chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The product was administered to a patient after being improperly stored.; This spontaneous report has been received from a prescriber nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with one improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, vaccination scheme frequency and anatomical location were not reported; lot number U008180, that was verified to be a valid lot number with an expiration date reported and established as 12-MAR-2023) for prophylaxis (product storage error). The aforementioned administered dose underwent a temperature excursion as follows: 13 (units not provided) for 297 days. There was no previous temperature excursion. No other adverse event was reported (no adverse event).  The report was considered to be non-valid due to lack of the patient's identifiers.  Follow up information was received on 24-JUN-2022 from the prescriber nurse.  The reporter informed that she is attempting to return forms, but her fax machine does not work and she was looking for an alternate route to send them. Additional information will be mailed.  Follow up information was received from the prescriber nurse on 06-JUL-2022. The patient was a 14-years-old female.  On 08-OCT-2021, the patient received dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular Injection, lot # T013205, expiration date established as 03-DEC-2021, administered intramuscularly in right deltoid; Hepatitis B vaccine manufacturer: GlaxoSmithKline, lot # 5295P, administered intramuscularly in right deltoid; meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) manufacturer: GlaxoSmithKline, lot # AMVA438A, administered intramuscularly in left deltoid; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), manufacturer: GlaxoSmithKline, lot # 57C57, administered intramuscularly in right deltoid; all for prophylaxis. On 17-NOV-2021 the patient was administered an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously in right arm. The patient had no significant response to the vaccination.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: "patient had no adverse reactions"; Caller states that improperly stored vaccine was "possibly" administered on unknown dates to unknown patients./patient was administered PROQUAD on 25-MAY-2022, which had been incorrectly stored in the refrigerator.; This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender.  The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, there was an improperly storage for measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), rHA lot number U014143 has been verified to be valid, expiration date: 31-OCT-2022, administered for prophylaxis (strength, dose, anatomical location of vaccination and route of administration were not provided), (product storage error). It was accidentally stored in the refrigerator with a temperature of 38 degree Fahrenheit (F) for a time frame of 168 hours. Moreover, on an unknown date, that improperly storage vaccine was possibly administered to unidentified patients. No previous temperature excursion was reported.  Follow information has been received on from the registered nurse 11-JUL-2022.  A call was received from the Nurse Practitioner reporting information on a 4-year-old male child with a history of asthma (well-controlled). Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX). There was no known drug allergies.   On 25-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), which had been incorrectly stored in the refrigerator. It was administered subcutaneously in the left arm. There was no adverse reactions.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details.; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion. No additional AE details or PQC. Names of vaccines involved (including lot/exp) PNEUMOVAX 23 U022819 01/14/2023; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies or concomitant therapies was provided.   On 11-APR-2022, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #U022819, expiration date: 14-JAN-2023, strength, dose and route of administration were not provided) for prophylaxis after a non-supported temperature excursion (Incorrect product storage).   The vaccine involved was stored at 7 degrees Fahrenheit (F) for 96 hours. There was no previous temperature excursion reported. No additional adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Caller reporting that a dose of VARIVAX was administered after its expiration date. Date administered: 10Jun2022, date expired: 21May2022. Caller confirmed the vaccine has no previous temperature excursions. No PQC. No additional information.; This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 10-JUN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), dose: 0.5 ml, lot # T017685 for prophylaxis. The dose expired on 21-MAY-2022 (route of administration was not reported).  The vaccine has no previous temperature excursions.
Age: 58.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No adverse event; RN reporting that a patient received a dose of MMRII on 6/14/2022 with a labeled expiry of 6/2/2022. No additional information provided. Caller abandoned call prior to agent obtaining consent to contact. No additional AE/PQC was reported at time of c; This spontaneous report was received from a registered nurse, concerning a 58-year-old patient of unspecified gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 14-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 ml, lot # T018893 for prophylaxis. The dose expired on 02-JUN-2022 (route of administration was not reported).    No adverse events were reported.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccines administered after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 16-JUN-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U025200 was confirmed to be valid, expiration date: 13-AUG-2023, administered subcutaneously (reported as "SQ") (strength and site of administration were not provided) and hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #U031911 was confirmed to be valid, expiration date: 11-NOV-2022, administered intramuscularly (reported as "IM") both for prophylaxis (strength and site of administration were not provided). Both vaccines were exposed to the temperature of 13.5 degrees Celsius for 10 minutes (product storage error). No previous temperature excursions were reported. No additional adverse events or product quality complaints were reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling about the size of a quarter at the injection site.; Patient developed redness and swelling about the size of a quarter at the injection site.; This spontaneous report was received from a registered nurse (R.N.) via an employee, and refers to a 4-year-old patient of unknown gender.  The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. Historical vaccines included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), and varicella virus vaccine live (oka/merck) (VARIVAX), both received at 12 months with no reaction.  On 13-JUN-2022, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), administered as an injection for prophylaxis (strength, dose, lot #, expiry date, and anatomical location were not provided).  On the same day, the patient experienced redness and swelling about the size of a quarter at the injection site. The patient was given "Benedryl" and ice, then sent home. On an unknown date in June 2022, the patient recovered from the events.  The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events; Caller reported VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 13-MAY-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose of 0.5 ml, subcutaneously, lot # U022321 confirmed to be valid with an expiration date: 15-JUL-2023 (anatomical location was not reported) for prophylaxis. The vaccine underwent a temperature excursion of 6 degrees Fahrenheit for 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Age: 24.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: No additional AE reported; HCP reported that PROQUAD got administered to a 24 years old patient instead of MMR II; This spontaneous report was received from a registered nurse and refers to a 24-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot #W002783, expiration date: 24-JUL-2023, administered for prophylaxis (dose, strength, and route of administration were not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Wrong vaccine administered). No additional adverse event (AE) reported. No further information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator and referred to a patient of unknown gender and age. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 02-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter subcutaneously (valid lot #U022321 with an expiration date: 15-JUL-2023) for prophylaxis. The vaccine was administered after temperature excursion, temperature 6 Fahrenheit with a time frame of 30 mins (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator 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 16-JUN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) after temperature excursion (product storage error), 0.5 milliliter, lot #U022321 with expiration date: 15-JUL-2023, administered subcutaneously (SQ) as prophylaxis (strength was not provided). The vaccine underwent temperature excursion of 6 Fahrenheit for 30 minutes. It did not have previous temperature excursion. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE occurred; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 14-JUN-2022, the patient vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose reported as 1 dose, lot # U039723 with expiration date on 15-DEC-2023, administered subcutaneously for prophylaxis (strength, vaccination scheme frequency and anatomical location were not provided) (product storage error). The administered dose of the vaccine experienced a temperature excursion at -2.5 degrees Celsius (C) for a time frame of 5 hours and 6 minutes. It was stated that there were not previous temperature excursions. Additionally, it was confirmed that no adverse events occurred.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005711: US-009507513-2206USA005588: US-009507513-2206USA005579: US-009507513-2206USA005817:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; an expired dose of MMR II was administered to a patient; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant therapy was included sterile diluent (manufacturer unknown).  On 05-MAY-2022, the patient was vaccinated an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant Human albumin (rHA) 0.5 milliliter once, (lot #T007234, with expiration date: 27-FEB-2022), for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; improperly stored vaccine; This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 15-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002599, expiration date: 24-JAN-2024 (strength, exact dose and route of administration were not provided) for prophylaxis (Product storage error).  On an unknown date, before the administration, the vaccine underwent temperature excursion (missing information, clarification pending) at unknown conditions for an unknown period of time. No previous temperature excursions were reported. No adverse events were reported (No adverse event).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller is a HCP calling to report a TE for PNEUMOVAX 23.; This spontaneous report was received from a Registered nurse referring to a patient of an unknown age and gender.  The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication were not provided.  On 09-JUN-2022, the patient was vaccinated with an improperly stored dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U022819 with expiration date on 14-JAN-2023, administered for prophylaxis (strength, vaccination scheme frequency and , dose, route of administration and anatomical location were not provided).  The administered vaccine experienced the temperature excursion of 0.2 degrees Celsius (C) for a time frame of 24 hours. There was a previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA006770: US-009507513-2206USA007094: US-009507513-2206USA007068: US-009507513-2206USA007098: US-009507513-2206USA006670: US-009507513-2206USA006731: US-009507513-2206USA007090: US-009507513-2206USA007045: US-009507513-2206USA006852: US-009507513-2206USA006952: US-009507513-2206USA007098: US-009507513-2206USA007059:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 22-MAR-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number U022819 with expiration date 14-JAN-2023 (dose, route, and anatomical location were not reported) for prophylaxis. The vaccination occurred after the temperature excursion occurred (product storage error). The pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was exposed to 1.4 degrees Celsius during 48 hours and it was reported that there were a previous temperature excursion. No additional adverse events were reported. ; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA006770: US-009507513-2206USA007094: US-009507513-2206USA006674: US-009507513-2206USA007098: US-009507513-2206USA007068:
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: Patient had no adverse effects or symptoms from this dose; A dose of PROQUAD and VARIVAX were both given to a patient on the same day; This spontaneous report has been received from a medical assistant regarding to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  On an unknown date (also reported as 17-JUN-2022), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA [recombinant human albumin]) (PROQUAD) (strength and route of administration not reported)  (lot number U029320 with expiration date 19-MAR-2023) administered at a dose of 0.5 mL, once, for prophylaxis and varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported) (lot number U020238 with expiration date 28-JUN-2023) administered at a dose of 0.5 mL, once, for prophylaxis.  The medical assistant reported that on the day of vaccination, both doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA [recombinant human albumin]) (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) were administered to the patient (overdose). The patient did not have adverse effects (no adverse event) or symptoms from this dose.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no addtional adverse event were reported; patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 13-JUN-2022, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot # 1821791 confirmed to be valid with expiration date: 26-JUL-2022, for prophylaxis. The vaccine underwent a temperature excursion of 50.7 degrees Fahrenheit for 35 minutes (product storage error). There was no previous temperature excursion. There were no additional adverse events reported.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administered dose of improperly stored VARIVAX; This spontaneous report was received from Other and refers to a 13-months-old (also reported as 14-months-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot # W002596, expiration date: 24-JAN-2024, administered in left vastus lateralis for prophylaxis (strength, exact dose, and route of administration were not provided). Prior to being administered to the patient, the vaccine experienced a temperature excursion for a total of 32 minutes. The temperature of the freezer was higher than the recommended temperature (exact temperature of excursion was not provided).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; dose of VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured; This spontaneous report was received from 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 24-MAY-2022,, improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter lot #U029496 expiration date: 21-SEP-2023 (route of administration and anatomical location were not provided) was administered for prophylaxis. The vaccine experienced a temperature excursion of 7.3 degree Fahrenheit four 2 hours (product storage error). There was previous temperature excursion. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007855: US-009507513-2206USA007845: US-009507513-2206USA007717: US-009507513-2206USA007710: US-009507513-2206USA007839: US-009507513-2206USA007547: US-009507513-2206USA007894: US-009507513-2206USA007527: US-009507513-2206USA007706: US-009507513-2206USA007910: US-009507513-2206USA007693:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; Caller is a medical assistant who reports an expired dose of VAQTA was administered to a patient on 20Jun2022.; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 20-JUN-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, 0.5 ml, once, lot # T031202, expiration date 14-JUN-2022 (strength, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No other adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of PROQUAD was administered.; This spontaneous report was received from a licensed practical nurse (LPN) concerning a patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant medication were not reported.   On 27-JUN-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter subcutaneously (lot #T037957, expiration date: 09-MAY-2022; strength and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Disability, Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer, regarding a case in litigation and concerning a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, after receiving the suspect vaccine, the pt suffered herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event of herpes zoster was considered to be not recovered/not resolved. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed with caller the patient did not experience any other AE.; Caller reported an AE for ROTATEQ. The caller said the patient received a dose after a temperature excursion occurred.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 28-JUN-2022, the patient was vaccinated with improperly stored (product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (exact dose, strength, lot #, expiration date were not provided) for prophylaxis. Temperature excursion information: above 9 degree Celsius (8.98 degree Celsius; discrepant information) for 1 hour 40 minutes (also reported as 8 degree Celsius for 47 minutes). There was no additional adverse event reported.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report was received from mother's patient and refers to a child female. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 05-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live manufacturer unknown (strength, lot number, expiration date, and route of administration were not provided), also, on an unknown date she experienced diarrhea.   The outcome regarding this event was not provided.   The causality assessment between therapy with and the aforementioned event was not provided.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, Vaccination site urticaria
Clinical narrative: a wheel appeared at the injection site.; HCP reporting PROQUAD was accidentally administered intradermally instead of subcuta; This spontaneous report was received from a registered nurse and refers to a male child (age reported as 2 or 4 years old). The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 29-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (dose, vaccination scheme, lot #, and expiry date were not provided) administered intradermally instead of subcutaneously, for prophylaxis (Incorrect route of product administration). It was reported the injection was administered at "a very shallow", about 15 degree angle.  On 29-JUN-2022, a wheel appeared at the injection site (Vaccination site urticaria). On the same day the patient recovered form the event.  The causality assessment between the event and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Caller was Healthcare Business Professional. Caller reported AE for Patient.  Patient was administered improperly stored GARDASIL 9 on unknown, previous date: Improperly Stored / Administered Detail Summary is located within following space.  Caller; No additional AE reported; This spontaneous report has been received from other regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot number 1780876 with expiration date in 11-SEP-2023 (formulation, strength, dose and route of administration were not reported).  The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was stored at a temperature of 35.0 Fahrenheit (°F) for the time frame of 18 minutes. No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available at this time. No additional AE.; Pharmacist calling for TE evaluation on refrigerated products in TE case 02199944 states one dose of PNEUMOVAX 23 in PFS was administered to a patient.          ?    Names of vaccines involved (including lot/exp) PNEUMOVAX 23 PFS   T040402   9/30/2; This spontaneous report was received from a pharmacist 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 06-JUL-2022, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one dose (lot number T040402 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), reported expiration date: 30-SEP-2022; exact dose, vaccination schedule, site and route of administration were not provided) for prophylaxis (Product storage error). The vaccine underwent temperature excursion in temperature above 46 degree Fahrenheit (48.2F) in a timeframe of 3 hours. No previous temperature excursions were reported. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: ROTATEQ had a known temperature excursion; No additional AE reported; A patient was inadvertently administered ROTATEQ after the labeled expiration date; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender. Information regarding medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.   On 07-JUL-2022, the patient was inadvertently administered an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters (ml) for prophylaxis (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number 1742078 has been verified to be valid, expiration date reported and established as 06-JUL-2022) (expired vaccine used).   The reporter stated that the vaccine had a known temperature excursion (product storage error). No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: PPV, PPV
Symptoms: Induration, Pruritus, Skin warm, Swelling
Clinical narrative: she had developed itching, swelling, induration and skin warm to the touch.; she had developed itching, swelling, induration and skin warm to the touch.; she had developed itching, swelling, induration and skin warm to the touch.; she had developed itching, swelling, induration and skin warm to the touch.; patient was administered a second unnecessary dose of PNEUMOVAX 23 and the patient developed side effects; This spontaneous report has been received from  a nurse referring a 67-year-old female patient.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On an unknown date in 2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1st dose, as prophylaxis (lot number, expiration date, and route of administration were not provided). On 05-JUL-2022, the patient was vaccinated with an unnecesary second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 2nd dose, lot  number U034712, expiration date: 30-JUL-2023, as prophylaxis (route of administration was not provided (extra dose administered).  On 06-JUL-2022, the patient had developed itching, swelling, induration and skin warm to the touch, it was stated that the patient was the patient was seen by the healthcare provider and was treated with ketorolac tromethamine (TORADOL). The outcome of the events pruritus, swelling, induration and skin warm were not provided.  The causality assesment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and pruritus, swelling, induration and skin warm was not provided. ; Sender's Comments:  US-009507513-2207USA002506:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported at time of call; Patient received a dose of PNEUMOVAX23 on 6/6/2022 with a labeled expiry of 5/26/2022.; This spontaneous report has been received from a registered pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 06-JUN-2022, the patient received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T033369, and labeled expiration date 26-MAY-2022, for prophylaxis (Expired product administered) (Route of administration and anatomical location were not reported). It was reported that no temperature excursions were involved, and no additional adverse events were reported (No adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE reported.; Nurse reports that a twelve month old patient was accidently administered both VARIVAX and PROQUAD on Jul 5, 2022.; This spontaneous report has been received from a registered nurse concerning a 12-month-old patient of unknown gender. The concomitant medications, medical history, drug reactions or allergies, and concurrent conditions were not reported.  On 05-JUL-2022, the patient was accidently administered both measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) once, lot # W002785, expiration date 24-JUL-2023 (strength, dose, route of administration and anatomical location were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) once, lot # U029496, expiration date 21-SEP-2023 (strength, dose, route of administration and anatomical location were not provided) for prophylaxis (accidental overdose). No further information was provided. No additional adverse event (AE) was reported. No product quality complaints (PQC) was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reported PROQUAD was administered to patient after a temperature excursion. Date of administration was Mar 23, 2022. No further information provided. This is patient one of three, cross reference AE cases: 02202238 and 02202256. No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with an improperly stored (-8.3 Celsius degrees, time frame: 1 hour, 1 minute and 0 seconds) measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, once, lot number U029320 was found to be valid, expiration date: 19-MAR-2023 (strength, exact dose, route of administration and injection site were not reported) for prophylaxis (product storage error). No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA003330: US-009507513-2207USA003487:
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HCP calling to inquire on catch-up dosing with GARDASIL 9 for patient who received first two doses of GARDASIL in her 20s and now wishes to complete 3-dose vaccine schedule.; No additional AE; This spontaneous report was received from a physician and refers to a 43-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5ml / 0, 2, 6 month intervals, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) in her 20s.  Now the patient wished to complete 3-dose vaccine schedule (inappropriate schedule of product). No additional information provided, no additional adverse events reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional adverse event reported; ROTATEQ was administered to a patient today 12Jul2022 and the patient was 12 weeks and 1 day old; This spontaneous report was received from a physician and refers to a 12-week-and-1-day-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 12-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, first dose, lot #1837118, expiration date: 25-MAR-2023, administered orally (strength was not provided) for prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporting a patient received VARIVAX on 11JUL2022 that was improperly stored multiple times; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-JUL-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U002396 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and confirmed as 22-JAN-2023) (exact dose, route of administration, and anatomical location were not provided) as prophylaxis (product storage error). The temperature excursion was of 45.3 degrees Fahrenheit (F) for 20 hours and 44 minutes. The vaccine also suffered previous temperature excursions of: 72.2F for 21 hours and 14 minutes, 70F for 24 hours, and 70F for 23 hours and 59 minutes. No additional adverse events (AE) were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 8 Year-Old Male Received Heplisav-B; Initial Report Received on 25-Apr-2022  A registered pharmacist reported that an 8-year-old male patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported. The patient had no known allergies.  No concomitant medications at the time of vaccination were reported.  On 28-Nov-2021, the patient received a dose of HEPLISAV-B (Lot # 934601, expiration date 16 Mar 2022, NDC # 43528-003-05, route unknown) in the left arm by a pharmacist. No adverse reactions were reported.  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: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose 2 years ago, series not completed; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years prior to the reporting).   On an unknown date, the patient did not  received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comment:  Reporter stated patient received 1st dose of Shingrix 2 years ago. Patient wanted to know if patient should restart the series or should just get 2nd dose. No additional details as this was the only information provided. Additional supportive information Till the time of reporting patient did not received second dose of vaccine which led to inappropriate schedule of vaccine. Reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR103676:Same reporter. Patient 2
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This case was reported by a consumer via sales rep and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-July-2022 Reporter's comment: The reporter was an employee. The reporter was patient itself. The patient received Shingrix on an unknown date and experienced tinnitus. The reporter agrees to follow up from GlaxoSmithKline.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Gout, Lethargy, Paraesthesia
Clinical narrative: serious case gout; lethargic; still has tingling in buttocks; This case was reported by a nurse via sales rep and described the occurrence of gout in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number y442t, expiry date 10th July 2023) for prophylaxis.   On 24th June 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced gout (serious criteria other: serious as per reporter), lethargy and tingling. On an unknown date, the outcome of the gout and lethargy were unknown and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the gout, lethargy and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Jul-2022 Reporter's Comments: The patient received 2nd dose of Shingrix on Friday, 24th June 2022  and had severe reaction, she was lethargic, had serious case gout and was still having tingling in buttocks at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 1st one before covid, then unable to get the 2nd one; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.       Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comments: The patient received the 1st shot before Covid and then unable to get the second shot.The reporter said It was January 2020 and in March everything was shut down. The patient asked if he/she protected from shingles as he/she only received 1 dose.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tooth abscess
Clinical narrative: abscessed tooth; This case was reported by a consumer via interactive digital media and described the occurrence of tooth abscess in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced tooth abscess. The patient was treated with antibiotics nos. On an unknown date, the outcome of the tooth abscess was not recovered/not resolved.   It was unknown if the reporter considered the tooth abscess to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-Jul-2022 Reporter's Comments: The patient self-reported this case. The patient was due for the 2nd dose of Shingrix vaccine but had developed an abscessed tooth, she had been on antibiotics for the treatment and asked about the ingredients in Shingrix and asked would there be any interference and if she should wait. The reporter did not consent to follow up.