chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: The patient has displayed no adverse events at this point; female patient came in on 19Aug2024 and received a RotaTeq. The patient came back today [01Nov2024] and the patient was given anonter 2ml dose; This patient is currently 8 months; At the time there were refrigerator issues; This spontaneous report was received from a licensed vocational nurse states and refers to a 5-month-old female patient.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 19-AUG-2024, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2mL, lot #2003170, expiration date was reported as 30-NOV-2024, but upon review it was found to be 19-SEP-2025, administered orally for prophylaxis (strength was not provided). However, at that time  there were refrigerator issues (Product storage error ) and the reporter did not believe that the patient received this dose. Then on 01-NOV-2024 (also reported as today), when the patient was 8 months and 6 days old, the patient was given another 2mL dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #2003170, expiration date was reported as 30-NOV-2024, but upon review it was found to be 19-SEP-2025, orally as prophylaxis. After giving the dose it was discovered that a dose was given previously (on 19-AUG-2024) (Inappropriate schedule of product administration) (Product administered to patient of inappropriate age). The patient had not display any adverse events at that point after receiving this second, unintentional dose. This was all the information that was given regarding this case.
Sex: F
Vaccine: PNC15, PNC21, PPV
Symptoms: Antibody test negative, Vaccination failure
Clinical narrative: She had been given pneumococcal vaccine recently with very low titers, suggesting poor response to polysaccharide antigens; She had been given pneumococcal vaccine recently with very low titers, suggesting poor response to polysaccharide antigens; Literature Report:   This literature marketed report was received from the authors in a published literature article titled as stated above, concerning a 68-year-old female patient. The patient's concurrent conditions included scleroderma, end-stage renal disease, lacunar stroke with right-sided hemiplegia. Historical conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (unknown manufacturer) injection; or pneumococcal 15v conj vaccine (CRM197) (unknown manufacturer) injection; or pneumococcal 21v conj vaccine (CRM197) (unknown manufacturer) injection; (strength, exact dose, route of administration, anatomical location, lot number and expiration were not reported) as prophylaxis.   On an unknown date, the patient experienced very low titers - antibody test negative, suggesting poor response to polysaccharide antigens (Vaccination failure). The outcome of the events was not reported.   The causality assessment between the suspect vaccine and the event was considered as related.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.17
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; HCP states PRIORIX was given on 3/29/2024, 9 days after VARIVAX administration due to not having the PRIORIX available at time of scheduled visit.  Both products were given at age of 14 months. Demographics unknown. LOT/Exp unknown. No adverse effect; This spontaneous report was received from a Nurse referred to a 14-months-old patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.         On 20-MAR-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), (strength, dose, dose number, frequency, scheme, route, anatomical location, lot number and expiration date were not reported), for immunisation.    On 29-MAR-2024, 9 days after varicella virus vaccine live (oka/merck)(VARIVAX) vaccination, the patient was vaccinated with measles vaccine live (schwartz), mumps vaccine live (rit 4385), rubella vaccine live (wistar ra 27/3)(PRIORIX), (strength, dose, dose number, frequency, scheme, route, anatomical location, lot number and expiration date were not reported), for immunization (inappropriate schedule of product administration). No adverse event was reported.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no reports of adverse reactions or medical symptoms at this time/no additional AE; Nurse stated that a pediatric patient was inadvertently given an adult formulation of VAQTA today, 11/6/2024, at their practice during a routine appointment; This spontaneous report was received from a registered nurse and refers to a child (pediatric) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 06-NOV-2024, pediatric patient was inadvertently vaccinated with an adult formulation (accidental overdose) of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter (strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis by health professional at their practice during a routine appointment instead of pediatric dose (0.5 mL). This was the patient's first dose of hepatitis a vaccine, inactivated (VAQTA) in the series and confirmed that no reports of adverse reactions of medical symptoms at this time.  Lot # is being requested and will be submitted if received.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Influenza virus test negative, Vaccination failure
Clinical narrative: Absent titers to streptococcus pneumoniae and haemophilus in?uenza without improvement following Pneumovax challenge; This literature-marketed information has been received from the authors of a published article, titled as below, regarding a 34-year-old female patient.  The patient's medical history included multiple sclerosis on rituximab. The patient's concurrent conditions included upper respiratory tract infection and hypogammaglobulinaemia. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  Then on an unknown date, the patient underwent workup that revealed decreased immunoglobulin G (IgG) of 466 mg/dl, absent titers to streptococcus pneumoniae and haemophilus influenza without improvement following pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) challenge (confirmed immunological vaccine failure). At the time of the report, the patient's outcome was unknown.  The reporter considered absent titers to Streptococcus pneumoniae and Haemophilus influenza without improvement following pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) challenge to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  Lot # is being requested and will be submitted if received.  Literature Report:
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: No additional AE; an additional dose of PEDVAX HIB was given to a patient.; This spontaneous report was received from a Medical Assistant and refers to a 1-year-old.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified day in 2023, at 2 months old, the patient received the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection. Then, the patient received the second dose of the vaccine on an unspecified day in 2023, at 4 months old. On 22-OCT-2024, at 1 year and 6 days old, the patient was vaccinated with the third dose of the vaccine (dose, route of administration, anatomical site of vaccination, lot# and expiration date were not reported).  On 06-NOV-2024, the patient was accidentally vaccinated with the fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter (ml), lot #X020942, expiration date: 07-MAR-2026 (strength, and route of administration were not provided) (extra dose administered). All the doses were administered as prophylaxis.  No adverse events were reported.   Lot # is being requested and will be submitted if received.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical assistant reports GARDASIL 9 was administered to an 8 year old patient yesterday. Caller would like to keep patient information anonymous at this time and does not wish to receive follow-up. No additional AE details provided. No additional AE; no adverse event; This spontaneous report has been received from medical assistant referring to an 8-year-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (Lot No. Y012864 has been verified to be a valid lot number for [hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date reported and upon internal validation established as 29-MAY-2026) (strength, dose number, exact dose quantity volume, route of administration, anatomical location of administration and vaccination scheme frequency were not provided) (product administered to patient of inappropriate age)  No additional adverse event reported (No adverse event)
Age: 2.0
Sex: M
Vaccine: PNC15, PNC21, PPV
Symptoms: Antibody test abnormal, Vaccination failure
Clinical narrative: immune work-up at 2 years old which showed low titers to pneumococcal vaccine; immune work-up at 2 years old which showed low titers to pneumococcal vaccine; Initial information has been received from the authors of a published literature article titled as stated below, regarding to a 6-year-old male with failure to thrive, status post adenoidectomy x 3, bilateral myringotomy placement x 2 and tonsillectomy x 1 presented for recurrent ear infection. Patient developed ear infections at 6 months old that would persist despite antibiotics and surgeries. His perianal skin infection persisted for 12 months, despite adequate treatment.   On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  Outside allergist performed immune work-up at 2 years old which showed low titers to pneumococcal vaccine (manufacturer unknown) injection (antibody test abnormal and vaccination failure) and low IgG. Never had any overwhelming systemic infections. Due to the persistence and re-occurrence of infections despite surgeries and antibiotics, repeat immune work-up was performed. B and T-cell flow cytometry, dihydrorhodamine (DHR) test and complement were normal. DTaP and pneumococcal vaccine (manufacturer unknown) injection, titers showed adequate post-vaccine response. However, he had low IgG (367), low class-switched B cells, absent T cell proliferation to tetanus, lymphocytosis, eosinophilia (2.07) and genetic testing that showed compound heterozygous CARMIL2 deficiency.  The outcome of antibody test abnormal and vaccination failure was unknown. According to the Authors, the causal relationship between antibody test abnormal and vaccination failure and suspect vaccine was related.   A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical Assistant calling to report adverse event regarding improperly stored and administered VAQTA.  Medical Assistant stated that the supply of VAQTA at their facility was exposed to temperature excursions beginning in May 2024 and the product was; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drugs reactions or allergies and concomitant medications were not reported.   On an unspecified day in May 2024 (reported as beginning in May 2024) a temperature excursion occurred in a supply of hepatitis a vaccine, inactivated (VAQTA). Then on 03-OCT-2024, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, (Lot number [Y007585] has been verified to be a valid lot number for [hepatitis a vaccine, inactivated (VAQTA)] expiration date reported and upon internal validation established as 31-OCT-2025) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided) (product storage error)  No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient received expired dose of VARIVAX; This spontaneous report was received from a nurse, concerning to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-NOV-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, one single dose, administered for prophylaxis (strength, scheme, injection site and route of administration were not provided; Lot # W034708 has been verified to be valid for this vaccine, expiration date reported and confirmed as 01-NOV-2024). (Expired vaccine used). No previous temperature excursion reported. No aaditional adverse event (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; inadvertently administering a VARIVAX vaccine after experiencing a temperature excursion; This spontaneous report was received from a medical assistant, concerning to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) suffered a temperature excursion (TE) of 17 minutes at -11.8 degrees Celsius.   On 18-OCT-2024, the patient was vaccinated with the vaccine involved in the TE varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, injection site and route of administration were not provided; Lot # Y004553 has been verified to be valid for this vaccine, expiration date reported and confirmed as 20-FEB-2026). (Improper storage of product in use). No additional adverse event (No adverse event).
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No Additional AE; needle hub defects/the needle broke off from the syringe and stayed in the patient; part of the syringe where the needle twists on to the syringe broke up therefore detaching the needle; the needle broke off from the syringe and stayed in the patient/part of the syringe where the needle twists on to the syringe broke up therefore detaching the needle; This spontaneous report was received from a medical assistant and refers to a 12-month-old female. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 08-NOV-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot number, expiry date, and route of administration were not provided). It was reported that this vaccine was diluted with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, 0.5 milliliter, administered subcutaneously (valid lot number 1950650, with and expiration date of 30-JAN-2026).  It was reported that the syringe of sterile diluent (BAXTER STERILE DILUENT) that was used to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had needle hub defects, since after administering the full dose of the vaccine, and removing it from the patient, the needle broke off from the syringe and stayed in the patient. Caller stated it seemed that a part of the syringe where the needle twists on to the syringe broke up therefore detaching the needle (needle issue, syringe issue, poor quality device used). There was no leakage, and no Additional adverse event was reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported; Medical Assistant calling to report adverse event regarding improperly stored and administered VAQTA.  Medical Assistant stated that the supply of VAQTA at their facility was exposed to temperature excursions beginning in May 2024 and the product was; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 03-OCT-2024 the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # Y007585 and expiration date 31-OCT-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided).  Medical Assistant stated that the supply of hepatitis a vaccine, inactivated (VAQTA) at their facility was exposed to temperature excursions beginning in May-2024 and the product was administered to the patient (product storage error). Medical Assistant confirmed the patient involved has not reported any medical concerns or symptoms after being administered the improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (no adverse event).
Age: 2.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller reported PROQUAD and VARIVAX were administered after a temperature excursion; This spontaneous report was received from a consumer (reporter qualifications not provided) concerning an unknown number of patients of unspecified age and gender. The patients' medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On unreported date (s), doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 6.008 degrees Fahrenheit (F) during a timeframe of 30 minutes with previous temperature excursion.   On unspecified date (s), the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) lot #X021753, expiration date 23-FEB-2025 (dosage regimen, exact dose, anatomical location and route of administration were not provided); and/or varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # W031812, expiration date 05-OCT-2024 (dosage regimen, exact dose, anatomical location and route of administration were not provided) (product storage error). Both vaccines were administered as prophylaxis.  No other adverse events (AE) were reported (no adverse event). This report was considered to be non-valid due to lack of patients' identifiers.  Follow up information was received from from other healthcare professional regarding a 3-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 19-SEP-2024, the patient was vaccinated at public health clinic/hospital with public funds with an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) intramuscular and varicella virus vaccine live (oka/merck) (VARIVAX). The temperature excursion was for less than 30 minutes.  It was mentioned that the point in the process the medication error occurred was storage in clinical practice; the operator of vaccines was healthcare professional and was trained. Also it was reported that although temperature excursion the vaccines were ok to be used.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller reported PROQUAD and VARIVAX were administered after a temperature excursion; This spontaneous report was received from a consumer (reporter qualifications not provided) concerning an unknown number of patients of unspecified age and gender. The patients' medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On unreported date (s), doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 6.008 degrees Fahrenheit (F) during a timeframe of 30 minutes with previous temperature excursion.   On unspecified date (s), the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) lot #X021753, expiration date 23-FEB-2025 (dosage regimen, exact dose, anatomical location and route of administration were not provided); and/or varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # W031812, expiration date 05-OCT-2024 (dosage regimen, exact dose, anatomical location and route of administration were not provided) (product storage error). Both vaccines were administered as prophylaxis.  No other adverse events (AE) were reported (no adverse event). This report was considered to be non-valid due to lack of patients' identifiers.  Follow up information was received from from other healthcare professional regarding a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 27-AUG-2024, the patient was vaccinated at public health clinic/hospital with public funds with an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) intramuscular and varicella virus vaccine live (oka/merck) (VARIVAX). The temperature excursion was for less than 30 minutes.  It was mentioned that the point in the process the medication error occurred was storage in clinical practice; the operator of vaccines was healthcare professional and was trained. Also it was reported that although temperature excursion the vaccines were ok to be used.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller reported PROQUAD was administered after a temperature excursion; This spontaneous report was received from a consumer (reporter qualifications not provided) concerning an unknown number of patients of unspecified age and gender. The patients' medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On unreported date (s), doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 6.008 degrees Fahrenheit (F) during a timeframe of 30 minutes with previous temperature excursion.   On unspecified date (s), the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) lot #X021753, expiration date 23-FEB-2025 (dosage regimen, exact dose, anatomical location and route of administration were not provided); and/or varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # W031812, expiration date 05-OCT-2024 (dosage regimen, exact dose, anatomical location and route of administration were not provided) (product storage error). Both vaccines were administered as prophylaxis.  No other adverse events (AE) were reported (no adverse event). This report was considered to be non-valid due to lack of patients' identifiers.  Follow up information was received from from other healthcare professional regarding a 11-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 22-SEP-2024, the patient was vaccinated at public health clinic/hospital with public funds with an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) intramuscular and varicella virus vaccine live (oka/merck) (VARIVAX). The temperature excursion was for less than 30 minutes.   It was mentioned that the point in the process the medication error occurred was storage in clinical practice; the operator of vaccine was healthcare professional and was trained. Also it was reported that although temperature excursion the vaccine was ok to be used.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller reported PROQUAD was administered after a temperature excursion; This spontaneous report was received from a consumer (reporter qualifications not provided) concerning an unknown number of patients of unspecified age and gender. The patients' medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On unreported date (s), doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 6.008 degrees Fahrenheit (F) during a timeframe of 30 minutes with previous temperature excursion.   On unspecified date (s), the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) lot #X021753, expiration date 23-FEB-2025 (dosage regimen, exact dose, anatomical location and route of administration were not provided); and/or varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # W031812, expiration date 05-OCT-2024 (dosage regimen, exact dose, anatomical location and route of administration were not provided) (product storage error). Both vaccines were administered as prophylaxis.  No other adverse events (AE) were reported (no adverse event). This report was considered to be non-valid due to lack of patients' identifiers.  Follow up information was received from from other healthcare professional regarding a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 26-AUG-2024  the patient was vaccinated at Public Health Clinic/Hospital with public funds with an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) intramuscular and varicella virus vaccine live (oka/merck) (VARIVAX). The temperature excursion was for less than 30 minutes.  It was mentioned that the point in the process the medication error occurred was storage in clinical practice; the operator of vaccine was healthcare professional and was trained. Also it was reported that although temperature excursion the vaccine was ok to be used.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller (phone EXT 2132) reported AE on behalf of a patient who was administered expired GARDASIL 9 on 11/7/2024 (w/ no TEs)--SUPPORTED via post-expiry memo. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. No; This spontaneous report was received from a medical assistant and refers to a patient of unknown and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 07-NOV-2024, the patient was vaccinated with an expiry dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W009829, expiration date: 19-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No temperature excursion reported. No additional adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site was sore; Delayed localized hypersensitivity reaction; Injection site became very itchy; Injection site became swollen; Injection site became red; Injection site became hard; Injection site became hot; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 52F7M) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included lisinopril.   On 28-OCT-2024, the patient received Shingles vaccine. On 02-NOV-2024, 5 days after receiving Shingles vaccine, the patient experienced delayed localized hypersensitivity reaction (Verbatim: Delayed localized hypersensitivity reaction). In NOV-2024, the patient experienced injection site itching (Verbatim: Injection site became very itchy), injection site swelling (Verbatim: Injection site became swollen), injection site erythema (Verbatim: Injection site became red), injection site induration (Verbatim: Injection site became hard) and injection site warmth (Verbatim: Injection site became hot). On an unknown date, the patient experienced injection site pain (Verbatim: Injection site was sore). The outcome of the injection site pain was resolved and the outcome of the injection site itching was resolving and the outcome of the injection site swelling, injection site induration and injection site warmth were not reported and the outcome of the injection site erythema and delayed localized hypersensitivity reaction were not resolved.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site swelling, injection site erythema, injection site induration, injection site warmth and delayed localized hypersensitivity reaction to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, injection site itching, injection site swelling, injection site erythema, injection site induration, injection site warmth and delayed localized hypersensitivity reaction to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-NOV-2024 The patient took shingles vaccine and had delayed localized hypersensitivity reaction. The patient experienced injection site was sore until 1st November then became very itchy, swollen, red, hard, hot, raised. The patient took an over the counter medication antihistamine one day before the reporting and on the day of reporting.  On the day of reporting the redness was more diffused but less itchy. The patient asked that she could get her second shingles injection.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Type IV hypersensitivity reaction
Clinical narrative: Injection site was sore; Delayed localized hypersensitivity reaction; Injection site became very itchy; Injection site became swollen; Injection site became red; Injection site became hard; Injection site became hot; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 52F7M) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included lisinopril.   On 28-OCT-2024, the patient received Shingles vaccine. On 02-NOV-2024, 5 days after receiving Shingles vaccine, the patient experienced delayed localized hypersensitivity reaction (Verbatim: Delayed localized hypersensitivity reaction). In NOV-2024, the patient experienced injection site itching (Verbatim: Injection site became very itchy), injection site swelling (Verbatim: Injection site became swollen), injection site erythema (Verbatim: Injection site became red), injection site induration (Verbatim: Injection site became hard) and injection site warmth (Verbatim: Injection site became hot). On an unknown date, the patient experienced injection site pain (Verbatim: Injection site was sore). The outcome of the injection site pain was resolved and the outcome of the injection site itching was resolving and the outcome of the injection site swelling, injection site induration and injection site warmth were not reported and the outcome of the injection site erythema and delayed localized hypersensitivity reaction were not resolved.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site swelling, injection site erythema, injection site induration, injection site warmth and delayed localized hypersensitivity reaction to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, injection site itching, injection site swelling, injection site erythema, injection site induration, injection site warmth and delayed localized hypersensitivity reaction to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-NOV-2024 The patient took shingles vaccine and had delayed localized hypersensitivity reaction. The patient experienced injection site was sore until 1st November then became very itchy, swollen, red, hard, hot, raised. The patient took an over the counter medication antihistamine one day before the reporting and on the day of reporting.  On the day of reporting the redness was more diffused but less itchy. The patient asked that she could get her second shingles injection.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to get her second dose of Shingrix; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about three years ago, from the reporting date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to get her second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-APR-2024 The patient self reported this case. The patient received her first dose of Shingrix and forgot to get her second dose, which led to incomplete course of vaccination.  The patient planned to receive it now. The reporter asked, should she take the second dose outside of the recommended schedule or start again and take both doses.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: Covid hit; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2020, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced covid-19 (Verbatim: Covid hit). The outcome of the covid-19 was not reported.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK receipt date: 14-OCT-2024 Patient reported that he got a Shingrix shot in January 2020. Patient could not get my second shot as Covid hit. His doctor at the time said he would still have some protection.  And a couple of years later when things settled down, he said he did not need to take the second shot. My doctor retired and my new doctor tells me I should still get the second Shingrix shot even though it's been more than 4 years after the first one.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: shingles on my back; blister; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine (Influenza vaccin) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccin. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on my back) and blister (Verbatim: blister). The outcome of the shingles and blister were not reported.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.     It was unknown if the company considered the shingles and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-OCT-2024 Reporter is the 50 year old healthy female. She received her first dose of Shingrix on a Wednesday as well as a flu shot, by Sat she had the start of shingles on her back. As of Monday, it started to blister. She believed that her physician was reporting it to vaccination reaction data base.
Sex: F
Vaccine: COVID19, FLUX, PPV, UNK
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré syndrome reportedly hospitalized; This serious case was reported by a physician and described the occurrence of guillain barre syndrome in a elderly female patient who received RSVPreF3 adjuvanted (RSVPreF3 vaccine + AS01E) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis, Pneumococcal vaccine for prophylaxis and Influenza vaccine for prophylaxis.   On an unknown date, the patient received RSVPreF3 vaccine + AS01E, COVID-19 vaccine, Pneumococcal vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving RSVPreF3 vaccine + AS01E, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barré syndrome reportedly hospitalized) (serious criteria hospitalization, GSK medically significant, life threatening and other: serious as per reporter). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to RSVPreF3 vaccine + AS01E.   The company considered the guillain barre syndrome to be unrelated to RSVPreF3 vaccine + AS01E.   Additional Information: GSK Receipt Date: 08-NOV-2024 The primary care physician (PCP) reported about visiting his mother in a nursing home and found out that another elderly woman (patient) in the nursing home got Guillain-Barré syndrome after receiving 4 vaccines at the same time which were flu, Covid, pneumococcal and RSV (brand unknown) vaccine.  The reporter said that woman (patient) was reportedly hospitalized as a result.  The reporter did not himself saw the woman and the woman was not his own patient and therefore he had no further information to share. It was unknown if the reporter considered the guillain barre syndrome to be related to flu, Covid, pneumococcal vaccine; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine RSVPreF3 vaccine + AS01E.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster oticus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Reoccurrence of shingles in the ear; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster otitis externa (Shingles in her ear in the past before being vaccinated with Shingrix).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster otitis externa (Verbatim: Reoccurrence of shingles in the ear) (serious criteria GSK medically significant). The outcome of the vaccination failure and herpes zoster otitis externa were not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster otitis externa to be related to Shingrix.     The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingrix.   Additional Information: GSK Receipt date: 06-NOV-2024 The patient reported that she had shingles in her ear in the past before being vaccinated with Shingrix.  The patient reported in the time that has gone by since her Shingrix vaccination she had a re-occurrence in the ear, but that it was less severe than before she was vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster oticus is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late for their second dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late for their second dose of Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-APR-2024 The pharmacist reported that the patient had received the information about a later than recommended 2nd dose of Shingrix vaccine, which led to drug dose administration interval too long. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 18th September 2021 received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 02 Jul 2024 The patient self-reported. She received the first dose of Shingrix 18 September 2021 and not yet received the second dose. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a2nd dose they say that is 2 to 6 months apart, but if a patient miss more than the 6 months, like a 1 year; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a2nd dose they say that is 2 to 6 months apart, but if a patient miss more than the 6 months, like a 1 year). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-AUG-2024 The reporter calling regarding the shingle vaccine, so the 2nd dose they say that was 2 to 6 months apart, but if a patient miss more than the 6 months, like a 1 year, was it okay to catch up the dose? Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEP, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Inadvertent Administration of a Vaccine Following Temperature Excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Shingrix, Boostrix and Engerix B. On an unknown date, an unknown time after receiving Shingrix, Boostrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Inadvertent Administration of a Vaccine Following Temperature Excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 27-AUG-2024 Nurse reported that following temperature excursion: Some vaccines such as Boostrix, Engerix-B and Shingrix have been administered to patients, which led to incorrect product storage. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.