chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as eual to or >12C for an estimated total time out of range of 72 hours. On 10-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -13C for an estimated total time out of range of 10 hours. On 16-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to 11C for an estimated total time out of range of 10 hours. On 25-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to 11C for an estimated total time out of range of 14 hours. On 07-OCT-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or <12C for an estimated total time out of range of 42.5 hours. On 08-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to currently 11 year female patient. The reporter stated that on an unknown date, the patient was administered the GARDASIL that was exposed to a temperature excursion (30 degrees Fahrenheit for 2 hours) (lot number and expiration date unknown), dose, route, anatomical location and dose number were not reported for an unknown indication. No adverse effect was reported. At the time of the report, date administered, vaccine lot number and expiration date, any treatment received, or possible hospital stay were not available. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Ultrasound antenatal screen
Clinical narrative: This consumer reports a possible exposure in utero. This female patient, age unknown started VARIVAX 1 vaccine on an unknown date in September 2013. The patient has no relevant medical history or concomitant medications. Her past drug history was unknown. On 20-DEC-2013, she had her menses that lasted until 23-DEC-2013. On 30-DEC-2013, she had another VARIVAX injection. On 17-JAN-2014 she had a blood test pregnancy that measured human chorionic gonadotropin 2-3 weeks. Also on 17-JAN-2014 she had an ultrasound showing the tubes were clear and a small sac but too early to see anything. As of 19-JAN-2014 it was unknown if she had her last VARIVAX on 30-DEC-2013 and she had a blood test pregnancy that measured human chorionic gonadotropin 2-3 weeks and an ultrasound showing the tubes were clear and a small sac but too early to see anything. She does not have the lot numbers or expiration dates of the VARIVAX. Additional information is not expected.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Ultrasound antenatal screen normal
Clinical narrative: This consumer reports a possible exposure in utero. This female patient, age unknown started VARIVAX 1 vaccine on an unknown date in September 2013. The patient has no relevant medical history or concomitant medications. Her past drug history was unknown. On 20-DEC-2013, she had her menses that lasted until 23-DEC-2013. On 30-DEC-2013, she had another VARIVAX injection. On 17-JAN-2014 she had a blood test pregnancy that measured human chorionic gonadotropin 2-3 weeks. Also on 17-JAN-2014 she had an ultrasound showing the tubes were clear and a small sac but too early to see anything. As of 19-JAN-2014 it was unknown if she had her last VARIVAX on 30-DEC-2013 and she had a blood test pregnancy that measured human chorionic gonadotropin 2-3 weeks and an ultrasound showing the tubes were clear and a small sac but too early to see anything. She does not have the lot numbers or expiration dates of the VARIVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 03-MAY-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX, lot # 672477/1604AA, expiration date: 13-JAN-2013) (dose and route were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 13-DEC-2013 at 17:30 ZOSTAVAX (Lot # J007858) was exposed to a temperature noted as equal to or > 12 degrees C for an estimated total time out of range of 9.75 hours. On 18-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # J007858, expiration date 28-SEP-2014) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or >12C for an estimated total time out of range of 72.0 hours. On 10-SEP-2013 at 17:30, ZOSTAVAX lot # J003360 was exposed to -13C for an estimated total time out of range of 10 hours. On 16-SEP-2013 at 17:30. ZOSTAVAX lot # J003360 was exposed to -14C for an estimated total time out of range of 10 hours. On 25-SEP-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to 11C for an estimated total time out of range of 14 hours. On 07-OCT-2013 at 07:30, ZOSTAVAX lot # J003360 was exposed to an exact T not recorded but noted as equal to or <12C for an estimated total time out of range of 42.5 hours. On 10-OCT-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood test, Fatigue, Hypersomnia, Insomnia
Clinical narrative: This spontaneous report as received from a 16 year old female consumer reporting on herself, with "pre-diabetes", but never diagnosed as diabetic and without drug reactions or allergies. On unspecified dates, the patient was vaccinated with dose 1 and 2 GARDASIL, 0.5 ml doses (0,2 and 6 months), intramuscular (lot number was not reported). In 2013, the patient received dose 3 GARDASIL. Secondary therapies were not reported. There was not concomitant medication. The consumer stated that on an unspecified date after her "second or third" GARDASIL dose, she stopped getting her period for 5-6 months. The gynecologist prescribed unspecified "pills" to induce menstruation after using for 10 days, which it did. The patient stated that "not too long ago", on an unspecified date she became unable to sleep at night. A week or two ago, in approximately 27-DEC-2013 the patient began having extreme fatigue during the day, leading to sleep for extended periods of time. In addition, the patient stated that recently she "shake" or tremble for short periods of time despite not being cold. At the time of the report, outcome for stopped getting her period was recovered. The outcome for the other events was not reported. On an unknown date, the patient performed a blood work and test urine (results not provided). The causality of the event was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Urine analysis
Clinical narrative: This spontaneous report as received from a 16 year old female consumer reporting on herself, with "pre-diabetes", but never diagnosed as diabetic and without drug reactions or allergies. On unspecified dates, the patient was vaccinated with dose 1 and 2 GARDASIL, 0.5 ml doses (0,2 and 6 months), intramuscular (lot number was not reported). In 2013, the patient received dose 3 GARDASIL. Secondary therapies were not reported. There was not concomitant medication. The consumer stated that on an unspecified date after her "second or third" GARDASIL dose, she stopped getting her period for 5-6 months. The gynecologist prescribed unspecified "pills" to induce menstruation after using for 10 days, which it did. The patient stated that "not too long ago", on an unspecified date she became unable to sleep at night. A week or two ago, in approximately 27-DEC-2013 the patient began having extreme fatigue during the day, leading to sleep for extended periods of time. In addition, the patient stated that recently she "shake" or tremble for short periods of time despite not being cold. At the time of the report, outcome for stopped getting her period was recovered. The outcome for the other events was not reported. On an unknown date, the patient performed a blood work and test urine (results not provided). The causality of the event was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to currently 15 year female patient. The reporter stated that on an unknown date, the patient was administered the GARDASIL that was exposed to temperature excursion (30 degrees Fahrenheit for 2 hours) (lot number and expiration date unknown), dose, route, anatomical location and dose number were not reported for an unknown indication. No adverse effect was reported. At the time of the report, date administered, vaccine lot number and expiration date, any treatment received, or possible hospital stay were not available. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to currently 15 year male patient. The reporter stated that on an unknown date, the patient was administered GARDASIL that was exposed to a temperature excursion (30 degrees Fahrenheit for 2 hours) (lot number and expiration date unknown), dose, route, anatomical location and dose number were not reported for an unknown indication. No adverse event was reported. At the time of the report, date administered, vaccine lot number and expiration date, any treatment received, or possible hospital stay were not available. This is one of several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Pruritus
Clinical narrative: Case number PHHY2013US000766, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 470340) website on 02 Jan 2013 and a follow-up received from Quality Assurance Department (QA, reference number, 208953) on 15 Jan 2014. This report refers to 57-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1207201) in the left arm on 16 Oct 2012. About 5-minutes after receiving vaccines she said that, she had intense itchiness, her chest was heavy and she was having a little difficulty breathing. The pharmacist gave 50mg of liquid diphenhydramine for reaction. She rested about 20-minutes and felt better. The outcome of the events was reported as completely recovered as of 17 Oct 2012. The causality and seriousness of the events was not reported. Based on the investigation performed, the QA department concluded that the FLUVIRIN (batch number: 1207201) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 208953) on 15 Jan 2014: Updated batch review report.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Gastrointestinal inflammation, Tremor, Vomiting projectile
Clinical narrative: Case number PHHY2013US012316 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 477170) on 08 Feb 2013, with a follow up received from the QA department on 15 Jan 2014. This report refers to a 59-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1207201) intramuscularly on left arm on 28 Nov 2012. On 01 Dec 2012, she experienced projectile vomiting, shaking, extreme diarrhea episodes and was diagnosed with gastroenteritis noninfectious. The patient had a visit to emergency room. Outcome of the events were reported as recovered. Seriousness and causality of the events was not reported. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1207201 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 15 Jan 2014: Updated batch report.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia
Clinical narrative: Case number PHHY2013US032657 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484296) website on 04 Apr 2013 with a follow up information received from quality assurance department (reference number: 221069) on 15 Jan 2014. This report refers to a 04 year old male patient. He was vaccinated with FLUVIRIN (batch number: 1206501, expiry date: 30 Jun 2013) intramuscularly into the left gluteus on 16 Jan 2012. On 25 Jan 2013, he repeated involuntary movements of neck and taken his tongue all the way from his mouth. The patient commented that he was not doing that purposefully but it just happened. The patient had to visit the emergency room due to the events. The outcome of the events was reported as condition unchanged as of 13 Feb 2013. The seriousness and causality were not reported. Based on the batch review performed, it was concluded that this FLUVIRIN batch number 1206501 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up information received from QA department on 15 Jan 2014: Updated batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Paralysis
Clinical narrative: Case number PHHY2013US044407 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 485831) web site on 06 May 2013 with a follow up information received from Quality Assurance department (reference number: 227425) on 15 Jan 2014. This report refers to 53 year old female patient. Her medical history was not reported. Concomitant medications included BIEST, progesterone, testosterone, Adreneplus 300 and LUNESTA. She was vaccinated with FLUVIRIN 2012/2013 (batch number: 1206501, expiry date: 30 Jun 2013) intramuscularly into left arm on 15 Jan 2013. On 17 Jan 2013, she experienced extremely sore muscle in upper arm lasting to present (6 weeks). It seemed to be a semi paralyzed muscle. It was just now easing. The outcome of the event was condition unchanged as of 28 Feb 2013. The seriousness and causality assessment was not reported. Based on the batch review performed, it was concluded that this FLUVIRIN 2012/2013 batch number 1206501 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirments. Follow up information received from QA department on 15 Jan 2014: Updated batch review report.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2013US140311 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503425) website on 03 Dec 2013 and a follow-up information was received from Quality Assurance department (reference number: 268598) on 06 Dec 2013 and another follow up was received from QA department on 14 Jan 2014. This report refers to a 72-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501, Expiry date: 31 Mar 2014) into left arm and PNEUMOVAX (other manufacturer, batch number: H014561) into right arm on 16 Sep 2013. On 17 Sep 2013, she experienced a red patch on skin that was about four inches away from the injection site. The red patch was two inches by about four inches which was very warm to the touch. She went to the emergency room and was diagnosed with cellulitis and received KEFLEX. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events. Batch review report (reference number: 268598) received from quality assurance department on 14Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1308501) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 268598) on 06 Dec 2013: Updated reference number only. Follow up received from Quality Assurance Department on 14 Jan 2014: Updated Batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Dysgeusia, Injection site pain, Musculoskeletal pain
Clinical narrative: Case number PHHY2013US140384 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 503662) on 03 Dec 2013 with a follow up report received from the quality assurance department (reference number: 270578) on 14 Jan 2014. This report refers to a 73 year old female patient. Her medical history was not reported and her concomitant medications include LEVOXYL and NITROSTAT. She was vaccinated with FLUVIRIN (Batch number: 1308501; Expiry date: 31 Mar 2014) intramuscularly to left arm on 19 Sep 2013 at 8 PM. Approximately one hour after vaccination, she complained of a bad taste in mouth (metallic) and nausea. Approximately at 9:30 PM, she complained of heaviness/burning/pressure in chest. She had an on/off pain started in the right shoulder which moved to the left shoulder. She moved to the hospital at 10:15 PM. She took a nitroglycerin tablet while on the way to hospital but it helped only slightly. She was admitted to hospital at 10:45 PM. The outcome of the events was reported as complete recovery on an unspecified date. The patient was at home and she was doing fine (no symptoms). Causality was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1308501 was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Non significant follow up received from the QA department on 16 Dec 2013: Updated QA reference number. Follow up information received from QA department on 14 Jan 2014: Updated batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Case number PHHY2013US140384 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 503662) on 03 Dec 2013 with a follow up report received from the quality assurance department (reference number: 270578) on 14 Jan 2014. This report refers to a 73 year old female patient. Her medical history was not reported and her concomitant medications include LEVOXYL and NITROSTAT. She was vaccinated with FLUVIRIN (Batch number: 1308501; Expiry date: 31 Mar 2014) intramuscularly to left arm on 19 Sep 2013 at 8 PM. Approximately one hour after vaccination, she complained of a bad taste in mouth (metallic) and nausea. Approximately at 9:30 PM, she complained of heaviness/burning/pressure in chest. She had an on/off pain started in the right shoulder which moved to the left shoulder. She moved to the hospital at 10:15 PM. She took a nitroglycerin tablet while on the way to hospital but it helped only slightly. She was admitted to hospital at 10:45 PM. The outcome of the events was reported as complete recovery on an unspecified date. The patient was at home and she was doing fine (no symptoms). Causality was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1308501 was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Non significant follow up received from the QA department on 16 Dec 2013: Updated QA reference number. Follow up information received from QA department on 14 Jan 2014: Updated batch review report.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Case number PHHY2013US140136, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504054) website on 03 Dec 2013 with a follow up report received from the quality assurance department (QA reference number: 268620) on 14 Jan 2014. This report refers to a 33-year-old female patient. Her current condition included diabetes. She was vaccinated with FLUVIRIN (batch number: 1308601, expiry date: 31 Mar 2014) in the right arm and PNEUMOVAX (batch number: H014196) in the left arm, intramuscularly on 21 Sep 2013. On 22 Sep 2013, she experienced local reaction erythema which progressed and radiated from injection site and was warm to touch. The patient visited the emergency room. The patient received KEFLEX. It was diagnosed as cellulitis. The outcome of the events reported as not recovered as of 24 Sep 2013. The seriousness and causality of the events were not reported. Based on the batch review investigation performed, it was concluded that FLUVIRIN (batch number: 1308601) was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up received from the quality assurance department (QA reference number: 268620) on 14 Jan 2014: updated batch review report.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site infection, Pyrexia
Clinical narrative: Case number PHHY2013US140085 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 504585) website on 03 Dec 2013 with a non-significant, follow-up received from the quality assurance department (reference number: 269537) on 11 Dec 2013 and another follow up was received from QA department on 14 Jan 2014. This case refers to 57-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number 1308501, Expiry date: 31 Mar 2014) and PNEUMOVAX (other manufacturer, batch number H014653) both intramuscularly in the left arm on 23 Sep 2013. On 25 Sep 2013 after vaccination he had infection at site of injection along with fever which required antibiotic therapy. Following the events the patient visited emergency room. The outcome of the events was reported as complete recovery as of 27 Sep 2013. The seriousness and causality assessment of the events was not reported. Batch review report (reference number: 269537) received from quality assurance department on 14Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1308501) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 269537) on 11 Dec 2013: Reference number was updated. Follow up received from Quality Assurance Department on 14 Jan 2014: Updated Batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2013US136948 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 504613) web site on 25 Nov 2013 with a follow up received from the Quality Assurance department (QA reference number: 267227) on 14 Jan 2014. This report refers to a 61-year-old female patient. Her medical history included hypertension, chronic obstructive pulmonary disorder, asthma and arthritis. Her concomitant medications included Vitamin D2 50,000, meloxicam 7.5 mg, hydrochlorothiazide 25 mg, amlodipine 10 mg and ADVAIR 250/50. She was vaccinated with FLUVIRIN (batch number: 1308601, expiry date: 31 Mar 2014) intramuscularly in to the left arm on 21 Sep 2013. On 23 Sep 2013, she returned to the pharmacy and reported pain, inflammation and warmth at the injection site and visited emergency room (ER). Pharmacist referred her to a physician who diagnosed the condition as cellulitis. The reaction was treated with cephalexin 500 mg TID for 10 days. Final outcome of the events was reported as condition unchanged as on 28 Sep 2013. No further information about causality and seriousness was reported. The batch review stated that based on the review performed, this batch was manufactured in accordance with the approved internal procedures and was in compliance with cGMP requirements. Follow up received from the quality assurance department on 14 Jan 2014: The batch review report was updated.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Palpitations, Pollakiuria, Tremor
Clinical narrative: Case number PHHY2013US140111 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 504627) web site on 03 Dec 2013 with a follow up information received from Quality Assurance (QA) department (reference number: 269282) on 13 Jan 2014. This report refers to an 80 year old male patient. His medical history was not reported. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1308601, expiry date: 31 Mar 2014) intramuscularly in to the left arm on 28 Sep 2013. On the same day after vaccination he experienced tremors, heart racing and increase in urination, weakness and lightheadedness. He received one shot of EPIPEN and went to emergency room (ER) where he received BENADRYL and Prednisone 20 mg two daily for 5 days. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1308601 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Non significant follow up received from Quality Assurance Department (reference number: 269282) on 10 Dec 2013: Updated QA reference number only. Follow up information received from QA department on 13 Jan 2014: Updated batch review report.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness, Dysarthria, Feeling cold, Hyperhidrosis, Hypotension
Clinical narrative: Case number PHHY2013US140202, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504737) website on 03 Dec 2013 and a follow-up information was received from Quality Assurance (QA) department (reference number: 269616) on 11 Dec 2013 and another follow up was received from QA department on 13 Jan 2014. This report refers to a 14-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308601, Expiry date: 31 Mar 2014) in left arm on 29 Sep 2013. He sat down in waiting room and approximately five minutes after vaccination, he experienced loss of vision, sweating, cold, slurred speech, and low blood pressure and became pale. He called emergency and was evaluated by paramedics. Later he went to hospital for further evaluation as advised by paramedics. The patient recovered on the same day. The seriousness and causality of the events were not reported. Batch review report (reference number: 269616) received from quality assurance department on 13 Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1308601) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 269616) on 11 Dec 2013: Updated QA reference number only. Follow up received from Quality Assurance Department on 13 Jan 2014: Updated Batch review report.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: Case number PHHY2013US140202, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504737) website on 03 Dec 2013 and a follow-up information was received from Quality Assurance (QA) department (reference number: 269616) on 11 Dec 2013 and another follow up was received from QA department on 13 Jan 2014. This report refers to a 14-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308601, Expiry date: 31 Mar 2014) in left arm on 29 Sep 2013. He sat down in waiting room and approximately five minutes after vaccination, he experienced loss of vision, sweating, cold, slurred speech, and low blood pressure and became pale. He called emergency and was evaluated by paramedics. Later he went to hospital for further evaluation as advised by paramedics. The patient recovered on the same day. The seriousness and causality of the events were not reported. Batch review report (reference number: 269616) received from quality assurance department on 13 Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1308601) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 269616) on 11 Dec 2013: Updated QA reference number only. Follow up received from Quality Assurance Department on 13 Jan 2014: Updated Batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Tendon calcification, Tendonitis, X-ray abnormal, X-ray limb abnormal
Clinical narrative: Case number PHHY2013US140241 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504788) website on 03 Dec 2013 with a follow up information received from quality assurance department (reference number: 269601) on 15 Jan 2014. This report refers to a 55 year old female patient. Her medical history was not reported. Her concomitant medications included isosorbide, tramadol, clonazepam, spironolactone, mirtazapine, meclizine and diltiazem. She was vaccinated with FLUVIRIN (batch number: 1307901, expiry date: 31 Mar 2014) intramuscularly in left arm on 03 Sep 2013. On 04 Sep 2013, she experienced pain in the shoulder which lasted for few days. She had X-ray of the shoulder and her physician said she had calcification tendonitis. The outcome of the events was reported as condition unchanged as of 30 Sep 2013. The seriousness and causality of the events were not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1307901 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up received from QA department on 15 Jan 2014: Updated  QA reference number and batch review report.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Loss of consciousness, Paraesthesia
Clinical narrative: Case number PHHY2013US140305 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 505062) website on 03 Dec 2013 and a follow-up received from Quality Assurance department (QA, reference number: 269294) on 13 Jan 2014. This report refers to a 49-year-old female patient. Her concurrent conditions included chronic obstructive pulmonary disease (COPD), hypertension, and allergy to morphine/codeine. Her concomitant medication was unknown. She was vaccinated with FLUVIRIN (batch number: 1308601, expiry date: 31 Mar 2014) intramuscularly into her right arm on 24 Sep 2013. On the same day, she lost her consciousness in parking lot approximately 20-minutes after vaccination. She checked her blood pressure and was found to be 146/104 with a pulse of 88. She said that this was high for her. She also stated a tingling in her left arm. The outcome of the events was reported as condition unchanged as of 24 Sep 2013. The causality and seriousness were not reported. No further information was available. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1308601) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 269294) on 10 Dec 2013: Updated QA reference number only. Follow-up received from Quality Assurance department on 13 Jan 2014: Updated batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Condition aggravated, Local swelling, Pallor, Rheumatoid arthritis
Clinical narrative: Case number PHHY2013US136994 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 507520) on 25 Nov 2013 and a follow-up received from Quality Assurance department (QA, reference number: 269049) on 14 Jan 2014. This report refers to a 54-year-old female patient. Current condition of this patient includes rheumatoid arthritis and allergies to ibuprofen. Past medication includes Aleve. Concomitant medication includes anastrozole 1mg and hydroxychloroquine 200 mg. She was vaccinated with FLUVIRIN (batch number: 1308501, expiry date: 31 Mar 2014) intramuscularly in the left arm on 30 Sep 2013. On 02 Oct 2013 her rheumatoid arthritis symptoms became worse. Her face became white, and she had swollen arm and tender, excruciating pain in joints. She went to emergency room due to the events. Her doctor did physical examination and ordered Medrol dose pack and Ultracet. Outcome of the events was reported as recovered as of 04 Oct 2013. Seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1308501) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 269049) on 14 Jan 2014: Updated batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Case number PHHY2013US136994 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 507520) on 25 Nov 2013 and a follow-up received from Quality Assurance department (QA, reference number: 269049) on 14 Jan 2014. This report refers to a 54-year-old female patient. Current condition of this patient includes rheumatoid arthritis and allergies to ibuprofen. Past medication includes Aleve. Concomitant medication includes anastrozole 1mg and hydroxychloroquine 200 mg. She was vaccinated with FLUVIRIN (batch number: 1308501, expiry date: 31 Mar 2014) intramuscularly in the left arm on 30 Sep 2013. On 02 Oct 2013 her rheumatoid arthritis symptoms became worse. Her face became white, and she had swollen arm and tender, excruciating pain in joints. She went to emergency room due to the events. Her doctor did physical examination and ordered Medrol dose pack and Ultracet. Outcome of the events was reported as recovered as of 04 Oct 2013. Seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1308501) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 269049) on 14 Jan 2014: Updated batch review report.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Pharyngeal oedema, Pruritus generalised, Throat tightness
Clinical narrative: Case number PHHY2014US000845 is an initial spontaneous report from a health care professional via vaccine adverse event reporting system (VAERS reference number: 510180) website on 06 Jan 2014 with a follow up information received from quality assurance department (reference number: 273897) on 16 Jan 2014. This case refers to a 49 year old patient female patient. Her medical history included severe sensitivities to lot of medications. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1307901, expiry date: 31 Mar 2014) in her right arm on 25 Oct 2013. On the same day about 2 hours after vaccination she became itchy from head to toe, had asthma attack and her throat started to swell and close. She gave herself anaphylactic medications at home and was fine. The outcome of the events was reported as completely recovered on an unspecified date. The seriousness and causality assessment of the events was unknown. Based upon the batch review performed, it was concluded that the FLUVIRIN batch number 1307901 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up information received from QA department on 16 Jan 2014: Updated batch review report.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain, Joint range of motion decreased, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: About 4 hours after injection began with sever pain in left shoulder and down biceps area. Also has significant decrease range of motion to the shoulder. Still having problems. Have been through physical therapy, steroid injection in shoulder. MRI shows inflammation in tendon, bursa, edema, and numerous parital wide thickness tears in rotator cuff.. Still having weakness and pain to arm. Orthopedist is suggesting surgery.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema, Pain in extremity, Rotator cuff syndrome, Tendonitis, Ultrasound joint
Clinical narrative: About 4 hours after injection began with sever pain in left shoulder and down biceps area. Also has significant decrease range of motion to the shoulder. Still having problems. Have been through physical therapy, steroid injection in shoulder. MRI shows inflammation in tendon, bursa, edema, and numerous parital wide thickness tears in rotator cuff.. Still having weakness and pain to arm. Orthopedist is suggesting surgery.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb
Clinical narrative: About 4 hours after injection began with sever pain in left shoulder and down biceps area. Also has significant decrease range of motion to the shoulder. Still having problems. Have been through physical therapy, steroid injection in shoulder. MRI shows inflammation in tendon, bursa, edema, and numerous parital wide thickness tears in rotator cuff.. Still having weakness and pain to arm. Orthopedist is suggesting surgery.
Age: 41.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain lower
Clinical narrative: Client says she developed stabbing, radiating lower abdominal pain starting nine days after 2nd HAB occurring sporadically x 1 mnth until she took herself off gluten product. Pain returned 1 mnth later. Client stopped dairy products - pain is gone. Saw nutritionist, OB-GYN, Gastroenterologist.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Chest X-ray abnormal, Hypoxia, Influenza, Influenza A virus test positive, Pneumonia
Clinical narrative: A report from a physician concerns a 4 year old male. Relevant medical history and concomitant diseases were unknown. On an unknown date, patient received nasal FLUMIST. Reporter stated that the patient was sick from 31-DEC-2013 with cough, shortness of breath, and vomiting. Patient was seen in the physician's office on 03-Jan-2014. At the office he was diagnosed with pneumonia, hypoxia, and tested positive for influenza A. He had increased temperature and oxygen saturation 80 percent. The physician recommended the child to be taken to the emergency room. Patient was hospitalized from 03-Jan-2014 to 05-Jan-2014 and treated for his symptoms. Reporter stated that she spoke to the patient's parents and was told that the patient was completely recovered and doing fine. The reporter assessed the flu A, pneumonia, vomiting, shortness of breath, and hypoxia to be serious due to hospitalization.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Pseudocroup
Clinical narrative: A report from a physician concerns a 4 year old male. Relevant medical history and concomitant diseases were unknown. On an unknown date, patient received nasal FLUMIST. Reporter stated that the patient was sick from 31-DEC-2013 with cough, shortness of breath, and vomiting. Patient was seen in the physician's office on 03-Jan-2014. At the office he was diagnosed with pneumonia, hypoxia, and tested positive for influenza A. He had increased temperature and oxygen saturation 80 percent. The physician recommended the child to be taken to the emergency room. Patient was hospitalized from 03-Jan-2014 to 05-Jan-2014 and treated for his symptoms. Reporter stated that she spoke to the patient's parents and was told that the patient was completely recovered and doing fine. The reporter assessed the flu A, pneumonia, vomiting, shortness of breath, and hypoxia to be serious due to hospitalization.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Blood test normal, Body temperature increased, Cough, Dyspnoea, Hypoxia
Clinical narrative: A report from a physician concerns a 4 year old male. Relevant medical history and concomitant diseases were unknown. On an unknown date, patient received nasal FLUMIST. Reporter stated that the patient was sick from 31-DEC-2013 with cough, shortness of breath, and vomiting. Patient was seen in the physician's office on 03-Jan-2014. At the office he was diagnosed with pneumonia, hypoxia, and tested positive for influenza A. He had increased temperature and oxygen saturation 80 percent. The physician recommended the child to be taken to the emergency room. Patient was hospitalized from 03-Jan-2014 to 05-Jan-2014 and treated for his symptoms. Reporter stated that she spoke to the patient's parents and was told that the patient was completely recovered and doing fine. The reporter assessed the flu A, pneumonia, vomiting, shortness of breath, and hypoxia to be serious due to hospitalization.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Influenza, Influenza A virus test positive, Influenza virus test positive, Malaise, Pneumonia
Clinical narrative: A report from a physician concerns a 4 year old male. Relevant medical history and concomitant diseases were unknown. On an unknown date, patient received nasal FLUMIST. Reporter stated that the patient was sick from 31-DEC-2013 with cough, shortness of breath, and vomiting. Patient was seen in the physician's office on 03-Jan-2014. At the office he was diagnosed with pneumonia, hypoxia, and tested positive for influenza A. He had increased temperature and oxygen saturation 80 percent. The physician recommended the child to be taken to the emergency room. Patient was hospitalized from 03-Jan-2014 to 05-Jan-2014 and treated for his symptoms. Reporter stated that she spoke to the patient's parents and was told that the patient was completely recovered and doing fine. The reporter assessed the flu A, pneumonia, vomiting, shortness of breath, and hypoxia to be serious due to hospitalization.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Vomiting
Clinical narrative: A report from a physician concerns a 4 year old male. Relevant medical history and concomitant diseases were unknown. On an unknown date, patient received nasal FLUMIST. Reporter stated that the patient was sick from 31-DEC-2013 with cough, shortness of breath, and vomiting. Patient was seen in the physician's office on 03-Jan-2014. At the office he was diagnosed with pneumonia, hypoxia, and tested positive for influenza A. He had increased temperature and oxygen saturation 80 percent. The physician recommended the child to be taken to the emergency room. Patient was hospitalized from 03-Jan-2014 to 05-Jan-2014 and treated for his symptoms. Reporter stated that she spoke to the patient's parents and was told that the patient was completely recovered and doing fine. The reporter assessed the flu A, pneumonia, vomiting, shortness of breath, and hypoxia to be serious due to hospitalization.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMRV, FLUN4
Symptoms: Croup infectious, Influenza A virus test positive, Lymphadenopathy, Pyrexia
Clinical narrative: A report has been received from a physician concerning a 5 year old male patient. Medical history of the patient was not reported. Concomitant medications included diphtheria toxoid, pertussis vaccine acellular, tetanus toxoid and poliomyelitis vaccine inactivated. The patient had received nasal FLUMIST quadrivalent started on 11-SEP-2013. The reporter stated that the patient was seen at ER on the early hours of 19-DEC-2013 as parents noticed submandibular swelling but was not hospitalized. The reporter stated that the patient had croup infection which started on 16-DEC-2013, fever and cough. Patient was tested positive for influenza A and was prescribed TAMIFLU and steroids for his symptoms. Action taken with FLUMIST was not reported. Patient recovered from the event of flu A, croup and submandibular swelling on 20-DEC-2013. The company physician considered the events flu A, croup and submandibular swelling to be serious due to important medical event.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMRV, FLUN4
Symptoms: Cough, Croup infectious, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: A report has been received from a physician concerning a 5 year old male patient. Medical history of the patient was not reported. Concomitant medications included diphtheria toxoid, pertussis vaccine acellular, tetanus toxoid and poliomyelitis vaccine inactivated. The patient had received nasal FLUMIST quadrivalent started on 11-SEP-2013. The reporter stated that the patient was seen at ER on the early hours of 19-DEC-2013 as parents noticed submandibular swelling but was not hospitalized. The reporter stated that the patient had croup infection which started on 16-DEC-2013, fever and cough. Patient was tested positive for influenza A and was prescribed TAMIFLU and steroids for his symptoms. Action taken with FLUMIST was not reported. Patient recovered from the event of flu A, croup and submandibular swelling on 20-DEC-2013. The company physician considered the events flu A, croup and submandibular swelling to be serious due to important medical event.