
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: 15 year-old Given Heplisav-B; Initial Report Received on 23-Jul-2021 A Medical Center Operations Director reported that a 15 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No relevant medical history was reported. No relevant concomitant medications were reported. On 27-May-2021, the recipient received dose 1 of HEPLISAV-B (Lot # 93767, Expiration 11-Apr-2022; NDC # not reported) in the right deltoid. On 23-Jul-2021, the recipient presented for the second dose. The recipient reported he has not had any adverse reactions from the first dose. No additional information was provided. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds:

Current Illness:

ID: 1703337
Sex: U
Age:
State:

Vax Date: 07/13/2021
Onset Date:
Rec V Date: 09/16/2021
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: Pregnancy; Initial Report Received on 28-Jul-2021 A pregnant female, over the age of 18 years (state, race and ethnicity not provided), reported to the pregnancy registry that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. At the time of report, she reported being 6-weeks pregnant. No relevant medical history was reported. No concomitant medications were reported. On 13-Jul-2021, the pregnant patient was vaccinated with a "booster" of HEPLISAV-B (Lot #, expiration date and NDC # not reported). She declined participation the registry and no additional information was provided. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am