chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Vomiting, Weight decreased
Clinical narrative: About a week after my 2nd vaccine, the first week in Sept,  I developed the first symptoms of Parosmia and Disgeusia. I began smelling smoke that wasn't there. Then slowly, foods started tasting horrible. Things I love, like coffee and chocolate suddenly smelled horrible, and tasted putrid. Then on Halloween, all the candy tasted and smelled awful. From there this thing took a fast downward spiral. I didn't know what I could eat, or where I could "safely" breathe. Nearly all smells and tastes made me vomit. I dropped weight rapidly. There were about 12 "safe" foods left for me by the time this thing stopped getting worse. Everything, in the beginning, that was bad, had the same exact smell and taste/flavor, regardless of what it was. Chocolate, Lettuce, meat, rice, (and nearly everything else I used to eat) all tasted exactly the same, and it was horrible. I'm almost 10 months into this and I still have about 12-15 foods. I cant go out to eat anywhere. I can't eat with my family. No family BBQs. I can't enjoy a walk outside in the spring, or go shopping in the mall, or even many grocery stores because the smells are so bad. I'm isolated. There is no known treatment that's guaranteed to work. Most doctors have never even heard of this. It's taken away so much of my livelihood.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Intervertebral disc protrusion
Clinical narrative: Herniated disc; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-131-4429044-00.  An elderly female patient received BNT162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 10Apr2015 as 40mg/0.8ml (Batch/Lot number: unknown), as 40mg/0.4ml (1 in 2 wk) (Batch/Lot number: unknown) and (ongoing) as 40mg/0.4ml (1 in 2 wk) (Batch/Lot number: unknown), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "cervical spine surgery", start date: Jan2018 (unspecified if ongoing), notes: In Jan2018, the patient experienced cervical spine surgery. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 2, Intramuscular), administration date: 23Mar2021, for COVID-19 Immunization, reaction(s): "Spinal cord compression"; BNT162b2 (Dose 1, Intramuscular), administration date: 01Mar2021, for Covid-19 Immunization, reaction(s): "Spinal cord compression"; BNT162b2 (Dose 2, Intramuscular), administration date: 23Mar2021, for Covid-19 Immunization, reaction(s): "Spinal cord compression". The following information was reported: INTERVERTEBRAL DISC PROTRUSION (medically significant) with onset 08Jun2022, outcome "not recovered", described as "Herniated disc". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of intervertebral disc protrusion.  Clinical course: Solicited report by a consumer of an elderly female with events of pinched spinal cord and cervical spine surgery and non-serious herniated disc from lumbar 3 to sacral area with humira 40mg/0.4ml (adalimumab). On an unknown date, the patient experienced pinched spinal cord. In Jan2018, the patient experienced cervical spine surgery. On 08Jun2022, the patient experienced herniated disc from lumbar 3 to sacral area. dates, pinched spinal cord and cervical spine surgery resolved. on unknown bnt162b2 (Tozinameran) was also considered suspect. Cervical spine surgery on Jan2018 was due to a pinched spinal cord. Herniated disc from L-3 to Sacral area. Physical therapy treatment for herniated discs. Causality: Herniated disc (Intervertebral disc protrusion). Causality as per reporter (Drug/Vaccine): possible. Check all appropriate to adverse reaction: Other medically important condition. Did event abate after stopping drug NA  Follow-up attempts are completed. No further information is expected.
Age: 2.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE; 2 year old was concomitantly administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse practitioner referring to a 2-year-old patient of unknown gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 23-MAY-2022, the patient was concomitantly administered with 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength and route not reported, lot # U029150, expiration date: 16-MAR-2023, therapy type: rHA) and 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength and route not reported, lot # U016064, expiration date: 20-MAY-2023) for prophylaxis (overdose). No additional adverse event was reported.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: a patient recently had titers which showed that she is not immune to hepatitis B/Negative hepatitis B titers in a fully vaccinated patient; This spontaneous report has been received from a nurse concerning a 21 years old female patient. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On unknown dates, the patient received three doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) as a child (strength, dose, route, lot#, expire date were not reported) for prophylaxis.  On an unknown date (reported as recently), the patient had Negative hepatitis B titers which showed that she was not immune to hepatitis b (hepatitis B antibody negative). The outcome of the event was not provided.  Causality assessment was not provided.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Customer calling for TE evaluation of VARIVAX/ Temperature -14°C up to-10°C for 2 hours 5 minutes 0 seconds ; -10°C up to 8°C (-0.4C) for 1 hour 25 minutes 0 seconds; they just found out they had another TE 1 week ago/-14°C up to-10°C (-12C) for 0 hours 50 minutes 0 seconds; This spontaneous report was received from other unspecified reporter, regarding to a patient of unknown age, gender and race. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date in May 2022 (also reported as "a week ago and between 11-MAY-2022 and 24-MAY-2022") they reported that varicella virus vaccine live (oka/merck) (VARIVAX) with the lot number U039949 that has been verified to be valid (expiration date: 16-DEC-2022) underwent a temperature excursion at about 14 degrees Celsius (°C) up to 10°C (-12C) for 50 minutes; 14°C up to-10°C for 2 hours and 5 minutes; and finally from-10°C up to 8°C (-0.4C) for 1 hour and 25 minutes; then on an unspecified date in May 2022 (also reported as  between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with one of this doses of varicella virus vaccine live (oka/merck) (VARIVAX)  and  sterile diluent (dose, frequency, strength, and route of administration were not provided) for prophylaxis. No further adverse event (AE) details were available.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No further Adverse event details; they just found out they had another TE 1 week ago/-14°C up to-10°C (-12C) for 0 hours 50 minutes 0 seconds; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  Between 11-MAY-2022 and 24-MAY-2022, varicella virus vaccine live (oka/merck) (VARIVAX) lot #U039949, expiration date: 16-DEC-2023 (strength, and route of administration were not provided) was administered, following a temperature excursion (product storage error). The temperature was reported as -14 degree Celsius (C) up to-10 C for 2 hours 5 minutes 0 seconds; -10 C up to 8 C (-0.4 C) for 1 hour 25 minutes 0 seconds, there was a previous temperature excursion, reported as -14 C up to-10 C (-12 C) for 0 hours 50 minutes 0 seconds. No additional adverse events had been reported (no adverse event). No additional information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported.; Caller reported VARIVAX administered after temperature excursion.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) VARIVAX U019906  6/24/2023        ?    Temperatur; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-APR-2022, the patient was vaccinated with improperly stored (varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter subcutaneously, lot #U019906, expiration date: 24-JUN-2023, administered for prophylaxis (strength, and site of administration were not provided) (product storage error temperature too high). The vaccine was stored in the temperature of 6.8 Fahrenheit degrees for 1 hour and 36 minutes. No previous temperature excursion reported.  No additional adverse event was reported.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; improper storage of product in use; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.  On 11-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength was not provided).  The temperature excursion occurred on 23-MAR-2022, the vaccine was stored in a temperature of -14 degree Celsius (C) up to 10 C  for 3 hours; -10 C up to 8 C for 1 hour 30 minutes as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event details.
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; improper storage of product in use; This spontaneous report was received from Other Health Professional and refers to a 5-year-old female patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.  On 22-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength was not provided).  The temperature excursion occurred on 23-MAR-2022, the vaccine was stored in a temperature of -14 degree Celsius (C) up to 10 C  for 3 hours; -10 C up to 8 C for 1 hour 30 minutes as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event details.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE etails; improper storage of product in use; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.  On 26-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength was not provided).  The temperature excursion occurred on 23-MAR-2022, the vaccine was stored in a temperature of -14 degree Celsius (C) up to 10 C  for 3 hours; -10 C up to 8 C for 1 hour 30 minutes as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event details.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; TE evaluation states vaccines had been administered to multiple patients; This spontaneous report was received from a medical assistance and refers to a 14-month-old male patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-MAR-2022, the patient was vaccinated with the first dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported) administered subcutaneous route, lot # U025790 and expiration date 19-AUG-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of -14 degree celscius (C) up to -10 C for 3 hours and -10 C up to 8 C for 1 hour and 30 minutes on 23-MAR-2022; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA007852: US-009507513-2205USA007821:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Medical assistant reporting that a patient was administered PROQUAD after a temperature excursion. No additional information provided. Additional AE cases: 02177149, 02177160, 02177161, 02177162, 02177163, 02177164, 02177166, 02177167, 02177168. No a; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. Information regarding their medical history, concurrent conditions and concomitant therapies was not reported.  On 31-MAY-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot # U024508, expiration date 02-FEB-2023 (dose and route of administration were not reported) for prophylaxis (product storage error). The administered vaccine was stored in 8.3 degrees Fahrenheit (F) for 15 minutes. No previous temperature excursion was reported. The reporter confirmed the patient had no adverse experience.  The reporter stated that the company informed her she could use the product.  As of 07-JUN-2022, no further information was available for this case.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2206USA000990: US-009507513-2206USA000833: US-009507513-2206USA001100: US-009507513-2206USA001101: US-009507513-2206USA001052: US-009507513-2206USA000982: US-009507513-2206USA000988: US-009507513-2206USA001078: US-009507513-2206USA001045:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects or symptoms following administration/No other AE; Caller is a medical assistant who reports VARIVAX was administered following temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The patient's concomitant therapies included sterile diluent.  On 16-MAY-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot # U020244, expiration date 28-JUN-2023 (dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). It was unknown if patient sought medical attention or received any treatment for the event. The vaccine underwent temperature excursion of 6 Fahrenheit degrees for 7 minutes on 15-MAY-2022. There was no previous temperature excursions. No other adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additonal AE's and no PQC's were; A nurse stated that an improperly stored dose of PROQUAD was administered to a patient.  No additonal AE's and no PQC's were reported.; 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 19-MAY-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, use as directed to prevent measles, mumps, rubella and varicella infection, lot #U015480, expiration date: reported as 13-NOV-2023 but auto-populated as 13-NOV-2022 (site and route of administration were not provided) (product storage issue). No additional adverse events were reported.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No further adverse events; Caller is Medical Assistant reporting administered dose of expired MMR II.; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 08-JUN-2022, the patient was vaccinated with an expired vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, 1 dose, lot # T016352, expiration date 12-MAY-2022 (strength, dose number, route of administration and anatomical location were not provided) for prophylaxis at his vaccination appointment (expired product administered). The patient's father was informed of the event and the recommendations from the manufacturer and physician which was that even though it was expired, there was evidence to support potency of dose as long as stored properly. The patient's father was informed he could get repeat vaccine if desired which they declined. The patient experienced no reaction to the expired vaccine (no adverse event). There was no history of prior temperature excursions on vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) as no temperature excursion occurred as a result of reading from a Digital Data Logger. It was single use vaccine/vaccine-device. The operator of vaccine/vaccine-device was healthcare professional that was trained. It was unknown if vaccine/vaccine-device was available for return/evaluation. The vaccine was stored in vaccine fridge in clinic. The vaccine/vaccine-device was used according to the instruction leaflet.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE details; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 11-APR-2022, the patient was inadvertently vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U022819, expiration date: 14-JAN-2023 (strength, dose, site, and route of administration were not provided) administered for prophylaxis, after a non-supported temperature excursion (product storage error).   Vaccine was improperly stored for 96 hours in temperature of 70 Fahrenheit degrees. There were no previous excursions. It was not reported whether the digital data logger was involved to capture the temperature excursion. No additional adverse events details or product quality complaints were reported.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: no adverse event; 3rd dose administered on 13JUN2022, expired dose administered; misuse also included since the patient received a third dose of the vaccine.; This spontaneous report was received from a nurse and refers to a 43-year-old male patient. His medical history, concurrent condition and concomitant therapies details were not reported.  On 17-OCT-2019, the patient received the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No adverse event was reported after first dose. On 21-MAR-2019 (conflicting information), the patient received second dose of hepatitis a vaccine, inactivated (VAQTA) (strength, lot #, expiry date, and route of administration were not provided). No adverse event was reported after second dose. On 13-JUN-2022, he received third dose of hepatitis a vaccine, inactivated (VAQTA) vaccine lot #104058, expiration date 28-MAR-2022 (extra dose administered, expired dose administered). No additional adverse event or product quality complaint was reported.  Lot number 104058 is an invalid lot number for Hepatitis A Vaccine, Inactivated (VAQTA).
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report administered vaccine temperature excursion on multiple patients. Per caller vaccines went out of range yesterday and it was not discovered until this morning when checking the data logger; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 13-JUN-2022, the patient was vaccinated with a dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # U036586 was confirmed to be valid, expiration date reported as 21-OCT-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided). Vaccine was improperly stored for an unknown amount of time in an unknown temperature. Data logger was used to capture the temperature excursion.
Sex: M
Vaccine: BCG
Symptoms: Death, Lymphadenitis
Clinical narrative: Information has been received from the authors of a published literature article, titled as stated above, regarding a male patient of unknown age.  The patient's current condition included eczema, microthrombocytopenia and presumed wiskott-aldrich syndrome.   On an unknown date, the patient was vaccinated with bcg live (manufacturer unknown) (route and dosage information was unknown) as prophyaxis.  The patient developed bacille CalmetteGuérin lymphadenitis.    The outcome of lymphadenitis was unknown; however it was reported that the patient deceased at 7-year-old (unspecified cause of death).  The authors considered lymphadenitis to be related to bcg live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience  This is one of two reports from the same literature article (2206USA006251)
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: COVID-19, Diarrhoea, Norovirus test positive, SARS-CoV-2 test positive, Vomiting
Clinical narrative: COVID-19; norovirus; This spontaneous report was received from a physician and referred to a 6-month-old male patient. Concomitant medications, pertinent medical history and drug reactions/allergies were none.  On 07-FEB-2022 and 11-APR-2022, the patient was vaccinated with the first and second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally for routine immunization (strength, dose, lot #, and expiry date were not provided), respectively.  On 13-JUN-2022, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally for routine immunization (strength, and dose were not reported; lot # 1742476, expiry date was not provided, upon internal validation established as 18-MAR-2023).   Later that day (on 13-JUN-2022), the patient developed vomiting and diarrhea. The next day, the father of the patient and also the babysitter of the patient developed vomiting and diarrhea.  The patient received electrolytes NOS (+) glucose (PEDIALYTE) and paracetamol (TYLENOL) and modified feedings. The father and the babysitter of the patient did not require any medical treatment.  The physician stated that he knew that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was a live vaccine and he decided after the father and the babysitter developed the same symptoms as the patient, that he should report this adverse event.  On 15-JUN-2022, the patient was starting to feel better, and also that the father of the patient and the babysitter were also feeling better.  On an unknown date in June 2022, the patient was admitted. He tested positive for both COVID-19 and norovirus. It was reported that the nanny had recently come back from a cruise and most likely passed both on to the patient. The physician attributed patient's symptoms to the COVID-19 and norovirus rather than the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine.  The causality assessment between COVID-19 and norovirus and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse event; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received  on 16-JUN-2022 from an administrator regarding a patient of unknown age or gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unspecified date, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U022321, expiration date: 15-JUL-2023) was stored at an inappropriate temperature of 6F for a time frame of 30 minutes. The was no previous  temperature excursion.   On 09-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot #U022321, expiration date: 15-JUL-2023) administered subcutaneously for prophylaxis (strength was not provided). No adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AEs; PROQUAD and VARIVAX administered to 12 month old at same visit; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  On 17-JUN-2022, at the same visit, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD), 0.5 ml, lot #U010746, expiration date was not provided but upon internal validation was determined to be 03-OCT-2022; and varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, lot #U010400, expiration date was not provided but upon internal validation was determined to be 01-APR-2023, both vaccines administered subcutaneously for prophylaxis (vaccine overdose). No additional adverse events (AEs) were reported.
Age: 1.25
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: a 15 month old child received PROQUAD and VARIVAX on the same day. The patient was supposed to get MMRII but received PROQUAD instead due to human error; a 15 month old child received PROQUAD and VARIVAX on the same day. The patient was supposed to get MMRII but received PROQUAD instead due to human error; No additional AEs were reported; This spontaneous report was received from a medical assistant and refers to a 15-month-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unknown date, the 15-month-old child patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5ml, once, lot #:U031564, expiration date: 06-APR-2023; and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml,once, lot #: U026207, expiration date: 24-AUG-2023 (strengths, sites and routes of administration were not provided) for prophylaxis. The patient was supposed to get a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (exact dose, strength, lot #, expiration date, site and route of administration, albumin status were not provided) but received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead due to human error (wrong product administered; extra dose administered). There was no additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no other AE occurred; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, lot #u039948, expiration date: 16-DEC-2023 (route of administration was not provided). The administered dose of vaccine experienced the temperature excursion of -2.5 degrees Celsius for 5 hours and 6 minutes. There was no previous temperature excursion. No other adverse event (AE) occurred.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005588: US-009507513-2206USA005697: US-009507513-2206USA005817: US-009507513-2206USA005711:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE occurred; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 1 dose, lot #u039948, expiration date: 16-DEC-2023 (route of administration was not provided). The administered dose of vaccine experienced the temperature excursion of -2.5 degrees Celsius for 5 hours and 6 minutes. There was no previous temperature excursion. No other adverse event (AE) occurred.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005579: US-009507513-2206USA005697: US-009507513-2206USA005817: US-009507513-2206USA005711:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; ROTATEQ administered after temperature excursion. Temperature 49.8F; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-JUN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #U006165, expiration date: 18-OCT-2022, administered for prophylaxis (strength was not provided).  Administered dose of vaccine experienced the temperature excursion of 49.8 degrees Fahrenheit for 2 hours (Product storage error).  There was no additional adverse event or product quality complaint reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other adverse events reported; Caller reports that doses of improperly stored vaccines were administered to patients. Additional adverse events 02189036, 02189037, 02189038, 02189039 and 02189040 were filed. No further information provided. No other adverse events reported. No pro; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medication was not provided.  On 15-JUN-2022, the patient was vaccinated with the first dose of improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742084, expiration date 05-OCT-2022, orally, for prophylaxis (Incorrect product storage). Temperature was 47.17F, time frame 15 minutes. There was not previous temperature excursion. No other adverse events reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2206USA006096:02189036 US-009507513-2206USA006272:02189037 US-009507513-2206USA006061:02189038 US-009507513-2206USA006141:02189039 US-009507513-2206USA006019  :02189040
Age: 49.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details; A 49 year old patient was given a PROQUAD to save the patient money.; This spontaneous report has been received from a pharmacy manger, regarding a 49-years-old patient. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 16-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (recombinant human albumin (rHA)) (lot number W002781, which was determined to be valid, with an expiration date on 23-JUL-2023 but after internal review it was determined to be on 24-JUL-2023) (+) sterile diluent as prophylaxis (dose, route and anatomical location of administration was not reported) (product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: M
Vaccine: BCG
Symptoms: Lymphadenitis, Stem cell therapy
Clinical narrative: Information has been received from the authors of a published literature article, titled as stated above, regarding a male patient of unknown age.  The patient's current condition included eczema, microthrombocytopenia and wiskott-aldrich syndrome.   On an unknown date, the patient was vaccinated with bcg live (manufacturer unknown) (route and dosage information was unknown) as prophyaxis.  The patient developed bacille CalmetteGuérin lymphadenitis.  On an unspecified date the patient underwent a hematopoietic stem cell transplantation.   The outcome of lymphadenitis was unknown. The authors considered lymphadenitis was associated to bcg live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience  This is one of two reports from the same literature article (2206USA004823)
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; ROTATEQ administered after temperature excursion; Information has been received from a medical assistant referring to a patient of unknown ages and gender. Information about concurrent condition, concomitant medication and medical history was not provided.     On 20-JUN-2022, the patient were vaccinated with temperature excursion Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (2ml, lot # U006165, expiration date on 18-OCT-2022) orally for prophylaxis. No additional adverse events was reported. The vaccines had a temperature excursion of 49.8 Fahrenheit (F) for 2 hours. It was also confirmed that no previous temperature excursions occurred.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 07-MAR-2022, the patient was vaccinated with improperly stored (product storage error) dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. Temperature excursion information: temperature 1.5 degree Celsius, timeframe 24 hours. There was no previous temperature excursion. There was no additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP who is medical technologist lab manager reported an adverse event for VARIVAX. Caller explained VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022 and was administered to a patient. Caller did not have any further clarifyin; This spontaneous report was received from a medical technologist lab manager referring to a patient of unknown age and gender. the patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's allergies or drug reactions.  On 07-JUN-2022, varicella virus vaccine live (oka/merck) (VARIVAX), lot number: W002599, expiration date: 24-JAN-2024 was delivered after the receive by date of 06-JUN-2022. On 15-JUN-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event). There was no reported previous temperature excursion.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Caller is a medical assistant calling to report that an expired dose of PNEUMOVAX 23 was administered to a patient on 21JUN2022. Caller reports that the dose of PNEUMOVAX 23 expired on 8MAY2022 and did not experience a temperautre excursion through t; 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 21-JUN-2022, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml, lot #T032003, expiration date: 08-MAY-2022 (vaccination schedule, anatomical location and route of administration were not provided) for prophylaxis (Expired product administered). The reporter stated the vaccine did not experience a temperature excursion through the date of administration. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported.; Caller explained VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022 and was administered to a patient.; This spontaneous report was received from a medical technologist lab manager referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not reported.  On 07-JUN-2022, varicella virus vaccine live (oka/merck) (VARIVAX), formulation was defaulted to subcutaneous injection, lot number: W002599, expiration date: 24-JAN-2024 was delivered after the receive by date of 06-JUN-2022. On 15-JUN-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event). There was no reported previous temperature excursion.
Sex: M
Vaccine: VARCEL
Symptoms: Adenovirus test, Biopsy lung abnormal, Chemotherapy, Cytomegalovirus test negative, Herpes simplex test negative
Clinical narrative: vaccine-strain measles/vaccine-strain varicella; skin lesions along his scalp, thigh and groin with vaccine-strain varicella viremia; Litarature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 19-month-old male was diagnosed with intermediate risk, PRETEXT Ill P+ hepatoblastoma at 14 months of age. Concomitant therapy included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) .  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, 11 days after receiving varicella vaccines the patient treated per AHEP1531 with vincristine, cisplatin, oxorubicin and 5-fluorouracil for intermediate risk, PRETEXT Ill P+ hepatoblastoma. After two cycles of treatment, he developed skin lesions along his scalp, thigh, and groin with vaccine-strain varicella viremia, treated with acyclovir (Vaccination failure and Varicella post vaccine). The subsequent three months of chemotherapy were complicated by fevers and progressive lung infiltrates with no identified etiology. Despite broad anti-infective coverage and chemotherapy being withheld, progression of his nodules led to an extensive evaluation for bacterial, fungal and viral causes. A lung biopsy showed nodular histiocytic infiltrates with reactive multinucleate cells. Polymerase chain reaction testing and histopathology of the sample were negative for tuberculosis, varicella, adenovirus, herpes simplex and cytomegalovirus.  The reporter considered Vaccination failure and Varicella post vaccine to be related to varicella virus vaccine live (oka/merck) (VARIVAX).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of three cases derived from the same literature article.; Sender's Comments:  US-009507513-2206USA004317: US-009507513-2206USA006540:
Sex: M
Vaccine: VARCEL
Symptoms: Lung infiltration, Mycobacterium tuberculosis complex test negative, Polymerase chain reaction, Pulmonary mass, Pyrexia
Clinical narrative: vaccine-strain measles/vaccine-strain varicella; skin lesions along his scalp, thigh and groin with vaccine-strain varicella viremia; Litarature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 19-month-old male was diagnosed with intermediate risk, PRETEXT Ill P+ hepatoblastoma at 14 months of age. Concomitant therapy included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) .  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, 11 days after receiving varicella vaccines the patient treated per AHEP1531 with vincristine, cisplatin, oxorubicin and 5-fluorouracil for intermediate risk, PRETEXT Ill P+ hepatoblastoma. After two cycles of treatment, he developed skin lesions along his scalp, thigh, and groin with vaccine-strain varicella viremia, treated with acyclovir (Vaccination failure and Varicella post vaccine). The subsequent three months of chemotherapy were complicated by fevers and progressive lung infiltrates with no identified etiology. Despite broad anti-infective coverage and chemotherapy being withheld, progression of his nodules led to an extensive evaluation for bacterial, fungal and viral causes. A lung biopsy showed nodular histiocytic infiltrates with reactive multinucleate cells. Polymerase chain reaction testing and histopathology of the sample were negative for tuberculosis, varicella, adenovirus, herpes simplex and cytomegalovirus.  The reporter considered Vaccination failure and Varicella post vaccine to be related to varicella virus vaccine live (oka/merck) (VARIVAX).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of three cases derived from the same literature article.; Sender's Comments:  US-009507513-2206USA004317: US-009507513-2206USA006540:
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Vaccination failure, Varicella, Varicella post vaccine, Varicella virus test negative
Clinical narrative: vaccine-strain measles/vaccine-strain varicella; skin lesions along his scalp, thigh and groin with vaccine-strain varicella viremia; Litarature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 19-month-old male was diagnosed with intermediate risk, PRETEXT Ill P+ hepatoblastoma at 14 months of age. Concomitant therapy included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) .  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, 11 days after receiving varicella vaccines the patient treated per AHEP1531 with vincristine, cisplatin, oxorubicin and 5-fluorouracil for intermediate risk, PRETEXT Ill P+ hepatoblastoma. After two cycles of treatment, he developed skin lesions along his scalp, thigh, and groin with vaccine-strain varicella viremia, treated with acyclovir (Vaccination failure and Varicella post vaccine). The subsequent three months of chemotherapy were complicated by fevers and progressive lung infiltrates with no identified etiology. Despite broad anti-infective coverage and chemotherapy being withheld, progression of his nodules led to an extensive evaluation for bacterial, fungal and viral causes. A lung biopsy showed nodular histiocytic infiltrates with reactive multinucleate cells. Polymerase chain reaction testing and histopathology of the sample were negative for tuberculosis, varicella, adenovirus, herpes simplex and cytomegalovirus.  The reporter considered Vaccination failure and Varicella post vaccine to be related to varicella virus vaccine live (oka/merck) (VARIVAX).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of three cases derived from the same literature article.; Sender's Comments:  US-009507513-2206USA004317: US-009507513-2206USA006540: