VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1010905
Sex: F
Age:
State: MO

Vax Date: 01/20/2021
Onset Date: 12/01/2020
Rec V Date: 02/08/2021
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Symptoms: nipples are more sensitive/tender; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; This is a spontaneous report from a contactable consumer. A 33-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL9261), via an unspecified route of administration in right arm 20Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation . The patient's medical history was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid-19 prior to vaccination, not been tested for COVID-19 prior to vaccination. Concomitant medications were not reported. She had her first dose of bnt162b2 (lot EJ1686) on 30Dec2020 via unknown route in the right arm. The patient's concomitant medications were not reported. She reported an increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes since the first vaccine (Dec2020) but it has gotten more noticeable since the second vaccine. She has also reported that her nipples are more sensitive/tender since vaccination (20Jan2021). No treatment was given to the events. The outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 1010906
Sex: F
Age:
State: NC

Vax Date: 01/19/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
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Symptoms: Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 19Jan2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 22Jan2021, the patient developed an anaphylactic reaction. She went to the doctor and he was reluctant to give her steroids which was the normal way of treating the anaphylactic reactions because he said that the steroid would interfere with the effect of the vaccine. So, he gave her diphenhydramine hydrochloride (BENADRYL). She had to go back to the emergency room later that day and they used epinephrine (EPIPEN) and she had to have an intravenous (IV) and other than that some medications, it had prednisolone in it. Then she had to go back yesterday and she had another IV and they sent her home with an EPIPEN. The event was assessed serious as medically significant. The patient had recovered from the event in Jan2021.

Other Meds:

Current Illness:

ID: 1010907
Sex: M
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
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Symptoms: The patient's concomitant medication included adalimumab (HUMIRA); The patient's concomitant medication included adalimumab (HUMIRA); 24hr headache occurred after each vaccine dose; This is a spontaneous report from a contactable nurse (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH1284), intramuscular at deltoid right on 07Jan2021 at 10:30 at single dose for COVID-19 immunization. The patient medical history included mild coronary artery disease (CAD), allergy to sulfa and seasonal allergy, all from an unknown date and unknown if ongoing. The patient's concomitant medication included finasteride at 1 mg, clonazepam at 0.5 mg, cetirizine hydrochloride (ZYRTEC) at 10 mg, aspirin at 81 mg, fremanezumab (AJOVY) at 125 g monthly and adalimumab (HUMIRA) twice weekly. The patient previously received MMR/Flu vaccine for immunization and experienced brachial plexus neuritis (parsonage Turner syndrome). The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at deltoid right on 17Dec2020 at 10:30 at single dose for COVID-19 immunization and experienced tachycardia, elevated blood pressure (BP), headache and flushing face turned into red. In Jan2021, the patient experienced 24 hours headache. The patient outcome of the event was recovered.

Other Meds: FINASTERIDE; CLONAZEPAM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ASPIRIN [ACETYLSALICYLIC ACID]; AJOVY [FREMANEZUMAB]; HUMIRA

Current Illness:

ID: 1010908
Sex: U
Age:
State:

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Rec V Date: 02/08/2021
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Symptoms: stopped breathing; Initial information received on 27-Jan-2021 regarding an unsolicited valid serious case received from a consumer via media. This case involves patient (unknown demographics) who experienced stopped breathing (apnoea), while he/she received vaccine INFLUENZA VACCINE. It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious stopped breathing (apnoea) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was also reported that havent had one since 1978 and cant have one. Almost died stopped breathing. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. Information on the batch number was requested.; Sender's Comments: This case involves a patient (unknown demographics) who had apnoea, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1010909
Sex: M
Age:
State: TN

Vax Date:
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Rec V Date: 02/08/2021
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Symptoms: a 5 year old patient received Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Reference number- 00436824) and transmitted to company on 19-Jan-2021. This case involves a five-year-old male patient who received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (Product administered to patient of inappropriate age). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was a case of actual medication error due to inappropriate age at vaccine administration (latency same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1010910
Sex: F
Age: 71
State: FL

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/08/2021
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Allergies: penicillin, sulfa, quinine, red kidney beans

Symptom List:

Symptoms: Dizziness, tightness in back of neck, tightness both sides of throat, tightness in TMJ both sides immediately and over the next 30-40 minutes. Pink donut shaped 3 inch diameter patch at injection site the next day. Immediate reactions resolved within the 40 minute period.

Other Meds: lisinopril, vitamins, minerals

Current Illness: none

ID: 1010911
Sex: F
Age: 63
State:

Vax Date: 01/29/2021
Onset Date: 02/06/2021
Rec V Date: 02/08/2021
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Allergies: Sulfa drugs - Delayed drug eruption at 9 days nearly 20 years ago

Symptom List:

Symptoms: Patient woke up Saturday, 6 Feb, with multiple small raised welts on left shoulder around injection site. Site was itchy. Over the course of the day, site enlarged slightly with a little warmth, but nontender. That day, took a dose of Benadryl and applied topical Hydrocortisone. On Sunday, 7 Feb, area began to improve and applied more Hydrocortisone and took additional Benadryl . Pt stopped her Allegra these 2 days as she was not sure if could take all meds together. On Monday, 8 Feb, patient walked into our Allergy/Immunizations clinic (protocol for anyone who receives an injection and has concerns about a reaction) at our facility and I examined the area with very faint residual erythema, but nonpalpable and nontender. No further itching by Sunday night.

Other Meds: Patient on Allegra 180mg daily for seasonal allergies and Astelin nasal spray every morning.

Current Illness: None

ID: 1010912
Sex: F
Age: 82
State: NY

Vax Date: 01/29/2021
Onset Date: 02/08/2021
Rec V Date: 02/08/2021
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Allergies: None.

Symptom List:

Symptoms: Redness and heat on R foot, left after 15 minutes. Upset bowel system. Have always had opposite problem.

Other Meds: thyroid 05 grain, Alendronate sodium tablet, Ginkgo Biloba, M.C.H.C caps, Cogni-zone mag, Vit. E, Mag. K, B12, MacuGard with Astaxanthin, Biotin, Zinc citrate, L-Theanine, Lutein, liquid D3.

Current Illness: None.

ID: 1010913
Sex: F
Age: 43
State: GA

Vax Date: 02/05/2021
Onset Date: 02/08/2021
Rec V Date: 02/08/2021
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Allergies: None

Symptom List:

Symptoms: Swelling and soreness day 1-3, red itchy rash day 3 at injection site-about 2? in diameter

Other Meds: None

Current Illness: None

ID: 1010927
Sex: F
Age: 28
State: KY

Vax Date: 12/07/2020
Onset Date: 12/01/2020
Rec V Date: 02/08/2021
Hospital: Y

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Symptoms: Arm got infected; 2 syncopal episodes; Headache/H/A; Dizziness; Nausea; Allergic reaction to Chicken pox vaccine; Redness and sore arm/the reaction was a local reaction/ redness around injection site; Swelling around injection site; Erythema and rash left posterior arm; Nurse reported that a patient reported an allergic reaction to "some component" in the VARlVAX"/"definitely not an allergic reaction, just a local reaction."; Redness and sore arm/the reaction was a local reaction; This spontaneous report was received from a registered nurse, 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 provided. On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date not reported). On an unspecified date, the patient reported an allergic reaction to "some component" in the varicella virus vaccine live (oka/merck) (VARIVAX) (vaccination complication), then; the reporter stated that, the reaction was a local reaction, redness and sore arm (erythema and pain in extremity), and added that "definitely not an allergic reaction, just a local reaction". The outcome of vaccination complication, erythema and pain in extremity was reported as recovered. The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) was reported as related. This case has been considered non-valid due to the lack of patients' identifiers. Follow up information was received from a Registered nurse on 01-FEB-2021. This report was now considered valid. Information concerned to a 28 year old female patient. The patient's current conditions included allergy to latex and petroleum jelly, polycystic ovaries syndrome, gastrooesophageal reflux disease, hypothyroidism, bladder spasm and Type 2 Diabetes mellitus. Concomitant therapies included levothyroxine, metformin, oxybutynin chloride (DITROPAN) and famotidine (PEPCID). Historical vaccine included influenza vaccination. On 07-DEC-2020, the patient was vaccinated by the trained registered nurse with dose 1 of single use varicella virus vaccine live (oka/merck) (VARIVAX) (lot No. S003446, exp. date 04-FEB-2021), subcutaneously in the left arm. No illness at the time of vaccination. On 09-DEC-2020, the patient went to the emergency department (ED) since her "arm got infected" (localized infection). The patient was hospitalized. The ED records stated that the patient complaint of 2 syncopal episodes (syncope), H/A (also reported as headache), dizziness, nausea and allergic reaction to chicken pox vaccine (allergy to vaccine). ED provider noted erythema and rash left posterior arm (rash erythematous), redness and swelling around injection site (injection site erythema and injection site swelling). During hospitalization, the patient underwent a computerized tomography head without contrast, electrocardiogram, urinalysis, complete blood count with differential, amylase, comprehensive metabolic panel, lipase, magnesium and all were within normal limits. The patient was given cefalexin (KEFLEX) and doxycycline orally and discharged on an unknown date with prescription for both cefalexin (KEFLEX) 500 mg 4 times daily for 7 days and doxycycline 100 mg, 2 times daily for 7 days. On an unknown date, the patient's symptoms totally resolved. The reporter considered injection site swelling, localized infection, rash erythematous, allergy to vaccine, nausea, dizziness, headache, syncope, and injection site erythema medically significant events. The reporter considered injection site swelling, localized infection, rash erythematous, allergy to vaccine, nausea, dizziness, headache, syncope, and injection site erythema to be related to varicella virus vaccine live (Oka/Merck) (VARIVAX). On 12-JAN-2021, the patient returned to get the second dose of varicella virus vaccine live (oka/merck) (VARIVAX), however the records were reviewed by an advanced practitioner registered nurse, who recommend the patient to not received the second dose.

Other Meds: levothyroxine sodium; metformin; DITROPAN; PEPCID

Current Illness: Bladder spasm; Drug hypersensitivity; Gastrooesophageal reflux disease; Hypothyroidism; Latex allergy; Polycystic ovarian syndrome; Type 2 diabetes mellitus

ID: 1010928
Sex: F
Age: 0
State: TX

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/08/2021
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Symptoms: No further information provided./No other AE.; The customer administered GARDASIL 9 to a 7 month old patient on 1/6/2021; The nurse inadvertantly brought the wrong vaccine; Product dispensing error; This spontaneous report has been received from a registered nurse, concerning a 7 month old female patient. None pre-existing physician diagnosed allergies, birth defects, or medical conditions were reported. None concomitant medications were reported. On 06-JAN-2021, the nurse inadvertently brought the wrong vaccine, for a dispensing error into the patient's room and administered it to the patient. It was reported that the patient was waiting for long than usual , therefore she was trying to be quick and pulled the vaccine. 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) lot # T008101, expiration date of 01-MAY-2022 (reported as 01-MAY-2021), intramuscular (IM), in her thigh for prophylaxis. (inappropriate age, wrong product administered, product dispensing error). The nurse realized the error when she returned to the nurse's lab. The patient was asked to stay for observation, and this situation was reported immediately to the doctor, the company and the poison and infectious disease center. No adverse effects were observed or reported later. None illness at the time of vaccination were reported. The patient was vaccinated at the private doctor's office/hospital with private funds. No temperature excursion occurred as a result of a reading from a Digital Data Logger. It has been determined that case # US-009507513-2101USA003619, is a duplicate of case #US-009507513-2101USA004510. Therefore, case # US-009507513-2101USA004510 is being deleted from our files and the case are consolidated into case # US-009507513-2101USA003619. 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: Merck Sharp & Dohme Corp.; devicelotnumber: T008101; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness: Prophylaxis

ID: 1010929
Sex: U
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 02/08/2021
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Symptoms: inadvertently administered GARDASIL 9 to a 15 month old patient; No other AE; Information has been received from a registered nurse via a field representative referring to a 15 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history or drug reactions/allergies were not provided. On an unknown date, the patient was inadvertently administered one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, route, lot #, expiration date and anatomical location were not provided)(product administered to patient of inappropriate age). There were no other adverse event (AE) or product quality complaints (PQC). The outcome of the events was unknown. The causality assessment was not reported.

Other Meds:

Current Illness:

ID: 1010930
Sex: U
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/08/2021
Hospital:

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Symptoms: No additional AE details; Expired vaccine used; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported. On 11-JAN-2021 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # S030587, expiration date was 06-JAN-2021, route and strength were not reported) 0.5 milliliter for prophylaxis (expired vaccine used). No additional adverse event details was reported.

Other Meds:

Current Illness:

ID: 1010931
Sex: M
Age:
State: WA

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

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Symptoms: received his first two doses of GARDASIL 9 in 2019 as scheduled, but never came back for the third dose. He is inquiring about receiving the third dose now; No additional AE/PQC; This spontaneous report as received from a pharmacist regarding a 45-year-old male patient. The patient's concurrent condition, medical history and concomitant medication were not reported. On unknown dates in 2019, the patient was vaccinated with the first two doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, batch/lot# and expiration date were not reported) for prophylaxis as scheduled, but the patient never came back for the third dose (inappropriate schedule of product administration). The patient was inquiring about receiving the third dose now. No additional adverse event reported (no adverse event).

Other Meds:

Current Illness:

ID: 1010932
Sex: F
Age: 33
State: CA

Vax Date: 12/19/2020
Onset Date:
Rec V Date: 02/08/2021
Hospital:

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Symptoms: arm soreness; Pregnancy; This spontaneous report was received from a 33 years old female patient via Pfizer, referring to herself. The patient's concomitant medication included probiotics (unspecified), iron (unspecified) (+) minerals (unspecified) (+) vitamins (unspecified), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC). Concomitant vaccine included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Medical history included seasonal allergies and 2 previous pregnancies. The patient had no perinatal mental health (PMH), no history of genetic abnormalities materal or patemal. The patient's family medical history included seasonal allergies of father. On 29-SEP-2020, the patient was pregnant. The last menstrual period (LMP) was on 10-SEP-2020 and estimated date of delivery was 17-JUN-2021. The pregnancy outcome was pending and fetus outcome was on an unknown date in 2021. Ultrasound at 8 and 14 weeks was normal. On unknown dates, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/merck) (manufacturer unknown) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis (exposure during pregnancy). On 19-DEC-2020, the patient was vaccinated with the first dose of SARS-CoV-2 vaccine (unspecified) (reported as BNT16282) 0.3mcg via intramuscular route as COVID-19 vaccine. At 09:10 on 09-JAN-2021, the patient was vaccinated with the second dose of SARS-CoV-2 vaccine (unspecified) (reported as BNT16282) (0.3mcg, lot# EJ1685, expiration date March 2021) via intramuscular route in left deltoid as COVID-19 vaccine at workplace clinic. On the same day, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced arm soreness. No emergency room or physician office was required. The outcome of the event was unknown. Action taken with suspect vaccines was not applicable. The relationship between the event and all suspect vaccines was not reported.

Other Meds: diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid; ZYRTEC; FLONASE; iron (unspecified) (+) minerals (unspecified) (+) vitamins (unspecified); probiotics (unspecified)

Current Illness: COVID-19 immunisation; Gastrointestinal disorder; Pregnancy; Seasonal allergy

ID: 1010933
Sex: F
Age:
State: MI

Vax Date: 04/08/2009
Onset Date: 04/09/2009
Rec V Date: 02/08/2021
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Symptoms: patchy red rash all over; patchy red rash all over; hands/feet were swollen; lips were swollen; she was allergic to in the vaccine; This spontaneous report was received from a currently 23-year-old female nurse, concerning herself. The patient stated that she was allergic to a lot of different antibiotics. Information regarding the patient's medical history, historical drug and concomitant therapies were not provided. On 08-APR-2009 (when the patient was 11 years old), the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for prophylaxis. On 09-APR-2009, the patient experienced a severe reaction to the vaccine; she had symptoms of patchy red rash all over, hands and feet were swollen and lips were swollen. She spoke with her pediatrician and they were never able to determined what she was allergic to in the vaccine. She stated that she reviewed the ingredients in the varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine and believed that it could have been the neomycin content since she is "allergic to a lot of different antibiotics" (reported above) The outcome of the patchy red rash all over, hands and feet swollen and lips swollen was not reported. No causal relationship was reported.

Other Meds:

Current Illness: Allergic reaction to antibiotics

ID: 1010934
Sex: U
Age:
State: NY

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

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Symptoms: Medical assistant calling to check stability o fPEDVAXHIB and rotateq.; This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unspecified age and gender. Information regarding the patients' concomitant therapies, concurrent conditions, medical history and historical drugs was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # S030965 and expiration date 03-APR-2022; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen was not reported), lot # 1688824 and expiration date 07-NOV-2021, both administered as prophylaxis. The improperly stored doses of the suspect vaccines experienced the following temperature excursions: of 54.5 degree Fahrenheit (?F) for 11 hours and 30 minutes and 34.9 ?F for 30 minutes: previous temperature temperature excursions were reported for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) first 50.9?F for 2 hours 30 minutes, and 35.6?F for 1 hour. The call was made due to a digital data logger. This case was classified as non-valid due to no patients identifiers.

Other Meds:

Current Illness:

ID: 1010935
Sex: U
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/08/2021
Hospital:

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Allergies:

Symptom List:

Symptoms: Caller reports administration of ROTATEQ after temperature excursion; This spontaneous report has been received from a consumer concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported. On 11-JAN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml, Lot # 1691141, expiration date 01-NOV-2021 for prophylaxis (dosage regimen was not reported). The storage temperature was reported to had been at 1.3 ?C for 19 minutes. There was digital data logger involved, no previous temperature excursion was reported and no other information was available.

Other Meds:

Current Illness:

ID: 1010936
Sex: U
Age:
State: VA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: administration of ROTATEQ after temperature excursion; This spontaneous report was received from a reporter referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 18-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742457, expiration date reported as 16-FEB-2022 but upon internal validation established as 06-JAN-2022, at a dose of 2 milliliter, orally for prophylaxis. The vaccine was stored in a temperature of 1.3 degree Celsius for 19 minutes as recorded by a data logger. There was no previous temperature excursion reported.

Other Meds:

Current Illness:

ID: 1010937
Sex: F
Age:
State: SC

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

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Symptom List:

Symptoms: a baseball size lump that had developed at injection site; is very red and painful; is very red and painful; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided. On 20-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). The reporter stated that the patient received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) around noon at the doctors office and within 30 minutes noticed a penny size lump at the injection site. The patient drove from a medical center to the reporter's pharmacy to pick up a prescription and showed the reporter a baseball size lump that had developed at the injection site (injection site mass). The reporter stated that it appeared to be growing in size, it was very red (injection site erythema) and painful (injection site pain), and almost resembled a "tick bite". The outcome of injection site mass, injection site pain and injection site erythema was unknown. The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and injection site mass, injection site pain and injection site erythema was unknown.

Other Meds:

Current Illness:

ID: 1010938
Sex: U
Age:
State: HI

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

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Symptom List:

Symptoms: No other AE; a patient received VARIVAX after the product was improperly stored; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 19-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T010309, expiration date 24-MAR-2022, for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The patient did not experience any other adverse event. The vaccine was stored in a temperature of -12.8 degree Celsius for 9 hours and 6 minutes as recorded by a data logger. There was no previous temperature excursion reported.

Other Meds:

Current Illness:

ID: 1010939
Sex: U
Age:
State:

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: administration of ROTATEQ after temperature excursion; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 18-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1691141, expiration date 01-NOV-2021, at a dose of 2 milliliter, oral for prophylaxis. The vaccine was stored in a temperature of 1.3 degree Celsius for 19 minutes as recorded by a data logger. There was no previous temperature excursion reported.

Other Meds:

Current Illness:

ID: 1010940
Sex: F
Age: 6
State: WI

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: no reaction; Will wait 4 weeks and this vaccine wil be readministered correctly; HCP stated the manufacturer of the sterile water is hospira.MMR II was reconstituted with non-merck sterile water and administered to a patient; This spontaneous report has been received from a nurse, initially reported as a medical assistant, concerning a 6 years-old female patient. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported. On 11-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (dosage regimen, anatomical location, Lot # and expiration date were not reported). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was reconstituted with a non-Merck sterile water instead of the Merck specific sterile diluent. The nurse reported the manufacturer. The reporter informed that no reactions had occurred and the patient was fine. They will wait 4 weeks and the vaccine will be readministered correctly. The family was aware of this. Additionally, it was reported that the vaccine was not available for return since it was administered to the patient and no further information was provided.

Other Meds:

Current Illness: Prophylaxis

ID: 1010941
Sex: U
Age:
State: VA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Administration of ROTATEQ after temperature excursion; This spontaneous report has been received from an unspecified reporter(non healthecare professional) concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported. On 14-JAN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml, Lot # 1742457, expiration date reported as 16-FEB-2022 but upon internal validation established as 06-JAN-2022 for prophylaxis (dosage regimen was not reported). The storage temperature was reported to had been at 1.3 ?C for 19 minutes. There was digital data logger involved, no previous temperature excursion was reported and no other information was available

Other Meds:

Current Illness:

ID: 1010942
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

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Symptom List:

Symptoms: fever; illness; the doctor even divided the dose into 2 parts to help manage the reaction; Adverse reaction to MMR; there was also some problem with the lot number; This spontaneous report was received from a other health professional regarding to herself; a female patient of unknown age with egg allergy and crohn's disease. The patient's medical history included allergy to bee sting, pneumonia and anaesthetic complication pulmonary. Information regarding the patient's concomitant therapies and historical drugs was not provided. On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date the patient experienced adverse reaction to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) (vaccination complication), fever (pyrexia) and illness. There was also some problem with the lot number and she had to be vaccinated again on an unknown date. At that time, the doctor divided the dose in two parts to help manage the reaction. The outcome of pyrexia, vaccination complication and illness was unknown. The reporter considered vaccination complication to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) while the causality between fever and illness with the suspect vaccine was not provided. This is one of several cases from the same reporter.; Sender's Comments: US-009507513-2101USA010753:

Other Meds:

Current Illness: Crohn's disease; Egg allergy

ID: 1010943
Sex: U
Age:
State: NY

Vax Date: 12/07/2020
Onset Date: 12/07/2020
Rec V Date: 02/08/2021
Hospital:

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Symptoms: PROQUAD was administered after temperature excursion; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported. On 07-DEC-2020, the patient was vaccinated with one dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) 0.5 ml, subcutaneously, Lot # T013542, expiration date 17-0CT-2021 for prophylaxis (dosage regimen was not reported). The storage temperature was reported to had been at 32.4 ?Fahrenheit (F) for 4 hours. There was digital data logger involved and no previous temperature excursion was reported. This is one of multiple reports received from the same reporter.

Other Meds:

Current Illness:

ID: 1010944
Sex: U
Age:
State: TX

Vax Date: 12/17/2020
Onset Date: 12/17/2020
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
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Symptom List:

Symptoms: No other AE reported.; temperature excursion for the GARDASIL 9; This spontaneous report has been received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided. On 17-DEC-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # 1602284 has been verified to be a valid lot number, expiration date was 26-SEP-2021) via unknown route for prophylaxis. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was involved in temperature excursion (product storage error). The vaccine was stored at the temperature of 31.2 degrees Fahrenheit for 30 minutes. There were no previous temperature excursions. The digital data logger was involved. No product to retrieve. No other adverse event (AE) reported. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1010945
Sex: U
Age:
State: TX

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: No other AE reported.; temperature excursion for GARDASIL 9; This spontaneous report has been received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided. On 11-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # 1602284 has been verified to be a valid lot number, expiration date was 26-SEP-2021) via unknown route for prophylaxis. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was involved in temperature excursion (product storage error). The vaccine was stored at the temperature of 31.2 degrees Fahrenheit for 30 minutes. There were no previous temperature excursions. The digital data logger was involved. No product to retrieve. No other adverse event (AE) reported. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; 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: GARDASIL 9 SYRINGE

Current Illness:

ID: 1010946
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: fever; flu symptoms; achy; lethargic; She had an adverse reaction to Hep B vaccine; This spontaneous report was received from a other health professional regarding to herself; a female patient of unknown age with egg allergy and crohn's disease. The patient's medical history included allergy to bee sting, pneumonia and anaesthetic complication pulmonary. Information regarding the patient's concomitant therapies and historical drugs was not provided. On an unknown date the patient was vaccinated with On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date the patient experienced adverse reaction to hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (vaccination complication), fever (pyrexia) influenza like illness, was achy (pain) and lethargy. The outcome of pyrexia, vaccination complication, lethargy, pain and influenza like illness was unknown. The reporter considered vaccination complication to be related Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB) while the causality between fever, influenza like illness, pain and lethargy with the suspect vaccine was not provided. This is one of several cases from the same reporter.; Sender's Comments: US-009507513-2101USA009976:

Other Meds:

Current Illness: Crohn's disease; Egg allergy

ID: 1010947
Sex: F
Age: 1
State: NY

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

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Symptom List:

Symptoms: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse, referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported. On unspecified dates, the patients were vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T017686 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (lot number T017682 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (doses and frequencies were unknown by the reporter; vaccination schemes, routes of administration, and anatomical site of injection were not reported) as prophylaxis. The administered doses of the vaccine were stored on 19-JAN-2021, at a temperature of 9.1 degrees Fahrenheit (F), during a time frame of 2 hours, as recorded by a digital data logger. There were previous temperature excursions reported on 02-DEC-2020, 6 F to 14 F (11 F) during a time frame of 1 hour, and 14 F to 46 F (36F) during a time frame of 3 hours. On 14-DEC-2020, 6 F to 14 F (13.8 F) during a time frame of 6 hours, and 14 F to 46 F (15.8) during a time frame of 42 minutes. On 21-DEC-2020, 6 F to 14 F (8.8 F) during a time frame of 1 hour and 30 minutes. On 07-JAN-2021, 6 F to 14 F (9.5 F) during a time frame of 10 hours. On 18-JAN-2021, 14 F to 46 F (32.4 F) during a time frame of 5 hours 0 minutes and 0 seconds. No additional adverse events were reported in the patients. This is a non-valid case due to the lack of patient identifiers. Follow up information was received from the licensed practical nurse on 28-JAN-2021 regarding a 1 year old female patient. with 2 siblings, birth weight of 4.7 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), hepatitis a virus vaccine inactivated(HAVRIX) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR). The patient's concurrent conditions and medical history were not provided. Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h. On 14-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# T017686, expiration date 21-MAY-2022, subcutaneously in the left thigh, for prophylaxis, on a private doctor's office/hospital with public funds. This is one of several reports from the same reporter (US-009507513-2102USA002533,US-009507513-2102USA002536,US-009507513-2102USA002535,US-009507513-2102USA002534 and US-009507513-2102USA002537).; Sender's Comments: US-009507513-2102USA002533: US-009507513-2102USA002536: US-009507513-2102USA002535: US-009507513-2102USA002534: US-009507513-2102USA002537:

Other Meds: M-M-R II; HAVRIX; PREVNAR

Current Illness:

ID: 1010948
Sex: M
Age: 16
State: WA

Vax Date: 11/01/2019
Onset Date: 11/01/2020
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

Symptom List:

Symptoms: a GARDASIL 9 alternate dosing interval; This spontaneous report was received from a pharmacist referring to a 18 years old male patient. The patient's concomitant mediation, pertinent medical history and drug allergies or reactions were not reported. On an unknown date in November 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis. According to the prescribing information, instead of receiving the second dose 2 months later in January 2020, the patient missed the January 2020 dose and received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis on an unknown date in November 2020 (inappropriate schedule of product administration).

Other Meds:

Current Illness:

ID: 1010949
Sex: U
Age:
State: AL

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: No additional adverse event reported; Dose of V AQT A that was inadvertently administered after its labeled expiry date; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies pertinent medical history and concomitant therapies were not reported. On 18-JAN-2021, the patient was inadvertently vaccinated with a expired dose of hepatitis a vaccine, inactivated (VAQTA) 25U/0.5 ml, lot # S032359, expiration date 11-JAN-2021, 1 dosage form (route was not reported) for prophylaxis. There were no known temperature excursions on vaccine. Nurse inquired about need for revaccination. No additional adverse event reported, and no further information provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032359; expirationdate: 11-JAN-2021; 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: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1010950
Sex: M
Age:
State:

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
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Lab Data:

Allergies:

Symptom List:

Symptoms: No additional adverse effects to report; his son was administered an expired ROTATEQ vaccine; This spontaneous report was received from the father's son, a patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. On 26-JAN-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dosage form, oral (lot number and expiration date were not reported) for prophylaxis. No additional adverse effects were reported.

Other Meds:

Current Illness:

ID: 1010951
Sex: U
Age:
State: MO

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: an expired GARDASIL 9 was given to a patient; No additional AE/PQCs reported; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided about the patient's pertinent medical history, concomitant medication, drug allergies/reaction. On 27-JAN-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml (strength, route of administration, dose number, lot number was not reported with expiration date of 11-SEP-2020) for prophylaxis (expired product administered). No additional adverse event/product quality complaints (PQCs) was reported.

Other Meds:

Current Illness:

ID: 1010952
Sex: U
Age:
State: IL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: no adverse event; an improperly stored vaccine was administered; 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 25-JAN-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot number 1688504, expiration date reported as 18-NOV-2021, but upon internal validation was determined as 19-NOV-2021, 1 dosage form, oral for prophylaxis. No other adverse event was reported. The vaccines underwent a temperature excursion above 9 degrees Celsius (?C) (13.4?C) for 2 hours and 9 minutes. There were not previous temperature excursion. The call was due to digital data logger.; Sender's Comments: US-009507513-2101USA013457:

Other Meds:

Current Illness:

ID: 1010953
Sex: U
Age:
State: IL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Caller is reporting that an improperly stored vaccine was administered on 25JAN202 l.; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T013205, expiration date reported on 02-DEC-2021, but upon internal validation established as 03-DEC-2021 (anatomical location and administration route were not reported) and with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S004119 expiration date reported on 10-FEB-2021, but upon internal validation established as 11-FEB-2021 (anatomical location and administration route were not reported) both vaccines as prophylaxis. The vaccines had a temperature excursion of above 9 Celsius (?C) (13.4 ?C), during 2 hours and 9 minutes. It was confirm that a digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck. devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1010954
Sex: M
Age:
State: IN

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: patient had warts on hands that "went away" after GARDASIL 9 vaccination series; This spontaneous report as received from a pharmacist refers to a 21 year old male patient. 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) for prophylaxis. The patient had warts on hands that "went away" after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination series. Also reported that these warts had been treated with "other medications" before and "nothing worked".

Other Meds:

Current Illness:

ID: 1010955
Sex: U
Age:
State: IL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/08/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Caller is reporting that an improperly stored vaccine was administered on 25JAN2021; This spontaneous report was received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported. On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, (lot #1688504 has been verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent, expiration date reported as 18-NOV-2021, but upon internal validation established as 19-NOV-2021) l for prophylaxis (strength and administration route were not provided) (product storage error). The vaccine was exposed to a temperature above 9 Celsius degrees (C) (13.4 C) for a time frame of 2 hours and 9 minutes recorded by a digital data logger; the vaccine did not experience previous temperature excursions.

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Current Illness:

ID: 1010956
Sex: U
Age:
State: AR

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/08/2021
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Symptoms: temperature excursion involving PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age or gender. The patient's medical conditions, alletgies or concomitant therapies were not reported. On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml, lot # T025510, expiration date 23-JAN-2022, for prophylaxis (route of administration, and anatomical site of injection were not reported), with a temperature excursion or 8.3F and 8.1F, time frame 5 minutes and 5 minutes respectively, there was no previous temperature excursion and recorded by a digital data logger. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2101USA013383:

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Current Illness:

ID: 1010957
Sex: U
Age:
State: AR

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/08/2021
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Symptoms: Nurse calling to report a temperature excursion involving PROQUAD; 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 reported. On 27-JAN-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were not reported, lot # T025510, expiration date 23-JAN-2022) (therapy type: recombinant Human albumin (rHA)) at a dose of 0.5 milliliter for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to a temperature of minus 8.3 Fahrenheit (F) for a time frame of 5 minutes and 8.1 F for a time frame of 5 minutes, as recorded by the digital data logger. There were no previous temperature excursions. This is one of the several reports reported by the same reporter.; Sender's Comments: US-009507513-2101USA013383: US-009507513-2101USA013552: US-009507513-2101USA013563:

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Current Illness:

ID: 1010958
Sex: F
Age:
State: IN

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/08/2021
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Symptoms: no additional AE; Patient was inadvertently administered expired dose; This spontaneous report was received from a medical assistant referring to a 60 years old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 28-JAN-2021, the patient was inadvertently vaccinated with a expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S036494 with expiration date 09-JAN-2021, 1 ml (route was not reported) for prophylaxis (expired vaccine used). The product has not been involved in any temperature excursions. No additional adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; 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: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1010959
Sex: U
Age:
State: OH

Vax Date:
Onset Date: 01/28/2021
Rec V Date: 02/08/2021
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Symptoms: Improper storage of product in use; This spontaneous report was received from a licensed nurse practitioner concerning a patient of unknown gender and age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024281, dose:0 .5 milliliter, expiration date: 15-JUL-2022, dose number and route unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion 7.1 degrees Fahrenheit for 50 hours/ 45minutes. It was reported that the vaccine was no exposed a previous excursion and it was not recorded by data logger. No product quality complaint was involved.

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Current Illness:

ID: 1010960
Sex: F
Age:
State:

Vax Date: 12/06/2020
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Rec V Date: 02/08/2021
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Symptoms: Her pneumonia titers were low; This spontaneous report was received from a physician who was also the patient, reporting on herself. She was approximately 46 years old and her ethnicity was reported as other. Her concurrent conditions included autoimmune antibodies to thyroid with normal thyroid values, and unspecified food and environmental allergies. Her medical history and concomitant medications were not provided. On approximately 06-DEC-2020 (reported as "a full month prior, 30 days prior"), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date, the patient's pneumonia titers were low. The outcome of the event and the causal relationship between the event and the suspect vaccine were not reported.

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Current Illness: Anti-thyroid antibodies; Environmental allergy; Food allergy

ID: 1010961
Sex: U
Age:
State: OH

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/08/2021
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Symptoms: VARIVAX administered after a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown. On 28-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck)(VARIVAX) (0.5 ml, once, strength and route were not reported, lot # T024281 has been verified as valid, expiration date 15-JUL-2022) for prophylaxis. The vaccine administered experienced a temperature excursion of 7.1 degrees Fahrenheit, for a time frame of 59 hours 45 minutes. There were no previous temperature excursions. No digital data logger was involved.

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Current Illness:

ID: 1010962
Sex: U
Age:
State: LA

Vax Date: 01/28/2021
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Rec V Date: 02/08/2021
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Symptoms: Proquad was stored in the refrigerator instead of freezer; No further AE; This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 28-JAN-2021, the patient was vaccinated with an incorrect storage vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T025221 with expiration date of 19-JAN-2022), 0.5 ml, for prophylaxis (route of administration was not provided); and with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, for prophylaxis (route of administration, lot# and expiration date were not provided). The vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer since 01-DEC-2020 with a temperature of 44F during 1506 hours and had since then been administered to patients. There was not previous temperature excursion and this was not call because of a data logger. There was not adverse event involved.

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Current Illness:

ID: 1010963
Sex: U
Age: 13
State: TX

Vax Date: 10/01/2017
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Rec V Date: 02/08/2021
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Symptoms: a patient got 1st dose of GARDASIL 9 in October 2017. Patient missed the 2nd dose.; No additional AE reported; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In October 2017, 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, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient missed the second dose. No additional AE reported.

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Current Illness:

ID: 1010964
Sex: F
Age: 63
State:

Vax Date: 07/06/2016
Onset Date: 07/06/2016
Rec V Date: 02/08/2021
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Symptoms: Nasal congestion; hemorrhage from her nose; This spontaneous report was received from a 63 year old female patient who was reporting on herself. The patient's medical history included sinus infections. The patient's concomitant therapies included unspecified thyroid medicine and metformin hydrochloride(GLUCOPHAGE XR). the patient had drug reactions/allergies to scopolamine and prednisone. On 06-JUL-2016 (also reported as "about 5 years ago") the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter for prophylaxis (frequency, route of administration, anatomical location, lot number and expiration date were not provided). On the same date (also reported as "in the days following the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine"), the patient had nasal congestion for about two years followed by a hemorrhage from her nose (epistaxis). The patient did not seek medical attention and no lab diagnostics/studies were performed. The outcome of nasal congestion was resolved on approximately 06-JUL-2018 and epistaxis was reported as resolved on an unknown date. The causality assessment was not provided.

Other Meds: thyroid; GLUCOPHAGE XR

Current Illness: Drug allergy; Drug hypersensitivity

ID: 1010965
Sex: U
Age: 1
State: NJ

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/08/2021
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Symptoms: An expired dose of the vaccine was given on 1/29/2021; This spontaneous report was received from a physician concerning a 20 month old patient of an unknown gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 29-JAN-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA) 0.5ml lot # T008149 with expiration date of 06-JAN-2021 for prophylaxis (frequency, route of administration, anatomical location, lot number and expiration date were not provided).

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Current Illness:

ID: 1010966
Sex: U
Age:
State: OK

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/08/2021
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Symptoms: No additional AE/PQC involved; Nurse called to report expired dose of MMR II given to patient; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 03-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). No additional Adverse Event (AE)/Product Quality Complaint (PQC) was involved.

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Current Illness:

ID: 1010967
Sex: M
Age: 1
State: NY

Vax Date: 12/08/2020
Onset Date: 12/08/2020
Rec V Date: 02/08/2021
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Symptoms: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 1 year old male patient with 1 siblings, birth weight of 8.3 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), hepatitis a virus vaccine inactivated(HAVRIX) and influenza virus split virion 4v vaccine inactivated (FLULAVAL). The patient's concurrent conditions and medical history were not provided. Since 12-FEB-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h. On 08-DEC-2020, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot# T017686, expiration date 20-NOV-2021 subcutaneously in the left thigh, for prophylaxis, on a private doctor's office/hospital with public funds. This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments: US-009507513-2101USA011364:Original Case : 2101USA011364

Other Meds: M-M-R II; HAVRIX; FLULAVAL (influenza virus split virion 4v vaccine inactivated)

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm