chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to approximately 18 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. The patient was vaccinated with first dose of GARDASIL (route, dose not reported) for vaccination on an unknown date in May 2012 and second dose of GARDASIL on an unknown date in January 2013. The reporter stated that male client was vaccinated at another facility with third dose of GARDASIL on 17-JUN-2014 (reported as today) and is late for his GARDASIL vaccination. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date roughly 20 unspecified were vaccinated with (Oka/Merck) VARIVAX injection (strength, dose, frequency, route of administration and indication were not provided that reached 18/5F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert, however, in house stability data can support those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. NO adverse effects reported. NO product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available.   Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning (Oka/Merck) VARIVAX temperature excursion and the patient (patient ID# 168840) of unspecified age  and gender who were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J008652: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5F for 10 hours and 44 minutes. This is one of several reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old female patient with immune deficiency disorder, arthritis, ADHD, scoliosis and ovarian cyst. The reporter stated that the patient was vaccinated with RECOMBIVAX HB (intramuscular, dose was unknown) on 01-DEC-1994, 18-JAN-1995 and 22-MAY-1995. Concomitant therapies included ADDERALL (dose and frequency unknown). The reporter stated that the patient had titers drawn prior to starting school on an unspecified date. The reporter stated that the patients titers were low. The patient did not seek any medical attention. The outcome of the event was unknown. No additional information was reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 36 year old female patient with no drug allergies. The patient's medical history was reported none. On 25-JUN-2014 (reported as today) the patient was vaccinated with GARDASIL (Dose/Frequency: 0.5 milliliter (ml)) intramuscular in the left arm. The concomitant medications were not reported. Approximately on 25-JUN-2014 (reported as today) the patient was 32 weeks pregnant. The patient was 32 weeks pregnant. The patient became pregnant with LMP on 13-NOV-2013 (approximately) and EDD of 20-AUG-2014 (approximated). Initial exposure to GARDASIL was at 32 week(s). The pregnancy outcome was unknown. On 25-JUN-2014, the patient was inadvertently vaccinated with GARDASIL instead of DTaP. This was reported as staff error only. The reporter stated that the patient was previously vaccinated with GARDASIL series on unspecified dates. No adverse effects reported. The outcome of 32 weeks pregnant client was inadvertently vaccinated with GARDASIL was unknown. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified patients of unknown age and unknown gender. The patients medical history was not reported. On an unknown date the patient was vaccinated with ROTATEQ. Concomitant medications were not reported. The unspecified patients administered the first dose of ROTATEQ after the patients were 134 weeks and 6 days old. No adverse effects were reported. The outcome of been administered first dose of ROTATEQ after the patients were 14 weeks and 6 days old was unknown. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 64 year old male patient. The patient's medical history was not reported. On 25-JUN-2014 (reported as today) the patient was vaccinated with PROQUAD (Dose/Frequency: 0.5 milliliter (ml) subcutaneous in the left arm. Concomitant medications were not reported. On 25-JUL-2014, the patient was vaccinated with PROQUAD and VARIVAX. The patient was supposed to get vaccinated with MMR II and VARIVAX. No adverse effects reported. The outcome of wrong vaccine administered was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Atrial fibrillation, Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL. Pertinent medical history and concomitant medications were not reported. The reporter stated that on an unknown date the patient experienced syncope and atrial fibrillation after receiving a dose of GARDASIL. The outcome of the events was unknown. The causality was unknown. No further information was available. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to an unspecified patient of unknown age. The patient's medical history was not reported. On 23-JUN-2014 the patient was vaccinated with ZOSTAVAX. (dose, frequency were not reported) (lot # J003360, expiry date: 21-JUN-2014. Concomitant medications were not reported. On 23-JUN-2014, the patient administered expired dose of ZOSTAVAX which was expired on 21-JUN-2014. No adverse effects reported. The pharmacy intern was asked for potency information. Potency supported. The outcome of expired dose of ZOSTAVAX administered was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to her daughter. The nurse reported that her daughter received all 3 doses of GARDASIL, however, nurse found out that second dose of GARDASIL her daughter received in early April 2014 was improperly stored due to temperature excursion. Nurse received a call from daughter's physician's (name unspecified) office informing her that second dose of GARDASIL given to her daughter underwent temperature excursion (details not provided) and physician wanted to revaccinate her daughter. No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patients medical history and current condition as not known. On 18-MAR-2014 the patient was vaccinated with ZOSTAVAX, of dose 0.65 ml reported lot # J013134 and expiry date 17-02-2015 via subcutaneous route. Other concomitant drugs are not reported. On an unknown date the patient experienced bell's palsy and shingles. It was reported that the patient received treatment by office visit. Cancer and over dose are not reported. Also product quality issue was not reported. The outcome of bell's palsy and shingles was reported as not recovered. Causality was unspecified by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-JUN-2014 the patient ws vaccinated with properly stored, expired dose of ZOSTAVAX 19400 PFU) (lot # J010447,expiry date: 22-APR-2014) (subcutaneous, dose unknown). Pertinent medical history and concomitant medications were not reported. No adverse events were reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient received ZOSTAVAX (lot number, dose, route and indication were not reported) in September 2012 (day unknown) and on 22-JUN-2014. No adverse symptoms requested. The action taken and outcome were not provided. It was not specified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a medical assistant via a field employee regarding an unspecified patient. No information about medical history, drug reactions and allergies were specified. On an unknown date the patient ws vaccinated with PNEUMOVAX23 (dose not reported), subcutaneously. No concomitant reactions were reported. On an unknown date the patient developed an unspecified reaction to PNEUMOVAX23. The outcome of the event is unknown. The causality of the event was not specified by the reporter. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant via a field employee regarding an adult (reported as some age within his 20's, exact age not known), male patient. No information about medical history, drug reactions and allergies was specified. On an unknown date in approximately May 2014 (reported as about a month ago), the patient was vaccinated with PNEUMOVAX23 (dose not reported) vial, subcutaneously. No concomitant medications were reported. On an unknown date the patient developed swelling at the injection site and swelling continued to the patient's elbow of the arm injection was given. The field employee also reported that the medical assistant reported to her that this patient sought medical attention, had to go to emergency room because of this (it is not know whether the patient stayed overnight and the hospital name is unspecified). There was no product quality complaint with PNEUMOVAX23. The outcome of the event is unknown. The causality of the event was not specified by the reporter.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Stiff wrist and fingers on right arm.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Brain oedema, Catatonia, Insomnia, Moaning
Clinical narrative: My daughter, a happy friendly outgoing and energetic 4 year old (at the time), went completely catatonic for about 48 hours.  She wouldn't eat, or play, or interact with us.  She didn't sleep, she just moaned very softly for two days.  On the first full day, we took her to a pediatric chiropractor, who detected some brain swelling and adjusted her. It took a little more then two days, before she acted even remotely herself again.  Time listed above is extremely approximate, it is only just recently that it was suggested we report this reaction.  Thank you.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: Fever, chills, exteme fatigue, nausea, vomiting, abdominal pain, diarrhea.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, chills, exteme fatigue, nausea, vomiting, abdominal pain, diarrhea.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, Swelling and Itching at Injection Site - has continued to get worse through the weekend. Recommended that patient try an oral antihistamine and follow up with primary physician if not improved by tomorrow.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abdominal X-ray, Blood test, Cyanosis, Electrocardiogram, Hypotonia
Clinical narrative: Adverse event included sudden limpness, unresponsiveness, pallor, and cyanosis.  Called 911 and maintained efforts to revive child.  Event duration lasted maybe 10-15 minutes.  Child was much improved by the time the fire department arrived, and was taken by ambulance to Hospital for evaluation.  Tests included EKG, x-ray of abdomen, blood test, and urine test.  No problems were identified, and the hospital was unable to determine a possible cause of the event.  Child was admitted overnight for monitoring, and no further adverse event occurred.  The hospital indicated that it was unlikely the vaccines taken earlier that morning (DTaP-Hib and PCV) were a factor in the adverse event.  As a parent of the child, however, I am submitting this report because the symptoms our daughter experienced five hours after having DTaP-Hib and PCV vaccines are IDENTICAL to those described in a Pediatrics-published study and occurred in a child under 2 years of age and within 48 hours after administration of a pertussis-containing vaccine, exactly as described in the study.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pallor, Unresponsive to stimuli, Urine analysis, X-ray normal
Clinical narrative: Adverse event included sudden limpness, unresponsiveness, pallor, and cyanosis.  Called 911 and maintained efforts to revive child.  Event duration lasted maybe 10-15 minutes.  Child was much improved by the time the fire department arrived, and was taken by ambulance to Hospital for evaluation.  Tests included EKG, x-ray of abdomen, blood test, and urine test.  No problems were identified, and the hospital was unable to determine a possible cause of the event.  Child was admitted overnight for monitoring, and no further adverse event occurred.  The hospital indicated that it was unlikely the vaccines taken earlier that morning (DTaP-Hib and PCV) were a factor in the adverse event.  As a parent of the child, however, I am submitting this report because the symptoms our daughter experienced five hours after having DTaP-Hib and PCV vaccines are IDENTICAL to those described in a Pediatrics-published study and occurred in a child under 2 years of age and within 48 hours after administration of a pertussis-containing vaccine, exactly as described in the study.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Left Arm, Pain, swollen deltoid area, redness, firmness of deltoid (relative to contra-lateral), calor of deltoid 99.8 F vs 95.0 F on contra-lateral.  We took patient to Dr. today 1:30PM who said that the reaction would likely dissipate in a few days.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Endotracheal intubation, Injection site haemorrhage, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 87 year old male patient. The pharmacist received this information from the patient's daughter. On 04-JUL-2011 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, frequency were unspecified). Concomitant therapies included COUMADIN and FLOMAX. On 04-JUL-2011, 12 hours of receiving ZOSTAVAX the patient passed away. The patient received the ZOSTAVAX and started to bleed heavily from the injection site. According to the patient's daughter, on the day of the ZOSTAVAX injection and the patient stated that "he did not feel well and had lost a profuse amount of blood." He was taken by ambulance to an unspecified hospital and sought medical attention. The patient was intubated in the hospital. He passed away on 04-JUL-2011. No cause of death was provided. The outcome of the other events was unknown. The events were considered as disability and life threatening by the reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old patient. No information about medical history concurrent conditions and concomitant medications were reported. The reporter stated that on 23-MAY-2014 the patient was vaccinated with pediatric dose of VAQTA, dose 0.5 ml, route intramuscular. No adverse effect reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 3 year old child patient of unknown gender. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, dose, route not reported). Concomitant therapy was not reported. On an unknown date the patient developed chicken pox after receiving (Oka/Merck) VARIVAX. The patient had sought medical attention. Outcome of the event was unknown. This is one of several reports received from the same reporter (other MARRS#1406USA009700). Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 11 year old female patient. On unknown dates the patient was vaccinated with three doses of (Oka/Merck) VARIVAX (lot #, dose, route not reported). Confirmed extra dose administration. Concomitant therapy was not  reported. On an unknown date the patient developed the varicella like rash. The physician stated that the patient's varicella like rash was distinct in an unspecified way. The patient had sought medical attention. Outcome of the event was unknown. This is one of several reports received from the same reporter (other MARRS#1406USA009945). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of GARDASIL (lot #, dose, route, not reported) that underwent a temperature excursion on an unknown date. Concomitant therapy was not reported. No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (lot#, dose, route, indication not reported) that underwent a temperature excursion on an unknown date. Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of ROTATEQ (lot #, dose, route, not reported that underwent a temperature excursion on an unknown date. Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of VAQTA (lot #, dose, route not reported) that underwent a temperature excursion on an unknown date. Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to an unspecified amount of patients of unknown age and gender. The health worker reported that PNEUMOVAX23 (lot #, dose, route not reported) that underwent a temperature excursion had been administered to these unspecified amount of patients on an unknown date. Concomitant therapies were not reported. No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to 4 patients of unknown age and gender. On an unknown date the 4 patients received improperly stored PROQUAD (lot #, strength, dose, frequency, route unspecified). Temperature excursions for the vaccine were supported with in-house stability data. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The reporter reported that on 16-JUN-2014 the patient was administered a dose of RECOMBIVAX HB, (1 ml, lot#, strength, frequency and route unspecified) which was exposed to 70F for 72 hours. No adverse effects reported. Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Influenza virus test, Injection site erythema, Injection site rash, Pyrexia, Streptococcus test
Clinical narrative: Pt got vaccines on 6/19/14, varicella, Hib, Hep A on left thigh, around 6/25/14 mom notified fever and a rash and red skin at injection site (about 1 x 1 cm area). Pt seen in ER with fever.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: Pt got vaccines on 6/19/14, varicella, Hib, Hep A on left thigh, around 6/25/14 mom notified fever and a rash and red skin at injection site (about 1 x 1 cm area). Pt seen in ER with fever.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 19-JUN-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J010447, expiration date 22-APR-2014), (dose and route unspecified). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX. Concomitant medications were not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX stored at temperatures between -12 Celsius (C) to -10 C. No adverse effect reported. The outcome of vaccinated with (Oka/Merck) VARIVAX stored at temperatures between -12C to -10C was unknown. This case is linked to case #1406USA012262 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX. Concomitant medications were not reported. ON an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX stored at temperatures between -12 Celsius (C) to -10C. No adverse effect reported. The outcome of vaccinated with (Oka/Merck) VARIVAX stored at temperatures between -12C to -10C was unknown. This case is linked to case # 1406USA013699 (same reporter link). Additional information is requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to multiple patients of unknown age and gender. On an unspecified date because of a system error this multiple patients received 2 doses of ZOSTAVAX (lot # unspecified), subcutaneous injection, dose and location unspecified. No adverse effects were reported. The patients did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown demographics. No further information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date the patient was vaccinated with ZOSTAVAX (therapy dates, dose, route was not reported) that was stored improperly. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Ataxia, CSF glucose increased, CSF protein increased, Cerebrovascular accident
Clinical narrative: Case number PHHY2013US012322 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 448053) on 08 Feb 2013, and with a follow up report received from a QA department (reference number: 210506) on 25 Jun 2014. This report refers to a 71-year-old male patient. His medical history included atrial fibrillation, hypertension, diabetes mellitus type 2, pacemaker secondary to SSS (sick sinus syndrome) and chronic kidney disease. This polymedicated patient was vaccinated with FLUVIRIN, (batch number: 1102501, expiry date: 30 Jun 2012) intramuscularly on right arm on 01 Sep 2011. On 22 Dec 2011, the patient developed ataxia and weakness. The patient was hospitalized on 22 Dec 2011 due to stroke secondary to numerous vascular risk factors. The patient developed progressive ascending weakness causing respiratory compromise which requiring mechanical ventilation. The patient was diagnosed with Guillain Barre Syndrome by physician. Laboratory tests included: CSF protein increased (55) and CSF glucose increased (175) on 04 Jan 2012. EMG (electromyogram) - nerve conduction study showed mild polyneuropathy, primarily demyelinating (date not reported). The patient had a visit to emergency room. Outcome of the events were reported as condition unchanged. Seriousness and causality of the events was not reported. No further information was available. Based on the document review, it was stated that the FLUVIRIN, batch number 1102501 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 210506) on 25 Jun 2014. Updated batch review report and expiry date of vaccine.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Demyelinating polyneuropathy, Electromyogram abnormal, Guillain-Barre syndrome, Mechanical ventilation, Nerve conduction studies abnormal
Clinical narrative: Case number PHHY2013US012322 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 448053) on 08 Feb 2013, and with a follow up report received from a QA department (reference number: 210506) on 25 Jun 2014. This report refers to a 71-year-old male patient. His medical history included atrial fibrillation, hypertension, diabetes mellitus type 2, pacemaker secondary to SSS (sick sinus syndrome) and chronic kidney disease. This polymedicated patient was vaccinated with FLUVIRIN, (batch number: 1102501, expiry date: 30 Jun 2012) intramuscularly on right arm on 01 Sep 2011. On 22 Dec 2011, the patient developed ataxia and weakness. The patient was hospitalized on 22 Dec 2011 due to stroke secondary to numerous vascular risk factors. The patient developed progressive ascending weakness causing respiratory compromise which requiring mechanical ventilation. The patient was diagnosed with Guillain Barre Syndrome by physician. Laboratory tests included: CSF protein increased (55) and CSF glucose increased (175) on 04 Jan 2012. EMG (electromyogram) - nerve conduction study showed mild polyneuropathy, primarily demyelinating (date not reported). The patient had a visit to emergency room. Outcome of the events were reported as condition unchanged. Seriousness and causality of the events was not reported. No further information was available. Based on the document review, it was stated that the FLUVIRIN, batch number 1102501 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 210506) on 25 Jun 2014. Updated batch review report and expiry date of vaccine.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory disorder
Clinical narrative: Case number PHHY2013US012322 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 448053) on 08 Feb 2013, and with a follow up report received from a QA department (reference number: 210506) on 25 Jun 2014. This report refers to a 71-year-old male patient. His medical history included atrial fibrillation, hypertension, diabetes mellitus type 2, pacemaker secondary to SSS (sick sinus syndrome) and chronic kidney disease. This polymedicated patient was vaccinated with FLUVIRIN, (batch number: 1102501, expiry date: 30 Jun 2012) intramuscularly on right arm on 01 Sep 2011. On 22 Dec 2011, the patient developed ataxia and weakness. The patient was hospitalized on 22 Dec 2011 due to stroke secondary to numerous vascular risk factors. The patient developed progressive ascending weakness causing respiratory compromise which requiring mechanical ventilation. The patient was diagnosed with Guillain Barre Syndrome by physician. Laboratory tests included: CSF protein increased (55) and CSF glucose increased (175) on 04 Jan 2012. EMG (electromyogram) - nerve conduction study showed mild polyneuropathy, primarily demyelinating (date not reported). The patient had a visit to emergency room. Outcome of the events were reported as condition unchanged. Seriousness and causality of the events was not reported. No further information was available. Based on the document review, it was stated that the FLUVIRIN, batch number 1102501 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 210506) on 25 Jun 2014. Updated batch review report and expiry date of vaccine.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza, Malaise, Pain, Pyrexia
Clinical narrative: Case number PHHY2012US111520 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 468746) on 04 Dec 2012 and a follow up report from the QA department (QA reference number: 210483) received on 25 Jun 2014. This case refers to 45-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1206701) in right arm on 18 Sep 2012. One week after the vaccination, the patient experienced chills, fever, aches, malaise and flu. The outcome of events was reported as complete recovery as of 05 Oct 2012. The seriousness and causality of the events was not reported. Based on the document review, it was stated that the FLUVIRIN, (batch number 1206701) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department (QA reference number: 210483) received on 25 Jun 2014: Updated batch review report.
Age: 21.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Delusion, Disorientation, Memory impairment
Clinical narrative: Case number PHHY2013US012008, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 474468) website on 08 Feb 2013 and a follow up report from the QA department (QA reference number: 210497) received on 25 Jun 2014. This report refers to a 21-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 123534) into right arm and GARDASIL (other manufacturer, batch number: H009746) into left arm on 06 Nov 2012. She received both the vaccines intramuscularly. It was reported, couple of hours after vaccination, she became disoriented, delusional and lost track of time. She did not recognize others and did not remember much until she woke up next morning. The outcome of the events was reported as recovered as of unspecified date. The event seriousness and causality was not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 123534 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 25 Jun 2014: Updated batch review report.
Age: 61.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Abasia, Guillain-Barre syndrome, Impaired work ability, Sensory loss, Walking aid user
Clinical narrative: Case number PHHY2013US012051, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 474948) website on 08 Feb 2013 and a follow up report from the Quality Assurance department (QA ref: 210569) received on 25 Jun 2014: This report refers to a 61-year-old male patient. His medical history included lumbar herniated discs and back pain. His concomitant medication included KENALOG and TORADOL. He was vaccinated with FLUVIRIN (batch number: 098446P1, Expiry date: 30 Jun 2010) and with tetanus/diphtheria vaccine (other manufacturer, batch number: A008A) on 20 Oct 2009. It was reported that within 3 weeks of vaccination, he lost feeling in feet, arms, and hands. He lost his weight ("lost 30-40") and could not walk (used a walker). He was diagnosed with Guillain-Barre syndrome (neurological) on an unspecified date. It was reported that he had to use a wheelchair and was using a cane at the time of report. It was also informed that the patient can no longer work. He visited the emergency room, because of the events. The reporter assessed the events as serious (disability). The outcome of the events was reporter as not yet recovered. The causality of the events was not provided. Based on the document review, it was stated that the FLUVIRIN, batch number 098446P1 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 25 Jun 2014: Updated batch review report.
Age: 61.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Weight decreased, Wheelchair user
Clinical narrative: Case number PHHY2013US012051, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 474948) website on 08 Feb 2013 and a follow up report from the Quality Assurance department (QA ref: 210569) received on 25 Jun 2014: This report refers to a 61-year-old male patient. His medical history included lumbar herniated discs and back pain. His concomitant medication included KENALOG and TORADOL. He was vaccinated with FLUVIRIN (batch number: 098446P1, Expiry date: 30 Jun 2010) and with tetanus/diphtheria vaccine (other manufacturer, batch number: A008A) on 20 Oct 2009. It was reported that within 3 weeks of vaccination, he lost feeling in feet, arms, and hands. He lost his weight ("lost 30-40") and could not walk (used a walker). He was diagnosed with Guillain-Barre syndrome (neurological) on an unspecified date. It was reported that he had to use a wheelchair and was using a cane at the time of report. It was also informed that the patient can no longer work. He visited the emergency room, because of the events. The reporter assessed the events as serious (disability). The outcome of the events was reporter as not yet recovered. The causality of the events was not provided. Based on the document review, it was stated that the FLUVIRIN, batch number 098446P1 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 25 Jun 2014: Updated batch review report.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Eye movement disorder, Face injury, Loss of consciousness, Muscle tightness
Clinical narrative: Case number PHHY2013US012256, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 475511) website on 08 Feb 2013, and with a follow up report received from a QA department (reference number: 211611) on 26 Jun 2014: This report refers to a 15-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1205801, expiry date: 30 Jun 2013) intramuscularly to left arm on 16 Nov 2012. Approximately 5 to 10 minutes after vaccination, the patient was standing and fainted. He hit his chin on a counter and started having a seizure that involved tense muscles, eyes rolled back, tongue back, and the patient was unconscious (unknown if the seizure started before or after hitting his chin). The seizure lasted less than 30 seconds and the patient regained consciousness without treatment. The patient was taken to the hospital by father for follow-up. Patient had received influenza vaccine last year and in years past according to father and patient. Patient had never experienced a seizure in the past. Patient reported no allergies and was feeling healthy prior to vaccination. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1205801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 211611) on 26 Jun 2014. Updated batch review report and expiry date of vaccine.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope, Tongue paralysis
Clinical narrative: Case number PHHY2013US012256, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 475511) website on 08 Feb 2013, and with a follow up report received from a QA department (reference number: 211611) on 26 Jun 2014: This report refers to a 15-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1205801, expiry date: 30 Jun 2013) intramuscularly to left arm on 16 Nov 2012. Approximately 5 to 10 minutes after vaccination, the patient was standing and fainted. He hit his chin on a counter and started having a seizure that involved tense muscles, eyes rolled back, tongue back, and the patient was unconscious (unknown if the seizure started before or after hitting his chin). The seizure lasted less than 30 seconds and the patient regained consciousness without treatment. The patient was taken to the hospital by father for follow-up. Patient had received influenza vaccine last year and in years past according to father and patient. Patient had never experienced a seizure in the past. Patient reported no allergies and was feeling healthy prior to vaccination. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1205801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 211611) on 26 Jun 2014. Updated batch review report and expiry date of vaccine.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rotator cuff syndrome
Clinical narrative: Case number PHHY2013US012277 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 475540) web site on 08 Feb 2013 and a follow up report received from the Quality Assurance (QA ref: 211111) department received on 25 Jun 2014: This report refers to a 58-year-old female patient. Her concomitant medication include pravastatin 40 mg. She was vaccinated with FLUVIRIN (batch number: 123324, Expiry date: 30 Jun 2013) intramuscularly to left arm on 12 Nov 2012. She claimed that her arm had been sore since receiving the vaccine. Patient visited emergency room. Her doctor diagnosed it as rotator cuff tendonitis on 26 Nov 2012, for which she received a Medrol dose pack. Further to the treatment, doctor advised her to use cortisone shot or physical therapy. Outcome of the events were reported as condition unchanged as of 26 Nov 2012. Seriousness and causality were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 123324 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from the QA department received on 25 Jun 2014: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Convulsion, Feeling abnormal, Nuclear magnetic resonance imaging brain normal, Scan with contrast normal
Clinical narrative: Case number PHHY2013US032597, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481616) website on 04 Apr 2013, and with a follow up report received from a QA department (reference number: 221847) on 25 Jun 2014. This report refers to 65-year-old male patient. His medical history was not reported and concomitant medication included Benazepril 20 mg daily, levothyroxine 100 ug daily, NEXIUM 40 mg daily, Chlorthalid 25 mg daily, Testos 0.5 ml injection bi-weekly. He was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into left arm on 11 Jan 2013. On the same day post vaccination he had loss of memory from 11 pm and he was not feeling right. He experienced a severe seizure at 5 am the next day (12 Jan 2013). Lab test included MRI (with and without contrast) which ruled out brain tumour or any brain problems. An appointment with neurologist was scheduled. The event outcome was reported as condition unchanged as of 16 Jan 2013. Seriousness and causality were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1206801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 221847) on 25 Jun 2014. Updated batch review report.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Case number PHHY2013US032563, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 483117) on 04 Apr 2013, and with a follow up report received from a QA department (reference number: 221046) on 25 Jun 2014. This report refers to a 25-year-old male patient. Concomitant medications included lithium and olanzapine. He was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into left arm on 26 Jan 2013. On the same day after vaccination (time to onset unspecified), the patient returned to pharmacy after feeling faint while shopping. Outcome of the event was reported as recovered. Seriousness and causality of the event was not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1206801 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 221046) on 25 Jun 2014. Updated batch review report.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Fatigue, Injection site swelling, Lymphadenopathy, Oropharyngeal pain, Rash pustular
Clinical narrative: This case was received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 526138. A 24 year-old male patient with a history of a sulfa allergy had received on 07 March 2014, an intradermal left arm injection of ACAM2000 (lot number VV00403A) and 10 days later was found to have left arm swelling at site of smallpox vaccination, new pustular acne-like lesions that spread to the upper chest, back and right shoulder, felt fatigued with sore throat and swollen cervical lymph nodes for 24 hours. The patient was seen in the emergency room. Treatment included ADVIL prn. Current illnesses was arm soreness at site of typhoid and anthrax vaccine given two days prior (manufacturers, lot numbers, routes and sites of administration not reported). Other medications were reported as none. Lab data and prior vaccinations were not reported. No further information was available at the time of the report. Outcome was recovered. Although the lot number for ACAM2000 was reported as VV00403A. To date, the only ACAM2000 lot number released from bulk lot VV04003 was VV04003A. Documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Acne pustular, Fatigue, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: This case was received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 526138. A 24 year-old male patient with a history of a sulfa allergy had received on 07 March 2014, an intradermal left arm injection of ACAM2000 (lot number VV00403A) and 10 days later was found to have left arm swelling at site of smallpox vaccination, new pustular acne-like lesions that spread to the upper chest, back and right shoulder, felt fatigued with sore throat and swollen cervical lymph nodes for 24 hours. The patient was seen in the emergency room. Treatment included ADVIL prn. Current illnesses was arm soreness at site of typhoid and anthrax vaccine given two days prior (manufacturers, lot numbers, routes and sites of administration not reported). Other medications were reported as none. Lab data and prior vaccinations were not reported. No further information was available at the time of the report. Outcome was recovered. Although the lot number for ACAM2000 was reported as VV00403A. To date, the only ACAM2000 lot number released from bulk lot VV04003 was VV04003A. Documents held by sender: none.