chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fatigue, Hypoaesthesia, Hypotension, Nausea, Vision blurred
Clinical narrative: Low blood pressure; blurry vision; fatigue; numbness of the right arm and right leg; nausea; This is a spontaneous report received from contactable reporter (Nurse) from a sales representative.  A 17-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 18Jul2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation; meningococcal vaccine a/c/y/w conj (CRM197) (MENVEO), on 18Jul2022 as dose 2, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: use Synthroid daily; "allergic to Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Menveo (dose 1, single), for Immunisation. The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "Low blood pressure"; VISION BLURRED (non-serious), outcome "unknown", described as "blurry vision"; FATIGUE (non-serious), outcome "unknown"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness of the right arm and right leg"; NAUSEA (non-serious), outcome "unknown".   Additional information: Second dose of Menveo was administered on 18Jul2022, in the right arm and Trumenba was administered on the left arm, on the same day.  Follow-up attempts are completed. No further information is expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse event; Caller is a Merck agent calling to report an adverse event on behalf of a vaccine coordinator for PROQUAD. The vaccine coordinator is not on the line. Caller reports that she received an email from the customer notifying her that a dose of PROQUAD was; This spontaneous report was received from an other health care professional via company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unspecified day, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administered intramuscularly (Incorrect route of product administration) administered as prophylaxis and reconstituted with sterile diluent (dosage information, lot number, and expiration date were not provided). No additional adverse events (AE) were reported.  Follow up information has been received from the clinical supervisor at the pediatric office on 21-JUN-2022. Patient's identifiers were provided, therefore, this case is now considered valid.  The patient was a 4-year-old female, who on 26-MAY-2022, presented to the office with her grandmother, for her 4 years old child check up. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number U026794, expiration date 26-FEB-2023, was ordered as appropriate for age. The Certified Medical Assistant who prepared the vaccine administered it intramuscularly(in the left vastus lateralis) instead of subcutaneously as recommended in the packaging insert. The patient was not harmed. No adverse reactions were noticed. No post vaccine concerns were presented. The CMA was supervised by a registered nurse, who addressed the error inmediately and education was provided, the incident was discussed and the parents were advised.   The reporter considered the event was not related to measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired doses of VAQTA were administered; This spontaneous report was received from a medical assistant and referring to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant medication were not provided.  On 18-JUN-2022, the patient was vaccinated with an expired dose of  hepatitis A vaccine, inactivated (VAQTA), intramuscular injection, at a dose of 0.5 milliliter once, lot number T031201, expiration date: 14-JUN-2022 (expired product administered), (strength, anatomical location of administration and route of administration were not provided) for prophylaxis.  It was stated that the patient had no adverse effects or symptoms from this dose. It was also mentioned that there was no previous temperature excursion.  This is one 6 reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA006941: US-009507513-2206USA007065: US-009507513-2206USA007033: US-009507513-2206USA006900: US-009507513-2206USA006951:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Vaccination error
Clinical narrative: No adverse event; Pregnant patient was administered GARDASIL 9 in error .; Pregnant patient was administered GARDASIL 9 in error .; This spontaneous report was received from a nurse referring to a pregnant female patient of unknown age.   The patient concurrent conditions, medical history and concomitant medications were not provided. Last menstrual period (LMP) date,  pregnancy due date, and pregnancy outcome were not provided, nor infant details.   On 15-JUN-2022, the patient was vaccinated in error with  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Dose, administration route were not provided) (Lot number 1780879 is an invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) an expiration date was reported as 11-SEP-2023) as prophylaxis (Exposure during pregnancy).  It was reported that the patient and the fetus were doing good, therefore, no adverse events or additional information were reported. At the time of reporting, the outcome of the exposure during pregnancy was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Medical assistant reports patient was accidently administered an expired dose of MMR II on June 22, 2022. Product expired on Mar 7, 2022. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC; This spontaneous report was received from  a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-JUN-2022, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, once, for prophylaxis (lot number: T030481 expiration date: 07-MAR-2022, route of administration was not reported). The dose expired on 07-MAR-2022. There were no previous temperature excursions or adverse events reported.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; patient was accidentally give a 4th dose of GARDASIL 9 in 2019; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 17-DEC-2019, the patient was accidentally given the 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (extra dose administered). The patient experienced no side effects. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired dose of VARIVAX was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concurrent conditions were not reported. Concomitant medication included sterile diluent (lot# T009242 with expiration date: 15-OCT-2022).   On 24-JUN-2022, the patient was vaccinated an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter/once, lot #T020652 with expiration date: 16-JUN-2022, administered for prophylaxis (route of administration was not provided) (Expired product administered). The varicella virus vaccine live (oka/merck) (VARIVAX) had no history of temperature excursions. Dose was supported by post-expiry memo. The patient did not have any adverse effects or symptoms from administration of this dose (no adverse event). No other adverse event was reported.
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain, X-ray normal
Clinical narrative: continued injection site pain more than 4 weeks after injection; This spontaneous report was received from a consumer and refers to a 68-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, for prophylaxis (exact dose, route of administration, anatomical site, lot # and expiry date were not provided).  On an unknown date (reported as "more than 4 weeks after injection"), the patient was experiencing continued injection site pain. There was no redness or swelling. It was unknown if any treatment was received for this event. The patient had an X-ray performed which did not show any abnormality or foreign object. The outcome of the event was not reported.  The causal relationship between the event and the suspect product was not provided by the reporter.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Vaccination error
Clinical narrative: No other AE; Caller reported an AE for PEDVAX HIB. The caller said they have a patient who received PENTACEL and PEDVAX HIB on the same day, 23JUN2022. Confirmed with caller no other AE occurred. AE letter sent to prescriber. No other AE. No PQC.; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  Caller reported an adverse event for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). The caller reported that have a patient who received first dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U026802 and expiration date: 03-SEP-2021 (dose, indication and route were not reported), and first dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), lot # UJ529AAA expiration date: 22-JUL-2022 (dose, route of administration and indication were not provided),  on the same date, on 23-JUN-2022. No other adverse event occurred.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE or PQC reported.; MMR II that expired on 11MAY2022 was administered to a patient on 27JUN2022; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, concomitant medication, drug reactions, or allergies was not reported.   On 27-JUN-2022, the patient was vaccinated with the expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant Human albumin (rHA) (lot # T016198, and expiration date: 11-MAY-2022) (Expired product administered) (strength, dose, unit, and route of administration were not provided) for prophylaxis. The vaccine never had any temperature excursions.   No additional adverse event (AE) or product quality complaint (PQC) was reported. No additional information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; stored outside of recommended range; This spontaneous report was received from an office manager in charge of vaccine storage and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The concomitant therapies included sterile diluent used for vaccine reconstitution.   On an unknown date in2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U039722, expiration date 15-DEC-2023 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine underwent temperature excursion of 6 Fahrenheit degrees up tp 14 Fahrenheit degrees for 50 minutes and 14 Fahrenheit degrees up to 46 Fahrenheit degrees  (15 Fahrenheit degrees) for 30 minutes on 28-JUN-2022. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000544:Merck US-009507513-2207USA000563:Merck US-009507513-2207USA000680:Merck US-009507513-2207USA000470:Merck US-009507513-2207USA000561:Merck
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE details available; have been stored outside of recommended range; This spontaneous report was received from an office manager in charge of vaccine storage and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The concomitant therapies included sterile diluent used for vaccine reconstitution.   On an unknown date in2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U039722, expiration date 15-DEC-2023 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine underwent temperature excursion of 6 Fahrenheit degrees up tp 14 Fahrenheit degrees for 50 minutes and 14 Fahrenheit degrees up to 46 Fahrenheit degrees  (15 Fahrenheit degrees) for 30 minutes on 28-JUN-2022. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680:Merck US-009507513-2207USA000470:Merck US-009507513-2207USA000544:Merck US-009507513-2207USA000552:Merck US-009507513-2207USA000563:Merck
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE; patient received GARDASIL 9 series outside of the recommended dosing schedule / 2nd dose 10/27/17 / 3rd dose 1/8/18; This spontaneous report was received from a physician and refers to an approximately 11-year-old (11 years old when starting suspect vaccine's series) patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 05-JUL-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) for prophylaxis (dose, route of administration, anatomical location, lot #, and expiration date were not provided).  On 27-OCT-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, anatomical location, lot #, and expiration date were not provided).  On 08-JAN-2018, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, anatomical location, lot #, and expiration date were not provided) (inappropriate schedule of vaccine administered, reported as patient received suspect vaccine's series outside of the recommended dosing schedule). There was no additional adverse event (AE). At the time of report, physician was unwilling to provide additional patient information as she had not talked to the patient's mother at that time.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; She reported that an expired MMR II got administered to a patient today (7/5/2022); This spontaneous report has been received from a nurse concerning a 20-year-old male patient. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 05-JUL-2022, the patient received a vaccine dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) lot # T022310, expiration date: 30-JUN-2022 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered improperly stored GARDASIL 9; No additional adverse event reported; This spontaneous report has been received from a health care business professional (reported as: office manager), regarding a patient of unknown age and gender. The patient's medical history, previously drug reactions and allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis; lot number lot number 1780876 has been verified to be valid, expiration date reported and established as: 09-NOV-2023 (dose, formulation, route of administration, and anatomical location were not provided) (product storage error).  The suspect vaccine had a temperature excursion of 35 Fahrenheit degree with a time frame of 18 minutes. No previous temperature excursion was reported. No additional adverse event reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of ROTATEQ was administered to a patient.; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 07-JUL-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot # T030490, expiration date 21-APR-2022, administered orally (strength and dose number were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Age: 34.0
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: no side effects reported; Nurse called stating an expired Merck Sterile Diluent was reconstituted with VARIVAX and administered to a patient on 6/13/2022. No side effects reported. Confirmed with caller that expired diluent has had no temperature excursions. AE filed. No PQC; expired Merck Sterile Diluent was reconstituted with VARIVAX administered to a patient; This spontaneous report was received from a registered nurse and refers to a 34-year-old patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-JUN-2022, the patient was administered an expired dose of sterile diluent (STERILE DILUENT) solution for injection/infusion, lot # S024549, expiration date: 29-MAY-2022, administered once (strength, dose, route of administration, and indication were not provided) reconstituted with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis (expired product administered, product preparation issue). No side effects reported (no adverse event).
Sex: F
Vaccine: MMR
Symptoms: Occupational exposure to product
Clinical narrative: Per caller another Medical assistant pulled the needle out of a patient because they moved then accidental squirted it in another medical assistant eye.; This spontaneous report was received from a healthcare business professional and refers to a female patient (medical assistant) of unknown age. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 07-JUL-2022, the patient was accidentally squirted in the eye with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) by another medical assistant who was pulling the needle out of a patient, patient was being vaccinated for prophylaxis, because they moved (occupational exposure to product). Medical assistant has flushed her eye several times and had not reported any issues at the time of report.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002610:
Age: 67.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient did not develope side effects; The patient was administered a second unnecessary dose of PNEUMOVAX 23; This spontaneous report has been received from a registered nurse (RN) concerning to a 67-year-old patient.      The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  On 19-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose/route/frequency of administration, lot number, and expiration date were not reported) for prophylaxis.  On 29-JUN-2022, the patient was vaccinated with an unnecessary second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (extra dose administered) (lot number U034712 with expiration date 30-JUL-2023) (strength, dose/route/frequency of administration date were not reported) for prophylaxis. The patient did not develop side effects. No additional adverse events (AEs) were reported (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA002428:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: No additional AE; it was given subcutaneously as opposed to intramuscularly; injection site is "7 inches too low"; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 29-JUN-2022, the patient was administered her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #,and expiry date were not provided). The mother of the patient is a nurse and stated that the recent injection site was "7 inches too low" on the deltoid (product administered at inappropriate site) and believed it was given subcutaneously as opposed to intramuscularly (incorrect route of product administration). No additional information was provided. No additional adverse event/product quality complaint (PQC) was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine, PEDVAXHIB, was administered to a patient on 8Jul2022.; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-JUL-2022, the patient was administered an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # U014992, expiration date: 29-OCT-2023 (strength, dose, anatomical site, and route of administration were not provided) administered for prophylaxis (product storage error). Before being administered, the vaccine experienced a temperature excursion of 32 degrees Fahrenheit for 40 minutes. There were no previous temperature excursions. No additional adverse events reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reported VARIVAX was administered to patient after a temperature excursion.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improper storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U020238, expiration date: 28-JUN-2023 (dose regimen, route of administration and anatomical location were not provided), as prophylaxis (Product storage error). No adverse events (No adverse event) or product quality complains were reported.  The improper storage lot # underwent a temperature excursion of -8.3 degrees Celsius (C) for about 1 hour and 1 minute without previous excursions.  This is one patient of three received from the same reporter.; Sender's Comments:  US-009507513-2207USA003330: US-009507513-2207USA003332:
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event; HCP said that the patient received 1st dose of GARDASIL 9 at the age of 13. Patient received her 2nd dose today (07/12/2022) when she is now 16 years old.; This spontaneous report was received from a registered nurse and refers to a 16-year-old female patient. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On an unknown date in 2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 12-JUL-2022, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, prefilled syringe, 0.5 milliliter, lot # U008900, expiration date 12-AUG-2023 (strength, route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; The patient had completed the HIB series and was due to receive polio but was inadvertently given PEDVAXHIB instead; The patient received an extra dose of PEDVAXHIB; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported. The patient had completed the Haemophilus influenzae Type b (HIB) series.  On 30-SEP-2021, the patient was due to be vaccinated with polio vaccine but instead of this vaccine, he/she was inadvertently given an extra dose haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter (lot number T030710 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date reported and confirmed as 15-APR-2023) (route of administration and anatomical location were not provided) as prophylaxis (Wrong product administered) (Extra dose administered).  The reporter stated this was noticed when the parent got a call from school stating the vaccinations were not up to date and the records were checked. No additional adverse events (AE) were reported.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event; Patient was administered an expired dose of MMR II on 07-JUL-2022; This spontaneous report was received from a pharmacy intern and refers to a female patient of unknown age. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 07-JUL-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot # T020655 confirmed to be valid with expiration date:16-JUN-2022 (exact dose, route of administration and injection site were not reported) for prophylaxis (expired product administered). No additional adverse event was reported.
Age: 62.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE.; Caller stated a 62 year old patient had a first dose of VAQTA in January 2019, but did not come back for the second dose until today, 13JUL2022.; This spontaneous report was received from a pharmacist and refers to a 62-year-old patient of unknown gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On an unknown date in January 2019, the patient was vaccinated with a first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (dose, strength, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 13-JUL-2022, the patient was vaccinated with a second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, 0.5 milliliter, lot # U036184, expiration date 02-MAR-2023 (strength, route of administration and anatomical location were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004690: US-009507513-2207USA001345: US-009507513-2207USA004695: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004697: US-009507513-2207USA004691: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 22-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004691: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: hepatitis B nonresponder; This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 20 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 24 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 9. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA006075: US-009507513-2207USA006076: US-009507513-2207USA006077: US-009507513-2207USA006078: US-009507513-2207USA006080: US-009507513-2207USA006081: US-009507513-2207USA006082: US-009507513-2207USA006083: US-009507513-2207USA006084: US-009507513-2207USA006074: US-009507513-2207USA006073: US-009507513-2207USA006079:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA001345: US-009507513-2207USA004691: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 05-JUL-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA001345: US-009507513-2207USA004691: US-009507513-2207USA004707: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA001345: US-009507513-2207USA004691: US-009507513-2207USA004707: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004709: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 28-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004698: US-009507513-2207USA004691: US-009507513-2207USA004707: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004700: US-009507513-2207USA004710: US-009507513-2207USA004709: US-009507513-2207USA004714: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 29-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004707: US-009507513-2207USA001345: US-009507513-2207USA004698: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004712: US-009507513-2207USA004709: US-009507513-2207USA004691: US-009507513-2207USA004700: US-009507513-2207USA004710: US-009507513-2207USA004715:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 23-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004707: US-009507513-2207USA001345: US-009507513-2207USA004698: US-009507513-2207USA004697: US-009507513-2207USA004714: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004712: US-009507513-2207USA004709: US-009507513-2207USA004691: US-009507513-2207USA004700: US-009507513-2207USA004710:
Sex: M
Vaccine: HEPA, PPV
Symptoms: Blister, Erythema multiforme, Product administered to patient of inappropriate age, Rash, Rash papular
Clinical narrative: pneumococcal vaccine used in 15 months old patient; erythema multiforme; Literature report:   This literature marketed report has been received from authors of the literature article entitled as stated above and refers to a 15-month-old male patient. He was otherwise healthy. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) four doses (Inappropriate age) and hepatitis a vaccine, inactivated (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported for both) for prophylaxis. On an unknown date, he presented to dermatology with a 12-day history of a generalized eruption consisting of raised pruritic plaques. Several plaques had central and linear erosions. The patient had no other symptoms and was afebrile. The parents of the patient report no relevant changes in diet, linen, or environment, and no drugs had been administered prior to the outbreak, but the patient had recently received an initial dose of hepatitis a vaccine, inactivated (manufacturer unknown) and the 4th dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The rash was localized to lower extremities and temples 5 days post-vaccination, with an onset 3 days post-vaccination. Pediatricians advised applying hydrocortisone 1% cream to the plaques and giving colloidal oatmeal baths. Eight days post-vaccination new lesions formed. An oral H1 histamine antagonist, triamcinolone 0.1%, and mupirocin 2% ointments were added to the patient's treatment. Eleven days post-vaccination, new lesions continued to arise. The child was prescribed prednisone (15mg/5mL solution, 1mg/kg/dose, for 5 days) and referred to dermatology. During the physical examination, the patient was alert, afebrile, and appeared to be a healthy growing toddler. Physical examination revealed multiple well-defined, circular, erythematous plaques with a darker central vesicle on the extremities. Trunk, mucosal surfaces, and the palmoplantar regions were spared. Due to the history, physical findings, and the correlation of the eruption following vaccination, the patient was diagnosed with erythema multiforme (EM). Sixteen days post-vaccination, following a 10-day course of oral prednisone, most of the lesions had resolved with no new outbreaks. The authors considered the event of erythema multiforme to be related to suspect vaccines.  Upon internal review, the event of erythema multiforme was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.