chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Heart rate increased, Immediate post-injection reaction, Migraine, Myalgia
Clinical narrative: Immediately after the shot was administered, I experienced severe muscle pain throughout my whole left arm, I could not touch or move my arm without crippling pain. A few hours after the shot I felt incredibly dizzy and very weak. I felt flushed and experienced a fast heartbeat. That night I woke up to throbbing pain in my face, I looked in the mirror to find out that the left half of my nose had swelled to twice the normal size. Since I have gotten this shot I have experienced headaches and migraines, dizziness and fatigue even until today (almost a week after).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Swelling face, Tenderness
Clinical narrative: Immediately after the shot was administered, I experienced severe muscle pain throughout my whole left arm, I could not touch or move my arm without crippling pain. A few hours after the shot I felt incredibly dizzy and very weak. I felt flushed and experienced a fast heartbeat. That night I woke up to throbbing pain in my face, I looked in the mirror to find out that the left half of my nose had swelled to twice the normal size. Since I have gotten this shot I have experienced headaches and migraines, dizziness and fatigue even until today (almost a week after).
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Seizure, Syncope
Clinical narrative: Information has been received from a nurse via a company representative referring to a female patient of unknown age. Concomitant medication included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as Tdap) and meningitis vaccine. Information regarding medical history and drug reactions/allergies were not reported. On 26-JUL-2016, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route were unknown). On an unknown date in July 2016, when the patient was leaving the office, she fainted and got a seizure. The patient sought medical attention. It was unknown if treatment was given for the events or if lab diagnostics studies were performed. The outcome of the events was unknown. The causality was not reported. Upon internal review, the event seizure was considered to be medically significant. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Shooting pain up and down arm. Patient states pain was a 10+ on scale from 1-10.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Syncope, Tinnitus
Clinical narrative: About 3 minutes after vaccine given, pt. felt headache, dizziness, tinnitus, and syncope. Resolved after about 10 minutes.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test abnormal, Exposure during pregnancy, Haemorrhage, Muscle spasms, Premature separation of placenta
Clinical narrative: Placental Abruption. Symptoms were heavy bleeding and cramping.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: Placental Abruption. Symptoms were heavy bleeding and cramping.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Computerised tomogram head normal, Electroencephalogram, Full blood count, Metabolic function test normal, Status epilepticus
Clinical narrative: Status epilepticus (onset 22 hours after vaccinations).
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Electroencephalogram abnormal, Endotracheal intubation, Seizure
Clinical narrative: Status epilepticus (onset 22 hours after vaccinations).
Age: 27.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis, Hepatitis viral test positive, Incomplete course of vaccination, Liver function test increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis in a 28-year-old male patient who received TWINRIX  adult (batch number A4XD4, expiry date 7th October 2017). Concomitant products included  TWINRIX adult. On 25th April 2016, the patient received the 2nd dose of TWINRIX  adult. On an unknown date, less than a year after receiving TWINRIX  adult and an unknown time after receiving TWINRIX  adult, the patient experienced hepatitis (serious criteria GSK medically significant and other: as per reporter). On an unknown date, the outcome of the hepatitis was unknown. the reporter considered the hepatitis to be unlikely related to TWINRIX  adult. Additional details were provided as follows: the reporter was not sure if this is an adverse event due to the fact that the patient did not finish the series. On 23rd March 2016, the patient received the 1st dose of TWINRIX  adult. The patient was given 2 doses of TWINRIX  adult. The patient was waiting for the 3rd dose. The patient called healthcare professional and said he was tested positive for hepatitis. The healthcare professional was not sure which hepatitis. the patient was concerned that TWINRIX  adult gave him the hepatitis. The patient also said he had elevation in "ALC" levels of the liver. the patient visited the emergency room. the reported lot number (A4X04) for TWINRIX  adult did not exist and was updated to A4XD4, according to sales database.
Age: 17.0
Sex: F
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Rash generalised, Rash morbilliform, Rash pruritic
Clinical narrative: Information has been received from a registered nurse referring to a 12 or 13 years old female patient. The patient's medical history concurrent condition and concomitant medications were unknown. On an unknown date (about 6 to 12 months ago), the patient was vaccinated with the first dose of M-M-R II subcutaneously (dose, frequency, lot# and expiration date unknown). On an unspecified date, the patient experienced a measles like rash from "head to toe" after receiving M-M-R II. The rash was ago "itchy and pimply, lasting for about a week". The patient recovered from the event.  The casual relationship between the events and M-M-R II was known. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of an unknown gender and age. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of VAQTA (lot # L046953, expiration date 14-JAN-2017; LIQUID PEDVAXHIB (lot # L038501, expiry 16-AUG-2018 and lot L051124, expiry 14-OCT-2018; RECOMBIVAX HB (lot M010212, expiry 21-JAN-2019, lot L016427, expiry 13-APR-2017 and lot L045117, expiry 06-OCT-2018; ROTATEQ (lot M004890, expiry 10-NOV-2017 by oral route and GARDASIL (lot K010215, expiry 05-MAY-2017 and lot M014929, expiry 27-MAY-2017. The reporter stated that the vaccines were exposed for 15 hours and then they backed in range. There were no previous temperature excursion. There were no concomitant medications and adverse events reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history and concomitant conditions were not reported. In approximately 2016 (reported as "unknown dates starting on or after 14-MAY-2016"), the patients were vaccinated with PNEUMOVAX23 injection (lot # L048265, expiration date 10-JUN-2017, dose, route and anatomical location of administration were not reported) where were improperly stored at 53.2 F for 73 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effect was reported and no product quality complaint was involved. This is one of two cases received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered  nurse (R.N.), concerning a 12 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported.  It was reported that on an unknown date the 12 years old patient received a dose of ZOSATAVAX 0.65 ml per subcutaneous route (lot # and expiration date were not provided). Concomitant therapies were not provided. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Confusional state, Disorientation, Head injury, Loss of consciousness
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 19 year old non pregnant female patient. None pertinent medical history, drug reactions or allergies were reported. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (site of administration, lot #, expiry date and dose were not reported). Patient's concomitant therapies were reported as none. On 19-JUL-2016, after receiving GARDASIL 9 the patient passed out and hit her head on the floor. The patient was unable to recall the event of passing out. She woke up confused and not oriented. The patient was treated (unspecified treatment) in the doctor's office and then transferred to an unspecified emergency room. No lab diagnostic studies were performed. The reporter was unsure if patient was admitted to the hospital and none lab diagnostics studies were performed. A reporting time the outcome regarding of the events was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Acute stress disorder, Computerised tomogram head abnormal, Concussion, Confusional state, Contusion
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 19 year old non pregnant female patient. None pertinent medical history, drug reactions or allergies were reported. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (site of administration, lot #, expiry date and dose were not reported). Patient's concomitant therapies were reported as none. On 19-JUL-2016, after receiving GARDASIL 9 the patient passed out and hit her head on the floor. The patient was unable to recall the event of passing out. She woke up confused and not oriented. The patient was treated (unspecified treatment) in the doctor's office and then transferred to an unspecified emergency room. No lab diagnostic studies were performed. The reporter was unsure if patient was admitted to the hospital and none lab diagnostics studies were performed. A reporting time the outcome regarding of the events was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Disorientation, Fall, Haematoma, Head injury, Headache
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 19 year old non pregnant female patient. None pertinent medical history, drug reactions or allergies were reported. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (site of administration, lot #, expiry date and dose were not reported). Patient's concomitant therapies were reported as none. On 19-JUL-2016, after receiving GARDASIL 9 the patient passed out and hit her head on the floor. The patient was unable to recall the event of passing out. She woke up confused and not oriented. The patient was treated (unspecified treatment) in the doctor's office and then transferred to an unspecified emergency room. No lab diagnostic studies were performed. The reporter was unsure if patient was admitted to the hospital and none lab diagnostics studies were performed. A reporting time the outcome regarding of the events was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hyperhidrosis, Hyporesponsive to stimuli, Leukocytosis, Loss of consciousness, Lymphocyte percentage decreased
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 19 year old non pregnant female patient. None pertinent medical history, drug reactions or allergies were reported. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (site of administration, lot #, expiry date and dose were not reported). Patient's concomitant therapies were reported as none. On 19-JUL-2016, after receiving GARDASIL 9 the patient passed out and hit her head on the floor. The patient was unable to recall the event of passing out. She woke up confused and not oriented. The patient was treated (unspecified treatment) in the doctor's office and then transferred to an unspecified emergency room. No lab diagnostic studies were performed. The reporter was unsure if patient was admitted to the hospital and none lab diagnostics studies were performed. A reporting time the outcome regarding of the events was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Neurological examination abnormal, Neutrophil count increased, Neutrophil percentage increased, Presyncope
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 19 year old non pregnant female patient. None pertinent medical history, drug reactions or allergies were reported. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (site of administration, lot #, expiry date and dose were not reported). Patient's concomitant therapies were reported as none. On 19-JUL-2016, after receiving GARDASIL 9 the patient passed out and hit her head on the floor. The patient was unable to recall the event of passing out. She woke up confused and not oriented. The patient was treated (unspecified treatment) in the doctor's office and then transferred to an unspecified emergency room. No lab diagnostic studies were performed. The reporter was unsure if patient was admitted to the hospital and none lab diagnostics studies were performed. A reporting time the outcome regarding of the events was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pulse abnormal, Pupillary light reflex tests normal, Syncope, Vomiting, White blood cell count increased
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 19 year old non pregnant female patient. None pertinent medical history, drug reactions or allergies were reported. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (site of administration, lot #, expiry date and dose were not reported). Patient's concomitant therapies were reported as none. On 19-JUL-2016, after receiving GARDASIL 9 the patient passed out and hit her head on the floor. The patient was unable to recall the event of passing out. She woke up confused and not oriented. The patient was treated (unspecified treatment) in the doctor's office and then transferred to an unspecified emergency room. No lab diagnostic studies were performed. The reporter was unsure if patient was admitted to the hospital and none lab diagnostics studies were performed. A reporting time the outcome regarding of the events was recovering. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report was received from a 78 year old female patient with an allergy to sulfur. No other information about concomitant medications or past medical history was reported. On an unknown date (reported as "over a year ago"), the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously. After the patient received the ZOSTAVAX, she had to go to the medical center because she developed a rash and small red bumps all over her body (onset date unknown). The patient received unspecified treatment. There were no diagnostic studies or laboratory tests performed. It has been over a year, and the patient has not recovered from the rash or the red bumps all over her body. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients' were vaccinated with improperly stored ROTATEQ (dose, strength, route, frequency, lot # and indication unknown) (incorrect product storage). The vaccine was exposed to a high of 9.5 degree Celsius temperature for a time frame of 24 hours. No adverse events were reported. Data logger was involved. It was reported that there was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients' were vaccinated with improperly stored PNEUMOVAX23 (dose, strength, route, frequency, lot # and expiration date unknown) (incorrect product storage). The vaccine was exposed to a high of 9.5 degree Celsius temperature for a time frame of 24 hours. No adverse events were reported. Data logger was involved. It was reported that there was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose abnormal, Diabetes mellitus inadequate control
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 16 year old female patient. The patient pertinent medical history included diabetes. On an unknown date, the patient was vaccinated with GARDASIL. On an unknown date, the patient sugar was uncontrollable (blood glucose abnormal). The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a pediatric patient of unknown age and gender and reporting as pediatric. Patient's pertinent medical history, drug, allergies and concomitant therapies were not reported. On 05-MAY-2015, the patient was vaccinated with the first dose of VAQTA (lot number and expiration date were not reported) intramuscularly. Later, the patient was administered with a second dose of VAQTA (lot number and expiration date were not reported) also intramuscularly. It was reported that the patient received two doses without six months between dose. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a reporter (role unspecified) via a company representative refers to a 5 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, at the age of 5, the patient was vaccinated subcutaneously with an adult dose of the chicken pox vaccine (manufacturer unknown) injection (dose, lot # and expiration date were not reported). The patient did not experience an adverse event. The relatedness between the event and the chicken pox vaccine (manufacturer unknown) was not reported. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients. No information on patients' pertinent medical history, concomitant medications, drug reactions or allergies was reported. On unknown dates in 2016 (after 02-MAY-2016), the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # L035129, expiration date: 14-SEP-2017, and lot # L046887, expiration date: 23-NOV-2017, subcutaneously. On 02-MAY-2016, administered doses of VARIVAX underwent temperature excursions prior to being administered. Maximum temperature was reported as 7.5 degrees Fahrenheit for 30 minutes, 14.2 degrees Fahrenheit for 20 hours and 7.3 degrees Fahrenheit for 30 minutes. About 15 patients received at least one of improperly stored vaccines: VARIVAX and PROQUAD (captured in MARRS# 1608USA000485). There was no known adverse effects. This is one of two reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients. No information on patients' pertinent medical history, concomitant medications, drug reactions or allergies was reported. On unknown dates in 2016 (after 02-MAY-2016), the patients were vaccinated with improperly stored doses of PROQUAD, lot # reported as L050900, expiration date: 14-JUN-2017, route of administration not reported. Lot # L050900 is an invalid lot number for for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. On 02-MAY-2016, administered doses of PROQUAD underwent temperature excursions prior to being administered. Maximum temperature was reported as 7.5 degrees Fahrenheit for 30 minutes, 14.2 degrees Fahrenheit for 20 hours and 7.3 degrees Fahrenheit for 30 minutes. About 15 patients received at least one of improperly stored vaccines: PROQUAD and VARIVAX (captured in MARRS# 1607USA007633). There were no known adverse effects. This is a one of two reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients' were vaccinated with improperly stored GARDASIL 9 (dose, strength, route, frequency, lot # and indication unknown). The vaccine was exposed to a high of 9.5 degree Celsius temperature for a time frame of 24 hours. No adverse events were reported. Data logger was involved. It was reported that there was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients' were vaccinated with improperly stored M-M-R II (dose, strength, route, frequency, therapy type, lot # and indication unknown) (incorrect product storage). The vaccine was exposed to a high of 9.5 degree Celsius temperature for a time frame of 24 hours. No adverse events were reported. Data logger was involved. It was reported that there was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B antibody negative, Urticaria
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 22 year old female patient. The patient did not have any pertinent medical history, concomitant medications and drug reactions or allergies. On unspecified dates since 30-NOV-1993, the patient was vaccinated with two three dose series of RECOMBIVAX HB (intramuscular, exact dose, lot #, expiration date and anatomical location were not reported). On 21-DEC-2015, the patient had a "susceptible titers" drawn and because of that, she had the series of RECOMBIVAX HB repeated. During the patient's second series, on 13-JUL-2016, she received 0.5 ml of RECOMBIVAX HB in the right deltoid (unspecified which dose in the series, lot # M003658, expiration date 02-JUN-2018). The nurse reported that afterwards, on 22-JUL-2016, the patient sought medical attention at an unspecified physician's office for hives on her back and arm with no throat tightness or fever reported. The nurse reported that the patient was taking BENADRYL for treatment of the hives. The outcome of hives on back and arms and "susceptible titers" was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L033693, expiration date: 31-MAY-2017, lot # reported as M019707, expiration date: 25-OCT-2017 orally (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.4 degrees Celsius for 1  hour 17 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses  of LIQUID PEDVAXHIB (lot # L051122, expiration date: 12-OCT-2018, lot # M001814, expiration date: 15-OCT-2018, lot # M006710, expiration date 06-DEC-2018 intramuscularly (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.4 degrees Celsius for 1 hour 17 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to 54 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided. On 04-APR-2016, the patient was vaccinated with improperly stored doses of VARIVAX lot # K011674, expiration date 01-JUN-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. In approximately 2016 (reported as "unknown dates starting on or after 14-MAY-2016"), the patients were vaccinated with GARDASIL 9 injection (lot # L043213, expiration date 28-AUG-2017 (lot # L026602, expiration date 19-OCT-2017) (dose, route and anatomical location of administration were not reported), which were improperly stored at 53.2 F for 73 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effect was reported and no product quality complaint was involved. This is one of two cases received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immune system disorder, Postural orthostatic tachycardia syndrome, Small fibre neuropathy
Clinical narrative: Information was received on 29-JUL-2016 in the form of an initial legal complaint regarding an approximately 17 year old female consumer who was administered a series of three GARDASIL injections from 04-MAR-2010 through 20-JAN-2011. As a result of the three GARDASIL injections the patient experienced serious adverse immunological and other disease reactions beginning approximately in March 2011 and continuing thereafter until this date. Due to the complexity and heterogeneous nature of her disease process the patient's actual disease process remained medically undiagnosed until approximately August 2015, when diagnosed as a postural orthostatic tachycardia syndrome (POTS) with a further diagnosis in February 2016 of an underlying small fiber neuropathy existing within and throughout her body. Prior to February 201, without an adequate medical diagnosis of the patient's underlying disease process, it was not reasonably known, ascertainable or ascertained that there was a causal connection between GARDASIL and the disease process. However based upon the foregoing diagnoses plaintiff believes that the GARDASIL vaccinations were the proximate cause of her underlying disease process. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received rom a pharmacy technician regarding a patient unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 01-AUG-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose and route of administration were not reported, lot # L044529, expiration date 09-FEB-2017). There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 2 hours. There was no data logger involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician referring to himself a male patient of unknown age. Patient's pertinent medical history, drug reactions and allergies were not reported. On unspecified date in 2015("last year") the patient was vaccinated with ZOSTAVAX 19400 PFU (site of administration, lot #, expiry date and dose were not reported. There was no concomitant medication reported. Subsequently in approximately 2016, reported as "recently" the patient developed a "mild case" of shingles which was an unspecified "light" rash that was located on his left shoulder. It was also reported that "within a couple of days" the light rash "was going away" (recovering). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report concerning an unspecified number of patients of an unknown gender and age was received from a medical assistant. The patient's concurrent conditions and medical history were not provided. On multiple unspecified dates, an unspecified number of patients were vaccinated with an improperly stored dose of VARIVAX lot # M003441, expiration date 19-JAN-2018. The reporter stated that the vaccine was exposed to a temperature of 10F for 25 minutes and it was detected by a digital data logger. In addition, it was stated that there was no previous temperature exposure. There was no concomitant medications and symptoms reported (no adverse event). No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning two patients of unknown age and gender. Medical history, concomitant therapies and concurrent conditions were not reported. On unknown dates improperly stored doses of VARIVAX lot # M004326, Exp. date 25-JAN-2018 had been administered. Dose, route, anatomical location and dose number were not reported. It was reported that, on an unknown date, the refrigerator was out of range for 9 hours, with a highest temperature of 19 degrees F. The healthcare worker reported that vaccines had been administered before the excursion was identified. No prior temperature excursions were reported. No adverse events were reported. No product quality complaint was involved. At the time of reporting the outcome of the event was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Electrocardiogram, Full blood count, Head injury, Loss of consciousness, Metabolic function test
Clinical narrative: A few seconds after receiving the injections, pt complained she couldn't see and passed out. She hit her head on a chair. We picked her up and laid her on exam table. Gave her an ice pack. Checked her BP and pulse. Patient went for labs and EKG.
Age: 13.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Visual impairment
Clinical narrative: A few seconds after receiving the injections, pt complained she couldn't see and passed out. She hit her head on a chair. We picked her up and laid her on exam table. Gave her an ice pack. Checked her BP and pulse. Patient went for labs and EKG.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RVX
Symptoms: Crying, Diet refusal, Lethargy, Screaming, Staring
Clinical narrative: The patient is a 4mo old female with a history of adverse reaction after receipt of 2mo vaccines (on or about 20 May 2016). The MOP states she received vaccine at 11:30 a.m. and at about 15:30 pm she developed severe crying, would not nurse, was inconsolable and screaming. She states about 10 minutes later she became lethargic, staring and not responding to stimulation or Interaction, although was conscious. She states she had two episodes of projectile vomiting. Baby was taken to the ER, treated, observed the released home hours later.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RVX
Symptoms: Unresponsive to stimuli, Vomiting projectile
Clinical narrative: The patient is a 4mo old female with a history of adverse reaction after receipt of 2mo vaccines (on or about 20 May 2016). The MOP states she received vaccine at 11:30 a.m. and at about 15:30 pm she developed severe crying, would not nurse, was inconsolable and screaming. She states about 10 minutes later she became lethargic, staring and not responding to stimulation or Interaction, although was conscious. She states she had two episodes of projectile vomiting. Baby was taken to the ER, treated, observed the released home hours later.
Age: 18.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Blood pressure decreased, Hyperhidrosis, Pallor, Visual impairment
Clinical narrative: Had 1st dose of GARDASIL 9 and within 3-5 min became pale, sweaty, could not see and B/P dropped.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blindness, Blood pressure decreased, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Had dose #3 and about 15 min after receiving GARDASIL 9 and MENACTRA - stated she couldn't see; became pale, sweaty - pressure dropped but did not completely Faint.
Age: 11.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Headache, Syncope
Clinical narrative: Fainted and headache after receiving MENVEO.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Fainted and vomiting after receiving MENVO.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: Fever-Day 10 after vaccine-lasting 5 days. Rash-Day 13 after vaccine-lasing 4 days. Joint pain-Day 14 after vaccine-lasting 2 days. Treatment: Acetaminophen for fever/Ibuprofen-Joint pain.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Erythema, edema, pain.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: 12-24 post had red spots at site of injection and low grade fever.
Age: 29.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: New front office employee at this PEDS practice with only TDAP and MMR #1 IMM. Proof. Declined titers. AM after rec'ing vaccines, RA site 3x51/2 cm of redness; LA (SQ) site with 61/2x7cm area redness; Positive warm to touch. Afebrile. Office NP rec'd Ibuprofen/BENADRYL PRN. No induration resolved by 08/01/16.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: (L) arm redness, warmth and swollen.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Nausea
Clinical narrative: 2 weeks post shot - Patient states redness from shot has resolved but she is still nauseous that she says, is related to the shot. Patient has fibromyalgia and chronic fatigue syndrome. Nausea already present before getting shot. Patient started on day of shot.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: 2 weeks post shot - Patient states redness from shot has resolved but she is still nauseous that she says, is related to the shot. Patient has fibromyalgia and chronic fatigue syndrome. Nausea already present before getting shot. Patient started on day of shot.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: 2 weeks post shot - Patient states redness from shot has resolved but she is still nauseous that she says, is related to the shot. Patient has fibromyalgia and chronic fatigue syndrome. Nausea already present before getting shot. Patient started on day of shot.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: 2 weeks post shot - Patient states redness from shot has resolved but she is still nauseous that she says, is related to the shot. Patient has fibromyalgia and chronic fatigue syndrome. Nausea already present before getting shot. Patient started on day of shot.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: Vaccine given 7/15 2pm. On 7/16 at 5pm uncomfortable (neck stiffness upper back discomfort) took 3 ADVIL/heating pad. Better on 7/18/16.
Age: 60.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Asthenia, Hypoaesthesia, Mobility decreased, X-ray
Clinical narrative: Pain and decreased ROM (L) shoulder ongoing eval by ortho.
Age: 60.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray
Clinical narrative: Pain and decreased ROM (L) shoulder ongoing eval by ortho.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Rash generalised, Streptococcus test, Swollen tongue
Clinical narrative: Information was received from a registered nurse referring to a 17 years old female patient. The patient had neither medical history, concomitant therapy nor known drug allergies. In the afternoon of 25-JUL-2016, the patient received a dose (dose number unspecified) of GARDASIL 9 injection intramuscularly (lot# M009362, expire date was 13-JUN-2018). On 26-JUL-2016 the patient woke up with tongue swelling and a systemic rash. She visited the physician on the same day, and was advised to take an unspecified dose of oral BENADRYL. On 28-JUL-2016, the patient was evaluated at an unspecified Urgent Care facility (demographics unknown) and had a tested for Strep (result unknown). She was administered an unspecified amount of an unspecified intravenous solution and an unspecified amount of SOLU-MEDROL. The unspecified Urgent Care facility prescribed SOLU-MEDROL (45mg, once daily, oral), prednisone (manufacturer unknown) for 3 days and an unspecified amount of oral BENADRYL as needed for an unspecified symptom. On 29-JUL-2016, tongue swelling improved in an unspecified improvement and the unspecified rash improved for an unspecified amount of time after each dose of prednisone (manufacturer unknown) taking. The reporter considered that the events were life threatening or significant disability or incapacity due to the patient's tongue affected. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Balance disorder, Dizziness, Fall, Feeling abnormal, Noninfective encephalitis
Clinical narrative: This spontaneous report was received from a 56 year old female patient who was reporting on herself. The patient's pertinent medical history included unspecified "immune disorder" and postural orthostatic tachycardia syndrome. She did not have any drug reactions or allergies. On 06-JUL-2016, the patient was vaccinated with the first dose of PNEUMOVAX 23 intramuscularly (dose, lot # and expiration date were not reported). The patient was also taking unspecified concomitant medications. On unknown dates in 2016 reported as "while on PNEUMOVAX 23", the patient became sleepy, spacey, lightheaded, dizzy and did not want to talk to people (and normally liked to talk to people). The patient also felt like she had a brain inflammation. On an unknown date in July 2016 (reported as "sometime after receiving PNEUMOVAX 23"), she had balance issues and fell on 29-JUL-2016. The patient sought medical attention, she talked with her physician. No treatment was given to the patient for the events and no lab diagnostics procedures were performed. The outcome of all events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not provided. Upon internal review the event of the patient feeling like she had brain inflammation was considered to be medically significant. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Social avoidant behaviour, Somnolence
Clinical narrative: This spontaneous report was received from a 56 year old female patient who was reporting on herself. The patient's pertinent medical history included unspecified "immune disorder" and postural orthostatic tachycardia syndrome. She did not have any drug reactions or allergies. On 06-JUL-2016, the patient was vaccinated with the first dose of PNEUMOVAX 23 intramuscularly (dose, lot # and expiration date were not reported). The patient was also taking unspecified concomitant medications. On unknown dates in 2016 reported as "while on PNEUMOVAX 23", the patient became sleepy, spacey, lightheaded, dizzy and did not want to talk to people (and normally liked to talk to people). The patient also felt like she had a brain inflammation. On an unknown date in July 2016 (reported as "sometime after receiving PNEUMOVAX 23"), she had balance issues and fell on 29-JUL-2016. The patient sought medical attention, she talked with her physician. No treatment was given to the patient for the events and no lab diagnostics procedures were performed. The outcome of all events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not provided. Upon internal review the event of the patient feeling like she had brain inflammation was considered to be medically significant. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative and refers to a 20 year old female patient. The patient's concurrent conditions included anxiety. The patient's concomitant medications included an unspecified anxiety medication. She did not have any drug reactions or allergies. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose, anatomical location, lot # and expiration date were not reported, intramuscularly) and at that time, the patient had no adverse event to report. On 02-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # M003659, expiration date 20-SEP-2017) and she fainted after the dose was administered. The patient received a treatment for the adverse event. There was no laboratory tests performed. The outcome of fainting was reported as recovered on the same day. The relatedness between the event of GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored ROTATEQ (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored M-M-R II (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions, but no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Initial unsolicited report received from a consumer on 12 October 2015. This case involves a 65-years-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, dose, dose in series, expiry date were not reported) intramuscularly in left deltoid on 23 September 2015. The patient's illness at time of vaccination reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known allergies, fibromyalgia, peripheral neuropathy feet. Previous medication included TRAMADOL HYDROCHLORIDE (Tramadol) and HYDROCODONE BITARTRATE/PARACETAMOL (Vicodin) for pain management. Concomitant medications were not reported. Laboratory data and corrective treatment was not reported. On 23 September 2015, the patient's injection site became red, warm and swollen two days after the vaccination. The patient's symptoms abated two days after vaccination and began having tingling of left hand, shooting pains from elbow to fingers in left arm, aching, increased with movements. The patient required ER/doctor visit. Laboratory data and corrective treatment was not reported. The outcome was reported as not recovered. Patient's pain persisted since 48 hours after vaccination. List of documents held by sender: none.