chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: day 2 redness and sore arm day  4  symptoms resolved day 7 symptoms reappear and are more pronounced such as itching redness and soreness at day 8 feeling better
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Generalised tonic-clonic seizure, Injection site haemorrhage, Injection site reaction
Clinical narrative: At approximately 1:00am, 6-7 hours after the the flu shot was given, I had a grand mal seizure.  The seizure happened while sleeping in my bed.  The force of the violent seizure caused me to posterior dislocate my left shoulder (same arm where the flu shot was given).  I also have multiple compression fractures of my thoracic spine from the seizure.  A petechiae rash was present on my left arm at the injection site spreading across my neck and face.  I have never had a seizure and have no family history of seizure activity.  The seizure was a reaction to the flu shot.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Joint dislocation, Magnetic resonance imaging, Petechiae, Spinal compression fracture, X-ray
Clinical narrative: At approximately 1:00am, 6-7 hours after the the flu shot was given, I had a grand mal seizure.  The seizure happened while sleeping in my bed.  The force of the violent seizure caused me to posterior dislocate my left shoulder (same arm where the flu shot was given).  I also have multiple compression fractures of my thoracic spine from the seizure.  A petechiae rash was present on my left arm at the injection site spreading across my neck and face.  I have never had a seizure and have no family history of seizure activity.  The seizure was a reaction to the flu shot.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported severe pain and redness at and around the site of injection for 4 days after vaccination. The area of redness included the top of the shoulder down to the elbow.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: pain/sore at injection site, and pain in left hip joint when walking
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Influenza vaccine received on 2-25-20 Injection site was red and tender, the area was 3 in diameter, on 2-26-20 This morning the area is 6-7 in across and red, hot & painful
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: SkinRash METHYLPREDNISOLONE 125 MG ONCE 125 mg/1 VIAL INTRAMUSCULAR NOW, PREDNISOLONE 20 MG EVERY DAY TAKE FOUR TABLETS BY MOUTH EVERY DAY FOR 2 DAYS, THEN THREE TABLETS BY MOUTH EVERY DAY FOR 2 DAYS, THEN TWO TABLETS BY MOUTH EVERY DAY FOR 2 DAYS, THEN ONE TABLET BY MOUTH EVERY DAY FOR 2 DAYS, TAKE WITH FOOD
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SkinRash, Rash & UrticariaPruritus
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TD
Symptoms: Alopecia, Blood test
Clinical narrative: hair loss
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Third Hep B given too soon
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Lymphadenopathy, Pain
Clinical narrative: Trouble breathing aches pains swollen lymph nodes chills
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash maculo-papular
Clinical narrative: 61/2 x 6 1/2 macular papular rash on left deltoid
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient started complaining of discomfort by bedtime. Saturday L upper arm was red around injection site. Sunday morning Left arm swollen from shoulder to elbow, red & tender. Went to urgent care
Sex: F
Vaccine: UNK, UNK, MMR, UNK, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: the patient did not experience any symptoms; the patient was administreted VARIVAX and MMR II while pregnant; This spontaneous prospective pregnancy report was received from a physician and refers to a female patient of an unknown age. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On an unspecified date, the patient became pregnant. The dates of last menstrual period (LMP), approximate date of conception, and estimated date of delivery (EDD) were not provided and were unable to calculate. The pregnancy outcome was pending.  On 16-SEP-2019, the pregnant patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) (lot # R030808, expiration date reported as 01-JAN-2020, but upon internal validation established as 24-OCT-2020) (dose number and route of administration were not provided) and a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S008695, expiration date 21-MAR-2021) (dose number and route of administration were not provided) both for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT), 2 doses (strength, exact dose, frequency, route of administration, lot # and expiration date were not reported). The patient did not experienced any symptoms.
Sex: F
Vaccine: UNK, UNK, MMR, UNK, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: the patient did not experience any symptoms; the patient was administreted VARIVAX and MMR II while pregnant; This spontaneous prospective pregnancy report was received from a physician and refers to a female patient of an unknown age. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On an unspecified date, the patient became pregnant. The dates of last menstrual period (LMP), approximate date of conception, and estimated date of delivery (EDD) were not provided and were unable to calculate. The pregnancy outcome was pending.  On 16-SEP-2019, the pregnant patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) (lot # R030808, expiration date reported as 01-JAN-2020, but upon internal validation established as 24-OCT-2020) (dose number and route of administration were not provided) and a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S008695, expiration date 21-MAR-2021) (dose number and route of administration were not provided) both for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT), 2 doses (strength, exact dose, frequency, route of administration, lot # and expiration date were not reported). The patient did not experienced any symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Influenza like illness, Pain
Clinical narrative: headache; dizziness; Falls; aching all over / pain; shoulder pain; passed out; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (On 29th August 2019, the patient received 1st dose refer the case US2020AMR034862).   On 20th February 2020, the patient received the 2nd dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria hospitalization). On 21st February 2020, the patient experienced passed out (serious criteria hospitalization and GSK medically significant) and shoulder pain (serious criteria hospitalization). On an unknown date, the patient experienced headache (serious criteria hospitalization), dizziness (serious criteria hospitalization), fall (serious criteria hospitalization) and general body pain (serious criteria hospitalization). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the passed out, fall and shoulder pain were unknown and the outcome of the influenza-like symptoms, headache, dizziness and general body pain were recovered/resolved.   It was unknown if the reporter considered the passed out, influenza-like symptoms, headache, dizziness, fall, general body pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: On Thursday afternoon, the patient received a dose of Shingrix. On Friday morning, she experienced flu-like symptoms again. The patient bent over to load her dishwasher and passed out. When the patient regained consciousness, the patient tried to use her microwave and passed out again. When the patient regained consciousness again, the patient called 911. The patient was evaluated and her vital signs were good. The patient was advised to visit her physician. After her appointment, the patient went to the emergency room and was admitted to the hospital and was discharged 2 days later. All lab tests results were fine.  The patient was still experiencing headache and dizziness, but the patient did not know if they were caused by the vaccine or the falls. The patient was taking pills for the pain.  Emergency room visit required.  The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fall, Headache, Influenza like illness, Laboratory test normal
Clinical narrative: headache; dizziness; Falls; aching all over / pain; shoulder pain; passed out; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (On 29th August 2019, the patient received 1st dose refer the case US2020AMR034862).   On 20th February 2020, the patient received the 2nd dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria hospitalization). On 21st February 2020, the patient experienced passed out (serious criteria hospitalization and GSK medically significant) and shoulder pain (serious criteria hospitalization). On an unknown date, the patient experienced headache (serious criteria hospitalization), dizziness (serious criteria hospitalization), fall (serious criteria hospitalization) and general body pain (serious criteria hospitalization). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the passed out, fall and shoulder pain were unknown and the outcome of the influenza-like symptoms, headache, dizziness and general body pain were recovered/resolved.   It was unknown if the reporter considered the passed out, influenza-like symptoms, headache, dizziness, fall, general body pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: On Thursday afternoon, the patient received a dose of Shingrix. On Friday morning, she experienced flu-like symptoms again. The patient bent over to load her dishwasher and passed out. When the patient regained consciousness, the patient tried to use her microwave and passed out again. When the patient regained consciousness again, the patient called 911. The patient was evaluated and her vital signs were good. The patient was advised to visit her physician. After her appointment, the patient went to the emergency room and was admitted to the hospital and was discharged 2 days later. All lab tests results were fine.  The patient was still experiencing headache and dizziness, but the patient did not know if they were caused by the vaccine or the falls. The patient was taking pills for the pain.  Emergency room visit required.  The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Musculoskeletal pain, Pain
Clinical narrative: headache; dizziness; Falls; aching all over / pain; shoulder pain; passed out; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (On 29th August 2019, the patient received 1st dose refer the case US2020AMR034862).   On 20th February 2020, the patient received the 2nd dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria hospitalization). On 21st February 2020, the patient experienced passed out (serious criteria hospitalization and GSK medically significant) and shoulder pain (serious criteria hospitalization). On an unknown date, the patient experienced headache (serious criteria hospitalization), dizziness (serious criteria hospitalization), fall (serious criteria hospitalization) and general body pain (serious criteria hospitalization). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the passed out, fall and shoulder pain were unknown and the outcome of the influenza-like symptoms, headache, dizziness and general body pain were recovered/resolved.   It was unknown if the reporter considered the passed out, influenza-like symptoms, headache, dizziness, fall, general body pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: On Thursday afternoon, the patient received a dose of Shingrix. On Friday morning, she experienced flu-like symptoms again. The patient bent over to load her dishwasher and passed out. When the patient regained consciousness, the patient tried to use her microwave and passed out again. When the patient regained consciousness again, the patient called 911. The patient was evaluated and her vital signs were good. The patient was advised to visit her physician. After her appointment, the patient went to the emergency room and was admitted to the hospital and was discharged 2 days later. All lab tests results were fine.  The patient was still experiencing headache and dizziness, but the patient did not know if they were caused by the vaccine or the falls. The patient was taking pills for the pain.  Emergency room visit required.  The reporter consented to follow up.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Incorrect dose administered, Product administration error
Clinical narrative: The patient was administered VARIVAX and M-M-R II on 08-JAN-2020. It was also reported that the patient was accidentally administered VARIVAX and M-M-R II again on 20-FEB-2020.; The patient was administered VARIVAX and M-M-R II on 08-JAN-2020. It was also reported that the patient was accidentally administered VARIVAX and M-M-R II again on 20-FEB-2020.; The patient was administered  M-M-R II on 08-JAN-2020. It was also reported that the patient was accidentally administered M-M-R II again on 20-FEB-2020.; The patient was administered  M-M-R II on 08-JAN-2020. It was also reported that the patient was accidentally administered M-M-R II again on 20-FEB-2020.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 08-JAN-2020, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S012036 with expiration date on 17-APR-2021) and one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (recombinant human albumin (rHA)) (Lot number S007814 has been verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, expiration date reported as 13-MAR-2021, but upon internal validation established as 14-MAR-2021). It was also reported that the patient accidentally was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S025611 with expiration date on 18-AUG-2021) and one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) (lot number S014429 with expiration date on 09-MAY-2021) on 20-FEB-2020 (extra dose administered, product administration error, inappropriate schedule of vaccine administered and inappropriate dose of vaccine administered). All the vaccines were administered as prophylaxis (route of administration, and anatomical location were not provided). No additional adverse event information was reported.
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Epistaxis, Erythema, Oedema peripheral
Clinical narrative: The patient had a nose bleed; The patient experienced pain in her left axilla area; The patient experienced swelling in her left axilla; drug use for unapproved indication; The patient developed red streaks on her left arm; The patient developed red streaks on her left arm and into her chest area; This spontaneous report was received from a nurse practitioner concerning a 64-year-old female patient. The patient's pertinent medical history included auto-immune connective tissue disorder. The patient's drug reactions or allergies included sulfa, omeprazole (PRILOSEC) and esomeprazole magnesium (NEXIUM). No information was provided regarding the patient's concomitant medications.  On 22-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection on the left arm, 1 dose, administrated via intramuscular, lot No. S029916 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date reported as 20-DEC-2021, but upon internal validation established as 12-JUN-2021 for auto-immune disorder & over 60 years old (product use in unapproved indication). Following the injection, the patient developed red streaks on her left arm and into her chest area (vaccination site streaking and rash macular).  On 09-FEB-2020, the patient had a nosebleed (epistaxis).  On an unspecified date in February 2020, the patient experienced pain and swelling in her left axilla area (axillary pain and peripheral swelling) that had not resolved when the patient came back to see her healthcare professional on 20-FEB-2020. The healthcare professional directed the patient to get an ultrasound to check on the pain in her axilla. It was unknown by reporter if the patient had gotten the ultrasound to date.  The outcome of vaccination site streaking, rash macular, epistaxis, axillary pain and peripheral swelling and the causal relationship between all the aforementioned events and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, Varicella virus test negative
Clinical narrative: Physical therapist reported that she received one or more doses of VARIVAX, but titers drawn indicated insufficient antibodies; She received one or more doses of VARIVAX/The patient received an additional dose of Varivax on an unknown date to boost her immunity/Treatment Provided: additional dose of Varivax administered; She receoved one or more doses of VARIVAX/The patient received an additional dose of Varivax on an unknown date to boost her immunity/Treatment Provided: additional dose of Varivax administered; This spontaneous report was received from a female physical therapist of unknown age, referring to herself.  Her current condition included a history of not producing an adequate response to a vaccine. Her past drug and medical history, as well as concomitant medications, were not provided.   On an unknown date, the patient was vaccinated with one or more doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (reported as vaccination) via subcutaneous (concentration and anatomical location of vaccination were not reported; dose, frequency of vaccination scheme, lot number and expiry date were unknown to the reporter).   On an unknown date, the patient sought medical attention and varicella titers were drawn which indicated that the patient had insufficient antibodies (varicella virus test negative).  On an unknown date, the patient received an additional dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) to boost her immunity (incorrect dose administered, circumstance or information capable of leading to medication error). The patient did not know her current antibody levels.   The outcome of varicella virus test negative was unknown. The causality assessment between varicella virus vaccine live (Oka/Merck) (VARIVAX) administration and the occurrence of the event, was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other adverse effects; that a 16 year old patient received an adult dose of VAQTA; This spontaneous report as received from a medical assistant refers to a 16-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-FEB-2020, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 50/1.0 units/ml (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: the patient disclosed that she was pregnant only after the dose was given; No additional adverse effects were reported in the patient; Information has been received from a nurse practitioner referring to a 25 years old female patient. The patient's concomitant medications included valacyclovir hydrochloride, sumatriptan, fluoxetine hydrochloride (PROZAC) and oxcarbazepine (TRILEPTAL). Drug reactions or allergies included morphine. Pertinent medical history was reported as none. Last menstrual period (LMP) was not reported.  On 02-MAR-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (subcutaneous; lot number S015463, expiration date 20-MAY-2021; strength, dose, and frequency unknown) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (subcutaneous; strength, dose, frequency, lot number and expiration date unknown). The patient disclosed that she was pregnant only after the dose was given (maternal exposure during pregnancy). The estimated date of delivery (EDD) and gestation period at exposure were not known. The pregnancy outcome was outcome pending. No additional adverse effects were reported in the patient. No product quality complaint (PQC) was reported.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood culture positive, Herpes zoster, Paraesthesia, Rash, Skin burning sensation
Clinical narrative: tingling; burning; rash on the scalp; shingles; This case was reported by a nurse via call center representative and described the occurrence of tingling in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number T44C7, expiry date 26th February 2022) for prophylaxis.   On 28th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2020, less than a day after receiving Shingrix and an unknown time after starting Valaciclovir, the patient experienced tingling, burning sensation scalp and rash. On an unknown date, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valaciclovir). On an unknown date, the outcome of the tingling, burning sensation scalp, rash and shingles were unknown.   It was unknown if the reporter considered the tingling, burning sensation scalp, rash and shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and reported tingling, burning and a rash on the left frontal scalp after 20 to 22 hours.  The patient had no history of shingles. On 4th February 2020 the smear test did but wasn't able to do a culture until the next day on 5th February 2020.The patient had shingles by culture. The patient was treated  with valacyclovir and referred him to an Opthamologist. The emergency visit required. The follow up consent was granted.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Smear test
Clinical narrative: tingling; burning; rash on the scalp; shingles; This case was reported by a nurse via call center representative and described the occurrence of tingling in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number T44C7, expiry date 26th February 2022) for prophylaxis.   On 28th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2020, less than a day after receiving Shingrix and an unknown time after starting Valaciclovir, the patient experienced tingling, burning sensation scalp and rash. On an unknown date, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valaciclovir). On an unknown date, the outcome of the tingling, burning sensation scalp, rash and shingles were unknown.   It was unknown if the reporter considered the tingling, burning sensation scalp, rash and shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and reported tingling, burning and a rash on the left frontal scalp after 20 to 22 hours.  The patient had no history of shingles. On 4th February 2020 the smear test did but wasn't able to do a culture until the next day on 5th February 2020.The patient had shingles by culture. The patient was treated  with valacyclovir and referred him to an Opthamologist. The emergency visit required. The follow up consent was granted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Lip swelling, Urticaria
Clinical narrative: Hives an lip swelling - was given Benadryl po and Epi SQ patient was then observed and then released home when all symptoms cleared.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported some hardness around the site. Slight swelling. Some itchiness around the area. Denies any redness. Patient's primary care provider was notified .
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to a 5-months-old male patient (previously considered non-valid).  On 17-JAN-2020, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength not reported) lot # R031056 with expiration date of 04-JUN-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Ischaemic stroke
Clinical narrative: ischemic stroke; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. ON or around 06-OCT-2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Approximately on 13-OCT-2015, reported as one week after zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered an ischemic stroke. As a direct and proximate result of use zoster vaccine live (ZOSTAVAX) use, the pt's symptoms had resulted in physical limitation not present prior to vaccination. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX) use, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of use zoster vaccine live (ZOSTAVAX) use, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.   Upon internal review the event of ischemic stroke was considered to be medically significant.  The event of ischemic stroke was considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Hearing aid user
Clinical narrative: sensorineural hearing loss requiring use of hearing aids; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 11-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered sensorineural hearing loss requiring use of hearing aids. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event sensorineural hearing loss requiring use of hearing aids was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event sensorineural hearing loss requiring use of hearing aids to be disability.   Upon internal review, the event sensorineural hearing loss requiring use of hearing aids was determined to be medically significant.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to an 8-months-old female patient (previously considered non-valid).  On 17-JAN-2020, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength not reported) lot # R031056 with expiration date on 04-JUN-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001375: US-009507513-2001USA006732: US-009507513-2003USA001379: US-009507513-2003USA001376: US-009507513-2003USA001378: US-009507513-2003USA001377:
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to a 13-year-old male patient (previously considered non-valid).  On 17-JAN-2020, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength not reported) lot # R029507 with expiration date on 10-JUL-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001374: US-009507513-2001USA006732: US-009507513-2003USA001376: US-009507513-2003USA001377: US-009507513-2003USA001378: US-009507513-2003USA001379:
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to a 4-weeks-old male patient (previously considered non-valid).  On 17-JAN-2020, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength not reported) lot # R031056 with expiration date on 04-JUN-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001374: US-009507513-2003USA001375: US-009507513-2003USA001379: US-009507513-2001USA006732: US-009507513-2003USA001377: US-009507513-2003USA001378:
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to a 4-months-old female patient (previously considered non-valid).  On 17-JAN-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength not reported) lot # 1660685 with expiration date on 21-MAR-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001374: US-009507513-2003USA001376: US-009507513-2003USA001375: US-009507513-2001USA006732: US-009507513-2003USA001378: US-009507513-2003USA001379:
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to an 8-months-old female patient (previously considered non-valid).   On 17-JAN-2020, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength not reported) lot # R031056 with expiration date on 04-JUN-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001374: US-009507513-2003USA001375: US-009507513-2003USA001376: US-009507513-2003USA001377: US-009507513-2003USA001379: US-009507513-2001USA006732: