chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Gait disturbance, Rash, Swelling
Clinical narrative: Case number PHHY2016US006090, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 607163) website on 18 Jan 2016. This report refers to a 63-year-old male patient. Historical condition was not reported. Current conditions included blood pressure, diabetes, leukemia and lymphoma. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15737P) intramuscularly into left arm on 14 Oct 2015. On 22 Oct 2015 after vaccination, the patient complained that he cannot open mouth properly, cannot talk properly, had a rash and swelling. The patient was advised to visit his physician right away. The outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the event "dyskinesia and gait disturbance" was upgraded based on the available information in the source document. Quality Assurance (QA) department confirmed that, the reported batch number (15737P) was not a valid batch number for FLUVIRIN. Hence, investigation could not be performed. Follow up information was received from QA department on 29 Jan 2016. Added QA department comment.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Computerised tomogram, Headache, Lumbar puncture, Vertigo
Clinical narrative: Initial unsolicited report received from a healthcare professional (nurse) on 10 November 2015. This case involves a 16-year-old female patient, who was vaccinated with first dose of MENACTRA (batch number: U5068AB, Expiry date: 10 September 2016) via intramuscular route in right deltoid and second dose of FLUZONE QIV (batch number: UI441AE, Expiry date: 30 June 2016) via intramuscular route in left deltoid on 06 November 2015. Illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Other medical history and concomitant medication were not reported. On 07 November 2015, next day after vaccination, the patient experienced headache and head spinning. It was reported that patient might have required hospitalization though not sure. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none. Follow-up information received from a physician on 28 December 2015. The patient's medical history includes undiagnosed neurologic issue that appears to be seizures. Relevant diagnostic tests were reported as CT scan and lumbar spinal tap. It was reported that in speaking with a family member patient was been evaluated by a neurologist, the family member (an MD) does not believe her issue to be related to the vaccines, apparently patient may have had undiagnosed issues appearing to be neurologic in nature, prior to vaccination. The patient was hospitalized for 2-3 days.
Age: 51.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anogenital warts, Drug administered to patient of inappropriate age
Clinical narrative: Information has been received a 51 year old female patient referring to herself. The patient was not sexually active, had never had a bad PAP smear nor a sexually transmitted disease previously. In approximately 2014 (reported as "about one and a half years ago"), the patient was vaccinated with a dose of unidentified Merck HPV vaccine administered (name, dose and lot number not provided) (inappropriate schedule of drug administration). After receiving the vaccine, the patient presented with perianal warts that were not going away after therapy with an unspecified medication. The outcome of perianal warts was not recovered. The causality was not provided. Additional information is not expected as no contact detail provided.
Age: 51.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anogenital warts, Inappropriate schedule of drug administration
Clinical narrative: Information has been received a 51 year old female patient referring to herself. The patient was not sexually active, had never had a bad PAP smear nor a sexually transmitted disease previously. In approximately 2014 (reported as "about one and a half years ago"), the patient was vaccinated with a dose of unidentified Merck HPV vaccine administered (name, dose and lot number not provided) (inappropriate schedule of drug administration). After receiving the vaccine, the patient presented with perianal warts that were not going away after therapy with an unspecified medication. The outcome of perianal warts was not recovered. The causality was not provided. Additional information is not expected as no contact detail provided.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Myocardial infarction, Pain, Seizure, Tachycardia
Clinical narrative: This spontaneous social media report was received from the patient's mother concerning her daughter, a 18 year old female patient via social media. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication were not reported. The reporter stated on the posts, that she buried her daughter on Saturday, a beautiful talented child, due to GARDASIL. The cause of death was not provided and it was unknown whether an autopsy was performed. Follow up information has been received from a social media revision on 01-FEB-2016 from a web site. It was stated in this web site, that the patient died on an unknown date, from a major seizure that caused a heart attack from complications of GARDASIL. It was stated that, until receiving the GARDASIL, she had never had health issues. She never had a seizure, or anything other than sports injuries. On an unknown date in 2012 (reported as last three and a half years), the patient experienced pain, seizures, tachycardia, light sensitivity, sound sensitivity, she couldn't eat and had been on total parenteral nutrition (TPN) for nutrition for years. Additional information has been requested. Patient, events and narrative information were updated.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Feeding disorder, Generalised tonic-clonic seizure, Hyperacusis, Myocardial infarction
Clinical narrative: This spontaneous social media report was received from the patient's mother concerning her daughter, a 18 year old female patient via social media. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication were not reported. The reporter stated on the posts, that she buried her daughter on Saturday, a beautiful talented child, due to GARDASIL. The cause of death was not provided and it was unknown whether an autopsy was performed. Follow up information has been received from a social media revision on 01-FEB-2016 from a web site. It was stated in this web site, that the patient died on an unknown date, from a major seizure that caused a heart attack from complications of GARDASIL. It was stated that, until receiving the GARDASIL, she had never had health issues. She never had a seizure, or anything other than sports injuries. On an unknown date in 2012 (reported as last three and a half years), the patient experienced pain, seizures, tachycardia, light sensitivity, sound sensitivity, she couldn't eat and had been on total parenteral nutrition (TPN) for nutrition for years. Additional information has been requested. Patient, events and narrative information were updated.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Pain, Parenteral nutrition, Photophobia, Seizure, Tachycardia
Clinical narrative: This spontaneous social media report was received from the patient's mother concerning her daughter, a 18 year old female patient via social media. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication were not reported. The reporter stated on the posts, that she buried her daughter on Saturday, a beautiful talented child, due to GARDASIL. The cause of death was not provided and it was unknown whether an autopsy was performed. Follow up information has been received from a social media revision on 01-FEB-2016 from a web site. It was stated in this web site, that the patient died on an unknown date, from a major seizure that caused a heart attack from complications of GARDASIL. It was stated that, until receiving the GARDASIL, she had never had health issues. She never had a seizure, or anything other than sports injuries. On an unknown date in 2012 (reported as last three and a half years), the patient experienced pain, seizures, tachycardia, light sensitivity, sound sensitivity, she couldn't eat and had been on total parenteral nutrition (TPN) for nutrition for years. Additional information has been requested. Patient, events and narrative information were updated.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous social media report was received from the patient's mother concerning her daughter, a 18 year old female patient via social media. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication were not reported. The reporter stated on the posts, that she buried her daughter on Saturday, a beautiful talented child, due to GARDASIL. The cause of death was not provided and it was unknown whether an autopsy was performed. Follow up information has been received from a social media revision on 01-FEB-2016 from a web site. It was stated in this web site, that the patient died on an unknown date, from a major seizure that caused a heart attack from complications of GARDASIL. It was stated that, until receiving the GARDASIL, she had never had health issues. She never had a seizure, or anything other than sports injuries. On an unknown date in 2012 (reported as last three and a half years), the patient experienced pain, seizures, tachycardia, light sensitivity, sound sensitivity, she couldn't eat and had been on total parenteral nutrition (TPN) for nutrition for years. Additional information has been requested. Patient, events and narrative information were updated.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Fatigue, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous social media report was received from the patient's mother concerning her daughter, a 18 year old female patient via social media. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication were not reported. The reporter stated on the posts, that she buried her daughter on Saturday, a beautiful talented child, due to GARDASIL. The cause of death was not provided and it was unknown whether an autopsy was performed. Follow up information has been received from a social media revision on 01-FEB-2016 from a web site. It was stated in this web site, that the patient died on an unknown date, from a major seizure that caused a heart attack from complications of GARDASIL. It was stated that, until receiving the GARDASIL, she had never had health issues. She never had a seizure, or anything other than sports injuries. On an unknown date in 2012 (reported as last three and a half years), the patient experienced pain, seizures, tachycardia, light sensitivity, sound sensitivity, she couldn't eat and had been on total parenteral nutrition (TPN) for nutrition for years. Additional information has been requested. Patient, events and narrative information were updated.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Seizure
Clinical narrative: This spontaneous social media report was received from the patient's mother concerning her daughter, a 18 year old female patient via social media. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication were not reported. The reporter stated on the posts, that she buried her daughter on Saturday, a beautiful talented child, due to GARDASIL. The cause of death was not provided and it was unknown whether an autopsy was performed. Follow up information has been received from a social media revision on 01-FEB-2016 from a web site. It was stated in this web site, that the patient died on an unknown date, from a major seizure that caused a heart attack from complications of GARDASIL. It was stated that, until receiving the GARDASIL, she had never had health issues. She never had a seizure, or anything other than sports injuries. On an unknown date in 2012 (reported as last three and a half years), the patient experienced pain, seizures, tachycardia, light sensitivity, sound sensitivity, she couldn't eat and had been on total parenteral nutrition (TPN) for nutrition for years. Additional information has been requested. Patient, events and narrative information were updated.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Gastrointestinal tube insertion, Pain
Clinical narrative: This spontaneous social media report was received from the patient's mother concerning her daughter, a 18 year old female patient via social media. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication were not reported. The reporter stated on the posts, that she buried her daughter on Saturday, a beautiful talented child, due to GARDASIL. The cause of death was not provided and it was unknown whether an autopsy was performed. Follow up information has been received from a social media revision on 01-FEB-2016 from a web site. It was stated in this web site, that the patient died on an unknown date, from a major seizure that caused a heart attack from complications of GARDASIL. It was stated that, until receiving the GARDASIL, she had never had health issues. She never had a seizure, or anything other than sports injuries. On an unknown date in 2012 (reported as last three and a half years), the patient experienced pain, seizures, tachycardia, light sensitivity, sound sensitivity, she couldn't eat and had been on total parenteral nutrition (TPN) for nutrition for years. Additional information has been requested. Patient, events and narrative information were updated.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Restlessness
Clinical narrative: Fever of 103.4, fussy, restless.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Presyncope, Vomiting
Clinical narrative: Pt received HPV Quadrivalent, Gardasil vaccine. While walking from the exam room to the waiting area for the 15 min wait she had a non traumatic vasovagal episode in which mother of patient eased child to the floor. Patient stated she felt ok after about a minute of resting on the floor where the fall occurred. She walked out the waiting area accompanied by mother of patient. Mother then reported 2 minutes later that child had another vasovagal response and vomited once.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Blood test, Coeliac disease, Complex regional pain syndrome, Computerised tomogram
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to a 13 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. It was reported that the patient was accidentally given four doses of GARDASIL, intramuscularly, on 10-JUL-2008, 12-SEP-2008, 04-JAN-2009 and 24-JAN-2011. Exact dose, lot numbers and expiration dates were not provided for these vaccinations. The consumer reported that, on an unspecified date, her daughter experienced "adverse reactions starting with the first shot" (not specified which of them occurred after the first vaccination). The patient experienced fatigue, vomiting, nausea, migraines, chronic pain, and on an unknown date, she was diagnosed with dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The patient was hospitalized in two hospitals (dates unspecified) and she was treated with unspecified pain medications. it was also reported, that the patient visited homeopathic doctor for detoxification (details unspecified). Laboratory diagnostic studies were performed: blood work, spinal tap, cat scan, magnetic resonance imaging (MRI) and numerous scopes (dates and detail were unspecified). The patient did not recover from dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Detoxification, Extra dose administered, Fatigue, Imaging procedure, Lumbar puncture
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to a 13 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. It was reported that the patient was accidentally given four doses of GARDASIL, intramuscularly, on 10-JUL-2008, 12-SEP-2008, 04-JAN-2009 and 24-JAN-2011. Exact dose, lot numbers and expiration dates were not provided for these vaccinations. The consumer reported that, on an unspecified date, her daughter experienced "adverse reactions starting with the first shot" (not specified which of them occurred after the first vaccination). The patient experienced fatigue, vomiting, nausea, migraines, chronic pain, and on an unknown date, she was diagnosed with dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The patient was hospitalized in two hospitals (dates unspecified) and she was treated with unspecified pain medications. it was also reported, that the patient visited homeopathic doctor for detoxification (details unspecified). Laboratory diagnostic studies were performed: blood work, spinal tap, cat scan, magnetic resonance imaging (MRI) and numerous scopes (dates and detail were unspecified). The patient did not recover from dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Nausea, Nuclear magnetic resonance imaging, Pain, Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to a 13 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. It was reported that the patient was accidentally given four doses of GARDASIL, intramuscularly, on 10-JUL-2008, 12-SEP-2008, 04-JAN-2009 and 24-JAN-2011. Exact dose, lot numbers and expiration dates were not provided for these vaccinations. The consumer reported that, on an unspecified date, her daughter experienced "adverse reactions starting with the first shot" (not specified which of them occurred after the first vaccination). The patient experienced fatigue, vomiting, nausea, migraines, chronic pain, and on an unknown date, she was diagnosed with dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The patient was hospitalized in two hospitals (dates unspecified) and she was treated with unspecified pain medications. it was also reported, that the patient visited homeopathic doctor for detoxification (details unspecified). Laboratory diagnostic studies were performed: blood work, spinal tap, cat scan, magnetic resonance imaging (MRI) and numerous scopes (dates and detail were unspecified). The patient did not recover from dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to a 13 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. It was reported that the patient was accidentally given four doses of GARDASIL, intramuscularly, on 10-JUL-2008, 12-SEP-2008, 04-JAN-2009 and 24-JAN-2011. Exact dose, lot numbers and expiration dates were not provided for these vaccinations. The consumer reported that, on an unspecified date, her daughter experienced "adverse reactions starting with the first shot" (not specified which of them occurred after the first vaccination). The patient experienced fatigue, vomiting, nausea, migraines, chronic pain, and on an unknown date, she was diagnosed with dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The patient was hospitalized in two hospitals (dates unspecified) and she was treated with unspecified pain medications. it was also reported, that the patient visited homeopathic doctor for detoxification (details unspecified). Laboratory diagnostic studies were performed: blood work, spinal tap, cat scan, magnetic resonance imaging (MRI) and numerous scopes (dates and detail were unspecified). The patient did not recover from dysautonomia, complex regional pain syndrome, celiac disease and postural orthostatic tachycardia syndrome (POTS). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 0.29
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Death
Clinical narrative: We called to schedule next set of shots and were informed that patient has died.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025032, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 22-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 26 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025033, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 72-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN, (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014  and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error (incorrect storage of drug).
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025035, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 04-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 03 Nov 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025034, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 68-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 31 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025049, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 38 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 01 Dec 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema, swelling, pruritus in a 5" x 5" area including (R) deltoid area and lateral upper (R) arm. Non tender, no c/o pain. Full ROM of (R) arm.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025052, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 07 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN, (batch number: 145701) intramuscularly at a dose of 0.5 ml on 17 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025053, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 77 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025054 is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 50 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025050, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 62 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 29 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degrees F during the excursion.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025056, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 36 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 01 Dec 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excision.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025078, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 50-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025055, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 42 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 66.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Decreased appetite, Dizziness, Nausea, Syncope
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received first dose of PREVNAR 13, via an unspecified route of administration at 13:00 on 21Jan2016 at 0.5 ml single and flu vaccine, via an unspecified route of administration on 21Jan2016 at an unspecified dose. Medical history included hyperlipidaemia (borderline). Concomitant medication included pravastatin. The patient, since the morning of 22Jan2016 when she woke up, she has been experiencing syncope, very dizzy, very nauseous and a lack of appetite. The outcome of the events was recovering. The pharmacist thought the side effects are related to PREVNAR 13.
Age: 53.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Cellulitis, Drug administration error
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A 53-year-old female patient received PREVNAR 13, intramuscular in arm on 08Dec2015 at 0.5 ml, single and ZOSTAVAX, intramuscular in arm on 08Dec2015 at 1 DF, single. Both vaccines were given at the same time and in the same deltoid muscle. No other vaccinations were given within four weeks. Medical history and concomitant medications were not reported. The patient experienced cellulitis of arm and neck on Dec2015 with outcome of unknown. She stated that the vaccines were not supposed to be administered together and definitely not in the same deltoid muscle. The patient had gotten the two vaccines and that she went to the emergency room on 10Dec2015. She reported cellulitis of the arm that the vaccines were administered in. The cellulitis also went up into her neck. The patient was not hospitalized. She was prescribed an oral antibiotic from the emergency room, as treatment for the cellulitis.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025077, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 23-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excision. No adverse event was reported following this maladministration.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025079, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 59-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 10 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 20.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Rash, Urticaria
Clinical narrative: Rash- hives on arms.
Age: 0.53
Sex: M
Vaccine: DTAP, FLU3, HEP, HIBV, PNC13, RV5
Symptoms: Autopsy, Blood chloride decreased, Blood sodium decreased, Blood urea increased, Death
Clinical narrative: Child received three vaccines with Rotateq at age 2, 4, and 6 months, however, he contracted gastroenteritis on 3/12/15 and died from dehydration and Rota Virus A infection on 3/13/15 which was detected on autopsy.
Age: 0.53
Sex: M
Vaccine: DTAP, FLU3, HEP, HIBV, PNC13, RV5
Symptoms: Dehydration, Gastroenteritis, Hyponatraemia, Rotavirus infection, Rotavirus test positive
Clinical narrative: Child received three vaccines with Rotateq at age 2, 4, and 6 months, however, he contracted gastroenteritis on 3/12/15 and died from dehydration and Rota Virus A infection on 3/13/15 which was detected on autopsy.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025082, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 63-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025089, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 17-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 04 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reporting following this maladministration. No further information was provided.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Initial unsolicited report received from a nurse on 14 December 2015. This case involves a 11-year-old male patient who was vaccinated with a intramuscular dose of MENACTRA (batch number U5179AA, expiry date and site of administration were not reported) and also received dose BOOSTRIX (manufacturer GSK, batch number 2729X, expiry date and site of administration were not reported), received a dose of Hep A (manufacturer other, batch number F3J75, expiry date and site of administration were not reported) and also received a dose of HPV (manufacturer other, batch number L014415, expiry date and site of administration were not reported) all vaccine administered on 11 December 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 11 December 2015, within seconds after vaccination patient passed out. Patient had no laboratory investigation. Corrective treatment was not reported. The outcome of event was recovered (passed out for 5 seconds). Upon internal review, the company decided to consider the event serious because of the important medical event passed out. List of documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Cough, Fatigue, Injection site pain, Myalgia
Clinical narrative: A lot of pain at the injection. Muscle Pain continued from time of injection to 2/1/2016. Most painful during the first two days (maybe an 8 on a pain scale). Seemed to hurt most in the mornings. Fever + symptoms from 1/26/2016-1/30/2016. 100+ degrees only on first day. Extreme fatigue and weakness during the whole duration. Developed a strenuous cough 1/28/2016-1/30/2016. Discoloration of the skin 1/30/2016-2/1/2016.
Age: 25.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Skin discolouration
Clinical narrative: A lot of pain at the injection. Muscle Pain continued from time of injection to 2/1/2016. Most painful during the first two days (maybe an 8 on a pain scale). Seemed to hurt most in the mornings. Fever + symptoms from 1/26/2016-1/30/2016. 100+ degrees only on first day. Extreme fatigue and weakness during the whole duration. Developed a strenuous cough 1/28/2016-1/30/2016. Discoloration of the skin 1/30/2016-2/1/2016.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025048, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 66 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1455701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025047, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 63-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 16 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Anaphylactoid reaction, Dyspnoea, Pyrexia, Throat tightness
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) on 17 December 2015. Manufacturer report number: 2015444928. This case involves an 18-year-old female patient who was vaccinated with a dose of MENACTRA (batch number, expiration date, dose, dose number, route and site of administration were  not reported) and a dose of TRUMENBA (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date at the same time, visit. The patient medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced fever, throat was closing up could not breathe which was like an anaphylactic response. It was reported that, on an unspecified date, the patient had to go to the emergency room. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. The reporter was not aware of causality of suspect vaccine with adverse event. Upon internal review, company assessed the event of it was like an anaphylactic response, throat constriction and could not breathe as serious and important medical event. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025046, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 20-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 24 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperatures was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025045, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 90-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 31 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025044, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 34-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025043, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 65-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025042, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 50-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 15 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025041, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 50-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 15 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Initial unsolicited report received from a physician on 20 August 2015. An 11-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of MENACTRA (batch number U4847BA) and a dose of ADACEL (batch number C4697AA, expiration date 19 February 2017) (dose, route and site of administration was not reported for vaccines) on an unspecified date. On an unspecified date after vaccination, the patient fainted. Patient was sent to the hospital for precautionary measures and to be monitored. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender: none.