chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 03-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of minus 40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several reports, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.    On 06-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 06-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 16-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 1.0
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; Patient, in combination with concomitantly administered MMRlI, was inadvertently administered PROQUAD instead of the intended VARIVAX; Patient, in combination with concomitantly administered MMRlI, was inadvertently administered PROQUAD instead of the intended VARIVAX; This spontaneous report was received from an other health professional referring to a 12 months old female patient. There was no pertinent medical history and drug reactions/allergies. Concomitant medication was not reported.   On 01-SEP-2021, the patient was in combination with concomitantly administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot# and expiration date were not reported) was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported, lot # T029102, expiration date: 23-FEB-2022) instead of the intended varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (accidental overdose and wrong product administered).  No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: PPV
Symptoms: Chemical burn, Pain in extremity, Peripheral swelling
Clinical narrative: caller had pain and swelling in her right arm from the shoulder to elbow for 5 days and since then has had pain from the shoulder all the way to fingers; physician thought this was a chemical injury to the vaccine; caller had pain and swelling in her right arm from the shoulder to elbow for 5 days and since then has had pain from the shoulder all the way to fingers; This spontaneous report as received from a 79-year-old female patient concerning herself with gastrooesophageal reflux disease.  There was no information about the patient's medical history. Concomitant therapies included famotidine (PEPCID).     On 02-AUG-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter in the left arm for prophylaxis (route of administration, lot number and expiration date were not reported).  On 06-AUG-2021, after receiving the vaccine, the patient experienced had pain and swelling in her right arm from the shoulder to elbow for 5 days) and since then had had pain from the shoulder all the way to fingers(pain in extremity, and peripheral swelling). The patient stated sometimes it was bad, sometimes not so bad. The patient mentioned that her physician thought this was a chemical injury (chemical burn) to the vaccine. The patient was treated with hot/cold compress and exercises. The patient sought unspecified medical attention.  The outcome of pain in extremity, peripheral swelling and chemical burn was reported as not recovered. The causality assessment for the events was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Varivax wa adminsitered on 02-asep-2021 and expired on 18-AUG-2021; No further AE reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 02-SEP-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliters (ml) as prophylaxis (lot number S025608, expiration date reported as 18-AUG-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). In addition, the reporter mentioned that the administered dose of the vaccine did not go through any temperature excursions. No additional adverse events were reported in the patient.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No signs or symptoms were reported; Temperature excursion on ROTATEQ that ocurred on 02-AUG-2021. ROTATEQ was administered to a patient on 27-AUG-2021; This spontaneous report was received from an unspecified reporter (other), referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 02-AUG-2021, the Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) had a temperature excursion of 8.882 Centigrade degrees (°C) for 7 hours 12 minutes. A previous temperature excursion was not reported.   On 27-AUG-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) orally, 1 time dose, lot# 1741375, expiration date 05-MAR-2022, for prophylaxis (strength, dose and frequency were not reported). No signs or symptoms were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired ROTATEQ was administered; This spontaneous report was received from a pediatrician, referring to a patient of unknown age and unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 27-AUG-2021, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1691140, expiration date 10-JUL-2021; dose and strength were not provided) orally for prophylaxis (expired product administered). The vaccine had no temperature excursions. No additional adverse event reported.  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2109USA000873:
Age: 13.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No further information is available; The patient received PROQUAD on 6/23/2021 and VARlVAX on 8/26/2021; The patient received PROQUAD when the patient was 13 years old; This spontaneous report was received from a registered nurse, referring to a 13 years old patient. The patient's medical history and concurrent condition were not provided. Concomitant vaccine included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).     On 23-JUN-2021, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, route, lot# and expiration date were unknown) for prophylaxis after the recommended age (product administered to patient of inappropriate age).   On 26-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot# T021822, expiration date 25-JUN-2022; strength, dose, frequency and route were unknown) for prophylaxis (inappropriate schedule of product administration). No further information was available.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient asymptomatic; An 11 year old was mistakenly given Pedvax Hib instead of meningococcal vaccine; An 11 year old was mistakenly given Pedvax Hib instead of meningococcal vaccine; the medication error resulted from similarities in the Pedvax Hib carton and the carton of the meningococcal vaccine; This spontaneous report was received from a pharmacist referring to an 11-year-old female patient. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, or previous drugs reactions/allergies was provided.  On 27-OCT-2011, the patient received the first immunization for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (administered dose, vaccination scheme, route and anatomical location of vaccination, lot number and expiration date were not reported). On 01-SEP-2021, an haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S030970 has been verified to be valid, expiration date reported and validated as 14-APR-2022) was inadvertently administered to the patient who was supposed to be getting a meningococcal vaccine (wrong product administered). The vaccine was administered intramuscularly in the right deltoid (dose number, administered dose and vaccination scheme were unknown by the reporter) as prophylaxis. The patient was over the recommended age for the vaccine (product administered to patient of inappropriate age) and was currently asymptomatic (no adverse event). The reporter also stated that the medication error resulted from similarities in the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) carton and the carton of the meningococcal vaccine (product packaging confusion).
Age: 38.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine used; No addittional adverse events reported; This spontaneous report was received from a nurse supervisor (conflicting information also reported as office manager) referring to a 38-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 02-SEP-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 milliliters (ml) as prophylaxis (lot number T014145, expiration date reported as 31-AUG-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). In addition, the reporter mentioned that the administered dose of the vaccine was found to be supported by a memo with no temperature excursions. No additional adverse events were reported in the patient.
Age: 50.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 50 year old patient received 2 doses of Gardasil; This spontaneous report was received from a pharmacist referring a 50-year-old patient's gender not reported. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  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) dose 2 for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).  The pharmacist mentioned that they discovered that the patient was 50 years old until after the second dose was administered. No additional adverse event was reported.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a currently 82-year-old patient (pt) of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 21-OCT-2015, the pt was administered with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions by a health care provider. Subsequently, the pt was treated by a physician for the following injuries resulting from pt's zoster vaccine live (ZOSTAVAX) used: shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). At the reporting time, the outcome of herpes zoster and ill-defined disorder was unknown. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient is currently asymptomatic; received a second dose of VARIVAX and MMR II accidentally/ additional dose/ extra dose administered; This spontaneous report was received from a nurse practitioner referring to a 3-year-old male patient.  No information regarding the patient's pertinent medical history, concurrent conditions, or drug reactions/allergies was provided.  On 21-APR-2021, the patient was vaccinated with the first doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and an unspecified varicella vaccine (manufacturer unknown) (administered doses, vaccination schemes, routes and anatomical locations of administration, lot numbers and expiration dates were not reported) as prophylaxis. On 04-SEP-2021 the patient received accidentally a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T035398 has been verified to be valid, expiration date not reported but upon internal validation established as 16-OCT-2022), subcutaneously in the left leg as prophylaxis (administered dose and vaccination scheme were not reported) (extra dose administered). On the same date, he also accidentally received a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number T007230 has been verified to be valid, expiration date not reported but upon internal validation established as 27-FEB-2022; administered dose, vaccination scheme, route of administration and anatomical location of vaccination were not reported) as prophylaxis (extra dose administered). The reporter stated that the patient was currently asymptomatic (no adverse event).
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The nurse is reporting that a patient received improperly stored vaccine on 31-AUG-2021; This spontaneous report was received from a nurse, referring to a 6-month-old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 31-AUG-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot# 1691301, expiration date 12-DEC-2021, for prophylaxis (strength, dose and frequency were not reported).  The temperature excursion was of 14.2 Centigrade degrees (°C) for 3 hours 15 minutes. However, a previous temperature excursion of 17.5 °C for 8 hours was also reported. A
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, COVID-19
Clinical narrative: The patient previously received the VARIVAX, series as a child, but a titer was perfgormed with result negative; The patient at the office who was diagnosed with COVID-19; This spontaneous report has been received from an nurse, concerning to a patient of unknown age and gender.     The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient previously received the varicella virus vaccine live (oka/merck)(VARIVAX)  series as a child. However on unknown date, a titer was performed and the titer result was negative (antibody test negative).    On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, anatomical location, lot number and expiration date were not reported) for prophylaxis.   On unknown date, the patient received a 3rd dose of varicella virus vaccine live (oka/merck)(VARIVAX)  (date refused by reporter) as prophylaxis.   On 28-AUG-2021, the patient was diagnosed with coronavirus disease (COVlD-19) and was scheduled to receive a dose of varicella virus vaccine live (oka/merck)(VARIVAX) on 07-SEP-2021 (also reported as "today"). The 4th dose of varicella virus vaccine live (oka/merck)(VARIVAX) has not been administered at this time.    The outcome for the events was unknown.   The causal relationship between varicella virus vaccine live (oka/merck)(VARIVAX) and both events was not reported.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further information is available; a patient received improperly stored vaccine on 9/2/2021; Information has been received from a nurse referring to a 5 months patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 02-SEP-2021,  the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 dose, lot # 1691301, expiration date: 12-DEC-2021, strength, frequency were unknown) orally for prophylaxis (Product storage error). No adverse effects were reported.  The stored temperature was 14.2 degree Celsius. The time frame was 3 hours and 15 minutes. There was a previous temperature excursion with stored temperature 17.5 degree Celsius for 8 hours.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; Administration of expired dose of ROTATEQ.; This spontaneous report was received from nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were unknown.      On 07-SEP-2021, the patient received an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1684166, expiration date 27-JUN-2021, dose, 2 ml/one time; strength was unknown) orally for prophylaxis (expired product administered). No additional adverse events reported. No product quality complaints reported.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; Patient was accidentally administered a third dose of VARIVAX; This spontaneous report was received from a nurse and refers to a 5 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a first and a second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, lot #, expiration date, dose, route and frequency were not reported) for prophylaxis.       On 08-SEP-2021, the patient was accidentally administered a third dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot # T027301, expiration date 12-AUG-2022 (route was not reported) for prophylaxis.        No adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported.; Medical assistant called to report a temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021. See case number 02007815 for TE details. ROTATEQ was administered to four patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date in 2021, the patient was vaccinated with a one (1) time dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (concentration, dose number and vaccination scheme frequency were not reported; lot number 1707449, was verified to be a valid lot number with an expiration date reported and established as 28-MAR-2022) for prophylaxis after that the vaccine experienced a temperature excursion of 35.4 degrees Fahrenheit (F) and 35.8 degrees Fahrenheit (F) during a time frame of 15 minutes (cumulative) that occurred on 03-AUG-2021 and 05-AUG-2021 (product storage error). It was stated that no previous temperature excursion was reported. It was reported that the patient did not experienced any signs or symptoms after the administration. No additional adverse event (AE) was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002968: US-009507513-2109USA002967: US-009507513-2109USA002969:
Sex: F
Vaccine: HPV9
Symptoms: Grip strength decreased, Muscular weakness
Clinical narrative: the patient began to experience weakness in her hands and legs; The patient was found to have decreased grip strength; This spontaneous report was received from a physician via company representative, referring to a 21-year-old female patient. Information regarding the patient's pertinent medical history, concomitant therapies and previous drug reactions or allergies were unknown by the reporter.  On 07-SEP-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (ml) as prophylaxis (formulation, vaccination scheme frequency and anatomical location were not reported; route of administration, lot number and expiration date were unknown by the reporter). On the same date, at an unspecified time after the administration, while the patient was still in the office, the patient began to experience weakness in her hands and legs (muscular weakness) and was found to have decreased grip strength. The patient declined to remain in the office for observation and that evening the patient reported that her symptoms had not decreased.  On an unknown date in September 2021, the patient was hospitalized and it was reported that she would be in the hospital for 5 days. The patient saw a neurologist who did not believe that the patient's condition was caused by the hpv rl1 6 11 16 18 31 33 45 52 58 vlp (yeast) vaccine (GARDASIL 9). According to the reporting physician, the neurologist stated that "it should not have happened that fast from the vaccine". No treatment was administered for adverse events. It is unknown if laboratory studies or diagnoses were performed.  The outcome of the events muscular weakness and grip strength decreased was reported as not recovered. The reporting physician did not provide the causality assessment between the events muscular weakness and grip strength decreased and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).; Sender's Comments:  US-009507513-2109USA002610:
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Nurse called to report that a dose of PEDV AX HIB expired 7 /9/21 and was administered; Information has been received from a nurse, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-AUG-2021, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R027322, expiration date on 09-JUL-2021 (anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; An expired dose of Pneumovax 23 was administered to a patient; This spontaneous report was received from a pharmacist (also reported as MNSC specialist), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 10-SEP-2021, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine, 1 dose, lot # T010293 with expiration date of 30-AUG-2021 (anatomical location was not provided) for prophylaxis. The reporter stated that the vaccine dose was properly stored through time of administration. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported.; Medical assistant called to report a temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021. See case number 02007815 for TE details. ROTATEQ was administered to four patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date in 2021, the patient was vaccinated with a one (1) time dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose was not reported; lot number 1707449, was verified to be a valid lot number with an expiration date reported and established as 28-MAR-2021) for prophylaxis after that the vaccine experienced a temperature excursion of 35.4 degrees Fahrenheit (F) and 35.8 degrees Fahrenheit (F) during a time frame of 15 minutes (cumulative) that occurred on 03-AUG-2021 and 05-AUG-2021 (product storage error). It was stated that no previous temperature excursion was reported.  It was reported that the patient did not experienced any signs or symptoms after the administration. No additional adverse event (AE) was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002597:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported.; Medical assistant called to report a temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021. See case number 02007815 for TE details. ROTATEQ was administered to four patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date in 2021, the patient was vaccinated with a one (1) time dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (concentration, dose number and vaccination scheme frequency were not reported; lot number 1707449, was verified to be a valid lot number with an expiration date reported and established as 28-MAR-2021) for prophylaxis after that the vaccine experienced a temperature excursion of 35.4 degrees Fahrenheit (F) and 35.8 degrees Fahrenheit (F) during a time frame of 15 minutes (cumulative) that occurred on 03-AUG-2021 and 05-AUG-2021 (product storage error). It was stated that no previous temperature excursion was reported.  It was reported that the patient did not experienced any signs or symptoms after the administration. No additional adverse event (AE) was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002597:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported.; Medical assistant called to report a temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021. See case number 02007815 for TE details. ROTATEQ was administered to four patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date in 2021, the patient was vaccinated with a one (1) time dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (concentration, dose number and vaccination scheme frequency were not reported; lot number T033812, was verified to be a valid lot number with an expiration date reported and established as 29-DEC-2021) for prophylaxis after that the vaccine experienced a temperature excursion of 35.4 degrees Fahrenheit (F) and 35.8 degrees Fahrenheit (F) during a time frame of 15 minutes (cumulative) that occurred on 03-AUG-2021 and 05-AUG-2021 (product storage error). It was stated that no previous temperature excursion was reported. It was reported that the patient did not experienced any signs or symptoms after the administration. No additional adverse event (AE) was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002597:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered following a supported temperature excursion; This spontaneous report was received from a healthcare business professional referring to a 4-year-old male patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 13-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T038830 with an expiration date on 17-NOV-2022) for prophylaxis, following a supported temperature excursion on 28-JUN-2021 (product storage error).         The dose of varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to a temperature excursion of 8.4 degrees Fahrenheit (°F) during a time frame of 1 hour, 30 minutes, and 0 seconds. There was no prior temperature excursion.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 1st Dose Administered to a 15-year-old; Initial Report Received on 20-Jul-2021 and 23-Jul-2021   A pharmacist reported that a 15 year-old male patient (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.    No relevant medical history was reported.   No relevant concomitant medications were reported.   On an unspecified date, a 15 year-old male patient received the first dose of HEPLISAV-B (Lot # 934601, expiration date 16-Mar-2022; NDC # and serial number were not reported) injection in the left deltoid from a medical office. No adverse effects were reported. The reporter asked if the second dose of HEPLISAV-B should be given or if another vaccine should be used.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: 15 year-old Given Heplisav-B; Initial Report Received on 23-Jul-2021  A Medical Center Operations Director reported that a 15 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.  No relevant concomitant medications were reported.  On 27-May-2021, the recipient received dose 1 of HEPLISAV-B (Lot # 93767, Expiration 11-Apr-2022; NDC # not reported) in the right deltoid.    On 23-Jul-2021, the recipient presented for the second dose.  The recipient reported he has not had any adverse reactions from the first dose.    No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 28-Jul-2021  A pregnant female, over the age of 18 years (state, race and ethnicity not provided), reported to the pregnancy registry that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. At the time of report, she reported being 6-weeks pregnant.    No relevant medical history was reported.  No concomitant medications were reported.  On 13-Jul-2021, the pregnant patient was vaccinated with a "booster" of HEPLISAV-B (Lot #, expiration date and NDC # not reported).    She declined participation the registry and no additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; Initial Report Received on 30-Jul-2021  A certified medical assistant reported that a 41 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Medical history included previous vaccination for hepatitis B (vaccine not specified) but there was no titer. Therefore, a new series of hepatitis B vaccine was initiated. The patient was reported to be well and healthy.   No relevant concomitant medications were reported.  On 30-Jul-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933621, expiration date 26-Jul-2021, NDC # 4352800301, serial number not provided) in the left deltoid. There were no adverse reactions reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 27.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose of Heplisav-B was Given; Initial Report Received on 04-Aug-2021  A pharmacist  reported that a 27 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No medical history was reported other than an allergy to Bactrim.    No relevant concomitant medications were reported.  On 03-Aug-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933622, expiration date 01-Aug-2021, NDC # 43528000301, and serial number not provided). The route and site of injection were not provided. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose of Heplisav-B was Given; Initial Report Received on 09-Aug-2021  A pharmacist reported that a 19 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Relevant medical history was not reported.    Relevant concomitant medications were unknown.  On 03-Aug-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933094, expiration date 17-Apr-2021, NDC # 43528-003-05, and serial # 368019294006) to the left deltoid at a pharmacy. This was the first dose of the series. No adverse effects were reported. At the time of reporting, no additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose of Heplisav-B was Given; Initial Report Received on 13-Aug-2021  A certified medical assistant reported that a 60  year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 11-Aug-2021, the patient received a dose of HEPLISAV-B (Lot # 933624, expiration date 10-Aug-2021, serial number 178642652628 and NDC # not reported) in the left deltoid. No adverse effects were reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose of Heplisav-B was Given; Initial Report Received on 13-Aug-2021  A pharmacist reported that a 26 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. The patient was not pregnant.  No relevant concomitant medications were reported.    On 12-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, and NDC # not reported).  On 13-Aug-2021, the patient received the second dose of HEPLISAV-B (Lot # 933622, expiration date 01-Aug-2021, serial number 597626603178 and NDC # 43528-003-05) in the left deltoid. No adverse effects were reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date and had pain and burning sensation, refer case US2021AMR190657).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received 2nd dose and felt bad for about 18 hours. The patient had no issue since, about 5 years. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190657:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Headache, Hyperhidrosis
Clinical narrative: cold hot, cold, hot; Sweats; dull headache; This case was reported by a consumer via media and described the occurrence of feeling hot and cold in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced feeling hot and cold, sweating and headache dull. On an unknown date, the outcome of the feeling hot and cold, sweating and headache dull were unknown.   It was unknown if the reporter considered the feeling hot and cold, sweating and headache dull to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient stated that everyone would react differently to the shots. The patient had both shot of Shingles vaccine the first one not happen and 2nd shot, the patient reacted to acted as a 3 to 4 day bug. hot ,cold hot ,cold , sweats an a dull headache. this was within the last 4 days and was hoping never to have shingles. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Headache; arm is gets very sore; body aches; fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced headache, pain in arm, general body pain and fatigue. On an unknown date, the outcome of the headache, pain in arm, general body pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, pain in arm, general body pain and fatigue to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and it was not painful, but arm was gets very sore and side effects not fun.headache, body aches, fatigue but it only lasts a day or so. The patient just had 1st shot in July booster shot set for November. The follow up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Coma, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles/ shingles on brain; coma; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), coma (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the coma was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, coma and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was known to patient. The age at vaccination was not reported. The reporter stated that, the patient received Shingles shot and ended in a coma a couple of years ago for over a month, they said he had shingles on the brain. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided. The case had been linked with US2021AMR190777, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190777:same reporter