chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PHARMACIST GAVE ONLY HALF DOSE OF MODERNA BIVALENT VACCINE INSTEAD OF THE FULL DOSE. AS SOON AS THE PHARMACIST NOTICED THIS MISTAKE, THE PHARMACIST INFORMED THE PATIENT TO GET THE OTHER HALF DOSE TO COMPLETE ONE FULL DOSE(FOLLOW CDC GUIDELINE)  , PT HAS NO SIDE EFFECT. (PHARMACIST MISTAKENLY THOUGHT MODERNA BIVALENT AS MODERNA MONIVALENT BOOSTER )
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given incorrect Moderna 6M-5Y formulation.  Patient was scheduled for Moderna Bivalent Booster and received a monovalent formulation for their age group.  Patient had previously completed primary series and did not require a 3rd dose of the monovalent formulation.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was received incorrect Moderna 6M-5Y formulation.  Patient was scheduled for Moderna Bivalent Booster and received a monovalent formulation for their age group.  Patient had previously completed primary series and did not require a 3rd dose of the monovalent formulation.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient  received incorrect Moderna 6M-5Y formulation.  Patient was scheduled for Moderna Bivalent Booster and received a monovalent formulation for their age group.  Patient had previously completed primary series and did not require a 3rd dose of the monovalent formulation.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received incorrect Moderna 6M-5Y formulation.  Patient was scheduled for Moderna Bivalent Booster and received a monovalent formulation for their age group.  Patient had previously completed primary series and did not require a 3rd dose of the monovalent formulation.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Within two weeks I noticed hair loss over whole body. After body hair  all gone head extremely this. My body began to grow back. However almost a year later body hair is falling out again head has still been thinnin. I use to have full head now is beyond thin.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received incorrect Moderna 6M-5Y formulation.  Patient was scheduled for Moderna Bivalent Booster and received a monovalent formulation for their age group.  Patient had previously completed primary series and did not require a 3rd dose of the monovalent formulation.
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Customer reported 1 dose of GARDASIL 9 that was administered after experiencing temperature excursion which started on estimated date of 14Dec2022, ended on 20Feb2023.   Temperature: 63F for 1641 hours 0 minutes 0 seconds Date of administration: 20Fe; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 20-FEB-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) after experiencing temperature excursion which started on estimated date of 14-DEC-2022, ended on 20-FEB-2023, lot # U031056 expiration date of 16-JUN-2024, for prophylaxis (product storage error) (route of administration and frequency were not reported).    Temperature: 63F (Fahrenheit) for 1641 hours 0 minutes 0 seconds. Prior excursion: No-one continuous excursion of 1641 hours.  No additional event reported.   This is a non-valid report due to lack of patient's identifiers.  Follow-up information has been received from the nurse 02-MAR-2023. The reporter confirmed that the spontaneous report referred to an 11-years-old male patient who on 20-FEB-2023, was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as previously reported, with a dose of 0.5 ml by intramuscular route. It was confirmed that no side effects were reported by the patient or his parents. No more medical information had been reported.  This report was prior considered to be non-valid due to lack of patient's identifiers; on 02-MAR-2023 the nurse confirmed the patient's demographics and the case became to be valid.
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Off label use
Clinical narrative: No additional adverse event reported; Healthcare provider is reporting a 2 week old female patient was administered ROTATEQ on 20FEB2023. Caller is inquiring on the possible adverse events associated with off label use of product. No further information provided.  No additional AE report; This spontaneous report was received from a Medical Assistant referred to a 2 week old female patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 20-FEB-2023, the patient was vaccinated with her first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1879875 expiration date 19-NOV-2023, once, oral, (strength was not provided), for prophylaxis (Off label use in unapproved age group). The reporter was inquiring on the possible adverse events associated with off label use, however it was reported that no additional adverse event reported, at the time of reporting.
Age: 2.0
Sex: M
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional AE's reported; Office Manager called to report that a patient over 2 years old received an extra dose of ROTATEQ accidently. The patient already received the 3 dose regimen at the appropriate age but received an extra dose on 2/16/23. No reported patient side effec; This spontaneous report was received from an office manager and refers to a 2-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug allergies/ reactions were not reported.  On an 16-FEB-2023, the patient was accidently vaccinated with extra dose of with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) product quantity: 1, 2 milliliter by mouth for prophylaxis (Extra dose administered) (strength, lot #, and expiry date were not provided). The patient already received the 3 dose regimen at the appropriate age. No reported patient side effects. No additional adverse events reported (No adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired PNEUMOVAX 23 that was administered yesterday 2/26/2023.; This spontaneous report was received from a pharmacist and referred to a patient of unspecified age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 26-FEB-2023, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #U022984, expiration date: 29-JAN-2023, administered for prophylaxis (strength and route of administration were not provided) (Expired product administered). No additional adverse event details available.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; CMA called to report TE from 2/22/23 and states that 4 doses of PROQUAD were administered prior to stability evaluation on 3/2/23; This non-valid spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown ages and genders. Information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 22-FEB-2023, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (once, 0.5 mL, lot number: W034977 has been verified to be a non-valid lot number, expiration date: 05-MAY-2024, routes of administration and anatomical locations were not provided) for prophylaxis (product storage error).   On 22-FEB-2023, the vaccines experienced a temperature excursion from -14 to -10 (-13.6) degrees Celsius for 21 minutes. It was stated that 4 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were administered prior to stabilty evaluation. There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). No further information was provided. The outcome of product storage error and no adverse event was unknown.   This case is non-valid due to an unknown number of patients and lack of patients' identifiers.  Follow-up information has been received from a medical assistant on 16-MAR-2023  The patient was a 5 years-old male, who had a birth weight 6lbs 11.9 oz.  On 01-MAR-2023, the patient was vaccinated with improper storage vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)( lot # W028568 has been verified to be valid lot, expiration date 06-MAR-2024), subcutaneously in right deltoid (product storage error). The outcome was informed as recovered.  The reporter considered the event to be attributable to the suspect vaccine, and important medical event (medically significant); Sender's Comments:  US-009507513-2303USA006895: US-009507513-2303USA006896: US-009507513-2303USA006894: US-009507513-2303USA000873:Master Case US-009507513-2303USA000873:Master Case
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; T.E recorded; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-MAR-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1st dose, once, lot #W024334, expiration date: 01-AUG-2024 (exact dose, and route of administration were not provided), administered for prophylaxis (product storage error). The vaccine underwent temperature excursion (T.E.). No additional adverse event (AE) was reported.
Sex: U
Vaccine: PNC15
Symptoms: Crying, Injection site pain, Pain
Clinical narrative: excessive crying; pain/burning with injection; This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unknown gender, whose medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (strength, dose, frequency, anatomical vaccination site, lot number, expiration date, and route of administration were not provided).  On an unknown date, the patient experienced excessive crying and pain/burning with injection. At the time of reporting, the outcome of the events was not provided. The  The causal relationship between the events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2303USA002529:same reporter link
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event; a patient received the first dose of GARDASIL 9 in 2020 and then received the second dose 5 months ago (in 2022); This spontaneous report was received from a pharmacist, refereing to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified date in 2020, 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) and on an unspecified dae in 2022, the patient was vaccinated wth the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strengths, anatomical sites of vaccination, routes of administration, lot numbers and expiration dates were not reported), both as prophylaxis (inappropriate schedule of product administration).
Age: 1.25
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AEs; patient was administered PROQUAD and VARIVAX on 3/7/23; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-MAR-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, both administered for prophylaxis (overdose) (strengths, dosages, vaccination schemes, routes of administration, anatomical site of injections, lot numbers, and expiration dates were not reported). No additional adverse event was reported.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an elderly patient of unknown gender who was 72 years old at time of vaccination. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 26-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Subsequently on an unknown date, the patient was treated by providers due to the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster and postherpetic neuralgia. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs; 4 year old child received an extra dose of MMR-II; This spontaneous report was received from the nurse, and refers to a 4-year-old child of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 17-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided). On 27-SEP-2022, the second doses of suspect therapies were administered. On 14-MAR-2023, the child received third, additional doses (extra dose administered). No additional adverse event information was provided.
Age: 59.0
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, Ill-defined disorder, Scar
Clinical narrative: Covid (minor); The vaccines have been difficult; shingles outbrakes / small breakouts of shingles; shingles outbrakes January 2023; scars remain; This spontaneous report was received from a consumer and refers to currently 71-year-old patient of unknown gender. On an unknown date in 1982, in the middle 30s, the patient had shingles outbreaks. The patient was not immune compromised. There was no information about the patient's concurrent conditions or concomitant therapies provided.  On an unknown date in 2013, at the age of 59, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (formulation, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with 1st and 2nd dose of varicella zoster vaccine rge (cho) (SHINGRIX) (formulation, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with all covid-19 vaccines (formulation, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient stated that the vaccines were difficult, but the patient repeated them (ill-defined disorder). On an unknown date, the patient had minor covid-19 infection. On an unknown date, the patient reported that continued to have small breakouts of shingles. On an unknown date in January 2023, the patient stated that had the worst shingles outbreak ever, in both sides of the body, heavy on shoulder to shoulder, light breakout down arms and full breakouts on chest. On an unknown date in 2023 (reported as after 6 weeks), the patient noted scars, but stated that it was clearing. The patient received valaciclovir (VALTREX) 500 mg as a maintenance. The outcome of covid-19, herpes zoster, scar and ill-defined disorder was unknown. The outcome of herpes zoster reported on an unknown date in January 2023 was considered as recovering/resolving.  Causal relationship between covid-19, herpes zoster, scar, ill-defined disorder and zoster vaccine live (ZOSTAVAX) was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: female patient received 2 doses of GARDASIL 9 six days apart (3/9/2023 and 3/15/2023); no additional AEs; This spontaneous report was received from a field employee on behalf of a nurse and refers to a 25-year-old female patient. Concurrent conditions, medical history, concomitant medications were not reported.  On 09-MAR-2023, 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) injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis.   On 15-MAR-2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided). Therefore, she received 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) six days apart (Inappropriate schedule of product administration). No further information provided. No additional adverse event (AE) reported. No product quality complaint (PQC) reported.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no additional AEs; LVN called to add unreported excursion time to supported TE evaluation on 1/10/23. Caller reports that 1 dose was administered on 2/20/23 after receiving supported TE result without knowledge of additional TE that occurred on 1/8/23. No further infor; This spontaneous report was received from a licensed vocational nurse, referring to a 6-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 20-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 milliliter (ml), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W010523, expiration date was reported and validated as 25-SEP-2023) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse events.  On 08-JAN-2023, the vaccine experienced a temperature excursion of 3.5 degrees Celsius (C) for 11 hours and 14 minutes and on 10-JAN-2023, a temperature excursion of 5.5 C for 15 hours and 45 minutes. There was no previous temperature excursion.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Caller reported patient only got 1 dose of GARDASIL 9 in OCT 2022. Patient missed 2nd dose. No additional; AE reported. No PQC reported. AE follow up letter was not sent as caller denied consent. No further information was provided.; No additional AE reported.; This spontaneous report was received from a pharmacist, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified day in October 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown date, the patient missed the second dose (product dose omission issue). No additional adverse event reported.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Medical Assistant reports that 2 doses of GARDASIL-9 were given to a 25-year-old female over a span; No additional AE/; This spontaneous report was received from an other health professional and referred to a 25-year-old female patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  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) injection (2 doses, exact dose, strength, lot #, expiry date, anatomical location and route of administration were not provided) administered for prophylaxis over a span of 6 days (Inappropriate schedule of product administration). Reporter inquired if the patient should get a 3rdshot or for any recommendations on moving forward. Patient had no reactions/symptoms. No additional adverse event (AE) (No adverse event).
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: HEPATITIS B: 5/13/2014, 10/14/2005, 9/17/2004, 7/12/2004; HEPATITIS B: 5/13/2014, 10/14/2005, 9/17/2004, 7/12/2004; HEPATITIS B: 5/13/2014, 10/14/2005, 9/17/2004, 7/12/2004; This spontaneous report has been received from a physician, via medical records from a case in litigation for ZOSTAVAX (2204USA001772), referring to a 4-month-old female patient (pt). Information about the pt's concomitant medication, current condition and historical condition was unknown.     The pt was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, strength, batch/lot#, route, and expiration date were unknown) for prophylaxis on 12-JUL-2004, 17-SEP-2004, 14-OCT-2005 and 13-MAY-2014 (inappropriate schedule of product administration, extra dose administered). The outcome of the events was unknown.; Sender's Comments:  US-009507513-2204USA001772:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Poor quality product administered, Product leakage
Clinical narrative: product is opened she noticed leakage in the pouch.; No additional AE; Doses from the same box have been administered to multiple patients; This spontaneous report has been received from a nurse regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  It was reported that the nurse notice that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ ) was open and she noticed leakage in the pouch (Product leakage), then on 16-MAR-2023, the patient was vaccinated wit Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ ) oral liquid, at a dose of 2 milliliters (ml), orally administered, for prophylaxis (lot number W026137, which has been verified to be valid, expiration date reported and established as 05-FEB-2024)(Poor quality product administered) (strength, and vaccination scheme frequency were not provided).  No additional adverse events were reported in the patient.
Age: 1.08
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Overdose
Clinical narrative: overdose; irritability; This spontaneous report was received from a medical assistant and refers to a 13-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-MAR-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) subcutaneous injection, lot number: W024554, expiration date (auto-populated as): 31-JAN-2024, administered subcutaneously for prophylaxis (dose and strength were not provided) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneously for prophylaxis (dose, strength, lot number, and expiration date were not provided) (overdose).   It was reported that since receiving a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) on the same day, the patient has only had irritability.  The outcome of the event was not provided.   The causality between the suspects and events was not reported.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; CMA called to report TE from 2/22/23 and states that 4 doses of PROQUAD were administered prior to stability evaluation on 3/2/23; This non-valid spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown ages and genders. Information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 22-FEB-2023, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (once, 0.5 mL, lot number: W034977 has been verified to be a non-valid lot number, expiration date: 05-MAY-2024, routes of administration and anatomical locations were not provided) for prophylaxis (product storage error).   On 22-FEB-2023, the vaccines experienced a temperature excursion from -14 to -10 (-13.6) degrees Celsius for 21 minutes. It was stated that 4 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were administered prior to stabilty evaluation. There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). No further information was provided. The outcome of product storage error and no adverse event was unknown.   This case is non-valid due to an unknown number of patients and lack of patients' identifiers.  Follow-up information has been received from a medical assistant on 16-MAR-2023  The patient was a 29-months male (2 years-old), who had a birth weight 7lbs 14 oz.  On 28-FEB-2023, the patient was vaccinated with improper storage vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W028568 has been verified to be valid lot, expiration date 06-MAR-2024), subcutaneously in left thigh (product storage error). The outcome was informed as recovered.  The reporter considered the event to be attributable to the suspect vaccine, and important medical event (medically significant).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA000873:Master case US-009507513-2303USA006896: US-009507513-2303USA006895:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; CMA called to report TE from 2/22/23 and states that 4 doses of PROQUAD were administered prior to stability evaluation on 3/2/23; This non-valid spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown ages and genders. Information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 22-FEB-2023, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (once, 0.5 mL, lot number: W034977 has been verified to be a non-valid lot number, expiration date: 05-MAY-2024, routes of administration and anatomical locations were not provided) for prophylaxis (product storage error).   On 22-FEB-2023, the vaccines experienced a temperature excursion from -14 to -10 (-13.6) degrees Celsius for 21 minutes. It was stated that 4 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were administered prior to stabilty evaluation. There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). No further information was provided. The outcome of product storage error and no adverse event was unknown.   This case is non-valid due to an unknown number of patients and lack of patients' identifiers.   Follow-up information has been received from a medical assistant on 16-MAR-2023  The patient was a 12-months female, who had a birth weight 6lbs  9.3 oz, without brothers or sisters.  On 27-FEB-2023, the patient was vaccinated with improper storage vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W028568 has been verified to be valid lot, expiration date 06-MAR-2024), subcutaneously in right  thigh (product storage error). The outcome was informed as recovered.  The reporter considered the event to be attributable to the suspect vaccine, and important medical event (medically significant).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA000873:
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; CMA called to report TE from 2/22/23 and states that 4 doses of PROQUAD were administered prior to stability evaluation on 3/2/23; This non-valid spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown ages and genders. Information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 22-FEB-2023, the patients were vaccinated with improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (once, 0.5 mL, lot number: W034977 has been verified to be a non-valid lot number, expiration date: 05-MAY-2024, routes of administration and anatomical locations were not provided) for prophylaxis (product storage error).   On 22-FEB-2023, the vaccines experienced a temperature excursion from -14 to -10 (-13.6) degrees Celsius for 21 minutes. It was stated that 4 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were administered prior to stabilty evaluation. There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). No further information was provided. The outcome of product storage error and no adverse event was unknown.   This case is non-valid due to an unknown number of patients and lack of patients' identifiers.  Follow-up information has been received from a medical assistant on 16-MAR-2023  The patient was a 12-months male, who had a birth weight 9lbs 3.5 oz.  On 28-FEB-2023, the patient was vaccinated with improper storage vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W028568 has been verified to be valid lot, expiration date 06-MAR-2024), subcutaneously in left thigh (product storage error). The outcome was informed as recovered.  The reporter considered the event to be attributable to the suspect vaccine, and important medical event (medically significant).; Sender's Comments:  US-009507513-2303USA006894: US-009507513-2303USA000873:
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Missed dose; No additional AE reported; This spontaneous report was received from a pharmacist and refers to a 45-year-old female patient. No medical history, concurrent conditions nor concomitant medications were reported.  On 05-OCT-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (prefilled syringe, lot # W001494, expiration date 15-SEP-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  The patient received a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and then missed the second dose (Missed dose). Pharmacist stated that the patient was okay and declined to be contacted any further. No "AE" follow up letter was sent. No further information provided. No additional adverse event (AE) reported (No adverse event). No product quality complaint (PQC) reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to state that the patient was given PROQUAD after a TE event.; no additional AE/PQC.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (PROQUAD) subcutaneous injection (dose, vaccination scheme, anatomical location, frequency, lot number and expiration date were not provided) for prophylaxis, after a temperature excursion (product storage error).   No additional adverse events were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA006989: US-009507513-2303USA006931: US-009507513-2303USA007002: US-009507513-2303USA006933: US-009507513-2303USA007031: US-009507513-2303USA006940: US-009507513-2303USA006990: US-009507513-2303USA007041:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to state that the patient was given PROQUAD after a TE event.; no additional AE; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concomitant medications, previous drug reactions, and allergies were not provided.  On an unknown date, the patient was administered an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided) (product storage error). No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA006931: US-009507513-2303USA006967: US-009507513-2303USA007002: US-009507513-2303USA006933: US-009507513-2303USA007031: US-009507513-2303USA006940: US-009507513-2303USA006990: US-009507513-2303USA007041:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP called to state that the patient was given VARIVAX after a TE event.; No additional AE reported; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported). (Product storage error). The administered dose underwent a temperature excursion, but parameter where not reported. It was unknown if any previous temperature excursion happened. No additional adverse event was reported.    This case is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2303USA007002:MSD US-009507513-2303USA006967:MSD US-009507513-2303USA006931:MSD US-009507513-2303USA006933:MSD US-009507513-2303USA007031:MSD US-009507513-2303USA006940:MSD US-009507513-2303USA007041:MSD
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to state that the patient was given PROQUAD after a TE event.; No additional AE reported; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported). (Product storage error). The administered dose underwent a temperature excursion, but parameters where not reported. It was unknown if any previous temperature excursion happened. No additional adverse event was reported.    This case is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2303USA006967:MSD US-009507513-2303USA006931:MSD US-009507513-2303USA006933:MSD US-009507513-2303USA007031:MSD US-009507513-2303USA006940:MSD US-009507513-2303USA006990:MSD US-009507513-2303USA007041:MSD
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; A patient was given an extra dose of PNEUMOVAX 23; This spontaneous report has been received from a nurse regarding a 22-years-old male patient. Patient's drug reactions and allergies and concomitant medication were unknown by reporter. His pertinent medical history included splenectomy.  On 16-MAR-2023, the patient was vaccinated with a dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), injection, administered as prophylaxis, (strength, dose, and route of administration were not provided; lot number W007035 was validated as a valid number; expiration date were established as 20-OCT-2023). On 16-MAR-2023, the patient was vaccinated with an extra dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (extra dose administered). No additional adverse event was reported.
Sex: F
Vaccine: HEPA
Symptoms: Mobility decreased
Clinical narrative: refused to move the leg or walk; This spontaneous report was received from the physician, via company representative, and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dosage form, administered in her leg (unspecified), for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient was administered hepatitis a vaccine, inactivated (VAQTA) and "36-48 minutes after administration into leg, the patient refused to walk", "refused to move the leg or walk". The physician stated there was no redness, swelling at injection site, or fever observed. The physician reported that the patient did not go to emergency room, and was now walking on the affected leg (considered as recovering) No additional information provided. The action taken with the suspected vaccine regarding refused to move the leg or walk was reported as not applicable.   The causal relationship between the event of ''refused to move the leg or walk'' and hepatitis a vaccine, inactivated (VAQTA) was not provided.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose: 31-MAY-2005, second dose: 20-JUL-2005 and third dose: 04-JAN-2006; This spontaneous report has been received from a health care professional via immunization record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)) (MARRS #2207USA005557), concerning a male patient of unknown age.  The patient was vaccinated with the first, second and third dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) on 31-MAY-2005, 20-JUL-2005 and 04-JAN-2006 (inappropriate schedule of product administration), respectively, all as prophylaxis (all formulations were reported as unspecified; strengths, doses, anatomical locations, routes of administration, lot numbers and expiration dates were not reported).; Sender's Comments:  US-009507513-2207USA005557: US-009507513-2303USA007137:
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose: 06-APR-2006, second dose: 19-JUL-2020; This spontaneous report has been received from a health care professional via immunization records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)) (2207USA005557), concerning a male patient of unknown age.  The patient was vaccinated with the first, and second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) injection on 06-APR-2006, and 19-JUL-2020) (inappropriate schedule of product administration), respectively; as prophylaxis (strengths, doses, anatomical locations, routes of administration, lot numbers and expiration dates were not reported).; Sender's Comments:  US-009507513-2303USA007136: US-009507513-2207USA005557:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; PNEUMOVAX 23 expired on 1/13/2023 and was administered on 3/3/2023; This spontaneous report was received from a pharmacist, referring to a patient with unknown age and gender. The patient's concomitant therapy, concurrent condition, medical history and drug reactions/allergies were not reported.  On 03-MAR-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number U021995 has been verified to be a valid lot number, expiration date was reported as 13-JAN-2023, dose, route and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event (AE) reported (no adverse event).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Goth both doses, year later shingles; Shingles came back, 12th time; This serious case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included blood cholesterol increased (High cholesterol).   In JUL-2020, the patient received the 2nd dose of Shingrix. In MAY-2020, the patient received the 1st dose of Shingrix. In JAN-2021, between 5 and 6 months after receiving Shingrix and between 7 and 9 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Goth both doses, year later shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles came back, 12th time). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023042079   Additional Information: GSK Receipt Date: 17-MAR-2023 The reporter was patient's wife. The reporter reported that patient received both doses of Shingrix, shingles came back one year later. The patient had 12th time Shingles. The reporter was consented to follow up. This case was considered as vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming influenza were unknown at the time of reporting. This case is linked with case US2023042079 reported by same reporter.; Sender's Comments:  US-GSK-US2023042079:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got both shingles shots, still have shingles/Suspected vaccination failure; Shingles; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got both shingles shots, still have shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was not reported.   The reporter considered the vaccination failure, shingles and pain to be possibly related to Shingles vaccine and Shingles vaccine.   The company considered the vaccination failure, shingles and pain to be possibly related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient got both shingles shots and he/she still had shingles for the past three weeks, very annoying and painful. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter thought that the event might had been related to drug. The follow up would not possible as no contact details were available.