chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE; leaked out of a hole at the top of the syringe where the break occurred on her hand but did not report any other adverse issues or side effects related to the exposure; 1 of 10 vaccine syringes tip/leur lock was broken; leaked out of a hole at the top of the syringe where the break occurred on her hand but did not report any other adverse issues or side effects related to the exposure; This spontaneous report was received from the Nurse, 47-year-old female, who refers to herself. Her medical history, concurrent conditions and concomitant therapies were not reported.   On 07-MAR-2025, the nurse opened a sealed previously unopened carton of Hepatitis B Vaccine (Recombinant) Suspension for injection (RECOMBIVAX HB) (strength 5MCG/0.5ML, lot #Y009551, expiration date: 08-DEC-2026) and 1 of 10 vaccine syringes tip/ luer lock was broken, "clean off and like it was decapitated" (Syringe issue). The tray was sealed with a cellophane cover and there was no damage to the shipping container that the reporter could recall and no damage to the carton, tray or cellophane either. There were no other syringes in the tray/ carton that were broken or damaged. The HCP stated there were no obvious shards of glass in the broken syringe or tray, but she could not be sure. A defect was noticed prior to breaking the seal of cellophane, but she did open the tray to inspect further. The HCP reported there was a hole at the top of the syringe where the tip/ luer lock broke off that was about the size of the hole that would be present if the tip was still intact, and the vaccine could leak out. The HCP stated there was no obvious fluid or dried residue in the tray, but upon picking up the syringe she stated the syringe felt wet and some of the vaccine might leaked out of a hole (at the top of the syringe where the break occurred) on her hand, but did not report any other adverse issues or side effects related to the exposure (Accidental exposure to product, Occupational exposure to product). None of the doses of Hepatitis B Vaccine (Recombinant) Suspension for injection (RECOMBIVAX HB) in the affected carton were administered. No additional adverse events.
Sex: F
Vaccine: HEP, HEP
Symptoms: Incomplete course of vaccination, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; first dose in August ,2024 and their second dose in October 2024 but have not received their third dose at this time; This spontaneous report was received from a physician and refers to a 19-year-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date in August 2024, the patient was vaccinated with the first dose of hepatitis B vaccine (RECOMBIVAX HB) 0.5 ml, lot x017743, expiration date 21-FEB-2026 (route of administration and anatomical location were not provided) for prophylaxis. On an unknown date in October 2024, she was administered the second dose of hepatitis B vaccine (RECOMBIVAX HB) 0.5 ml, lot # y003449, expiration date 16-OCT-2026 (route of administration and anatomical location were not provided) for prophylaxis (Inappropriate schedule of product administration). At the time of the report, she did not receive the third dose of the suspect vaccine. No adverse events were reported.
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; Nurse reported patient was mistakenly administered a third dose of MMR II on Mar 10, 2025. Patient received first dose of MMR II on Sep 24, 2024 and second dose of MMR II on Jan 20, 2025. No further information provided by nurse. No additional AE rep; This spontaneous report was received from a nurse and refers to a 64-year-old male patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 24-Sep-2024, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot # and expiration date were not reported) and on 20-Jan-2025, the patient received the second dose of  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot # and expiration date were not reported), both diluted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (indication, expiration date, and lot # were not reported).  On 10-Mar-2025, the patient was mistakenly vaccinated with the third dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot #X027902, expiration date: 04-Dec-2025) diluted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (indication, expiration date, and lot # were not reported). No additional adverse event was reported.  Lot # is being requested and will be submitted if received.
Age: 3.0
Vaccine: HPV4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a patient possibly received GARDASIL quadrivalent when the patient was 3 years old at the time of the vaccination; No additional AEs were reported; This spontaneous report was received from an office manager in the physician's office and refers to a 3-year-old patient of unknown gender.   The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were were not reported.   On an unknown date, the 3-year-old patient was possibly vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (lot #K006447, expiration date: 19-Jun-2016; strength, dose and route were not provided) for Prophylaxis (Product administered to patient of inappropriate age). No additional adverse events (AEs) were reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Customer reported a 32-year-old female patient received one dose of GARDASIL 9 in 2019 and has not received additional doses since.  No symptoms reported.  No other information available at time of report.  Caller consented to correspondence.  No add; Noadditional AE/No PQC reported; This spontaneous report was received from a Pharmacist and refers to a(n) 32-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 an unknown date in 2019, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), 0.5 mL (0.5ML), administered by Unknown route (lot # and expiration date were not reported), as Prophylaxis, and had not received additional doses since. No symptoms or adverse events reported.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HPV4
Symptoms: Colonoscopy, Smear cervix abnormal
Clinical narrative: She had an "abnormal pap smear"; This spontaneous report was received from other health professional and refers to a 37-year-old female patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date (reported as received the first generation Gardasil vaccine series in year 2006/2007), the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), administered by Unknown route (dose, anatomical location, lot #, and expiration date were not reported) as prevention of human papilloma virus (HPV).  On an unknown date, the patient experienced an abnormal pap smear requiring colonoscopy for further evaluation on 01-APR-2025. At the reporting time, the outcome of event was not provided. Additional information was not known at that time.  The causal relationship between the event and the suspect vaccine was not reported.  Additional information is not expected.
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; administered improperly stored GARDASIL 9; This spontaneous report was received from a consumer (reported as vaccine coordinator), referring to a 10-year-old male patient. The patient's medical history and concomitant therapies was not reported. The patient's concurrent conditions included asthma, and allergies.  On 23-OCT-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #X025115, expiration date: 19-May-2026, dose and strength were unknown), administered by Intramuscular route for prophylaxis. No additional AE/PQC. The suspect vaccine was improperly stored the fridge temperature dropped below freezing while the office was closed (Improper storage of product in use).
Age: 9.0
Sex: M
Vaccine: IPV, TDAP, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storge of product in use; This spontaneous report was received from a consumer or and refers to a 10-year-old male patient. The patient's medical history, concomitant therapies were not reported. The patient's concurrent condition included autism.   On 23-Oct-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y007193, expiration date: 06-Jun-2026) administered by intramuscular route as prophylaxis (strength and dose were not provided); Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) (lot #UT976AA, expiration date: 03-Oct-2026) administered by intramuscular route for an unknown indication (strength and dose were not provided); and Ipv (Polio vaccine inact) (lot #X1D141M, expiration date: 31-Oct-2026) administered by intramuscular route for an unknown indication (strength and dose were not provided) after temperature excursion (TE) (Product storage error). Fridge temperature dropped below freezing over the weekend while office was closed. Temperature was 25F, time frame was 1 hour. No additional adverse event (AE) (No adverse event).
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called to state that the patient received a third dose of PEDVAXHIB at 6 months of age. No symptomatic adverse events were reported.; HCP called to state that the patient received a third dose of PEDVAXHIB at 6 months of age. No symptomatic adverse events were reported.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 27-Jan-2025, the patient received the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (lot #Y005248, which upon internal review confirmed to be a valid lot#; expiration date: 17-Sep-2026), at a dose of 0.5 mL (0.5ml/ series) at 6 months of age (Product administered to patient of inappropriate age) for prophylaxis. No symptomatic adverse events were reported (No adverse event). HCP has declined to answer any further questions and has also declined any AE follow-up.
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: full blown rash; This spontaneous report was received from a physician and refers to a 14-year-old male patient.    The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, lot #, and expiration date were not reported) for prophylaxis.   On an unknown date (also reported as the same date in the evening after receiving the vaccine), the patient experienced full blown rash.    The patient recovered/resolved from the event of full-blown rash on an unspecified date. Nothing changed in the patient's diet other than receiving the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). The patient received a unknown antihistamine for the rash.   The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: PNC21
Symptoms: Fatigue, Headache, Hypersensitivity, Injection site irritation, Injection site swelling
Clinical narrative: She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; She also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; This spontaneous report was received from the consumer and refers to herself,  a 62-year-old female patient.   The patient's medical history included drug reactions/allergies to lisinopril and other unspecified medications. The patient's concurrent conditions included high blood pressure and high cholesterol. Historical drugs included lisinopril. Concomitant medications included Carvedilolo, Atorvastatin, Vitamin E, Vitamin D, and Acyclovir.  On an unspecified date in February 2025 (3 weeks ago but the patient was unsur of the exact date), the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site lot # and expiration date were not reported) administered for prophylaxis.  On an unspecified date in 2025, the patient experienced swelling in the arm that received the vaccine, irritation and a "raised" area around the site (vaccination site swelling; vaccination site irritation; vaccination site mass). She reached out to the pharmacy where she received the vaccine and she stated that she received a cortisone shot and has been taking benadryl. She reported the swelling has decreased but is not resolved. She also reported having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns (headache; fatigue; sinus disorder; hypersensitivity). She stated that she did not receive any patient education from the pharmacist at the pharmacy prior to or after receiving the vaccine. She stated that she was going to attempt to get in contact and make an appointment with a primary care provider today as her symptoms have not responded. Therefore, at the time of reporting, the patient had not recovered from the reported adverse events. No additional adverse event (AE) and no product quality compliant (PQC) was noted. No additional information was reported.  The causal relationship between the reported adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: PNC21
Symptoms: Sinus disorder, Sluggishness
Clinical narrative: She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; She also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; She reports swelling in the arm that received the vaccine, irritation and a "raised" area around the site; SHe also reports having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns; This spontaneous report was received from the consumer and refers to herself,  a 62-year-old female patient.   The patient's medical history included drug reactions/allergies to lisinopril and other unspecified medications. The patient's concurrent conditions included high blood pressure and high cholesterol. Historical drugs included lisinopril. Concomitant medications included Carvedilolo, Atorvastatin, Vitamin E, Vitamin D, and Acyclovir.  On an unspecified date in February 2025 (3 weeks ago but the patient was unsur of the exact date), the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site lot # and expiration date were not reported) administered for prophylaxis.  On an unspecified date in 2025, the patient experienced swelling in the arm that received the vaccine, irritation and a "raised" area around the site (vaccination site swelling; vaccination site irritation; vaccination site mass). She reached out to the pharmacy where she received the vaccine and she stated that she received a cortisone shot and has been taking benadryl. She reported the swelling has decreased but is not resolved. She also reported having a headache, feeling "sluggish" and having "severe sinus and allergy" concerns (headache; fatigue; sinus disorder; hypersensitivity). She stated that she did not receive any patient education from the pharmacist at the pharmacy prior to or after receiving the vaccine. She stated that she was going to attempt to get in contact and make an appointment with a primary care provider today as her symptoms have not responded. Therefore, at the time of reporting, the patient had not recovered from the reported adverse events. No additional adverse event (AE) and no product quality compliant (PQC) was noted. No additional information was reported.  The causal relationship between the reported adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HEPA, HEPA, HEPA, HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: dministered improperly stored GARDASIL 9 and VAQTA following a TE; No additional AE; This spontaneous report was received from a consumer or other non health professional on 10-Mar-2025 and refers to 16-month-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The vaccines experienced temperature excursion on 26-Oct-2024 at 25 F for 1 hour. There was no pereious temperature excursion. On an unknown date, the patient may be vaccinated with Hepatitis A Vaccine, Inactivated (lot #X025908, expiration date: 24-Apr-2025), or Human Papillomavirus 9-valent Vaccine, Recombinant (lot #Y007193, expiration date: 06-Jun-2026), or Hepatitis A Vaccine, Inactivated (lot #X023974, expiration date: 18-Apr-2025) (unknown), or Hepatitis A Vaccine, Inactivated (lot #X010374, expiration date: 13-Nov-2024) (unknown), administered as prophylaxis (due to incomplete source document, it was unknown whech specific vaccine was administered) (Product storage error). No additional AE (no adverse event).
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported.; Customer called to report expired GARDASIL 9 administered to a patient post product expiration.  Expiration date was 29JAN2025.  Product was administered on 07FEB2025.; This spontaneous report was received from a nurse and refers to a 25-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 07-FEB-2025, the patient was vaccinated with an expired second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 milliliters (mL) administered intramuscularly, lot #W026152; which has been verified to be valid lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation establish as 29-JAN-2025 (strength and anatomical site of administration were not reported) administered for Prophylaxis (Expired product administered). No temperature excursion occurred. No symptoms reported (No adverse event).
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; administration of an expired dose of PNEUMOVAX-23 on 18-MAR-2025; This spontaneous report was received from a registered nurse and refers to a 51-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 18-MAR-2025, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (lot #X014729, expiration date: 22-Nov-2024), 1 dose/once (strength, dose, anatomical location not reported) for prophylaxis. No symptomatic adverse events were reported. There were no temperature excursions during the product lifetime.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: patient was recently diagnosed with HPV e6 and e7; patient had 2 doses at age 13 of GARDASIL dates of administration as follows: 8/28/2012 and second dose 12/3/2012, and third dose (GARDASIL 9) on 9/19/2016; Originally, patient had 2 doses at age 13 of GARDASIL dates of administration as follows: 8/28/2012 and second dose 12/3/2012, and third dose (GARDASIL 9) on 9/19/2016; This spontaneous report was received from a nurse via company representative and referred to a 23-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were unknown.   On 03-Dec-2012, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (dose, route, anatomical site, lot # and expiration date were not reported) for the treatment of prophylaxis. On 28-Aug-2012, the patient was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL)  (dose, route, anatomical site, lot # and expiration date were not reported) for the treatment of prophylaxis. On 19-Sep-2016, the patient was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9)  (dose, route, anatomical site, lot # and expiration date were not reported) for the treatment of prophylaxis (inappropriate schedule of product administration; interchange of vaccine products).   On an unknown date in 2025 (reported as recently), the patient was recently diagnosed with HPV e6 and e7 (papilloma viral infection). At the reporting time, the outcome of papilloma viral infection was not reported. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not applicable.   The causal relationship between the event of papilloma viral infection and both suspect therapies was not reported.   Lot # is being requested and will be submitted if received.
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Precautionary AE being filed due to HCP being unable to determine if products were administered to any patients during a temperature excursion; Information has been received from Business Partner/CRO on 31-Mar-2025.  This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #Y011712) 0.5 mL (expiration date was not reported) for prophylaxis. On 07-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported)for prophylaxis. The vaccine underwent temperature excursion (Product storage error). No additional adverse event was reported.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02762511-02762488 , CLIC number : , ESTAR number : , IRMS number : 500UW00000V5avRYAR|19032025170024|9692 , Central date : 2025-03-19 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2260591 , MNSC case number : 02762511 , MNSC interaction number : 02762488 , Integration log UniqueID : 500UW00000V5avRYAR|19032025170024|9692 , Service cloud CaseID : 500UW00000V5avRYAR
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Precautionary AE being filed due to HCP being unable to determine if products were administered to any patients during a temperature excursion; Information has been received from Business Partner/CRO on 31-Mar-2025.  This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-Feb-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #Y011712) 0.5 mL (expiration date was not reported) for prophylaxis. On 07-Feb-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. This vaccine underwent temperature excursion (Product storage error). No additional adverse event was reported.
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired GARDASIL 9 vaccine was inadverntly administered to a patient; This invalid spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 24-MAR-2025, the patient was inadvertently vaccinated with an expired dose with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #X014788, expiration date: 07-MAR-2025 for prophylaxis (exact dose, route of administration, and anatomical location were not reported). No adverse event was reported.   This case is invalid due to unidentifiable patient.  This is an amended report. Causality assessment for the event of no adverse event was added.
Age: 5.0
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect storage; no patients had any adverse affects; This spontaneous report was received from a licensed practical nurse and refers to a 6-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-AUG-2023, at 10:56 hours the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot #W001598, expiration date: 14-Jan-2024 (strength, dose number, dose, route and anatomical location were not provided) for prophylaxis; the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The temperature excursion was: 13.6°C during 6 hours 31 minutes. No adverse events reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-24 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : W001598 HB , Central date : 2025-03-21 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number :
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: they have a 48 year old female patient who is single and  sexually active who wants to complete the GARDASIL 9 series; No other AE/PQC.; This spontaneous report was received from a Medical Assistant and refers to a 48-year-old (Product use issue) female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. No adverse event reported. Additionally, it was mentioned that the patient is single and sexually active and wanted to complete the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) series.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administered PROQUAD with a possible TE; This spontaneous report was received from a Physician and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 25-Mar-2025, the patient was vaccinated with a possible improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot #Y010306, expiration date: 01-Dec-2025 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis; the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The data logger went out overnight but freezer stayed running. No data to ensure proper storage conditions. No confirmed case of TE as temperatures stayed within range the day before and the morning after.  No adverse event reported.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Irritability, Pyrexia, Rash
Clinical narrative: Nurse called to report AE for a patient after receiving their first dose of MMR II. Patient received her MMR II dose on 03/03/2025, the dose was given subcutaneous on the right thigh. Nurse reports patient experienced a rash on her torso, irritabilit; Nurse called to report AE for a patient after receiving their first dose of MMR II. Patient received her MMR II dose on 03/03/2025, the dose was given subcutaneous on the right thigh. Nurse reports patient experienced a rash on her torso, irritabilit; Nurse called to report AE for a patient after receiving their first dose of MMR II. Patient received her MMR II dose on 03/03/2025, the dose was given subcutaneous on the right thigh. Nurse reports patient experienced a rash on her torso, irritabilit; Nurse called to report AE for a patient after receiving their first dose of MMR II. Patient received her MMR II dose on 03/03/2025, the dose was given subcutaneous on the right thigh. Nurse reports patient experienced a rash on her torso, irritabilit; This spontaneous report was received from a nurse concerning 1-year-old female patient.   The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 03-MAR-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) that was diluted with a sterile diluent,  subcutaneous Injection (lot #X011632, expiration date: 23-APR-2025), dose number 1, 0.5 mL, administered by Subcutaneous route in Right Thigh as prophylaxis.  On 13-MAR-2025, the nurse reported that after receiving their first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), the patient experienced a rash on her torso, irritability and fever of 100.2 F on that day. Then on the following day (14-MAR-2025), the patient still had a fever and rash got worse and was covering her from head to toe. Nurse explained the rash covered her face, chest, torso, hands, all the way down her legs and her feet. Nurse explained the rash was pretty much everywhere and the patient was miserable. Patient was examined by the doctor and no treatment was given. Doctor advised parents of the patient to give acetaminophen (TYLENOL) if needed for fever control and to reach back out if any questions. Consequently, on unspecified date in March 2025 (reported as now) the patient recovered from the events.  The causal relationship was not provided.
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired VARIVAX administered today for one patient.; This spontaneous report was received from a Pharmacist and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 26-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X007373, expiration date: 12-Mar-2025) 0.5 mL (0.5 mL once) and sterile diluent (MERCK STERILE DILUENT) (Expired vaccine administration) for prophylaxis. No additional AE (no adverse event).   This is an invalidity case due to lack of patient's identifiers.
Sex: M
Vaccine: PNC21
Symptoms: Asthenia, Confusional state, Fatigue, Lethargy
Clinical narrative: confusion; severe lethargy; weakness; fatigue; This spontaneous report was received from a physician assistant and refers to an adult male patient in his 50's. The patient's medical history was not reported. The patient's concurrent conditions were not specified. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection, strength: 168 mcg/mL, at a dose of 0.5 mL, administered by intramuscular route for prophylaxis (anatomical location, lot # and expiration date were not reported).  On an unknown date, within an hour of receiving the vaccine, the patient experienced confusion, severe lethargy, fatigue and weakness. On the following day, the patient had an office visit.  At the time of reporting, the patient recovered from all reported events.  Causality assessment was not provided.  Lot# has been requested and will be submitted if received.
Sex: F
Vaccine: PNC21
Symptoms: Confusional state, Fatigue, Lethargy, Neurological symptom, Pneumococcal infection
Clinical narrative: stroke-like symptoms; indication : Pneumococcal Disease; confusion; fatigue; severe lethargy; This spontaneous report was received from a medical assistant via company representative and refers to a female patient in her 50's. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, she was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) 168 mcg/ml injection, 0.5 ml intramuscularly (lot # and expiration date were not provided) for "Pneumococcal Disease" (Product use in unapproved indication).  On an unknown date, the patient experienced severe lethargy, fatigue, confusion, and stroke-like symptoms. She went to the emergency department. The outcome of the events was not provided. Causality assessment was not reported.  Upon internal review, the event of stroke-like symptoms was considered to be medically significant.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: PNC21
Symptoms: Product use in unapproved indication
Clinical narrative: stroke-like symptoms; indication : Pneumococcal Disease; confusion; fatigue; severe lethargy; This spontaneous report was received from a medical assistant via company representative and refers to a female patient in her 50's. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, she was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) 168 mcg/ml injection, 0.5 ml intramuscularly (lot # and expiration date were not provided) for "Pneumococcal Disease" (Product use in unapproved indication).  On an unknown date, the patient experienced severe lethargy, fatigue, confusion, and stroke-like symptoms. She went to the emergency department. The outcome of the events was not provided. Causality assessment was not reported.  Upon internal review, the event of stroke-like symptoms was considered to be medically significant.  Lot # is being requested and will be submitted if received.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Adrenal androgen excess, Autoimmune disorder, Hirsutism, Hypomenorrhoea, Menstrual disorder
Clinical narrative: polycystic ovary syndrome (PCOS); Autoimmune Injuries; Information has been received from a lawyer regarding a case in litigation referring to an adult female patient (pt) of unknown age. Prior to receiving the suspect vaccine, the pt was a healthy, active, and enthusiastic teenager who loved playing club volleyball, being involved in math and science clubs, socializing with friends, and excelling academically. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided.   On an unknown date, at the age of 15-year-old, the pt received three doses of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer, upon the recommendation of a physician and with the consent of her mother.   On an unknown date, following the third quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt experienced irregular periods excess androgens (hirsutism), and weight gain. The pt's periods became light and abnormal, even with the help of medroxyprogesterone. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to polycystic ovary syndrome (PCOS). The pt also contended that she sustained serious autoimmune injuries (Autoimmune disorder) as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. As a proximate result the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and would continue to incur these losses and expenses in the future.  The outcome of the events was considered to be not recovered. The lawyer considered the events of PCOS and autoimmune disorder to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The events of PCOS and autoimmune disorder were considered to be disabling by the lawyer.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Menstruation irregular, Polycystic ovarian syndrome, Weight increased
Clinical narrative: polycystic ovary syndrome (PCOS); Autoimmune Injuries; Information has been received from a lawyer regarding a case in litigation referring to an adult female patient (pt) of unknown age. Prior to receiving the suspect vaccine, the pt was a healthy, active, and enthusiastic teenager who loved playing club volleyball, being involved in math and science clubs, socializing with friends, and excelling academically. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided.   On an unknown date, at the age of 15-year-old, the pt received three doses of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer, upon the recommendation of a physician and with the consent of her mother.   On an unknown date, following the third quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt experienced irregular periods excess androgens (hirsutism), and weight gain. The pt's periods became light and abnormal, even with the help of medroxyprogesterone. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to polycystic ovary syndrome (PCOS). The pt also contended that she sustained serious autoimmune injuries (Autoimmune disorder) as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. As a proximate result the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and would continue to incur these losses and expenses in the future.  The outcome of the events was considered to be not recovered. The lawyer considered the events of PCOS and autoimmune disorder to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The events of PCOS and autoimmune disorder were considered to be disabling by the lawyer.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, FLU3, FLU3, HEP, HEPA, HEPA, HIBV, PNC13, RV5, DTAP, DTAPHEPBIP, FLU3, FLU4, FLU4, HEPA, HEPA, HIBV, PNC13, RV5
Symptoms: Autopsy, Death, Product administered to patient of inappropriate age
Clinical narrative: Passed away while napping; On 02-MAR-2023 vaccinated with hepatitis a vaccine inact (VAQTA); This spontaneous report was received from a Consumer or other non-health professional and refers to a 6-month-old male patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Prevnar (Pneumococcal vaccine conj 7v (CRM197)), and Prevnar (Pneumococcal vaccine conj 7v (CRM197)).   On 02-Mar-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (Product administered to patient of inappropriate age), (lot # and expiration date were not reported); Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (lot # and expiration date were not reported); Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot #FX6077 (Lot #FX6077 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent) (expiration date was not reported); 13 valent pneumococcal polysaccharide conjugate vaccine (Pneumococcal vaccine conj 13v (CRM197)) (PREVNAR 13) (lot #FX6077) (Dose number 3)(expiration date was not reported); influenza vaccine inact split 3v (FLULAVAL), (lot # and expiration date were not reported) influenza vaccine (FLUZONE) (lot # and expiration date were not reported); diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX), (lot # and expiration date were not reported); Hepatitis a vaccine inact (HAVRIX) (lot # and expiration date were not reported); Diphtheria vaccine toxoid; Hepatitis b vaccine rHBsAg (yeast);Pertussis vaccine acellular 3-component; Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid) (PEDIARIX) (lot # and expiration date were not reported); Influenza vaccine (split virion), inactivated (Influenza vaccine inact split 3v) (FLUZONE) (lot # and expiration date were not reported). All the vaccines were administered as immunization. Route of administration and anatomical location were not reported for any vaccine.  On 25-Mar-2025, when the patient was 2-year-old, he passed away while napping with no previous conditions. Autopsy performed, autopsy remarks as pending. No treatment received for event (as reported). The reported cause of death was Unknown.  The causal relationship between the patient's death and the suspect vaccines was not provided.; Reported Cause(s) of Death: Unknown
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, FLU3, FLU3, HEP, HEPA, HEPA, HIBV, PNC13, RV5, DTAP, DTAPHEPBIP, FLU3, FLU4, FLU4, HEPA, HEPA, HIBV, PNC13, RV5
Symptoms: Autopsy, Death, Extra dose administered
Clinical narrative: Passed away while napping; On 02-MAR-2023 vaccinated with hepatitis a vaccine inact (VAQTA); This spontaneous report was received from a Consumer or other non-health professional and refers to a 6-month-old male patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Prevnar (Pneumococcal vaccine conj 7v (CRM197)), and Prevnar (Pneumococcal vaccine conj 7v (CRM197)).   On 02-Mar-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (Product administered to patient of inappropriate age), (lot # and expiration date were not reported); Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (lot # and expiration date were not reported); Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot #FX6077 (Lot #FX6077 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent) (expiration date was not reported); 13 valent pneumococcal polysaccharide conjugate vaccine (Pneumococcal vaccine conj 13v (CRM197)) (PREVNAR 13) (lot #FX6077) (Dose number 3)(expiration date was not reported); influenza vaccine inact split 3v (FLULAVAL), (lot # and expiration date were not reported) influenza vaccine (FLUZONE) (lot # and expiration date were not reported); diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX), (lot # and expiration date were not reported); Hepatitis a vaccine inact (HAVRIX) (lot # and expiration date were not reported); Diphtheria vaccine toxoid; Hepatitis b vaccine rHBsAg (yeast);Pertussis vaccine acellular 3-component; Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid) (PEDIARIX) (lot # and expiration date were not reported); Influenza vaccine (split virion), inactivated (Influenza vaccine inact split 3v) (FLUZONE) (lot # and expiration date were not reported). All the vaccines were administered as immunization. Route of administration and anatomical location were not reported for any vaccine.  On 25-Mar-2025, when the patient was 2-year-old, he passed away while napping with no previous conditions. Autopsy performed, autopsy remarks as pending. No treatment received for event (as reported). The reported cause of death was Unknown.  The causal relationship between the patient's death and the suspect vaccines was not provided.; Reported Cause(s) of Death: Unknown