VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 0919831
Sex: F
Age: 25
State: NY

Vax Date: 12/28/2020
Onset Date: 01/04/2021
Rec V Date: 01/05/2021
Hospital:

Lab Data: n/a

Allergies: no known allergies

Symptoms: Patient reported swelling on the injection site, itchiness, warmth and soreness.

Other Meds: n/a

Current Illness: unknown

ID: 0919832
Sex: F
Age: 28
State: WA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: N/a

Allergies: Seasonal, mild

Symptoms: 12/31, 08:30pm: Immediate pain & welt developed at sight 12/31, 08:45pm: Slight numbness & tingling in left hand, persisted approximately 12 hours 12/31, 09:30pm (the following s/s persisted in varying degrees until 01/02): exhaustion/fatigue, headache, dizziness, nausea, chills 01/02, 08:30am: chills/cold sweat/fever (temp not confirmed, as my home thermometer had died, but I woke up later that night drenched in sweat as though a fever had broken, and since then my body temp has been normal (no cold chills or hot flashes) and other s/s have also decreased significantly) 01/03: minimal s/s - lingering fatigue, mild 01/04: 03:00a: woke up with cough - uncertain if related (seasonal allergies?)

Other Meds: Lamotrigine 150mg 1x/day Apri Birth Control CBD 30mg cap 1x/day Loratadine Allergy 1x/day

Current Illness: N/a

ID: 0919833
Sex: F
Age: 24
State: IL

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: N/A

Allergies: NKA

Symptoms: Symptoms were chills, fatigue, body aches, headache, fever, tachycardia that started about 12 hours after receiving the vaccine and lasted for about 3 days.

Other Meds: Sprintec

Current Illness: N/A

ID: 0919834
Sex: F
Age: 16
State: NY

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Age at the time of vaccination was 16. Not identified until after the vaccine was administered.

Other Meds:

Current Illness: None reported. Age 16 at the time of the vaccine. Not identified until after vaccination is complete.

ID: 0919835
Sex: F
Age: 62
State: IL

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data: none

Allergies:

Symptoms: light headed and nausea for 3 days

Other Meds:

Current Illness:

ID: 0919836
Sex: F
Age: 35
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies: amoxicillin (hives), ampicillin (rash), ibuprofen (dyspepsia)

Symptoms: 10 minutes after receiving vaccination, patient reported rapid heart rate, fatigue, felt weak, hot, and palpitations. Patient reported tachycardia with heart rate 160-170's. Transient numbness to hands and perioral region. Presented to ED, was monitored with resolution of symptoms. On 1/4/21 patient presented to ED with tachycardia with HR up to 160s, Episode was severe, causing lightheadedness, "throat squeezing", with bilat UE paresthesias. Episode lasted 20 minutes. Patient evaluated in ED and discharged with outpatient follow up with cardiology and endocrinologist.

Other Meds: levothyroxine, progesterone, estradiol

Current Illness: Hashimoto's diagnosed age 17, on levothyroxine since 2019, dose increased 12/25/20

ID: 0919837
Sex: F
Age: 60
State: PR

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies: Aspirin,almonds,walnuts,shellfish

Symptoms: Tight throat.Drank 1 pill benadryl.After few hours the symptoms were gone

Other Meds: Losartan,Keppra

Current Illness:

ID: 0919838
Sex: F
Age: 24
State: MI

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies: Lactose Intolerant Allergic to Cyanoacrylate Allergic to Cervical Cancer Vaccine

Symptoms: less than 24 hours after getting shot #1 i felt as if i was coming down with a cold, very congested, stuffy nose, slight sore throat probably from drainage. injection site pain which is normal, but i just felt under the weather. it cleared up within 48 hours of time of injection.

Other Meds: Zoloft 100mg Apri 28 day 1200mg Fish Oil HUM Daily cleanse skin supplement green algae and herbs 450mg Cranberry extract supplements

Current Illness: NA

ID: 0919839
Sex: F
Age: 62
State: MD

Vax Date: 01/02/2021
Onset Date: 01/02/2021
Rec V Date: 01/05/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Cold legs, Fever, bodyache including fingers ache, chills, nausea, body weakness, headache. From Saturday to Tuesday. Tylenol

Other Meds: None

Current Illness: None

ID: 0919855
Sex: U
Age:
State: MO

Vax Date: 10/08/2020
Onset Date: 10/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 1 dose of V ARIV AX administered 10/08/2020 after the vaccine experienced a temp excursion; No additional AE details; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided. On 08-OCT-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T000344 and expiration date 05-JAN-2022, frequency and route were not reported) for prophylaxis. It was reported that the suspect vaccine was exposed to a temperature minus 13.5 degree Celsius for a time frame of 8 hours and 55 minutes, the temperature excursions were detected by a data logger. There was no previous temperature excursion. No additional adverse event (AE) information provided.

Other Meds:

Current Illness:

ID: 0919856
Sex: F
Age:
State:

Vax Date: 12/08/2020
Onset Date: 12/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I think it was given IM instead of SQ; This spontaneous report was received from a consumer referring to herself of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided. On 08-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and dose were not reported, lot# was reported as T00370, expiration date was not provided) for prophylaxis. The reporter thought the suspect vaccine was given Intramuscular (IV) instead of subcutaneous (SQ). She wanted to know if it was ok if it was given IM. This agent referenced the varicella virus vaccine live (oka/merck) (VARIVAX) prescribing information (PI) regarding route of administration and method of administration. This agent referred the reporter to her healthcare provider. The reporter verbalized understanding and said if it was given IM instead of SQ she would call back.

Other Meds:

Current Illness:

ID: 0919857
Sex: U
Age: 55
State: MI

Vax Date: 11/23/2020
Onset Date: 11/23/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional information was provided regarding if the consumer experienced any side effects; PNEUMOVAX 23 was administered on 23 NOV 2020 after the excursion occurred; This spontaneous report was received from a registered nurse and refers to a 55-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in prefilled syringe, lot # T022294, expiration date: 26-MAR-2022, 1 time dose (injection site and route of administration were not provided) for prophylaxis. The administered vaccine had experienced a temperature excursion of above 9 degrees Celsius (C) (13.5 C) for 3 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds:

Current Illness:

ID: 0919858
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rash pruritic; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 28-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for painful itching rash (rash pruritic). The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX). Additional information was received on 22-DEC-2020 from a Licensed Practical Nurse via medical records concerning a patient of unknown age and gender who had risk factor for hepatitis C. On 28-AUG-2015, the pt. was vaccinated with zoster vaccine live (ZOSTAVAX) 0.65 ml subcutaneously in left arm (lot # L015416 with expiration date of 01-AUG-2016 with sterile diluent with expiration date of 15-MAY-2016.

Other Meds: STERILE DILUENT

Current Illness: Disease risk factor

ID: 0919859
Sex: U
Age: 1
State: IA

Vax Date: 12/03/2020
Onset Date: 12/03/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A pediatric patient was administered VAQTA (pediatric dose vial ) that was past expiration date.; This spontaneous report was received from a Nurse Practitioner referring to an 18 month old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 03-DEC-2020, the pediatric patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA)(strength, route, dose, frequency, and anatomical location were unknown) pediatric dose vial that was past expiration date, with lot # S034636 and expiration date 14-NOV-2020, for prophylaxis.

Other Meds:

Current Illness:

ID: 0919860
Sex: U
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: temperature excursion for MMR II; No additional AEs; This spontaneous report was received from a medical assistant referring to patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided. On unknown dates, these patients received improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, route, vaccination scheme and anatomical sites of vaccination were not reported, lot # S015284, expiration date 19-MAY-2021) for prophylaxis. The vaccine administered experienced a temperature excursion of 52.3 degrees Fahrenheit, for a time frame of 1 hour and 45 minutes. There were no previous temperature excursions. The call was not due to digital data logger. Due to Coronavirus (COVID-19), no one could monitor the data logger information. No additional adverse events reported. This case has been considered non-valid due to the lack of patients' identifiers.

Other Meds:

Current Illness:

ID: 0919861
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Caller is reporting a 4 year old given PROQUAD AND VARIVAX at the same time.; Caller reports no other AE with this event.; This spontaneous report was received from a caller and refers to a 4-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration, anatomical location, lot # and expiration date were not reported) at the same time (inappropriate schedule of product administration). Both vaccines were administered for prophylaxis. There was no other adverse event reported.

Other Meds:

Current Illness:

ID: 0919862
Sex: U
Age:
State: PA

Vax Date: 12/12/2020
Onset Date: 12/10/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. On 07-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis. The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-2012USA010555: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010629: US-009507513-2012USA010652: US-009507513-2012USA010667: US-009507513-2012USA010678: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:

Other Meds:

Current Illness:

ID: 0919863
Sex: F
Age: 65
State: IL

Vax Date: 07/13/2018
Onset Date: 07/13/2018
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: bad reaction; leg cramps; swelling at the injection site; vomiting; fever; This spontaneous report has been received from a 65 years old (currently was 67 years old) female patient. Concomitant therapies included levothyroxine sodium (SYNTHROID). The patient was allergic to sulfa. Information about medical history and concurrent conditions was not provided. On 13-JUL-2018, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date and dose details were not provided) intramuscularly for prevention of pneumococcal disease. On an unknown date, the patient started therapy with generic formulation of atorvastatin calcium (LIPITOR) (lot #, expiration date, strength, route and dose details were not provided) for unknown indication. On 13-JUL-2018, 6 hours after administration of the vaccine, the patient experienced swelling at the injection site, fever and vomiting. On an unknown date, the patient had a bad reaction after vaccination of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). On an unknown date, the patient experienced leg cramps from the generic formulation of atorvastatin calcium (LIPITOR). The patient was seen by her doctor on 14-JUL-2018 (reported as the next day) and did not recall if any treatment was provided for her symptoms or when she recovered from these symptoms. At the time of this report, the outcome of the events was unknown. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.

Other Meds: SYNTHROID

Current Illness: Sulfonamide allergy

ID: 0919864
Sex: F
Age:
State: MA

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No adverse event; a baby was administered a adult dose of VAQTA; the vaccine was expired; This spontaneous report was received from a medical assistant (also reported as nurse) referring to a 1-year-old female patient. The patient's concomitant medication, drug reactions, allergies and medical history were unknown. On 23-DEC-2020, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 1ml, once, lot # S030588 with expiration date 20-OCT-2020 (route of administration was not reported) for prophylaxis (incorrect dosage administered, no adverse event and expired product administered). No additional adverse event (AE) was reported.

Other Meds:

Current Illness:

ID: 0919865
Sex: U
Age:
State: CA

Vax Date: 09/23/2020
Onset Date: 09/23/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no additional AE/PQC reported; administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 23-SEP-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA) (PROQUAD) lot # T015598, expiration date 02-NOV-2021 for prophylaxis (exact dose, strength, dose #, route of administration and anatomical location were not provided). The temperature excursion was as follows: 20.5 degrees Fahrenheit (F) for 1 hour and 54 minutes. There was following previous excursion: from 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.3 F) for 23 hours. The digital data logger was involved. No additional adverse events were reported.

Other Meds:

Current Illness:

ID: 0919866
Sex: U
Age:
State: NY

Vax Date: 09/15/2020
Onset Date: 09/15/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; administration of improperly stored VARlVAX; This spontaneous report was received from a caller (unspecified) informing agent of the administration and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002842, expiration date 23-JAN-2022 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8 to -14 degrees Celsius from 05-SEP-2020 to 15-SEP-2020. Data logger was involved. There were no previous excursions reported.

Other Meds:

Current Illness:

ID: 0919867
Sex: U
Age:
State: PA

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; the MMRII expired on 12/9/2020 and was inadvertently administered to the patient on 12/23/2020; This spontaneous report has been received from a licensed practical nurse concerning a 1 year old of unknown gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported. On 23-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 ml, Lot # R035700, expiration date 09-DEC-2020 for prophylaxis (dosage regimen was not reported). It was reported that no additional adverse events were reported (AE) and that the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live did not experience any temperature excursion.

Other Meds:

Current Illness:

ID: 0919868
Sex: U
Age:
State: CA

Vax Date: 09/29/2020
Onset Date: 09/29/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 29-SEP-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T015598 with expiration date of 02-NOV-2021, for prophylaxis. The administered vaccine experimented temperature of excursi?n of 20.5 degrees Fahrenheit for 1 hour 54 minutes 0 seconds; previous temperature excursion? 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.3F) for 23 hours 0 minutes 0seconds. Digital data logger was involved.

Other Meds:

Current Illness:

ID: 0919869
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: anaphylactic reaction; This spontaneous report has been received from an approximately 57 years old male patient, referring to himself via Pfizer. The patient's concurrent conditions included an allergy to eggs. Medical history and concomitant medications were not provided. On an unknown date in 1970 (reported at the age of 7 years old), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. In approximately 1970, the patient experienced an anaphylactic reaction and required treatment with epinephrine. The patient worked in a long term care assisted living facility and was unable to obtain the mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose (COVID-19) vaccine (Pfizer-Biontech) due to the facility refused to vaccinate him after the patient divulged that he had the previously reaction with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine. The outcome of anaphylactic reaction was unknown. The reporter considered anaphylactic reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II). Upon internal review, anaphylactic reaction was determined to be medically significant.

Other Meds:

Current Illness: Egg allergy

ID: 0919870
Sex: F
Age: 66
State:

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Syncope; This spontaneous report as received from a pharmacist, and refers to a 66 year old female patient with asthma. The patient is allergic to sulfa, novocaine and lidocaine. Information regarding the patient's medical history was not reported. On 27-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T022294 and expiration date on 26-MAR-2022, intramuscular in the left deltoid for pneumococcal prophylaxis. On the same day, she had a syncope. The patient did not seek for medical attention and any treatment was given. At the reporting time, reported as "this morning", the syncope was improving but ongoing. The reporter considered syncope to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). Upon internal review, the event of syncope was considered to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: PNEUMOVAX 23 SYRINGE (DEVICE)

Current Illness: Asthma; Drug hypersensitivity

ID: 0919871
Sex: F
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919872
Sex: M
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919873
Sex: F
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919874
Sex: M
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919875
Sex: F
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919876
Sex: F
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919877
Sex: M
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919878
Sex: M
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919879
Sex: F
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919880
Sex: F
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919881
Sex: M
Age:
State: TX

Vax Date: 11/08/2020
Onset Date: 11/08/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919882
Sex: M
Age: 13
State: FL

Vax Date: 06/29/2018
Onset Date:
Rec V Date: 01/05/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Chron's disease; This spontaneous report was received from a physician referring to a 16 years old male patient. The patient's pertinent medical history, concomitant drugs and drug allergies were reported as unknown. On 29-JUN-2018, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, route, lot number and expiration date were not reported) for prophylaxis. And on 31-JAN-2019, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 30-JUN-2019, the patient was admitted to the hospital and on an unknown in 2019, he was diagnosed with Chron's disease. The outcome of Chron's disease was unknown. It was unknown if he received any treatment. It was unknown if the patient had sought medical attention or if any lab diagnostics/studies were performed. The outcome of crohn's disease was unknown. The causality between Chron's disease and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Upon internal review, Chron's disease was determined to be medically significant.

Other Meds:

Current Illness:

ID: 0919883
Sex: M
Age:
State: MS

Vax Date: 12/29/2017
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: cerebrovascular accident/right leg weakness, numbness, trouble ambulating and confusion/concomitant weakness related to his cerebrovascular accident; meningoencephalitis; dementia; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 29-DEC-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered right leg weakness, numbness, trouble ambulating and confusion. The pt was diagnosed with having a cerebrovascular accident, meningoencephalitis and dementia with concomitant weakness related to his cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be disabling.

Other Meds:

Current Illness: Routine health maintenance

ID: 0919884
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: congestive heart failure; renal failure; lung problems; Information has been received regarding a case in litigation from an attorney concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not provided. On unspecified date, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (lot #, expiration date, route of administration, dosage, and anatomical location were not provided) for prevention of shingles. After receiving the dose of Zoster Vaccine Live (ZOSTAVAX), the patient suffered congestive heart failure, lung problems and renal failure. As a result of these symptoms, the patient was seen and treated by the medical provider and was still under their care. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present prior the use of this vaccine, and the patient sustained severe and permanent personal and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX). The patient had not recovered from the events, and the author considered the events to be disabling. Upon internal review cardiac failure congestive and renal failure were considered medically significant.

Other Meds:

Current Illness:

ID: 0919885
Sex: U
Age: 1
State: MD

Vax Date: 12/07/2020
Onset Date: 11/17/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No other AE; Caller reports AE related to administration of expired PROQUAD.; Excursion occurred 11/17/2020; This spontaneous report was received from an office manager, referring to a 12-months-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported. On 17-NOV-2020, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number T016991, which has been verified to be valid, expiration date reported and validated as 11-NOV-2021) experienced temperature excursion (product storage error). On 07-DEC-2020, the patient received the mentioned vaccine, which was expired (expired product administered ) at a dose of 0.5 milliliter, as prophylaxis (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not provided). No additional adverse events were reported. This is one of several reports received from the same reporter.

Other Meds:

Current Illness:

ID: 0919886
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: temperature excursion; This spontaneous report was received from a registered nurse and refers to currently 11-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1637641 with expiration date 16-FEB-2022 (dose, route, and anatomical location were not reported) which where stored at temperature excursion. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was exposed to temperatures between 0.3 and 11 degrees Celsius during 4 hours 45 minutes and 1 hour, 30 minutes respectively. There was previous temperature excursion of 17 degrees Celsius during 2 hours and 42 minutes. Data digital logger was filled. This is one of several reports from the same source. 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: 1637641; expirationdate: 16-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: GARDASIL 9 SYRINGE

Current Illness:

ID: 0919887
Sex: U
Age:
State: ME

Vax Date: 07/19/2019
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a patient received the GARDASIL 9 vaccine on 19-JUL-2019. They have not received their second dose yet; No additional AE was reported; This spontaneous report was received from an administrator and refers to a 14-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 19-JUL-2019, 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) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. At the time of the report, the patient had not received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 0919888
Sex: U
Age:
State: IN

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she denies any further AE/PQC; patient has received the vaccine prior temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported. On 28-DEC-2020, the patient received an improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T021828, which has been verified to be valid, expiration date reported and validated as 25-JUN-2022). The vaccine administered experienced a temperature excursion of -6.7 degrees Celsius, for a time frame of 22 hours, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2012USA013452:

Other Meds:

Current Illness:

ID: 0919889
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient received an improperly stored vaccine; This spontaneous report as received from a medical assistant refers to a currently 5 year old female patient. On an unknown date, the patient was vaccinated with a 0.5 mL dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T025221 exp date 19-JAN-2022) (route not reported) first identified on 28-DEC-2020. There was a data logger issue reported. The temperature of excursion was -6.7 ?C for a time frame of 22 hours. There was no previous temperature of excursion.

Other Meds:

Current Illness:

ID: 0919890
Sex: U
Age:
State: IA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: improperly stored ROTATEQ was administered; This spontaneous report as received from a nurse refers to a 2 month old patient. On 28-DEC-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660991 exp date 27-APR-2021) orally. Data logger issue was reported. The temperature of excursion was 9?C (8.5 ?C) for a time frame of 2 hours and above 9 ?C (8.5 ?C) for a time frame of 2 hours. There was no previous temperature excursion.

Other Meds:

Current Illness:

ID: 0919891
Sex: F
Age: 62
State: OK

Vax Date: 07/31/2014
Onset Date: 09/14/2016
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No adverse event; Pneumococcal received on 31-JUL-2014 and 14-SEP-2016; This spontaneous report was received from a 65-year-old female patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported. On 31-JUL-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as "pneumococcal") for prophylaxis. (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On 14-SEP-2016, it was reported that another doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumococcal") was administered (inappropriate schedule of product administration). No adverse event involved with vaccine reported. This is one of two reports received from the same patient.; Sender's Comments: US-009507513-2004USA006765:

Other Meds:

Current Illness:

ID: 0919892
Sex: F
Age: 67
State:

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: allergic reaction from the PNEUMOV AX 23 vaccine; entire upper left arm is swollen 3 times the size; pain.; This spontaneous report was received from a 67-year-old female patient who was reporting on herself. The patient's medical history and concomitant therapies were reported as "no". She was allergic to latex and many unspecified antibiotics. She was vaccinated with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVENAR) last year and never had any issues with it. On 28-DEC-2020, the patient was vaccinated with dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection into left arm (dose, lot number, expiration date, route of administration and strength were not provided) as prevention for pneumonia. On 28-DEC-2020, few hours after vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the allergic reaction occurred. Her upper left arm was swollen 3 times the size, she also was experiencing pain. The patient reported that the pain was 10 on 1 to 10 scale. She sought medical attention and contacted her doctor. Her physician informed her to use ice and acetaminophen (TYLENOL) for pain and swelling. The patient still did not recover from the mentioned events. She wants to know how long it would take to recover from the reaction. The reporter considered all events to be related to with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).

Other Meds:

Current Illness: Allergic reaction to antibiotics; Latex allergy

ID: 0919893
Sex: F
Age:
State: PA

Vax Date: 09/25/2018
Onset Date: 09/01/2018
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe swelling in the arm, so bad it looked like cellulitis/ severe reaction; severe swelling in the arm, so bad it looked like cellulitis/ severe reaction; This spontaneous report was received from a female patient of unknown age who was reporting on herself. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided. On 25-SEP-2018, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) for prophylaxis. The patient requested ingredients contained in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) because on an unknown date in September 2018 she experienced severe swelling in the arm. The swelling looked so bad, like cellulitis. She sought for medical attention and informed her physician about this event, but also refused to inform if ant treatment was provided. The outcome of arm swelling looking like cellulitis was unknown. The reporter did not provide a causal assessment between the mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Upon internal review, cellulitis was determined to be medically significant.

Other Meds:

Current Illness:

ID: 0919894
Sex: U
Age:
State: VA

Vax Date: 10/26/2020
Onset Date: 12/28/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No other AE; The patient did not receive the full dose of GARDASIL 9; The patient did not receive the full dose of GARDASIL 9; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided. On 26-OCT-2020 and on 28-DEC-2020, the patient was vaccinated respectively first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) for prophylaxis. 28-DEC-2020, during the second vaccination, the needle broke (product administration interrupted) and therefore patient did not receive the full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (underdose). There was no product quality complain (PQC) because the needle was made by other manufacturer. No other adverse event (AE) was reported. Due to that the patient did not received full dose of vaccine the dose was determined to be invalid. 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.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: GARDASIL 9 SYRINGE

Current Illness:

ID: 0919895
Sex: M
Age:
State: NV

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/05/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient was given expired VAQTA; This spontaneous report as received from a medical assistant and refers to a 39-year-old male patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided. On 28-DEC-2020, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, intramuscular injection (anatomical location and strength were not provided) lot # S025258, expiration date 05-NOV-2020, for prophylaxis. At the reporting time the patient seems to be fine and have not sought for medical attention. No product quality complain was present. The patient did not die and the event of administration of expired vaccine was not life threatening. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm