chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil percentage, Essential hypertension, Full blood count, Glomerular filtration rate decreased, Glucose urine absent
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit normal, Haemoglobin decreased, Hyponatraemia, Lymphocyte count normal, Lymphocyte percentage decreased
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal, Mean platelet volume decreased, Metabolic function test
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte count normal, Monocyte percentage, Neutrophil count increased, Neutrophil percentage increased, Nitrite urine absent
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count normal, Protein total normal, Red blood cell count normal, Red blood cells urine positive, Red cell distribution width increased
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 RNA, SARS-CoV-2 test positive, Specific gravity urine normal, Urinary sediment present, Urine abnormality
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine, White blood cell count increased
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cells urine negative, pH urine normal
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 14.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Chest discomfort, Dizziness, Hypoacusis, Hypotension, Nausea
Clinical narrative: Roughly 5-10 minutes after receiving Hep B and IPV vaccine, patient started to feel faint, dizzy, and lightheaded. She also felt her vision was going dark vs black and had trouble hearing or seeing. She felt nausea but did not have emesis and also experienced chest discomfort. She did not have throat swelling, facial swelling, or hives. She did not lose consciousness. She was not severely altered. Vitals were checked showing hypotension which improved with time. The patient was sat down then laid down in which after 15-20 minutes she started to feel better. She was given water and no medications were required. Suspected vasovagal episode.
Age: 14.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Visual impairment
Clinical narrative: Roughly 5-10 minutes after receiving Hep B and IPV vaccine, patient started to feel faint, dizzy, and lightheaded. She also felt her vision was going dark vs black and had trouble hearing or seeing. She felt nausea but did not have emesis and also experienced chest discomfort. She did not have throat swelling, facial swelling, or hives. She did not lose consciousness. She was not severely altered. Vitals were checked showing hypotension which improved with time. The patient was sat down then laid down in which after 15-20 minutes she started to feel better. She was given water and no medications were required. Suspected vasovagal episode.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient did not experience any side effects; A patient was administered MMR II that expired on 11MAY2022; This spontaneous report was received from an office manager, concerning a 1-year-old male patient.without pre-existing medical conditions, allergies, birth defects or illness at the time of vaccination. He had none adverse event following prior vaccinations. The patient did not received any other vaccine 4 weeks prior to receive Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). He was not taking any concomitant medications.  On 25-JUL-2022, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) subcutaneous injection, administered as prophylaxis in the left arm, lot number T016197 with expiration date 11-MAY-2022 (dosage regimen was not provided). After the administration, it was noted that the vaccine was expired (Expired product administered).  The reporter stated that the vaccine should had been removed from the vaccine refrigerator, so no one could grab it to the patient. Additionally, the reporter stated that the expiration date should had been verified prior to the administration. The vaccine did not have any temperatures excursion (TEs). The patient did not experience any side effects. There was not prescription drug treatment required (No adverse event).  The reporter stated that on te same day, the patient recovered from the expired product administered and considered that it was related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reporting temperature excursions. One dose had been administered to a patient.; No additional AE; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # W003819, expiration date on 02-FEB-2024, for prophylaxis (strength, dose, route of administration and anatomical location were not reported) which had a temperature excursion (product storage error) at 44°F during a time frame of 672 hours. No previous temperature excursion were reported neither additional adverse events (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; PROQUAD was administered after TE. No additional AE.; This spontaneous report was received from a nurse and refers to an unknown age and gender patient, whose medical history, concurrent conditions, and previous adverse drug reaction/allergies were not provided.  On 29-JUN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA)  (PROQUAD) subcutaneous injection, administered for prophylaxis (lot number: U026799, has been verified to be a valid lot number, and expiration date: 26-FEB-2023; strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not provided).  The suspect vaccine experienced a temperature excursion of -9.3 degrees Celsius (°C) for a time frame of 27 minutes. No previous temperature excursion occurred.  No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported temperature excursion.; This spontaneous report was received from a nurse referring to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 21-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) lot #U026799, expiration date: 26-FEB-2023 for prophylaxis (strength, dose and route of administration were not provided) after temperature excursion to minus 9.3 degree Celcius for 27 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; PROQUAD mistakenly given to 16 year old instead of MMR II. Patient has had a prior dose of MMR II in the past. No additional AE. No PQC.; PROQUAD mistakenly given to 16 year old instead of MMR II. Patient has had a prior dose of MMR II in the past. No additional AE. No PQC.; This spontaneous report was received from a registered nurse referring to a 16-year-old patient of unknown gender. Patient's historical vaccine included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No more information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.   On 29-JUL-2022, the 16-year-old patient was mistakenly vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age) for prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion to a patient. VARIVAX was administered on Jul 29, 2022. No further information provided.; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies were not provided.   On 29-JUL-2022, the patient was vaccinated with improper storage varicella virus vaccine live (Oka/Merck) (VARIVAX) once as prophylaxis (lot number W011625 had been verified to be a valid number; expiration date reported and established as: 06-APR-2024; dose, route of administration, and anatomical location were not provided).   The vaccine experienced a temperature excursion of minus 8.1 Celsius degree with time frame of 1 hour 58 minutes and 0 seconds. It was stated that no previous temperature excursion occurred.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA002443: US-009507513-2208USA002737: US-009507513-2208USA003187: US-009507513-2208USA002739:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE; HCP reported VARIVAX was administered after a temperature excursion to a patient. VARIVAX was administered on Jul 29, 2022. No further information provided.; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies were not provided.   On 29-JUL-2022, the patient was vaccinated with improper storage varicella virus vaccine live (Oka/Merck) (VARIVAX) once as prophylaxis (lot number W011625 had been verified to be a valid number; expiration date reported and established as: 06-APR-2024; dose, route of administration, and anatomical location were not provided).   The vaccine experienced a temperature excursion of minus 8.1 Celsius degrees with a time frame of 1 hour 58 minutes and 0 seconds. It was stated that no previous temperature excursion occurred.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA002433: US-009507513-2208USA002737: US-009507513-2208USA002739: US-009507513-2208USA003187:
Age: 56.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: Caller reports that the patient missed her third dose of the GARDASIL 9 series; the patient is 56 years old, and was 56 years old when she received her first dose; No additional AE reported; This spontaneous report was received from a medical assistant referring to a 56-year-old female patient. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or 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, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). The patient was 56 years old when she received her first dose (Product administered to patient of inappropriate age).  The patient missed her third dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (Inappropriate schedule of product administration). No additional AE reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No further information provided. This is patient four of five. Cross reference cases: 02218306, 02218421,02218430 and 02218450.; HCP reported PROQUAD was administered after a temperature excursion to a patient. PROQUAD was administered on Aug 2, 2022.; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 02-AUG-2022, measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA) (PROQUAD) subcutaneous injection (lot number: W007748, expiration date 04-SEP-2023; strength, dose, and route of administration were not reported) was administered to the patient once after a temperature excursion of -8.1 Celsius degree for 1 hour and 58 minutes (product storage error). There was no additional adverse event (AE) reported, and no further information provided.   This is one of five reports received from the same reporter.     ; Sender's Comments:  US-009507513-2208USA002443: US-009507513-2208USA002433: US-009507513-2208USA002737: US-009507513-2208USA002739:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No adverse event; administered of improperly stored MMR II; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 28-JUL-2022, the patient was vaccinated with improperly stored with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) 1 dose, lot #U023829, expiration date: 30-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided). The temperature excursion was 10.1 Celsius (C) for 15 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA003406: US-009507513-2208USA003578: US-009507513-2208USA003290:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; Medical assistant reported PROQUAD was administered after a temperature excursion to multiple patients. This case is for patient two of four.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On unknown date, vaccines measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin [rHA]) underwent temperature excursion at 5.56 degrees Fahrenheit for 9 hours and 30 minutes. There was no previous temperature excursion.  On 03-AUG-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, once, lot #W010061, expiration date: 20-SEP-2023 (strength, dose, and route of administration were not provided), administered for prophylaxis (product storage error). There was no additional adverse event reported.  This is one of four reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022; This spontaneous report has been received from a medical assistant concerning a 4-year-old female patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date in 2022, the patient was vaccinated with the 1st dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) subcutaneous injection, 0.5 milliliter (lot number W002781 has been verified to be a valid lot number for mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA), expiration date reported and confirmed as 24-JUL-2023) (route of administration was not provided) as prophylaxis. According to temperature stability evaluation, the vaccine administered had been suffered a temperature excursion since 14-JUL-2022 (Product storage error).  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004135: US-009507513-2208USA003812: US-009507513-2208USA003988: US-009507513-2208USA004011: US-009507513-2208USA004012: US-009507513-2208USA004255: US-009507513-2208USA004105: US-009507513-2208USA004223: US-009507513-2208USA004255:
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022, no exact dates provided; This spontaneous report has been received from a medical assistant concerning a 3-year-old male patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date in 2022, the patient was vaccinated with the a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) subcutaneous injection, 0.5 milliliter, once (lot number W016358 has been verified to be a valid lot number for mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA), expiration date reported and confirmed as 16-NOV-2023) (route of administration and anatomical location were not provided) as prophylaxis. According to the temperature stability evaluation of vaccines, the vaccine administered had been suffered a temperature excursion since 14-JUL-2022, no exact dates provided (Product storage error).  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004135: US-009507513-2208USA004086: US-009507513-2208USA003812: US-009507513-2208USA003988: US-009507513-2208USA004011: US-009507513-2208USA004012: US-009507513-2208USA004255: US-009507513-2208USA004223: US-009507513-2208USA004255:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No addional AE reported; a dose of PROQUAD was administered to the patient on 10AUG2022 after experiencing a temperautre excursion; This spontaneous report has been received from a medical assistant, referring to a patient with unknown age or gender.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 10-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter (dose, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided) (lot number U031560 has been verified to be a valid lot number with expiration date on 06-APR-2023), administered as prophylaxis.   It was reported that the vaccine was administered after temperature excursion occurred (improper storage of product in use). No additional adverse event reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2208USA004819: #02224251 US-009507513-2208USA004963 #02224316 US-009507513-2208USA005443: #02224322 US-009507513-2208USA005345: #02224333 US-009507513-2208USA005272:#02224325
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Medical assistant reported that a 14 year old patient received PROQUAD.; This spontaneous report has been received from a medical assistant regarding a 14-year-old adolescent female patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 21-JUL-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) for prophylaxis, one dose (1 dose), administered in the left arm, (strength, exact dose, route of administration, and frequency were not provided) (lot number U029296 had been verified to be a valid number; expiration date was reported as 19-MAR-2023, and upon internal validation established as the same date) (Inappropriate age at vaccine administration). The outcome of inappropriate age at vaccine administration was reported as recovered.  No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Extra dose administered, Wrong product administered
Clinical narrative: accidently administered PROQUAD and VARIVAX to a 12 month old patient yesterday, 8/10/22, instead of VARIVAX and MMR-II therefore the patient received an extra dose of Varicella; accidently administered PROQUAD and VARIVAX to a 12 month old patient yesterday, 8/10/22, instead of VARIVAX and MMR-II therefore the patient received an extra dose of Varicella; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unspecified gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 10-AUG-2022, the patient was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (PROQUAD) (rHA), 0.5 milliliter, lot #U029150, expiration date: 16-MAR-2023 (anatomical location was not provided) administered subcutaneously as prophylaxis, and varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter, lot #U027326, expiration date: 02-SEP-2023 (anatomical location was not provided) administered subcutaneously as prophylaxis, instead of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant (M-M-R II), receiving and extra dose of varicella vaccine (accidental overdose and wrong product administered).  The reporter requested information about how to proceed with the patient and if there were any issues to be concerned about.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Dose of PROQUAD was administered to the patient on 10AUG2022 after experiencing a temperautre excursion.; Spontaneous information has been received from a medical assistant regarding a patient of unknown age or gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) experiences temperature excursion during 30 minutes with a temperature of 18.6-degree Fahrenheit. This vaccine had experienced a previous temperature excursion of 30 minutes at 9.8-degree Fahrenheit.  On 10-AUG-2022, the patient received measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (valid lot # U031560 with expiration date on 06-APR-2023) 0.5 mL as prophylaxis (route of administration was not reported). No additional information or adverse events were reported.   This is one of several reports from the same reporter; Sender's Comments:  US-009507513-2208USA005325: #02224322 US-009507513-2208USA004819: US-009507513-2208USA004963: US-009507513-2208USA005325: US-009507513-2208USA005345:
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: The patient received 4 doses of MMR II; No additional AE; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient.  The patient's concurrent conditions, medical history or concomitant medications were not provided.   On 19-JUN-2018, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose regimen details, lot # and expiration date were not provided). On 25-APR-2021, the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose regimen details, lot # and expiration date were not provided). On 05-AUG-2021, the patient received a third dose and on 12-AUG-2022, the patien received a fourth dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml dose (lot # U006485 with expiration date 26-FEB-2023). All the doses of the vaccine were administrated as prophylaxis.   The reporter confirmed that the fisrt two doses of 19-JUN-2018 and 25-APR-2021 were not indicated on the records received from the other pediatrician. No adverse events were reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Blood test
Clinical narrative: having hair loss; This spontaneous report was received from a physician and refers to a 12-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 08-JUN-2022, 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) prefilled syringe, injection, intramuscularly (IM), lot number: U032636, expiration date: 26-OCT-2023, (exact dose and injection site were not provided) as human papillomavirus (HPV) vaccine.  Since approximately 20-JUL-2022 (reported as three weeks previous to the physician visit), the patient started to experience hair loss after her first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination. The patient sought medical attention and on 10-AUG-2022, she went into the physician's office and reported the event. Some unspecified blood tests were drawn (results were not provided). No treatment was given for the event. It was reported that therapy was not discontinued. At the reporting time, the patient had not recovered from the event, her present status was reported as "still experiencing hair loss".  The causal relationship between hair loss and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  This is one of the two reports from the same reporter. ; Sender's Comments:  US-009507513-2208USA006656:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired dose of PROQUAD was administered.; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA), 0.5 ml (route reported as intramuscularly [IM] subcutaneously [SQ] [conflicting information]), lot # T034827 and expiration date 11-APR-2022 (expired product administered), as prophylaxis. No additional adverse events (AEs) or product quality complaint (PQC) reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Product Lot number issue; No adverse event; Extra GARDASIL 9 DOSE #4 administered on 03-AUG-2022; DOSE #1 administered on 15-NOV-2012 DOSE #3 administered on 22-MAY-2017; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 15-NOV-2012, the patient administered first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) formulation vial (reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), non valid lot# H013831), 0.5 milliliter, valid lot #H013831, expiration date: 06-MAR-2015, administered for prophylaxis (strength, and route of administration were not provided). On 22-JUL-2013, the patient administered second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) formulation vial (reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), non valid lot# J002641), 0.5 milliliter, valid lot # J002641, expiration date: 10-DEC-2015, administered for prophylaxis (strength, and route of administration were not provided) (product lot number issue). On 22-MAY-2017, the patient administered third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) formulation vial, 0.5 milliliter, lot #N000326, expiration date: 14-OCT-2019, administered for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration). 03-AUG-2022, the patient accidentally administered additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter, lot # 178076, expiration date: 09-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided) (extra dose administered). It was because the patient's records had not reflected the previous completed series. No additional adverse event information was provided (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: other zoster-related conditions; shingles; Information has been received regarding a case in litigation from a lawyer and referred to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On or about 03-APR-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot number and expiration date were unknown), as prescribed and/or administered by a healthcare provider at local clinic for the long-term prevention of shingles and zoster-related conditions. At the time of the pt's vaccination, the pt relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the pt's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced the pt to be vaccinated. Alternatively, on or about April 3, 2013, the pt's healthcare providers at local clinic, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine and believed that it was effective in preventing shingles on a long-term or permanent basis, and that it did not carry any significant risks of adverse effects. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers at local clinic for shingles, and other zoster-related conditions (Ill-defined disorder). As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered as not recovered. The causality was related.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Improperly stored PROQUAD vaccine was administered to a patient.      ?  ?; This spontaneous report has been received from a medical assistant, referring to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 12-AUG-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection(lot number: U026800, which has been to verified to be valid, expiration date reported and validated as 26-FEB-2023) to prevent measles, mumps, rubella and varicella infection (strength, dose, route of administration, and anatomical site of injection were not reported).The administered dose of the vaccine was stored at a temperature of -14 degrees Celsius (C), during a time frame 37 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist states he is not sure, but it is a possibility that a patient only received one dose of MMR II as a child.; No additional AE reported; This spontaneous report was received from pharmacist, referring to a currently 36-years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date when patient was a child, the patient  was possible vaccinated with only one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose regimen, lot #, expiration date, and route of administration were not provided) (inappropriate schedule of drug administration). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE's; an improperly stored PROQUAD vaccine was administered; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.  On 16-AUG-2022, the patient was vaccinated with improperly stored measles, mumps, rubella, and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, lot number U026800, expiration date 26-FEB-2023, for prophylaxis (strength, dosage, frequency, route were not provided) (product storage error).  Administered dose underwent a temperature excursion of -14 degrees Celsius (C) for 37 minutes. It was reported that there was not any previous temperature excursion. No additional adverse event was provided.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Laboratory test abnormal, Menstruation irregular, Ovarian failure
Clinical narrative: primary ovarian failure/ irregular mensesand secondary amenorrhea; Information has been received from a lawyer regarding a case in litigation concerning a 14-year-old female patient (pt). No information has been received regarding the pt's past medical history, concurrent conditions, or concomitant medication. Prior vaccination the pt was not suffering from premature ovarian failure.  On 20-OCT-2011 the  pt was inoculated with her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and on 04-JAN-2012 the second dose, as prophylaxis (exact dose, route of administration, lot number and expiration date were not provided). On 03-JUL-2012, the pt consulted a endocrinologist for irregular menses and secondary amenorrhea. On 06-JUN-2013, in a follow-up (FU) appointment for pt amenorrhea pt labs were consistent with primary ovarian failure. As a direct and proximate result of the vaccine the pt symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result of the manufacture, marketing, advertising, promotion, distribution and/ or sale of the vaccine the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt had incurred and will continue to incur medical expenses and other economic harm as a direct result of use of  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The events has been considered disabling by the reporter.
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; HCP called for evaluation of vaccine temperature excursion; This spontaneous report was received from a medical assistant referring to a 31-year-old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 05-AUG-2022, non-supported frozen vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml/once, lot #W005208, expiration date reported as 14-FEB-2023 but upon internal validation established as 14-FEB-2024 (strength, and route of administration were not provided) was administered for prophylaxis during temperature excursion (Product storage error). No further information provided. No additional adverse events (AEs).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008022:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; the improperly stored vaccine was administered; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-AUG-2022, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number 1775811, expiration date 07-DEC-2023, for prophylaxis (strength, dosage, frequency, route were not provided) (product storage error). No additional adverse event was provided. ; Sender's Comments:  US-009507513-2208USA008175:MSD US-009507513-2208USA008439:MSD
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccines administered after temperature excursio; the vaccines were administered IM (instead of SQ); This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 16-AUG-2022, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #U028164, expiration date: 09-SEP-2023 (vaccination schedule was not provided) and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 ml, lot #U006596, expiration date: 01-MAR-2023 (vaccination schedule was not provided), both administered intramuscularly instead of subcutaneously for prophylaxis (Product storage error, Incorrect route of product administration). The vaccines underwent temperature excursion in 32.9 degrees Fahrenheit (F) in a time frame of 28 hours and 39 minutes. It was reported measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) was stored within recommended temperature range, however the vaccines underwent previous temperature excursion, for which reporter was unable to provide data. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008668:dpoc# 02230999 US-009507513-2208USA008497: US-009507513-2208USA008558: US-009507513-2208USA008699:
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Caller was Healthcare Business Professional. Caller reported AE for Patient.  4 Month Old Patient was administered PROQUAD on 08/19/2022. Caller was unable to further clarify these statements at current call time.   Caller gave permission to be conta; This spontaneous report was received from a healthcare business professional referring to a 4-month-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 19-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number W010062 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date not reported, but upon internal validation established as 20-SEP-2023), for prophylaxis (dose, route of administration, and anatomical location were not reported) (Product administered to patient of inappropriate age).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: no adverse event; vaccines administered after temperature excursion.; es were administered IM (instead of SQ).; This spontaneous report was received from a 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 an unspecified date in 2022, doses of  varicella virus vaccine live (oka/merck) (VARIVAX) lot #U028164, expiration date: 09-SEP-2023; and doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot #U006596, expiration date: 01-MAR-2023 underwent a temperature excursion of 32.9 fahrenheit degrees during 28 hours and 39 minutes with previous temperature excursions.  On 15-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U028164, expiration date: 09-SEP-2023, administered intramuscularly (Subcutaneous injection formulation administered by other route) (strength, dosage regimen, and anatomical location were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 0.5 milliliter, lot #U006596, expiration date: 01-MAR-2023, administered intramuscularly (Subcutaneous injection formulation administered by other route) (strength , dosage regimen, and anatomical location were not provided) as prophylaxis. No adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2208USA008558: US-009507513-2208USA008497: US-009507513-2208USA008503: US-009507513-2208USA008699: