chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Fall, Grip strength decreased, Guillain-Barre syndrome, Haemoglobin decreased, Hypoaesthesia
Clinical narrative: Case number PHHY2016US092226 is an initial literature report received on 09 Jun 2016. The author discussed about a Guillain Barre Syndrome (GBS) case following influenza vaccination in an elderly patient with antecedent Salmonella infection. This report refers to a 77 year old female patient. Her medical history was not reported. Her current conditions included Salmonella infection, chronic kidney disease stage III and hypothyroidism. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) four weeks ago. She was presented with falls from general weakness in the setting of a diarrheal illness. She endorsed non-bloody watery diarrhea twice a day for the past 9 days without vomiting, pain or fever. She developed lower extremities (LE) weakness and numbness 1 day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5, straight leg raise both 2-3/5, hand grip both 2-3/5, triceps both 2/5 and biceps both 3/5) and areflexia. Laboratory results showed leukocytes 6.4000/muL , hemoglobin 10.3 g/dL, platelets: 475,000/muL, creatinine: 1.23 mg/dL and normal thyroid stimulating hormone (TSH), B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre Syndrome (GBS) and the cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1/muL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric intravenous immunoglobulin (IVIG) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome of GBS, areflexia, general weakness, fall, numbness and hemoglobin decreased was not reported. The seriousness of hemoglobin decreased was not reported. The causality of events to influenza vaccine was not reported. The author concluded the article stating that the trigger for this patient's GBS was likely her antecedent Salmonella infection.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Immunoglobulin therapy, Intervertebral disc degeneration, Lumbar puncture abnormal, Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Case number PHHY2016US092226 is an initial literature report received on 09 Jun 2016. The author discussed about a Guillain Barre Syndrome (GBS) case following influenza vaccination in an elderly patient with antecedent Salmonella infection. This report refers to a 77 year old female patient. Her medical history was not reported. Her current conditions included Salmonella infection, chronic kidney disease stage III and hypothyroidism. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) four weeks ago. She was presented with falls from general weakness in the setting of a diarrheal illness. She endorsed non-bloody watery diarrhea twice a day for the past 9 days without vomiting, pain or fever. She developed lower extremities (LE) weakness and numbness 1 day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5, straight leg raise both 2-3/5, hand grip both 2-3/5, triceps both 2/5 and biceps both 3/5) and areflexia. Laboratory results showed leukocytes 6.4000/muL , hemoglobin 10.3 g/dL, platelets: 475,000/muL, creatinine: 1.23 mg/dL and normal thyroid stimulating hormone (TSH), B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre Syndrome (GBS) and the cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1/muL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric intravenous immunoglobulin (IVIG) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome of GBS, areflexia, general weakness, fall, numbness and hemoglobin decreased was not reported. The seriousness of hemoglobin decreased was not reported. The causality of events to influenza vaccine was not reported. The author concluded the article stating that the trigger for this patient's GBS was likely her antecedent Salmonella infection.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Platelet count increased, Salmonella test positive, Sensory loss, Vitamin B12 normal, White blood cell count normal
Clinical narrative: Case number PHHY2016US092226 is an initial literature report received on 09 Jun 2016. The author discussed about a Guillain Barre Syndrome (GBS) case following influenza vaccination in an elderly patient with antecedent Salmonella infection. This report refers to a 77 year old female patient. Her medical history was not reported. Her current conditions included Salmonella infection, chronic kidney disease stage III and hypothyroidism. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) four weeks ago. She was presented with falls from general weakness in the setting of a diarrheal illness. She endorsed non-bloody watery diarrhea twice a day for the past 9 days without vomiting, pain or fever. She developed lower extremities (LE) weakness and numbness 1 day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5, straight leg raise both 2-3/5, hand grip both 2-3/5, triceps both 2/5 and biceps both 3/5) and areflexia. Laboratory results showed leukocytes 6.4000/muL , hemoglobin 10.3 g/dL, platelets: 475,000/muL, creatinine: 1.23 mg/dL and normal thyroid stimulating hormone (TSH), B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre Syndrome (GBS) and the cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1/muL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric intravenous immunoglobulin (IVIG) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome of GBS, areflexia, general weakness, fall, numbness and hemoglobin decreased was not reported. The seriousness of hemoglobin decreased was not reported. The causality of events to influenza vaccine was not reported. The author concluded the article stating that the trigger for this patient's GBS was likely her antecedent Salmonella infection.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown ages and genders. The patients' medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (which had the lot # L032182, expiration date 25-AUG-2017)(dose, route, strength and anatomical site of vaccination were not reported). Information regarding concomitant medication was not reported. Additionally, no adverse effects were reported. There was not a product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown ages and genders. The patients' medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (which had the lot # of K010215, expiration date 05-MAY-2017 and K016966, expiration date 10-MAY-2017) (dose, route, strength and anatomical site of vaccination were not informed). Information regarding concomitant medication was not reported. Additionally, no adverse effects were reported. There was not a product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as administrator) refers to a patient of unknown age and gender. On 03-JUN-2016, unspecified doses of improperly stored VARIVAX (lot# 1041204, expiry date: 20-OCT-2017 or 1048466, expiry date: 02-DEC-2017 or M000761, expiry date: 16-JAN-2018) was administered to the patient. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient with migraines and reaction/allergy to unspecified Nonsteroidal anti-inflammatory (NSAIDS) drugs. The patient's medical history was not reported. On 17-DEC-2010, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Units (PFU), 1 shot, subcutaneous (lot number and expiration date were unknown). Concomitant therapies included unspecified medications. On approximately 17-JUN-2016, reported as "about a week ago" the patient developed an unspecified rash on his chest. Then, the patient was seen by his unspecified physician on an unspecified date and he prescribed VALTREX for the adverse event. The outcome of rash was unknown. The causality between ZOSTAVAX and the rash was not provided. Additional information had been requested.
Age: 4.0
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: 4 year old child received one dose of Rotavirus vaccine in error. No immediate adverse event.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Left arm is sore, redness, and skin is warm to the touch.
Age: 16.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Dizziness, Eye movement disorder, Fall, Head injury, Injection site erythema
Clinical narrative: Patient began reporting right upper arm achiness, redness and swelling last night the she had a difficult time sleeping 7/6/2016 because of the pain.  Around approximately 100PM Central time on 7/7/2016 patient was in front of her mother and friend and suddenly reported feeling nauseated after eating some blueberries and then became dizzy and fell backwards hitting her head and appeared to of been convulsing at home with her eyes rolled back in her head.  Patient's mother and friend were present during this syncopal episode.  Patient's mother immediately went to her father, who is a paramedic, who then laid her flat and was unsure if she was breathing as she was lying on her side.  After a couple minutes the patient was able to sit up and was alert and oriented.  At the time of speaking with the mother over the phone around 130 pm she reported patient was sitting in the recliner with ice on her right upper arm, eating something but still reported her legs feeling shaky.  At the time of this interview patient had not been seen or taken into a healthcare provider for further assessment and treatment after falling and hitting her head.   Vaccinations were received on 7/6/2016 in the afternoon, patient was observed for 15 minutes prior to leaving with no side or adverse effects after receiving vaccinations.
Age: 16.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Injection site pain, Injection site swelling, Muscular weakness, Nausea, Seizure
Clinical narrative: Patient began reporting right upper arm achiness, redness and swelling last night the she had a difficult time sleeping 7/6/2016 because of the pain.  Around approximately 100PM Central time on 7/7/2016 patient was in front of her mother and friend and suddenly reported feeling nauseated after eating some blueberries and then became dizzy and fell backwards hitting her head and appeared to of been convulsing at home with her eyes rolled back in her head.  Patient's mother and friend were present during this syncopal episode.  Patient's mother immediately went to her father, who is a paramedic, who then laid her flat and was unsure if she was breathing as she was lying on her side.  After a couple minutes the patient was able to sit up and was alert and oriented.  At the time of speaking with the mother over the phone around 130 pm she reported patient was sitting in the recliner with ice on her right upper arm, eating something but still reported her legs feeling shaky.  At the time of this interview patient had not been seen or taken into a healthcare provider for further assessment and treatment after falling and hitting her head.   Vaccinations were received on 7/6/2016 in the afternoon, patient was observed for 15 minutes prior to leaving with no side or adverse effects after receiving vaccinations.
Age: 16.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Sleep disorder, Syncope
Clinical narrative: Patient began reporting right upper arm achiness, redness and swelling last night the she had a difficult time sleeping 7/6/2016 because of the pain.  Around approximately 100PM Central time on 7/7/2016 patient was in front of her mother and friend and suddenly reported feeling nauseated after eating some blueberries and then became dizzy and fell backwards hitting her head and appeared to of been convulsing at home with her eyes rolled back in her head.  Patient's mother and friend were present during this syncopal episode.  Patient's mother immediately went to her father, who is a paramedic, who then laid her flat and was unsure if she was breathing as she was lying on her side.  After a couple minutes the patient was able to sit up and was alert and oriented.  At the time of speaking with the mother over the phone around 130 pm she reported patient was sitting in the recliner with ice on her right upper arm, eating something but still reported her legs feeling shaky.  At the time of this interview patient had not been seen or taken into a healthcare provider for further assessment and treatment after falling and hitting her head.   Vaccinations were received on 7/6/2016 in the afternoon, patient was observed for 15 minutes prior to leaving with no side or adverse effects after receiving vaccinations.
Age: 1.3
Sex: M
Vaccine: HEPA, PPV, VARCEL
Symptoms: Culture stool, Dermatitis diaper, Haemorrhage, Nausea, Pyrexia
Clinical narrative: Started with a rash on his chest, fine without lesion. Maculopapular lesions erupted on 6/19/2016. Diaper dermatitis started 6/23/2016 which became severe with areas of bleeding. Seen in clinic 6/24/2016. Nausea, vomiting and 103 degree fever started overnight of 6/25-6/26. Took to emergency room, stool culture ordered results pending.
Age: 1.3
Sex: M
Vaccine: HEPA, PPV, VARCEL
Symptoms: Rash, Rash maculo-papular, Vomiting
Clinical narrative: Started with a rash on his chest, fine without lesion. Maculopapular lesions erupted on 6/19/2016. Diaper dermatitis started 6/23/2016 which became severe with areas of bleeding. Seen in clinic 6/24/2016. Nausea, vomiting and 103 degree fever started overnight of 6/25-6/26. Took to emergency room, stool culture ordered results pending.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced redness, swelling, hot to touch area, over entire right bicep.  States "I did not feel like myself."
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from physician via other company (Pfizer) (manufacturer report number - 2016305378) on 23 June 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of Tetanus Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient developed allergic to tetanus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Erythema, Hypersensitivity, Swelling
Clinical narrative: Redness and swelling, mild discomfort.  Allergic reaction.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported mild stinging and itching at the injection area. The reaction appeared like ant bites that were red and raised in a 2" by 3" inch area at the injection site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Skin rash and itching.
Age: 0.49
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Condition aggravated, Feeding disorder
Clinical narrative: Increased difficulty with feedings. Had initially subsided before visit, and then parents report significant increase in difficulty with feedings again.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The injection site was red, itchy and swollen
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Large rash started at roughly 1-2 inches in diameter and has since spread to 5-6 inches in diameter, pt does not report any other symptoms, symptoms still ongoing.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Chills, Cough, Dizziness, Fatigue
Clinical narrative: At time of vaccine, took Motrin (Tues). The next morning (Wed), woke up unexpectedly at 5:47am and felt drained. Had chills, mild dizziness, mild cough. Started day with a low grade fever (99.5) and by the afternoon fever was 101. Gave Motrin. Touching point of injection caused severe pain. Thursday woke up with temperature of 99.5. Took Motrin at noon. Slept from 5:00pm - 8:30pm and woke up feeling fine. Was not able to perform normal functions Wed and Thurs - exhausted and needed to sleep a lot.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Hypersomnia, Injection site pain, Pyrexia
Clinical narrative: At time of vaccine, took Motrin (Tues). The next morning (Wed), woke up unexpectedly at 5:47am and felt drained. Had chills, mild dizziness, mild cough. Started day with a low grade fever (99.5) and by the afternoon fever was 101. Gave Motrin. Touching point of injection caused severe pain. Thursday woke up with temperature of 99.5. Took Motrin at noon. Slept from 5:00pm - 8:30pm and woke up feeling fine. Was not able to perform normal functions Wed and Thurs - exhausted and needed to sleep a lot.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: Light fever, headache, lethargy, nausea, dizziness.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to an unknown number of patients of unknown ages and genders. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048236 expiration date 31-MAR-2018. Dose, route and frequency were not reported. No other suspect or concomitant therapy was reported. The doses were stored at 31.8 F for 1500 hours. The reporter stated that their office was not aware of any adverse effects from these administrations. This is one of two reports received from the same reporter (1606USA011808). 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 (also reported as administrator) refers to a patient of unknown age and gender. On 02-JUN-2016, unspecified dose of improperly stored PROQUAD (lot # L050907, expiry date: 14-JUN-2017/M004895, expiry date: 26-JUN-2017) was administered to the patient. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. 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 (also reported as administrator) refers to a patient of unknown age and gender. On 02-JUN-2016, unspecified dose of improperly stored PROQUAD (lot# L050907, expiry date: 14-JUN-2017/M004895, expiry date: 26-JUN-2017) was administered to the patient. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring 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. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally, lot # L033543, expiration date 30-MAY-2017, (dose was not provided). There were no adverse effects reported. No product quality complaint (PQC) was involved. 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 (also reported as administrator) refers to a patient of unknown age and gender. On 06-JUN-2016, unspecified dose of improperly stored PROQUAD (lot # L050907, expiry date: 14-JUN-2017/M004895, expiry date: 26-JUN-2017) was administrated to the patient. No adverse events were reported. The outcome was unknown. 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as administrator) refers to a patient of unknown age and gender. On 07-JUN-2016, unspecified dose of improperly stored PROQUAD (lot #L050907, expiry date: 14-JUN-2017/M004895, expiry date: 26-JUN-2017) was administered to the patient. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 17 week and 3 days old patient of unknown gender. Information about the patient's medical history and concurrent conditions was not provided. On 09-JUN-2016, the patient was vaccinated with the first dose of ROTATEQ, orally (dose, lot number and expiration date were not provided) at 17 week and 3 days of age, which is considered outside the recommended age range. No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure to communicable disease, Measles antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age (currently an adult). Nurse stated that the patient who had unknown vaccination history, may have received M-M-R II in childhood, was exposed to measles. Upon learning of exposure on 30-MAY-2016, the patient was tested serologically at an unknown hospital lab (no hospital stay) where patient was found to be seronegative to measles. The patient was then vaccinated with M-M-R II on 06-JUN-2016 (lot number L039612, expiry date: 07-OCT-2017). Nurse stated that the patient was doing fine but the outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 21-JUN-2016 the patient was inadvertently given a dose of M-M-R II (dose, route, lot # and expired date unknown) that was reconstituted with and unspecified amount of sodium chloride rather than the sterile diluent that was supplied with M-M-R II. Concomitant therapy was not provided. No adverse effects reported. Additional information had been requested.
Sex: U
Vaccine: MMRV
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 registered nurse. The patients' concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of PROQUAD lot # L045675 expiration date 09-MAY-2017, lot # M004893 expiration date 26-JUL-2017 or lot L050908 expiration date 14-JUN-2017 (strength, dose and frequency were not provided) subcutaneously. There were no concomitant medications and adverse events reported. 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 initial spontaneous report was from a registered nurse, concerning a patient of unknown age and gender. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. The reporter stated that on 06-JUL-2016; the patient was administered one dose of VARIVAX injection (dose, route and anatomical location were not reported); which was improperly stored. The dose was from one of the following lot numbers: L045956 with expiration date 17-NOV-2017, M00757 with expiration date 06-JAN-2018, L046885 with expiration date 23-NOV-2017 or L034369 with expiration date 08-SEP-2017. The excursion was due to a data logger: and the outcome of the excursion was reported as "supported until labeled expiry". There was not any previous excursion. It was also reported that no doses were administered. No adverse effects were reported and product quality complaint (PQC) was not involved. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as administrator) refers to a patient of unknown age and gender. On 04-JUN-2016, unspecified dose of improperly stored VARIVAX (lot # 1041204, expiry date: 20-OCT-2017 or 1048466, expiry date: 02-DEC-2017 or M000761, expiry date 16-JAN-2018) was administered to the patient (incorrect product storage). No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.63
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13, RVX
Symptoms: Injection site rash
Clinical narrative: Pt. mom reported that patient developed a rash around injection sites on both legs every time he received the immunization.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Oral mucosal blistering
Clinical narrative: Patient describes pain in eye and blisters in mouth. They went to eye doctor, per pt. Dr says pain could be due to shingles or an infection. They aren't sure. Pt prescribed VALTREX and erythromycin.
Age: 1.39
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Skin discolouration
Clinical narrative: Mother describe purple-red on legs, back, and tummy.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Somnolence
Clinical narrative: Severe drowsiness within 20 minutes of vaccine. Continued throughout the event with onset of fever. Mother took child to ER.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Tinnitus
Clinical narrative: Patient said she could not see and her ears were ringing about 5 minutes after the shot. It lasted about 10 seconds. We took the patients vitals and had her lay down for 15 min.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Body temperature increased, Seizure
Clinical narrative: PENTACEL administered at 9am. Seizure activity started around 1030pm, less than 5 min. Temp after seizure of 101.4.  Hhistory of febrile seizures.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted X 5 minutes after receiving vaccine, immediately assessed by FNP, V/S stable, O2 applied, Patient monitored in lying position X 15 mins, sitting X 15 mins. Left in stable condition.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dyspnoea, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Shoulder pain, stiffness neck, difficulty breathing, chest pain. Client states resolved after (O2 therapy).
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Neck pain
Clinical narrative: 2  hours after injection, patient developed erythema, pain and swelling at injection site. Then soreness in proximal cervical spine and generalized myalgia and fever. Was prescribed cephalexin 500mg 3x daily x 5 days and Prednisone 20mg x 5 days.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: 2  hours after injection, patient developed erythema, pain and swelling at injection site. Then soreness in proximal cervical spine and generalized myalgia and fever. Was prescribed cephalexin 500mg 3x daily x 5 days and Prednisone 20mg x 5 days.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bacteraemia, Biopsy skin abnormal, Blister, Blood culture positive, Bronchoscopy abnormal
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Central obesity, Chest X-ray abnormal, Cushingoid, Death, Dyspnoea
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Erythema, General physical health deterioration, Herpes virus infection, Immunosuppression
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Lipodystrophy acquired, Lung infiltration, Mechanical ventilation, Rash, Respiratory distress
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Scab, Skin lesion, Sputum culture positive, Sputum purulent, Staphylococcal infection
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Staphylococcus test positive, Varicella virus test positive, Viral test positive
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Endotracheal intubation, Erythema, General physical health deterioration, Haemodialysis, Haemorrhage
Clinical narrative: Information has been received from the author of a published article, concerning a 62 year old male patient. In 2014, he had been admitted to another hospital with pulmonary hemorrhage and was treated with rituximab, methylprednisolone, and azathioprine. The patient had schizophrenia and nonischemic cardiomyopathy with an ejection fraction of 30%. He also was undergoing hemodialysis thrice weekly. On an unknown date in 2015, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously at an outpatient clinic 47 days before admission (medication error). Concomitant medication included prednisone (manufacturer unknown) and mycophenolate mofetil. In February 2015, the patient was admitted to hospital with a rash that began on his face 2 days before admission and had spread to his trunk, upper arms and legs. In the emergency department, the patient was short of breath and was noted to have cushingoid features (moon faces, lipodystrophy and central obesity). There were hemorrhagic monotonous vesicles on an erythematous base covering the trunk, the proximal and distal upper extremities, and the proximal lower extremities. A punch skin biopsy revealed immunohistochemical evidence of human herpesvirus 3. The tissue block was later sent to laboratory, where the virus was confirmed to be the vaccine strain. The patient experienced respiratory distress and required emergent tracheal intubation and mechanical ventilation. Chest radiography revealed bilateral lung infiltrates, and both sputum and blood cultures grew methicillin-resistant Staphylococcus aureus. Bronchoscopy revealed purulent secretions but no evidence of pulmonary hemorrhage. Treatment included acyclovir, Vancomycin, and cefepime. Although the bacteremia cleared and there was a crusting of some of the skin lesions, the patient's condition gradually worsened, and eventually the family requested that treatment be discontinued; the patient died after 2 weeks of hospitalization. It was not reported if an autopsy was performed. The reporter considered the event to be disseminated disease in immunosuppressed patients receiving Live Zoster Vaccine. Upon internal review, the event was considered to be medically significant. Additional information has been requested.