chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation reaction
Clinical narrative: with adverse reaction to vaccine; This spontaneous report was received from a physician referring to a currently 76-year-old female. The patient's medical history included renal insufficiency, lung nodule, nephrolithiasis, appendicectomy, tubal ligation, prolapse repair, spinal laminectomy, hysterectomy, carpal tunnel decompression, spinal fusion, cholecystectomy, endoscopic retrograde cholangiopancreatography, intestinal obstruction, hand operation, cystoscopy, thumb Surgery, trigger finger release, arthroscopy, biopsy liver, magnetic resonance imaging of lumbar spine, and ultrasound abdomen. The patient's concurrent conditions andc therapies were not reported.  On 22-APR-2009, the patient started therapy with zoster vaccine live (ZOSTAVAX) subcutaneous injection (dose, strength, lot #, expiry date, and route of administration were not provided) administered for prophylaxis.  On an unknown date, the patient experienced adverse reaction to vaccine. The outcome of the event was not reported. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was related.; Sender's Comments:  US-009507513-2208USA008403: US-009507513-2208USA008360:
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; HCP called MNSC to inquire about MMR II dosing schedules and provided the following AE.  HCP states that a 19-year-old female patient with no MMR II immunity, received two doses of MMR II "approximately two and a half weeks apart". HCP states the dat; HCP called agency to inquire about MMR II dosing schedules and provided the following AE.  HCP states that a 19-year-old female patient with no MMR II immunity, received two doses of MMR II "approximately two and a half weeks apart". HCP states the dat; This spontaneous report was received from a certified medical assistant, and refers to a 19-year-old female patient. No information was reported concerning the patient's medical history, concurrent conditions or concomitant medications.   On 13-JUN-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot number T031436, expiration date on 15-SEP-2022, as prophylaxis. Approximately two and a half weeks later, the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot number U022175 with expiration date on 17-JUL-2023).   No adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Bone pain, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: she got to work and had to run to the bathroom with explosive diarrhea; she feels like the life has been sucked out of her; her bones hurt; headache; chills; exhaustion and states she feels like the life has been sucked out of her; Patient Age: 61 years old; she states she had these symptoms after her first shot as well; This spontaneous report was received from a registered nurse and a 61-year-old female patient referring to herself.  The patient's pertinent medical history was reported as none. Drug reactions/allergies included etodolac (LODINE), phenoxymethylpenicillin (PENICILLIN), esomeprazole sodium (NEXIUM) (case # 2208USA005859), omeprazole (PRILOSEC) (case # 2208USA005860), and atropine sulfate (+) hyoscine hydrobromide (DONNATAL). Concomitant therapies were unknown.  On 09-JUN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly for prophylaxis (dose, lot #, and expiry date were not provided) (Product administered to patient of inappropriate age). On an unknown date of June 2022 after the first shot, the patient stated that she experienced explosive diarrhea. Symptoms went away 3-4 days after the first shot (in approximately 13-JUN-2022) (the registered nurse indicated that the patient did not have any adverse events following the first dose, conflicting information). On 05-AUG-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly for prophylaxis (dose, lot #, and expiry date were not provided).   On 10-AUG-2022 (reported as "yesterday"), the patient reported that she got to work and had to run to the bathroom with explosive diarrhea. She also reported headache, chills, exhaustion and stated she felt like the life had been sucked out of her (ill-defined disorder) and her bones hurt (bone pain). She did not have a fever and had taken a coronavirus disease 2019 (COVID-19) test in an unspecified date in 2022, which was negative. No other lab diagnostics/studies performed. On the same date, the patient called the clinic office and stated she was experiencing diarrhea, chills and fatigue. The patient also stated that she had not had a reaction like this to any other vaccine but had issues with other medications listed in the drug reactions/allergies section. No treatment was give for the events. The outcome of all events were reported as recovered.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was considered as related.; Sender's Comments:  US-009507513-2208USA005859: US-009507513-2208USA005860:
Sex: F
Vaccine: HPV9
Symptoms: Headache, Ill-defined disorder, Product administered to patient of inappropriate age, SARS-CoV-2 test negative
Clinical narrative: she got to work and had to run to the bathroom with explosive diarrhea; she feels like the life has been sucked out of her; her bones hurt; headache; chills; exhaustion and states she feels like the life has been sucked out of her; Patient Age: 61 years old; she states she had these symptoms after her first shot as well; This spontaneous report was received from a registered nurse and a 61-year-old female patient referring to herself.  The patient's pertinent medical history was reported as none. Drug reactions/allergies included etodolac (LODINE), phenoxymethylpenicillin (PENICILLIN), esomeprazole sodium (NEXIUM) (case # 2208USA005859), omeprazole (PRILOSEC) (case # 2208USA005860), and atropine sulfate (+) hyoscine hydrobromide (DONNATAL). Concomitant therapies were unknown.  On 09-JUN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly for prophylaxis (dose, lot #, and expiry date were not provided) (Product administered to patient of inappropriate age). On an unknown date of June 2022 after the first shot, the patient stated that she experienced explosive diarrhea. Symptoms went away 3-4 days after the first shot (in approximately 13-JUN-2022) (the registered nurse indicated that the patient did not have any adverse events following the first dose, conflicting information). On 05-AUG-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered intramuscularly for prophylaxis (dose, lot #, and expiry date were not provided).   On 10-AUG-2022 (reported as "yesterday"), the patient reported that she got to work and had to run to the bathroom with explosive diarrhea. She also reported headache, chills, exhaustion and stated she felt like the life had been sucked out of her (ill-defined disorder) and her bones hurt (bone pain). She did not have a fever and had taken a coronavirus disease 2019 (COVID-19) test in an unspecified date in 2022, which was negative. No other lab diagnostics/studies performed. On the same date, the patient called the clinic office and stated she was experiencing diarrhea, chills and fatigue. The patient also stated that she had not had a reaction like this to any other vaccine but had issues with other medications listed in the drug reactions/allergies section. No treatment was give for the events. The outcome of all events were reported as recovered.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was considered as related.; Sender's Comments:  US-009507513-2208USA005859: US-009507513-2208USA005860:
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a dose of VARIVAX was administered to the patient on 10AUG2022 after experiencing a temperautre excursion; This spontaneous report was received from a medical assistant referring to a 14-month-old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 10-AUG-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, subcutaneously (lot # U026207, expiration date: 24-AUG-2023; strength, and anatomical location were not provided) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions of 18.6 Fahrenheit (F) for 30 minutes (product storage error). The previous temperature excursion as follow: 9.8 F for 30 minutes. No additional adverse event (AE) was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA005443: US-009507513-2208USA005325: US-009507513-2208USA005272: US-009507513-2208USA005345: US-009507513-2208USA004819:
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; PNEUMOVAX 23 that experienced a temperature excursion was administered to 1 patient; This spontaneous report was received from a medical student and refers to a 88-year-old female patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.   On 09-AUG-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, vial, at a dose of 0.5 ml, lot # U039721, expiration date 10-AUG-2023 for prophylaxis (dose #, anatomical location and route of administration were not provided).  The vaccine experienced a temperature excursion of 32.7 Fahrenheit (F) for 24 hours minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: PPV, PPV
Symptoms: Extra dose administered, Product storage error
Clinical narrative: No additional AE details; PNEUVMOAX 23 were administered after a supported temp excursion occurred.; 2 doses of PNEUVMOAX 23 were administered; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-AUG-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U026796, expiration date: 28-JAN-2023; dose, strength and route of administration were unknown) for prophylaxis after a supported temperature excursion occurred (product storage error). The temperature was 9.2 C and time frame was 48 minutes. No previous temperature excursion. It was reported that the patient was vaccinated with 2 doses (extra dose administered) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U026796, expiration date: 28-JAN-2023; dose, strength and route of administration were unknown) and the vaccination date of another dose was unknown. No additional adverse event (AE) details or product quality compliant (PQC).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient had no adverse effects or symptoms following the PROQUAD administration.; The patient received a dose of PROQUAD on 9Aug2022 after having received a varicella vaccine on 29Jun2022.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 29-JUL-2022, the patient was vaccinated with varicella zoster vaccine (VARICELLA VACCINE) (dosage regimen, strength, formulation, lot #, expiry date, anatomical location, and route of administration were not provided) (manufacturer unknown) as prophylaxis.  On 09-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter/ once, lot #W012741, expiration date 16-OCT-2023, (strength, anatomical location, and route of administration were not provided) reconstituted with sterile diluent, administered as prophylaxis (Inappropriate schedule of product administration). The patient had no adverse effects or symptoms following the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administration.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details provided.; Medical assistant calling reports 2 doses of expired PROQUAD were administered to 2 patients. Products did not experience any temperature excursions through the date of administration. See AE case 02225333 for additional patient. No additional AE det; This spontaneous report was received from a medical assistant and refers to a 3-year-old male patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent manufacturer unknown).   On 13-JUN-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), rHA (recombinant Human albumin) subcutaneous injection, lot #T029102, expiration date: 23-FEB-2022 (both confirmed to be valid), administered for prophylaxis (strength, dose, route and site of administration were not provided).  The suspected measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) did not experience any temperature excursions through the date of administration. There were no additional adverse event details provided (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006220:
Age: 1.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE reported; a patient received a dose of PROQUAD and a dose of MMRII; This spontaneous report has been received from a registered nurse regarding a 1-year-old female patient. The patient's concurrent conditions, pertinent medical history, and drug reactions/ allergies were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT) (lot number: W000452, expiration date 23-JUL-2024).  On 12-AUG-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant Human albumin (rHA)) lot #W010527, expiration date: 25-SEP-2023 (strength, dose, route of administration, and anatomical location were not provided), and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, lot #U039906, expiration date: 16-DEC-2023 (strength, dose, route of administration, and anatomical location were not provided) for prophylaxis (overdose). There was no additional adverse event (AE) reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; TE evaluation on VARIVAX reports 3 total doses have been administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 01-AUG-2022, the patient was vaccinated with improperly stored with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #T032315, expiration date: 22-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). Temperature was -14 Celsius degree (C) up to-10 C (-14.04 C) for time frame 0 hours 40 minutes 0 seconds. There was no previous temperature excursion. No additional adverse event details were provided (no adverse event).  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006426: US-009507513-2208USA006350:
Age: 20.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Allergy to vaccine, Product dose omission in error
Clinical narrative: allergic reaction to a flu; missed the 2nd dose of GARDASIL 9/Per caller they just forgot to go back for the rest of the series.; This spontaneous report has been received from a dietitian, referring to a 20 years old female patient. The patient's historical condition, current condition and concomitant drug were not reported.   On an unknown date (reported as years ago), the patient was vaccinated with influenza vaccine (FLU) (indication unknown). In August 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis. The dose, strength, route, lot number and expiration date were not reported for both suspect vaccines.  On an unknown date, the patient just forgot to go back for the rest of the series (product dose omission in error). So, she missed the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date, the pt had an allergic reaction to a influenza vaccine (FLU) shot years ago due to it having eggs as an ingredients (allergy to vaccine). The outcome of the allergy to vaccine was unknown. The causality assessment between the allergy to vaccine and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. The causality assessment between the allergy to vaccine and influenza vaccine (FLU) was related.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Non-supported frozen vaccine was administered on two separate occasions during temperature excursion on 8/5/22 and 8/9/22.; This spontaneous report was received from a medical assistant and refers to a 30-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 09-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml/once, lot #W005208 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) expiration date reported as 14-FEB-2023, but upon internal validation established as 14-FEB-2024, for prophylaxis (anatomical location and route of administration were not provided). The vaccine underwent temperature excursion (product storage error).  No additional adverse event (AE).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008336
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Adverse event, Inappropriate schedule of product administration
Clinical narrative: previous reaction; Pneumovax was adminstrated on 11/11/2005 and 11/01/08; This spontaneous report was received from a physician referring to a currently 76-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-NOV-2005, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, lot #, expiry date, and route of administration were not provided), administered for prophylaxis. On 01-NOV-2008, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration).  On an unknown date, the patient experienced reaction (adverse event). It was reported that the patient unable to get final dose due to the reaction. The outcome of the event was not reported. The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. ; Sender's Comments:  US-009507513-2208USA004458: US-009507513-2208USA008360:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccines administered after temperature excursio; the vaccines were administered IM (instead of SQ}.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 19-AUG-2022, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #U028164, expiration date: 09-SEP-2023; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 ml, lot #U006596, expiration date: 01-MAR-2023 (vaccination schedules were not provided) both administered intramuscularly for prophylaxis (Product storage error, Incorrect route of product administration). The vaccines were stored in 32.9 Fahrenheit degrees (F) in a time frame of 28 hours and 39 minutes. It was reported the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was stored within recommended range for this reported excursion. The vaccines had undergone previous excursion in 20.7 F in a time frame of 32 hours and 10 minutes. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008668:dpoc# 02231010 US-009507513-2208USA010122:dpoc# 02231010 US-009507513-2208USA009718:dpoc# 02231010 US-009507513-2208USA008558:dpoc# 02231010
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; 1 year old patient that received VAQTA, MMR-II, and VARIVAX on 12-JUL-2022 and received the VAQTA, MMR-II, and VARIVAX again on 26-JUL-2022.; This spontaneous report has been received from a nurse practitioner referring to a 1 year-old-patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 12-JUL-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL intramuscularly, hepatitis a vaccine, inactivated varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL subcutaneously, and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL; all vaccines for prophylaxis(strengths, lot numbers, anatomical locations, routes of administration, and expirations dates were not provided).      On 26-JUL-2022, the patient received the second dose with hepatitis a vaccine, inactivated (VAQTA), 0.5 mL (lot number U012007 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 18-JAN-2023), hepatitis a vaccine, inactivated varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (lot number T036561 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 28-OCT-2022) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 mL (lot number T033814 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 05-OCT-2022); all vaccines for prophylaxis (strengths, anatomical locations, and routes of administration were not provided) (inappropriate schedule of vaccine administered). No adverse event was reported.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Caller stated the first dose was given 18MAY2022. The second dose on 12JUN2022 and the third dose on 22AUG2022.; Caller stated the first dose was given 18MAY2022. The second dose on 12JUN2022 and the third dose on 22AUG2022.; This spontaneous report was received from a nurse referring to a 36-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 18-MAY-2022, the patient was vaccinated with the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, subsequently on 12-JUN-2022 she received the second dose (inappropriate schedule of product administration) both administered as prophylaxis (exact doses, strengths, anatomical injection sites, lot numbers, expiration dates, and routes of administration were not provided).   Additionally, on 22-AUG-2022, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe at dose 0.5 milliliter (ml) (lot number U037064 was verified to be a valid number, with an expiration date reported and established as 10-AUG-2024), administered for prophylaxis (strength, route of administration, and anatomical injection site were not reported) (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event for this patient; The caller said a patient received PROQUAD after a temperature excursion.; This spontaneous report has been received from a healthcare worker referring a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 19-AUG-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella recombinant human albumin (rHA) (OKA-MERCK) virus vaccine live (PROQUAD) (lot number u022729 had been verified to be a valid number; expiration date was reported as 16-JAN-2023, and upon internal validation established as the same date), 1 dose, for prophylaxis (strength, exact dose, anatomical location and route of administration were not provided) (product storage error). Administered dose of vaccine experienced temperature excursion of 11.5 Fahrenheit (F) for 52 minutes. There was no previous temperature excursion. No additional information of adverse event was reported.; Sender's Comments:  US-009507513-2208USA008545:MSD US-009507513-2208USA008698:MSD US-009507513-2208USA009042:MSD
Age: 1.5
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE; an 18 month old female was administered VARIVAX in FEB 2022 and then inadvertently given PROQUAD on 24AUG2022 instead of the intended MMR II. Caller referred to PROQUAD as MMR V.; an 18 month old female was administered VARIVAX in FEB 2022 and then inadvertently given PROQUAD on 24AUG2022 instead of the intended MMR II. Caller referred to PROQUAD as MMR V.; This spontaneous report was received from a registered nurse and refers to an 18-month-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date in February 2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, strength, formulation, lot #, expiration date, site and route of administration were not provided) for prophylaxis.  On 24-AUG-2022, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (reported as "MMR V") lot #: U024510, expiration date: 02-FEB-2023 (exact dose, strength, formulation, site and route of administration were not provided) for prophylaxis; instead of intended dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, strength, formulation, lot #, expiration date, albumin status, site and route of administration were not provided) for prophylaxis (wrong product administered; extra dose administered). There was no additional adverse event reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AE's; A pharmacist called to report that a dose of PNEUMOVAX 23 that expired on 4/24/2022 was administered to a patient on 8/18/2022.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reaction or allergies were not reported.   On 18-AUG-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), injection, lot # T028093, expiration date 24-APR-2022 (strength, dose, route of administration, and anatomical location were not provided) for prophylaxis (reported as "use a durected to prevent pnwumococcal infection") (expired product administered). No additional adverse events were reported.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Blood test, Contraindicated product administered, Viral titre decreased
Clinical narrative: Titer came back low; have a patient on immunosuppressing therapy and the patient inadvertently received a dose of MMRII.; This spontaneous report was received from a registered pharmacist concerning a 41-year-old non-pregnant female patient. The patient's medical history was not reported. Her concurrent conditions included multiple sclerosis, and b-cell deficiency. Her concomitant medications included ocrelizumab.   On 14-OCT-2016, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml, subcutaneously, lot # M004305, expiration date was not reported, but upon internal validation it was established as 25-JAN-2018, for prophylaxis (injection anatomical location was not provided).  On an unknown date (reported as "recently"), the patient underwent a blood work (unspecified) and her "titer came back low" (Antibody test negative). Therefore, on 26-AUG-2022, after she started immunosuppressive concomitant therapy, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 ml, subcutaneously in her left deltoid, lot # U025199, expiration date was not reported, but upon internal validation it was established as 13-AUG-2023, for prophylaxis (Contraindicated product administered). No other adverse events occurred.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; A patient was inadvertently administered an expired dose of MMR-II; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's pertinent medical history, drug allergies and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 30-AUG-2022, the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II) lot # T027936, expiration date: 18-AUG-2022, (dose, anatomical location and route of administration were not provided) as prophylaxis (expired product administered).  No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: sliced the medical assistants fingers; finger flanges broke off the syringe during administration; This spontaneous report was received from a medical assistant concerning a 42-year-old non-pregnant female patient who was also a medical assistant. The patient's medical history, concurrent conditions, and concomitant medication were not provided.   On 30-AUG-2022, the patient was administering a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, lot #U019412, expiration date 30-OCT-2023 for prophylaxis (route of administration, and injection anatomical location was not provided), and the finger flanges broke off the syringe barrel in half towards the end of the syringe, during administration and sliced the patient's fingers (Syringe issue) (Skin laceration). The patient wrapped her fingers with a medical gauze wrap and contacted her worker's compensation per facility protocol.  It was reported that the syringe tray and carton were intact and undamaged on receipt, and syringe tip cap was attached properly prior to use. Also, the broken HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe was discarded, and retrieval would not be possible.  At the time of the report, the patient was not recovered from the adverse event.   The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the adverse event was not provided.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA011450:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; A nurse reported that a dose of improperly stored PROQUAD pursuant to a temperature excursion was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), underwent a temperature excursion of -2.7 Celsius degree during 1 hour and 15 minutes.  On 31-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot #W010523, expiration date: 25-SEP-2023 (strength, anatomical location, and route of administration were not provided). No adverse event was reported.
Sex: U
Vaccine: HEPA, HEPA, MMR, RV5
Symptoms: Product storage error
Clinical narrative: A HCP called and reported an AE where doses of improperly stored products were possibly administered to patient(s) on unknown dates.; No additional AE reported.; This spontaneous report was received from a medical assistant regarding an unknown number of patients of unspecified age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with improper storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U038854, expiration date: 20-APR-2023, taken orally (dosage regimen and strength were not provided) as prophylaxis; measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot #T039671, expiration date: 24-NOV-2022, lot #U017524, expiration date: 03-JUN-2023, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis; hepatitis a vaccine, inactivated (VAQTA) lot #W002889, expiration date: 06-MAR-2023, lot #U024504, expiration date: 15-OCT-2022, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis (Product storage error). No additional adverse events were reported.  The improperly stored vaccines of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #T039671 and lot #U017524), and hepatitis a vaccine, inactivated (VAQTA) lot #W002889 underwent a temperature excursion of 48 degrees Fahrenheit (F) for 10 minutes without previous excursions. The improperly stored vaccines of hepatitis a vaccine, inactivated (VAQTA) lot #U024504 underwent a temperature excursion of 49 degrees Fahrenheit (F) for 10 minutes without previous excursions (This lot was stored in a second refrigerator).  This is a non-valid report due to lack of patients' identifiers.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional AE were reported; A dose of PROQUAD was administered to an adult instead of MMR II.  No additional AE's and no PQC's were reported.; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-SEP-2022, an adult patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot number W016357 was found to be valid, expiration date 16-NOV-2023 (strength, dose, route of administration and vaccination site were not reported) for prophylaxis (reported as "use as directed to prevent measles, mumps, rubella and varicella infection) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection for the same indication (wrong product administered). No additional adverse events were reported.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.  No additional AEs were reported, no fu; This spontaneous report was received from a healthcare worker and refers to a 7-month-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-AUG-2022, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number and expiration date were reported to be either W004504 and 16-JUN-2023 or W002562 and 12-OCT-2023, respectively (the reporter did not specify which lot number was administered to the patient) for prophylaxis (dose, strength, and route of administration were not provided). The vaccine was improperly stored (temperature: 11.3 Celsius degrees, time frame: 34 minutes, no previous temperature excursion) (product storage error). No additional adverse event was reported (no adverse event).
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.  No additional AEs were reported, no fu; This spontaneous report was received from a healthcare worker and refers to a 4-month-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 31-AUG-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number and expiration date were reported to be either W004504 and 16-JUN-2023 or W002562 (lot number confirmed to be valid) and 12-OCT-2023, respectively (the reporter did not specify which lot number was administered to the patient) for prophylaxis (dose, strength, and route of administration were not provided). The vaccine was improperly stored (temperature: 11.3 Celsius degrees, time frame: 34 minutes, no previous temperature excursion) (product storage error). No additional adverse event was reported (no adverse event).
Age: 2.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.  No additional AEs were reported, no fu; This spontaneous report was received from a healthcare worker and refers to a 2-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-AUG-2022, the patient was vaccinated with one dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, intramuscular injection, lot number and expiration date were reported to be either W003118 and 13-JUL-2023 or W015191 (lot number confirmed to be valid for formulation prefilled syringe) and 27-OCT-2023, respectively (the reporter did not specify which lot number was administered to the patient) for prophylaxis (dose, strength, and route of administration were not provided). The vaccine was improperly stored (temperature: 11.3 Celsius degrees, time frame: 34 minutes, no previous temperature excursion) (product storage error). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received.  No additional AEs were reported, no further inform; This spontaneous report was received from an other health professional and  refers to a 6-month-old patient.    The patient's concurrent conditions, medical history, drugs reactions or allergies were not provided.  On 25-AUG-2022, the patient was vaccinated with only one dose of improperly stored  rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # w002562 , expiration date: 12-OCT-2022 or with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # w004504 , expiration date: 16-JUN-2023 for prophylaxis. The vaccine was stored in temperature 11.3 degrees Celsius for a time frame of 34 minutes (product storage error). There was no previous temperature excursions. No additional adverse events were reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; patient received improperly stored vaccine; This spontaneous report was received from healthcare worker and refers to a 6-month-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-AUG-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #w004504, expiration date: 16-JUN-2023 or lot #w002562, expiration date: 12-OCT-2023) administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 11.3 degrees Celsius for 34 minutes. There was no previous temperature excursion.  There was no adverse event reported (no adverse event).  This is one of two reports received from the same reporter (link report #2209USA001298).; Sender's Comments:  US-009507513-2209USA001298:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; patient received improperly stored vaccine.; This spontaneous report was received from healthcare worker and refers to a 4-month-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-AUG-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #w004504, expiration date: 16-JUN-2023 or lot #w002562, expiration date: 12-OCT-2023) administered for prophylaxis (strength, and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 11.3 degrees Celsius for 34 minutes. There was no previous temperature excursion.  There was no adverse event reported (no adverse event).  This is one of two reports received from the same reporter (link report #2209USA001244).; Sender's Comments:  US-009507513-2209USA001244:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored PROQUAD was administered to a patient on 23Aug2022.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 23-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), lot #W017567, expiration date: 29-NOV-2023, administered as prophylaxis (strength and route of administration was not provided), after a temperature excursion of 1 hour at a temperature of  -10 Celsius degrees (C) up to 8 C (-9.6C) degrees (product storage error). No previous temperature excursions and no additional adverse events were reported
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Hearing loss; This spontaneous report was received from a lawyer and a female patient (pt) of unknown age regarding a litigation case. The pt's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around April 2012, the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the pt suffered hearing loss (Deafness). As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the pt symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of the event was considered as not recovered and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered deafness to be a disabling event.  Upon internal review, deafness was determined to be a medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE details were provided; a patient that was administered a dose of PROQUAD that was involved in a supported temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-SEP-2022 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) 0.5 milliliter, lot #U039259, expiration date: 09-JUN-2023, (anatomical location was not provided) administered subcutaneously as prophylaxis (Product storage error).  The improperly stored dose underwent a temperature excursion of 12.1 degrees Fahrenheit (F) for 12 hours without previous excursions. No adverse events were reported.