chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: CSF white blood cell count increased, Cellulitis, Chills, Computerised tomogram abnormal, Headache
Clinical narrative: Case number PHHY2013US000635 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference no: 473271) website received on 02 Jan 2013 with the follow up received from Quality Assurance Department (reference numbers: 203005) on 05 Feb 2013 and non-significant follow up received on 11 Feb 2014. This report refers to a 63-year-old male patient. His medical history included high blood pressure. Concomitant medications included ALEVE, FLOMAX, fluoxetine and AMBIEN. He was vaccinated with FLUVIRIN (batch number 1206701) in his left arm, PNEUMOVAX (other manufacturer, batch number H009826) in his left arm and ZOSTAVAX (other manufacturer, batch number H013021) in his right arm on 24 Oct 2012. On 25 Oct 2012, he experienced aseptic meningitis with myalgia, headache, chills and fever. On 26 Oct 2012, he was hospitalized. On 28 Oct 2012, he experienced left arm cellulitis. His cerebro spinal fluid analysis revealed white blood cell 15 (9S, 91M), protein 74, glucose 57 and culture was negative. His blood cultures were negative and CT arm revealed cellulitis. The outcome of the events was reported as recovered. The causality assessment of the events was not reported. Based on the QA investigation performed QA department stated the FLUVIRIN (batch number 1206701) was manufactured in accordance with the approved internal procedures and is in compliance with cGMP requirements. QA department canceled QA investigation with reference number 203016 as it was opened in error. Non-significant follow up received from Quality Assurance Department (reference numbers: 203005 and 203016) on 08 Jan 2013: Updated QA reference numbers only. Follow up received on 05 Feb 2013 and 11 Feb 2014 was combined: Updated QA investigation summary. There was no new medically significant information received on 11 Feb 2014.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Meningitis aseptic, Myalgia, Pyrexia
Clinical narrative: Case number PHHY2013US000635 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference no: 473271) website received on 02 Jan 2013 with the follow up received from Quality Assurance Department (reference numbers: 203005) on 05 Feb 2013 and non-significant follow up received on 11 Feb 2014. This report refers to a 63-year-old male patient. His medical history included high blood pressure. Concomitant medications included ALEVE, FLOMAX, fluoxetine and AMBIEN. He was vaccinated with FLUVIRIN (batch number 1206701) in his left arm, PNEUMOVAX (other manufacturer, batch number H009826) in his left arm and ZOSTAVAX (other manufacturer, batch number H013021) in his right arm on 24 Oct 2012. On 25 Oct 2012, he experienced aseptic meningitis with myalgia, headache, chills and fever. On 26 Oct 2012, he was hospitalized. On 28 Oct 2012, he experienced left arm cellulitis. His cerebro spinal fluid analysis revealed white blood cell 15 (9S, 91M), protein 74, glucose 57 and culture was negative. His blood cultures were negative and CT arm revealed cellulitis. The outcome of the events was reported as recovered. The causality assessment of the events was not reported. Based on the QA investigation performed QA department stated the FLUVIRIN (batch number 1206701) was manufactured in accordance with the approved internal procedures and is in compliance with cGMP requirements. QA department canceled QA investigation with reference number 203016 as it was opened in error. Non-significant follow up received from Quality Assurance Department (reference numbers: 203005 and 203016) on 08 Jan 2013: Updated QA reference numbers only. Follow up received on 05 Feb 2013 and 11 Feb 2014 was combined: Updated QA investigation summary. There was no new medically significant information received on 11 Feb 2014.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Hypotension
Clinical narrative: Case number PHHY2013US032608 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 482056) on 04 Apr 2013 with a follow-up received from Quality Assurance department (reference number: 221060) on 04 Mar 2014. This report refers to an 18-year-old female patient. The patient had a reported history of fainting while receiving vaccinations (unspecified). She was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly on 07 Jan 2013. On the same day, 10 minutes post vaccination; the patient became lightheaded and allegedly had a seizure. The patient had to go to emergency room due to the events. Her blood pressure was reported to be 68/42. The outcome of events lightheaded and seizure was reported as complete recovery. The seriousness and causality of events was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1206901) 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 Quality assurance department on 04 Mar 2014: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Bedridden, Fatigue, Grand mal convulsion, Impaired driving ability, Nasal congestion
Clinical narrative: Case number PHHY2013US140374 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 503649) website on 03 Dec 2013, with the follow-up received from Quality Assurance Department (reference number: 268984) on 04 Mar 2014: This report refers to a 65-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly in the right arm on 25 Jan 2013. On the same day, within 4 hours of vaccination he was bedridden with extreme tiredness and cold like symptoms with congestion, runny nose and achiness. These symptoms persisted for five weeks and the patient was getting up from bed only to eat. On 10 Mar 2013, few days after getting up, he had a grand mal seizure. He went to emergency room and was placed on long term medication for seizures. It was reported that the driving license was revoked for four months. He had nerve problems with extremities and still had bouts with extreme tiredness. Outcome of the events was reported as not recovered as of 23 Sep 2013. Reporter assessed the case as serious (life threatening and permanent disability). No causality was reported for the events. Based on the investigation performed, QA department stated that FLUVIRIN (batch number: 1206901) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 268984) on 09 Dec 2013: Updated QA reference number only. Follow-up received from Quality Assurance Department (reference number: 268984) on 04 Mar 2014: Updated batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Nervous system disorder, Pain, Rhinorrhoea
Clinical narrative: Case number PHHY2013US140374 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 503649) website on 03 Dec 2013, with the follow-up received from Quality Assurance Department (reference number: 268984) on 04 Mar 2014: This report refers to a 65-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly in the right arm on 25 Jan 2013. On the same day, within 4 hours of vaccination he was bedridden with extreme tiredness and cold like symptoms with congestion, runny nose and achiness. These symptoms persisted for five weeks and the patient was getting up from bed only to eat. On 10 Mar 2013, few days after getting up, he had a grand mal seizure. He went to emergency room and was placed on long term medication for seizures. It was reported that the driving license was revoked for four months. He had nerve problems with extremities and still had bouts with extreme tiredness. Outcome of the events was reported as not recovered as of 23 Sep 2013. Reporter assessed the case as serious (life threatening and permanent disability). No causality was reported for the events. Based on the investigation performed, QA department stated that FLUVIRIN (batch number: 1206901) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 268984) on 09 Dec 2013: Updated QA reference number only. Follow-up received from Quality Assurance Department (reference number: 268984) on 04 Mar 2014: Updated batch review report.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Laboratory test, Oropharyngeal pain, Pharyngeal oedema, Sensation of foreign body
Clinical narrative: Tongue swelled and there were bumps on it, swelling in throat. Took Allegra felt alittle better. Two hours later lump and pain in throat took 25mg Benadryl. Throat closed over for 3 seconds couldn't breath went to ER by ambulance. ER doctors afraid to give me anything else in case I had an allergic reaction to Benadryl or epinephrine. The Benadryl kept the reaction from getting worse and I was sent home after a few hours.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swollen tongue, Tongue disorder
Clinical narrative: Tongue swelled and there were bumps on it, swelling in throat. Took Allegra felt alittle better. Two hours later lump and pain in throat took 25mg Benadryl. Throat closed over for 3 seconds couldn't breath went to ER by ambulance. ER doctors afraid to give me anything else in case I had an allergic reaction to Benadryl or epinephrine. The Benadryl kept the reaction from getting worse and I was sent home after a few hours.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Pharyngeal oedema, Pruritus, Throat tightness, Tryptase increased
Clinical narrative: Tongue swelled and there were bumps on it, swelling in throat. Took Allegra felt alittle better. Two hours later lump and pain in throat took 25mg Benadryl. Throat closed over for 3 seconds couldn't breath went to ER by ambulance. ER doctors afraid to give me anything else in case I had an allergic reaction to Benadryl or epinephrine. The Benadryl kept the reaction from getting worse and I was sent home after a few hours.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff arm and shoulder.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paralysis
Clinical narrative: Case number PHHY2014US007328 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference ID: 513396) website on 20 Jan 2014, with the follow-up received from Quality Assurance Department (QA reference number: 277426) on 27 Feb 2014: This report refers to a 34-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13424P) intramuscularly in to the left arm on 30 Oct 2013. On the same day after vaccination, she experienced pain and limb paralysis. This went away after a day or so and reappeared after one and a half weeks. She visited the emergency room (ER) following these events. Final outcome of the events was reported as condition unchanged as on 17 Nov 2013. No further information about seriousness and causality was reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 13424P) 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 (reference number: 277426) on 27 Feb 2014: Updated batch review report.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Nausea, Syncope
Clinical narrative: Case number PHHY2014US007404 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514672) website on 20 Jan 2014, with the follow-up received from Quality Assurance Department (QA reference number: 277421) on 27 Feb 2014: This report refers to an 11-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 13421P) in the left arm on 22 Nov 2013. On the same day, 10-15 minutes after vaccination, she became faint and dropped to floor. Responded immediately after and seemed fine with some nausea. She was transported for safety precautions and mother was with child. Outcome of the events was reported as completely recovered as of 22 Nov 2013. The seriousness and causality of the events were not reported. No more information was available. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 13421P) 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 (reference number: 277421) on 27 Feb 2014: Updated batch review report.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Audiogram abnormal, Deafness unilateral, Vertigo
Clinical narrative: Case number PHHY2014US007011 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 515307) on 20 Jan 2014 with a follow up batch review report received from quality assurance department (QA ref: 277428) on 27 Feb 2014: This report refers to a 50-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 13462P; expiry date; not reported) intramuscularly to left arm on 01 Nov 2013. On 02 Nov 2013, she had left ear profound hearing loss and vertigo. An audiogram performed on 06 Nov 2013 revealed confirmation to the event hearing loss. Reporter assessed the event hearing loss as serious (disability). Outcome of the events were reported as condition unchanged. Causality was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 13462P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department on 27 Feb 2014. Batch review report updated.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Condition aggravated, Decreased appetite, Diet refusal, Failure to thrive, Gastrooesophageal reflux disease
Clinical narrative: Patient slept through the night and next day. Lethargic, did not nurse or feed. After 24 hrs he then remained awake, hyper, and screaming for 24 straight hours with no sleep whatsoever. Refused food and drink. Screamed in pain. Reflux symptoms exacerbated. Day 3-day 6 he ate very little and reflux was much more severe than usual. Lost one pound leading to Failure to Thrive. Dropped off the growth chart for his age.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Hypersomnia, Insomnia, Lethargy, Pain, Psychomotor hyperactivity
Clinical narrative: Patient slept through the night and next day. Lethargic, did not nurse or feed. After 24 hrs he then remained awake, hyper, and screaming for 24 straight hours with no sleep whatsoever. Refused food and drink. Screamed in pain. Reflux symptoms exacerbated. Day 3-day 6 he ate very little and reflux was much more severe than usual. Lost one pound leading to Failure to Thrive. Dropped off the growth chart for his age.
Age: 0.7
Sex: M
Vaccine: HIBV
Symptoms: Screaming, Weight decreased
Clinical narrative: Patient slept through the night and next day. Lethargic, did not nurse or feed. After 24 hrs he then remained awake, hyper, and screaming for 24 straight hours with no sleep whatsoever. Refused food and drink. Screamed in pain. Reflux symptoms exacerbated. Day 3-day 6 he ate very little and reflux was much more severe than usual. Lost one pound leading to Failure to Thrive. Dropped off the growth chart for his age.
Age: 56.0
Sex: F
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Chills, Feeling cold, Headache, Loss of consciousness, Medication error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 56 year old female patient. Relevant medical history and concomitant medication were not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX23 lot # J011651, subcutaneously in the right arm. Dose was not provided. Other suspect therapies included ZOSTAVAX lot # J011338, subcutaneously in the right arm and DTAP-IPV lot # T25EG, intramuscularly in the right deltoid. Dose was not provided. On 17-DEC-2013, the patient experienced headache, freezing, chills and passed out after shower. The outcome of passed out after shower, freezing, chills and headache was reported as recovered/resolved in December 2013. The reporter causality was unknown. The event of 'passed out after shower' was considered medically significant upon internal review. This case is linked to the following cases by the same reporter: 1312USA010905, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, HEPA, PNC13
Symptoms: Convulsion, Crying, Dyskinesia, Electroencephalogram abnormal, Fatigue
Clinical narrative: This spontaneous report as received from the patient's grandmother refers to a 12 month old female patient who was born underweight and because of that she had a brain hemorrhage within 2 months after she was born. On 05-NOV-2013, the patient was vaccinated with a dose of an unspecified hepatitis A vaccine (assumed to be VAQTA) intramuscular, lot number J003719 expiry 27-SEP-2015 (dose not reported). Concomitant therapy included PREVNAR 13 (dose, route and indication were not reported) on 05-NOV-2013. On 18-NOV-2013, after vaccination the patient experienced seizures with head and limbs jerking to the side, the reporter also stated that the patient had developed a decrease in ability to do things. At the time of the report the patient was recovering from seizures with head and limbs jerking to the side and decreased in ability to do things. The patient sought medical attention on an unspecified date. The reporter stated that the patient was initially prescribed Levetiracetam (manufacturer unknown) 100 mg/0.8 ml twice daily and then was using Levetiracetam (manufacturer unknown) 100 mg/1.3 twice daily. The reporter stated also that a 24 hour electroencephalogram (EEG) test was performed on an unspecified date after the brain hemorrhage, but there were no signs of seizures before the vaccinations. Upon internal review seizures with head and limbs jerking to the side was considered as medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, HEPA, PNC13
Symptoms: Activities of daily living impaired, Convulsion, Dyskinesia, Performance status decreased
Clinical narrative: This spontaneous report as received from the patient's grandmother refers to a 12 month old female patient who was born underweight and because of that she had a brain hemorrhage within 2 months after she was born. On 05-NOV-2013, the patient was vaccinated with a dose of an unspecified hepatitis A vaccine (assumed to be VAQTA) intramuscular, lot number J003719 expiry 27-SEP-2015 (dose not reported). Concomitant therapy included PREVNAR 13 (dose, route and indication were not reported) on 05-NOV-2013. On 18-NOV-2013, after vaccination the patient experienced seizures with head and limbs jerking to the side, the reporter also stated that the patient had developed a decrease in ability to do things. At the time of the report the patient was recovering from seizures with head and limbs jerking to the side and decreased in ability to do things. The patient sought medical attention on an unspecified date. The reporter stated that the patient was initially prescribed Levetiracetam (manufacturer unknown) 100 mg/0.8 ml twice daily and then was using Levetiracetam (manufacturer unknown) 100 mg/1.3 twice daily. The reporter stated also that a 24 hour electroencephalogram (EEG) test was performed on an unspecified date after the brain hemorrhage, but there were no signs of seizures before the vaccinations. Upon internal review seizures with head and limbs jerking to the side was considered as medically significant. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Skin test, Skin test positive
Clinical narrative: Case number PHHY2014US024884, is an initial literature report received on 25 Feb 2014. The authors discussed about a case of patient with gelatin allergy and anaphylaxis to the influenza vaccine. This report refers to a 4-year-old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of influenza vaccine (unknown manufacturer, batch number: not reported) without any incidents in the past. On an unknown date, he was vaccinated with influenza vaccine (manufacturer and batch number: not reported). Within 15 minutes of vaccination he experienced anaphylaxis with watery eyes, sneezing, diffuse hives and vomiting. He was referred for evaluation of egg allergy. Later he was confirmed with egg allergy and also diagnosed with gelatin allergy. Treatment for the events was rendered with epinephrine and an emergency action plan was provided for him. The final outcome of the events was not reported. The author concluded that his parents were more acutely concerned about the egg allergy given the recent reaction to the influenza vaccine.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Blood immunoglobulin E decreased, Food allergy, Lacrimation increased, Skin test positive
Clinical narrative: Case number PHHY2014US024884, is an initial literature report received on 25 Feb 2014. The authors discussed about a case of patient with gelatin allergy and anaphylaxis to the influenza vaccine. This report refers to a 4-year-old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of influenza vaccine (unknown manufacturer, batch number: not reported) without any incidents in the past. On an unknown date, he was vaccinated with influenza vaccine (manufacturer and batch number: not reported). Within 15 minutes of vaccination he experienced anaphylaxis with watery eyes, sneezing, diffuse hives and vomiting. He was referred for evaluation of egg allergy. Later he was confirmed with egg allergy and also diagnosed with gelatin allergy. Treatment for the events was rendered with epinephrine and an emergency action plan was provided for him. The final outcome of the events was not reported. The author concluded that his parents were more acutely concerned about the egg allergy given the recent reaction to the influenza vaccine.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Sneezing, Urticaria, Vomiting
Clinical narrative: Case number PHHY2014US024884, is an initial literature report received on 25 Feb 2014. The authors discussed about a case of patient with gelatin allergy and anaphylaxis to the influenza vaccine. This report refers to a 4-year-old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of influenza vaccine (unknown manufacturer, batch number: not reported) without any incidents in the past. On an unknown date, he was vaccinated with influenza vaccine (manufacturer and batch number: not reported). Within 15 minutes of vaccination he experienced anaphylaxis with watery eyes, sneezing, diffuse hives and vomiting. He was referred for evaluation of egg allergy. Later he was confirmed with egg allergy and also diagnosed with gelatin allergy. Treatment for the events was rendered with epinephrine and an emergency action plan was provided for him. The final outcome of the events was not reported. The author concluded that his parents were more acutely concerned about the egg allergy given the recent reaction to the influenza vaccine.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Lacrimation increased, Serology test, Skin test, Skin test positive
Clinical narrative: Case number PHHY2014US024884, is an initial literature report received on 25 Feb 2014. The authors discussed about a case of patient with gelatin allergy and anaphylaxis to the influenza vaccine. This report refers to a 4-year-old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of influenza vaccine (unknown manufacturer, batch number: not reported) without any incidents in the past. On an unknown date, he was vaccinated with influenza vaccine (manufacturer and batch number: not reported). Within 15 minutes of vaccination he experienced anaphylaxis with watery eyes, sneezing, diffuse hives and vomiting. He was referred for evaluation of egg allergy. Later he was confirmed with egg allergy and also diagnosed with gelatin allergy. Treatment for the events was rendered with epinephrine and an emergency action plan was provided for him. The final outcome of the events was not reported. The author concluded that his parents were more acutely concerned about the egg allergy given the recent reaction to the influenza vaccine.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Food allergy, Lacrimation increased, Sneezing, Urticaria
Clinical narrative: Case number PHHY2014US024884, is an initial literature report received on 25 Feb 2014. The authors discussed about a case of patient with gelatin allergy and anaphylaxis to the influenza vaccine. This report refers to a 4-year-old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of influenza vaccine (unknown manufacturer, batch number: not reported) without any incidents in the past. On an unknown date, he was vaccinated with influenza vaccine (manufacturer and batch number: not reported). Within 15 minutes of vaccination he experienced anaphylaxis with watery eyes, sneezing, diffuse hives and vomiting. He was referred for evaluation of egg allergy. Later he was confirmed with egg allergy and also diagnosed with gelatin allergy. Treatment for the events was rendered with epinephrine and an emergency action plan was provided for him. The final outcome of the events was not reported. The author concluded that his parents were more acutely concerned about the egg allergy given the recent reaction to the influenza vaccine.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2014US024884, is an initial literature report received on 25 Feb 2014. The authors discussed about a case of patient with gelatin allergy and anaphylaxis to the influenza vaccine. This report refers to a 4-year-old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of influenza vaccine (unknown manufacturer, batch number: not reported) without any incidents in the past. On an unknown date, he was vaccinated with influenza vaccine (manufacturer and batch number: not reported). Within 15 minutes of vaccination he experienced anaphylaxis with watery eyes, sneezing, diffuse hives and vomiting. He was referred for evaluation of egg allergy. Later he was confirmed with egg allergy and also diagnosed with gelatin allergy. Treatment for the events was rendered with epinephrine and an emergency action plan was provided for him. The final outcome of the events was not reported. The author concluded that his parents were more acutely concerned about the egg allergy given the recent reaction to the influenza vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Skin papilloma, Wart excision
Clinical narrative: This spontaneous report as received from a registered nurse (who is also the patient's mother) via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (route, lot number and expiration date were not reported). No other vaccines were given on the same day as GARDASIL. No concomitant medication was reported. On an unknown date, the patient developed warts in the ear, unspecified if one ear or two. The patient was taken to ear, nose and throat (ENT) physician who surgically removed the warts on an unknown date. The outcome of the events were reported as recovered (date unspecified). The reporter considered warts in the ear to be related to GARDASIL. It was reported that physician was now serotyping the warts to determine the origin. Follow up information was received from a registered nurse concerning the 12 years old female patient. On 15-JUN-2012 the patient was vaccinated with the first dose of GARDASIL (lot # 672547/17445AA, expiration date: 13-SEP-2014) (dose, route and anatomical location were not reported). On 16-AUG-2012 the patient was vaccinated with the second dose of GARDASIL (lot # 0636AE, expiration date: 09-JAN-2015) (dose, route and anatomical location were not reported). On 27-DEC-2012 the patent was vaccinated with the third dose of GARDASIL (lot# H015030, expiration date: 28-MAR-2015) (dose, route and anatomical location were not reported). The registered nurse reported that on 29-NOV-2012 during an office visit otitis externa and impetigo were found. The patient received treatment with BACTROBAN and mupirocin 2%. On 12-APR-2013 the patient's mother called the physician's office and stated that there was still an issue with the daughter ears. Treatment with BACTROBAN and mupirocin 2% was continued. On 12-AUG-2013 ear lesion culture was done-the result was negative for any bacterial infection. The physician suggested the mother to take the patient to an ENT (ear, nose, throat) physician. The nurse was unsure if treatment with BACTROBAN and mupirocin 2% continued. She had no information about serotyping being done by brother in law or any surgical removal. The patient's outcome was not reported. The relatedness between the otitis externa, impetigo and the vaccination with GARDASIL was not reported. This case has been downgraded. The event of wart excision was considered to be a non serious adverse event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bacterial test negative, Impetigo, Otitis externa, Skin papilloma, Wart excision
Clinical narrative: This spontaneous report as received from a registered nurse (who is also the patient's mother) via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (route, lot number and expiration date were not reported). No other vaccines were given on the same day as GARDASIL. No concomitant medication was reported. On an unknown date, the patient developed warts in the ear, unspecified if one ear or two. The patient was taken to ear, nose and throat (ENT) physician who surgically removed the warts on an unknown date. The outcome of the events were reported as recovered (date unspecified). The reporter considered warts in the ear to be related to GARDASIL. It was reported that physician was now serotyping the warts to determine the origin. Follow up information was received from a registered nurse concerning the 12 years old female patient. On 15-JUN-2012 the patient was vaccinated with the first dose of GARDASIL (lot # 672547/17445AA, expiration date: 13-SEP-2014) (dose, route and anatomical location were not reported). On 16-AUG-2012 the patient was vaccinated with the second dose of GARDASIL (lot # 0636AE, expiration date: 09-JAN-2015) (dose, route and anatomical location were not reported). On 27-DEC-2012 the patent was vaccinated with the third dose of GARDASIL (lot# H015030, expiration date: 28-MAR-2015) (dose, route and anatomical location were not reported). The registered nurse reported that on 29-NOV-2012 during an office visit otitis externa and impetigo were found. The patient received treatment with BACTROBAN and mupirocin 2%. On 12-APR-2013 the patient's mother called the physician's office and stated that there was still an issue with the daughter ears. Treatment with BACTROBAN and mupirocin 2% was continued. On 12-AUG-2013 ear lesion culture was done-the result was negative for any bacterial infection. The physician suggested the mother to take the patient to an ENT (ear, nose, throat) physician. The nurse was unsure if treatment with BACTROBAN and mupirocin 2% continued. She had no information about serotyping being done by brother in law or any surgical removal. The patient's outcome was not reported. The relatedness between the otitis externa, impetigo and the vaccination with GARDASIL was not reported. This case has been downgraded. The event of wart excision was considered to be a non serious adverse event. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Severe swelling, itchiness, redness, hot to the touch, at the injection site. Low grade fever by the afternoon (100.4).
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Pain in stomach, nausea, vomiting.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Nasopharyngitis, Pneumonia, Vaccine positive rechallenge
Clinical narrative: This consumer report (initial receipt 27-Feb-2014) concerns a female patient whose past medical history included a cold which developed after receiving the flu vaccine on an unspecified date (see 2014041012). For the next two years on unspecified dates, the patient received a flu shot (manufacturer and batch number not reported). Each time after receiving the flu shot, she developed some type of flu or cold or pneumonia afterwards. Outcome was not reported.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a 21 year old female consumer refers to herself. The patient had no pertinent medical history or drug reactions/allergies. On 10-JUN-2011 the patient was vaccinated with the first dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. On 02-SEP-2011 the patient was vaccinated with the second dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. No concomitant medication was reported. The patient performed a "home pregnancy test" at an unspecified date after the second vaccination which showed that she was pregnant. LMP (Last Menstrual Period) was 31-JUL-2011 (estimated date) and EDD (estimated due date) was 06-MAY-2012 (estimated date). Trimester(s) of exposure were the first. No adverse effects were reported. No treatment was given for the event. The patient did not seek medical attention. Follow up information was received from a nurse. She indicated that per the patient's medical record, a history note taken on 17-JUN-2012 indicated that the patient had 3 prior pregnancies: in 2007, November 2010 and in December 2011. She reported that in December 2011, the patient experienced a 16 week spontaneous abortion. And the patient delivered a healthy baby at 39 weeks with no pregnancy complications on 18-FEB-2013 (which has been captured in MARRS 1403USA003044). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a 21 year old female consumer refers to herself. The patient had no pertinent medical history or drug reactions/allergies. On 10-JUN-2011 the patient was vaccinated with the first dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. On 02-SEP-2011 the patient was vaccinated with the second dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. No concomitant medication was reported. The patient performed a "home pregnancy test" at an unspecified date after the second vaccination which showed that she was pregnant. LMP (Last Menstrual Period) was 31-JUL-2011 (estimated date) and EDD (estimated due date) was 06-MAY-2012 (estimated date). Trimester(s) of exposure were the first. No adverse effects were reported. No treatment was given for the event. The patient did not seek medical attention. Follow up information was received from a nurse. She indicated that per the patient's medical record, a history note taken on 17-JUN-2012 indicated that the patient had 3 prior pregnancies: in 2007, November 2010 and in December 2011. She reported that in December 2011, the patient experienced a 16 week spontaneous abortion. And the patient delivered a healthy baby at 39 weeks with no pregnancy complications on 18-FEB-2013 (which has been captured in MARRS 1403USA003044). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous retrospective pregnancy report was received from a nurse concerning a now 24 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 10-JUN-2011 the patient was vaccinated with the first dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. On 02-SEP-2011 the patient was vaccinated with the second dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. No concomitant medication was reported. The nurse indicated that per the patient's medical record, a history note taken on 17-JUL-2012 indicated that the patient had 3 prior pregnancies: in 2007, November 2010 and in December 2011. She reported that in December 2011, the patient experienced a 16 week spontaneous abortion (which has been captured in MARRS# 1109USA01887). The patient delivered a healthy baby at 39 weeks with no pregnancy complications on 18-FEB-2013. The LMP and EDD were not known. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from a nurse concerning a now 24 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 10-JUN-2011 the patient was vaccinated with the first dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. On 02-SEP-2011 the patient was vaccinated with the second dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. No concomitant medication was reported. The nurse indicated that per the patient's medical record, a history note taken on 17-JUL-2012 indicated that the patient had 3 prior pregnancies: in 2007, November 2010 and in December 2011. She reported that in December 2011, the patient experienced a 16 week spontaneous abortion (which has been captured in MARRS# 1109USA01887). The patient delivered a healthy baby at 39 weeks with no pregnancy complications on 18-FEB-2013. The LMP and EDD were not known. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Encephalopathy
Clinical narrative: This spontaneous report as received from registered nurse refers to a female patient of unknown age (age reported as in her teen years). The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 24-OCT-2011 the patient was vaccinated with GARDASIL (route, dosage, lot# not reported). On 10-JUL-2012 the patient was vaccinated with third dose of GARDASIL which was administered at an unspecified county health department. No concomitant medications were reported. On an unknown date the patient diagnosed with encephalopathy (medically significant) after receiving her third dose of GARDASIL. It was unknown if the patient sought medical attention. The outcome of encephalopathy is unknown. It was also reported that legal issues involved-AE has sent to legal. Upon internal review the event encephalopathy was considered as serious due to medically significant. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site urticaria, Irritability, Local swelling, Pyrexia, Urticaria
Clinical narrative: Hives on legs and abdomen, fussy, swollen hands and feet, fever 101.7. Seen in office 3/4/14. Rx'd. Reported to infectious disease and hospital. 3/7/14 rash is clear. Swelling in hands and feet better. No respiratory distress.
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site rash, Injection site swelling, Ophthalmic herpes zoster
Clinical narrative: Injection site rash and swelling (left arm). Dx of shingles around right eye the day after vaccine given. Seen at walk in. They referred to Dr.
Age: 5.0
Sex: M
Vaccine: MEA
Symptoms: Decreased eye contact, Disturbance in social behaviour, Gait disturbance, Hyperacusis, Psychomotor hyperactivity
Clinical narrative: Fever 102. Decreased interaction, increased hyperactivity. Decreased eye contact, walking back into mom (never happened before). Plugging ears to tune out people/sound. Overall regression.
Age: 5.0
Sex: M
Vaccine: MEA
Symptoms: Pyrexia, Regressive behaviour
Clinical narrative: Fever 102. Decreased interaction, increased hyperactivity. Decreased eye contact, walking back into mom (never happened before). Plugging ears to tune out people/sound. Overall regression.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Blood count abnormal, Neutrophil count decreased
Clinical narrative: A report from a pharmacist concerns a 5 year old male. No relevant medical history or concomitant medications were reported. The patient received nasal FLUMIST on 21-Jan-2014. Pediatrician administered FLUMIST to a child and after routine blood test one week ago (approx 3 weeks after receiving FLUMIST) child was found to have a low neutrophil count. The outcome of the low neutrophil count was unknown. The company physician considered the low neutrophil count to be serious as an important medical event.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema, Intussusception, Ultrasound abdomen, Urinary system X-ray
Clinical narrative: Intussusception requiring hospitalization. Intussusception occurred 6 days after rotavirus, DTaP, HepB, IPV, Hib, OMP, PCV13.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Abnormal behaviour, Gaze palsy, Seizure like phenomena, Staring, Unresponsive to stimuli
Clinical narrative: Patient not himself, afebrile but has staring spells, rolling up of eye balls, like seizure activity, and not responding to his name being called. It happened the night after vaccine are given. Admitted in hospital.
Sex: U
Vaccine: HPV4
Symptoms: Haemoptysis, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient was vaccinated with the first and the second dose of GARDASIL (lot# unspecified) (dose, route and location unspecified) respectively on unknown date. On an unspecified date after vaccinations, the patient had lymph node swelling and began to cough up blood. At the time of report, the patient had not recovered from the events. The patient had sought medical attention via went to see the physician. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 8 1/2 x 10 cm circular indurated erythematous region on (R) ant thigh.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with incontinence, acid reflux, diabetes, high blood pressure and gastroesophageal reflux disease (GERD). The patient had drug reactions/allergies with penicillin. On 12-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX for shingles prevention (lot#, expiry date, route, dose and strength not reported. The patient presented with shingles the following day, on 13-SEP-2012. The patient stated that the evening of 13-SEP-2012 she experienced tingling on her neck and itchiness around her neck, head and eyes. She also experienced unspecified pain. The patient visited an unspecified emergency room on 13-SEP-2012. The patient was not admitted to the hospital. The patient was diagnosed with shingles on 13-SEP-2012. She was prescribed VALCYCLOVIR by a physician, to treat the shingles. The patient was fully recovered on an unspecified date. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Local swelling, Pain in extremity
Clinical narrative: The day after the vaccine was given, the arm was sore, swollen, and red all in her upper arm. She had chills. Told to use ibuprofen, ice, and elevate the limb. Will call to follow up.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Faeces discoloured, Frequent bowel movements, Gastroenteritis rotavirus
Clinical narrative: This spontaneous report as received from a physician refers to a 17 week old female patient. on 18-FEB-2014 the patient was vaccinated with the first dose of ROTATEQ, (lot#, expiry date, dose and route not reported) for vaccination. The physician reported that within 48 hours of receiving the first dose of ROTATEQ (dose, route, lot#, expiry date unspecified), also reported as 21-OCT-2013, the patient developed what was believed to be rotavirus gastroenteritis. The physician reported that the patient had many (8 to 10) white "cheesy" stools a day. The outcome of the events was reported as not recovered. The patient had sought medical attention by contacting office. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient of unknown age. The medical history and drug allergy/reactions were reported as none. The reporter stated that the patient received 3 doses of RECOMBINANT (manufacturer unknown) which were administered on 24-FEB-1993, 05-APR-1993 and 22-OCT-1993 respectively. The lot number and the expiry date were not provided. The concomitant medications were reported as none. On an unknown date, when the titers were done showed negative antibody titers. The outcome of negative antibody titers was unknown. The patient had sought medical attention by calling the physicians office. There was no PQC involved. Additional information has been requested.
Age: 0.9
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 11 month old female patient who 9 days before turning 12 months old on an unknown date, was vaccinated with her first doses of VARIVAX and MMR II (doses, routes and lot numbers not reported. No adverse effects were reported. Additional information has been requested.