chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Contusion, Dyspnoea, Eye swelling, Inflammation, Lip swelling
Clinical narrative: I noticed small pink dots all over my sons back on Sunday evening before his bed time.  By Monday morning 3/10/14, the amount of dots had increased by 50% and had become more red and raised.  Now they were on his scalp, neck, back, chest, stomach, arms, legs, scrotum area. And they looked more like hives.  I gave my son 1/2 tsp of Benadryl around 10am.  The Benadryl did not seem to help because now the spots were getting larger and spreading rapidly.  They were looking more like blotches of hives.  I went to my pediatrician around 4pm on 3/10/14.  He said the rash was a common side effect of the MMR vaccine.  On 3/11/14, my son had a fever of about 100 degrees.  I gave him ibuprofen.  The rash started to spread and look more like a net.  His right eye was also swollen.  I continued the Benadryl therapy but it still didn't seem to work.  He had a fever all through the night.  3/11/14 evening my son had difficulty breathing and his face looked really puffy.  The rash was still very present and had started to move around his face. I also noticed areas that were purple that looked like bruises. 3/12/14 his left eye, cheeks and lips were swollen and had a fever of 102 degrees. The rash was all over his body and still had areas that looked like bruises.  I contacted my pediatrician and he suggested I take my son to the ER because he had never seen the rash also cause swelling in the face.  At the ER they gave him higher dose of Benadryl, 5cc and OraPed (Prednisone).  This seemed to reduce the inflammation drastically.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Swelling face
Clinical narrative: I noticed small pink dots all over my sons back on Sunday evening before his bed time.  By Monday morning 3/10/14, the amount of dots had increased by 50% and had become more red and raised.  Now they were on his scalp, neck, back, chest, stomach, arms, legs, scrotum area. And they looked more like hives.  I gave my son 1/2 tsp of Benadryl around 10am.  The Benadryl did not seem to help because now the spots were getting larger and spreading rapidly.  They were looking more like blotches of hives.  I went to my pediatrician around 4pm on 3/10/14.  He said the rash was a common side effect of the MMR vaccine.  On 3/11/14, my son had a fever of about 100 degrees.  I gave him ibuprofen.  The rash started to spread and look more like a net.  His right eye was also swollen.  I continued the Benadryl therapy but it still didn't seem to work.  He had a fever all through the night.  3/11/14 evening my son had difficulty breathing and his face looked really puffy.  The rash was still very present and had started to move around his face. I also noticed areas that were purple that looked like bruises. 3/12/14 his left eye, cheeks and lips were swollen and had a fever of 102 degrees. The rash was all over his body and still had areas that looked like bruises.  I contacted my pediatrician and he suggested I take my son to the ER because he had never seen the rash also cause swelling in the face.  At the ER they gave him higher dose of Benadryl, 5cc and OraPed (Prednisone).  This seemed to reduce the inflammation drastically.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site joint pain, Synovitis
Clinical narrative: Pain Right elbow diagnosed as Transient Synovitis by PT.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large red, hot swollen area around injection site, covering this entire upper thigh.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Intracranial pressure increased, Laboratory test normal, Lumbar puncture abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: About 30 minutes after receiving vaccine severe pain in head started unrelieved by normal migraine medications which have always worked 100% of the time. Saw my PCP once. Was seen in the emergency department twice. Was on home IV DHE therapy. Admitted the to hospital for 48 hours. Had a lumbar puncture which revealed intracranial hypertension.
Age: 0.33
Sex: F
Vaccine: DTAP, DTAPIPV, PNC13, RVX
Symptoms: Abdominal X-ray, Constipation, Ileus, Vomiting, X-ray abnormal
Clinical narrative: Began vomiting at 4pm. Symptoms worsens with increasing episodes and frequency of vomiting. Went to ER at 7pm with the diagnosis of constipation. Abdominal xray findings revealed an ileus. She had no prior problems with vomiting or constipation prior to administration of vaccines.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Pt received Pneumovax 3/10/2014 and returned to pharmacy on 3/12/2014 and reported adverse reactions from the vaccine. Pt was experiencing swelling at the injection site as well as itching around the injection site. She also reported pain to the point she had limited mobility and unable to take care of her child. She was instructed to take ibuprofen for pain and swelling, cold compress on areas of inflammation, and to use Benadryl for the itching. If symptoms have not resolved in 24-48 hours she should make an appointment with her physician.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Pt received Pneumovax 3/10/2014 and returned to pharmacy on 3/12/2014 and reported adverse reactions from the vaccine. Pt was experiencing swelling at the injection site as well as itching around the injection site. She also reported pain to the point she had limited mobility and unable to take care of her child. She was instructed to take ibuprofen for pain and swelling, cold compress on areas of inflammation, and to use Benadryl for the itching. If symptoms have not resolved in 24-48 hours she should make an appointment with her physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 10-MAR-2014, the patient was vaccinated with a dose of PEDVAXHIB, 0.5 ml intramuscularly, (lot number and expiration date were not provided), which was exposed to a temperature of 47F for 10 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 07-MAR-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB, 0.5 ml intramuscular, (lot number and expiration date were not provided), which was exposed to a temperature of 47F for 10 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Discomfort, Herpes zoster, Laboratory test, Pain
Clinical narrative: This spontaneous report as received from a 66 year old female consumer with sulfa drugs allergy reporting on herself. ON 30-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included ACTOS, NOVOLIN, CELEBREX, NEXIUM, lithium, PROZAC, lisinopril (manufacturer unknown) and TOPAMAX. The patient reported that on 05-MAR-2014, she started experiencing mild discomfort which turned into horrible pain. The consumer reported that she went to the emergency room on 06-MAR-2014. While in hospital the patient had a CAT scan performed (results not provided) along with other tests. The patient stated that an unspecified healthcare provider in the hospital instructed her to go to her physician's office for further advice. The patient left the hospital on 06-MAR-2014 and saw her physician the same afternoon. The patient stated that her physician diagnosed her with shingles. The patient stated that her physician noticed she had a rash on her back. The patient prescribed acetaminophen, PERCOCET, morphine, DILAUDID and acyclovir. The patient stated that the rash on her back was still present and she was still experiencing severe pain. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a 66 year old female consumer with sulfa drugs allergy reporting on herself. ON 30-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included ACTOS, NOVOLIN, CELEBREX, NEXIUM, lithium, PROZAC, lisinopril (manufacturer unknown) and TOPAMAX. The patient reported that on 05-MAR-2014, she started experiencing mild discomfort which turned into horrible pain. The consumer reported that she went to the emergency room on 06-MAR-2014. While in hospital the patient had a CAT scan performed (results not provided) along with other tests. The patient stated that an unspecified healthcare provider in the hospital instructed her to go to her physician's office for further advice. The patient left the hospital on 06-MAR-2014 and saw her physician the same afternoon. The patient stated that her physician diagnosed her with shingles. The patient stated that her physician noticed she had a rash on her back. The patient prescribed acetaminophen, PERCOCET, morphine, DILAUDID and acyclovir. The patient stated that the rash on her back was still present and she was still experiencing severe pain. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a 6 month old patient who on 01-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.62
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a 7 month old patient who on 12-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Merck) injection 0.5 ml, with lot # J005688 and expired date 07-MAY-2015, subcutaneously. On an unknown date of October 2013, VARIVAX (Merck) was actually exposed to temperature below 5 F, 4C for 288 hours (12 days). On an unknown date patient received one dose of the VARIVAX (Merck). No adverse effect was reported. The outcome of VARIVAX (Merck) was exposed to 4C for 288 hours and no adverse event was unknown. The reporter did not provide causality of VARIVAX (Merck) to event. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Dementia Alzheimer's type
Clinical narrative: This spontaneous report as received from the patient's father refers to his son of unknown age. The father reported on an unknown date the patient might was vaccinated with a shingles vaccine (unspecified dose/frequency, name and manufacturer). In 2013 ("within the past year"), the patient developed Alzheimer's disease within past year, after receiving shingles vaccine. The outcome of Alzheimer's disease is unknown. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from an office manager, refers to an approximately 5 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On an unspecified date in March 2001, when the patient was a neonate, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot number were not provided). On an unspecified date in April 2001, the patient was vaccinated with the second dose of RECOMBIVAX HB, 5 microgram (route and lot number were not provided). On an unspecified date in June 2006, the patient was vaccinated with the third dose of RECOMBIVAX HB, 5 microgram (route and lot number were not provided). On an unspecified date in March 2014, the patient was vaccinated with a fourth dose of RECOMBIVAX HB, 10 microgram (route and lot number were not provided). It was noted that the patient's weight in March 2014 was 189 pounds. No co-suspect or concomitant therapies were reported. At the time of the report, no adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 07-MAR-2014, the patient was vaccinated with a dose of PEDVAXHIB, 0.5 ml intramuscularly, (lot number and expiration date were not provided), which was exposed to a temperature of 47F for 10 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 10-MAR-2014, the patient was vaccinated with a dose of LIQUID PEDVAQXHIB, 0.5 ml intramuscularly, (lot number and expiration date were not provided), which was exposed to a temperature of 47F for 10 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pallor
Clinical narrative: Patient turned pale 10-15 min after vaccines were administered. No breathing problems. Oxygen saturation 98% - pt was stable. Kept in observation for 30 more minutes. Pulse - 140, Respirations 42.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 07-MAR-2014, the patient was vaccinated with a dose of LIQUID PEDVAQXHIB, 0.5 ml intramuscularly, (lot number and expiration date were not provided), which was exposed to a temperature of 47F for 10 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.24
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Two Hibs given on the same day - one separately and one included in the PENTACEL.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Pt started having rash, the same day she got PNEUMOVAX; that evening rash went all around inj area and under armpit. Welts (several) appeared next day.
Age: 8.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 8 year old patient. On 13-AUG-2013 the patient was vaccinated with the first dose of GARDASIL, 0.5ml, intramuscular (lot#, expiry date, frequency and indication not reported), when the patient was 8 years 6 months of age. On 14-OCT-2013, the patient was vaccinated with the second dose of GARDASIL, 0.5ml, intramuscular (lot#, expiry date, frequency and indication not reported), when the patient was 8 years 8 months of age. No adverse effects reported. It was reported if the patient had sought medical attention. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt developed redness, pain, swelling, and warmth to vaccine site day after vaccine administered.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Skin lesion
Clinical narrative: 4 x 4 cm indurated/erythematous lesion (L) deltoid.
Age: 33.0
Sex: U
Vaccine: FLU3, PPV, FLUC3, PPV
Symptoms: Cellulitis, Pyrexia, Skin warm
Clinical narrative: Cellulitis, fever > 103, warmth at the infection site, possible staph infections.
Age: 33.0
Sex: U
Vaccine: FLU3, PPV, FLUC3, PPV
Symptoms: Cellulitis, Injection site warmth, Pyrexia
Clinical narrative: Cellulitis, fever > 103, warmth at the infection site, possible staph infections.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a 4 month old patient who on 12-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a 6 month old patient on 14-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a 9 weeks old patient who on 13-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a 4 month old patient who on 12-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This  spontaneous report as received from a Registered Nurse concerning a 6 month old patient who on 05-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning a 6 month old patient who on 11-NOV-2013 was vaccinated with an expired dose of ROTATEQ lot # 0579AE, exp date reported 27-OCT-2013, oral (dose not provided). No adverse effect was observed. This is one of several reports received from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Throat tightness
Clinical narrative: Case number PHHY2013US020862, is an initial report received from Vaccine Adverse Event Reporting System (VAERS reference number: 480429) website on 04 Mar 2013 with follow-up information from the Quality Assurance Department (reference number: 227389) on 08 May 2013 and 05 Mar 2014. This report refers to a 51-year-old female patient. Her medical history included anaphylaxis with LEVAQUIN on an unspecified date in Nov 2012 and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly on the right arm on 05 Jan 2013 at 16:50 hrs. On the same day of vaccination at 16:55, she complained of flushing from her chest going up to her face and she also complained of dizziness and throat tightness. She was asked to lie down on the floor and called 911. At 17:00, she felt better but still felt tight. She was administered one 0.3mg EPIPEN into upper right thigh and at 17:05 paramedics arrived. The event outcome was reported as complete recovery. The seriousness and causality of the events was not reported. Based on the investigation performed by the QA department, it was confirmed that FLUVIRIN batch number 1206901, was manufactured in accordance with approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from a Quality Assurance Department (reference number: 227389) on 08 May 2013: Updated QA reference number. Follow-up received from the Quality Assurance Department (reference number: 227389) on 05 Mar 2014: Updated batch review report.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eye pruritus, Headache, Laryngitis, Oropharyngeal pain
Clinical narrative: Case number PHHY2014US001183 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 508544) website on 06 Jan 2014 and a follow up received from Quality Assurance Department (QA, reference number: 274884) on 07 Mar 2014. This report refers to a 31-year-old female patient. Her medical history and concomitant medications were not reported. On 14 Oct 2013, she was vaccinated with FLUVIRIN (batch number: 1309301, Expiry date: 30 Apr 2014) intramuscularly in the right arm. On the same day after vaccination, she developed headache which lasted throughout the day on 14 Oct 2013 as well as on 15 Oct 2013. On 16 Oct 2013 she complained that her eyes were itchy all day. On 17 Oct 2013, his throat started to bother him. From 18 Oct 2013 to 21 Oct 2013, across all these days, she developed laryngitis. On 20 Oct 2013 she also developed a very heavy feeling in her chest. The event outcome was reported as condition unchanged as of 21 Oct 2013. The seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309301) 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: 274884) on 07 Mar 2014: Updated batch review report.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Malaise
Clinical narrative: Case number PHHY2014US001313 is an initial spontaneous report received from a pharmacist via the Vaccine Adverse Event Reporting System (VAERS reference number: 509773) website on 06 Jan 2014 and a follow up report from the QA department received on 07 Mar 2014. This report refers to a 62-year-old female patient. Her concomitant medications and medical history was not reported. On 26 Oct 2013 at 2:30 pm, she was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in the left arm. On the same date after vaccination, she returned to pharmacy counter at 2:40pm complaining of not feeling well. She then complained of feeling like it was hard to swallow. Her blood pressure was monitored at 2:49pm and it was 130/80. She was administered EPI-PENS. She complained that, it was still hard to swallow but she did not have difficulty in breathing. Following these events on the same date, she was taken to the emergency room. The event outcome was reported as condition unchanged as on 26 Oct 2013. The seriousness and causality of the events were not reported. Batch review report (reference number: 275089) received from quality assurance department on 07 Mar 2014: Based on the document review, it was stated that the concerned FLUVIRIN batch number 1309301 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 07 Mar 2014: Batch review report from the QA department was updated.
Sex: U
Vaccine: FLU3
Symptoms: Condition aggravated, Neck pain, Pain
Clinical narrative: Case number PHHY2014US012710, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513677) website on 03 Feb 2014 with a follow up information received from the quality assurance department (QA number: 279556) on 07 Feb 2014 and another follow-up information was received from Quality Assurance Department (reference number: 279556) on 07 Mar 2014. This report refers to a patient of an unknown age and gender. The patient's current condition included fibromyalgia. The patient was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly on 26 Oct 2013. On 28 Oct 2013, 48 hours after vaccination the patient experienced a flare-up of fibromyalgia and symptoms described as neck and all body pain. It took approximately 2 weeks for the patient to get recovered. The seriousness and causality of the events were not reported. Batch review report (reference number: 279556) received from quality assurance department on 07 Mar 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1309701) 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 on 07 Feb 2014: The QA reference number (279556) was updated. Follow up received from Quality Assurance Department on 07 Mar 2014: Updated batch review report.
Age: 53.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US012758 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 514205) website on 03 Feb 2014 with a batch review report (QA reference number: 279132) received from quality assurance department on 07 Mar 2014: This report refers to a 53-year-old female patient. Her concurrent conditions included blood pressure abnormal and anxiety. Concomitant medications included TOPAMAX, unspecified medications for blood pressure and anxiety. She was vaccinated with FLUVIRIN (batch number: 1310201, Expiry date: 31 May 2014) intramuscularly into right arm on 18 Nov 2013. On the same day, she was vaccinated with INFANRIX (batch number: 2RX59) intramuscularly into left arm. On 19 Nov 2013, one day, after vaccinations, she experienced Bell's Palsy. Outcome of the event was reported as condition unchanged as of 21 Nov 2013. Seriousness and causality of the event was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1310201) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No further information was available. Follow-up received from QA department on 07 Mar 2014: Batch review report updated.
Age: 18.0
Sex: U
Vaccine: FLU3
Symptoms: Anxiety, Syncope
Clinical narrative: Case number PHHY2014US012819 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 514497) on 03 Feb 2014 and a follow-up information was received from Quality Assurance Department (reference number: 279124) on 07 Mar 2014. This report refers to an 18-years-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinate with FLUVIRIN (batch number: 1310101) intramuscularly on 21 Nov 2013. On the same day after vaccination the patient fainted. It was reported that the patient had needle anxiety. The outcome was reported as complete recovery. The seriousness and causality of the event were not reported. Batch review report (reference number: 279124) received from quality assurance department on 07 Mar 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1310101) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from Quality Assurance Department on 07 Mar 2014: Updated batch review report.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Rash, Wheezing
Clinical narrative: Case number PHHY2014US013473 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS, reference number: 515618) website on 03 Feb 2014 with a follow up report received from quality assurance department (reference number: 279339) on 07 Mar 2014. This report refers to an 18 year old female patient. Her current condition included polycystic ovary syndrome. She had no known drug allergy. Her concomitant medication included oral contraception. She was vaccinated with FLUVIRIN (batch number: 1309701, expiry date: 31 May 2014) intramuscularly into left arm on 20 Nov 2013. On 23 Nov 2013, she experienced itching which progressed to rash. Subsequently, within next 2 days she experienced wheezing and shortness of breath. She was taken to emergency room for medical support. Treatment was rendered with prednisone which was continued till the date of reporting. The outcome was reported as condition unchanged as of 04 Dec 2013. The causality and seriousness were not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1309701 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received from quality assurance department on 07 Mar 2014: Updated batch review report and expiry date.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Case number PHHY2014US013271 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 515876) website on 03 Feb 2014 with a follow up report received from quality assurance department (reference number: 279326) on 07 Mar 2014. This report refers to a 68 year old male patient. His medical history included asthma. His concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1310101, expiry date: 31 May 2014) intramuscularly into the right arm on 07 Dec 2013. On the same day after vaccination, he experienced breathing problems. Later he experienced another episode of breathing problems. It was reported that it was not anaphylaxis. Treatment for the event was rendered with BENADRYL. After receiving the treatment he was symptom free for 40 minutes. The final outcome of the event was complete recovery. The seriousness and causality of the event was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1310101 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received from quality assurance department on 07 Mar 2014: Updated batch review report and vaccine expiry date. QA reference number 279326 was closed.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Headache, Muscle spasms, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 (subcutaneous, left arm, lot J011651, exp date 22-AUG-2014). Co-suspect therapies included ZOSTAVAX (subcutaneous, left arm, lot J011338 exp date 19-DEC-2014) administered on 17-DEC-2013. On the same date the patient experienced cramping, fever (99.8), headache, vomiting, nausea and chills. The patient recovered on an unknown date in December 2013. The relatedness was not provided. This case is linked to 1312USA010905, 1403USA003215, 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 and 1403USA003252. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 (subcutaneous, left arm, lot J011651, exp date 22-AUG-2014). Co-suspect therapies included ZOSTAVAX (subcutaneous, left arm, lot J011338 exp date 19-DEC-2014) administered on 17-DEC-2013. On the same date the patient experienced cramping, fever (99.8), headache, vomiting, nausea and chills. The patient recovered on an unknown date in December 2013. The relatedness was not provided. This case is linked to 1312USA010905, 1403USA003215, 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 and 1403USA003252. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 59 year old female patient. On 17-DEC-2013, the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneous in the right arm. Other suspect therapies included ZOSTAVAX and BOOSTRIX. On 17-DEC-2013, 1 day after onset of therapy the patient experienced the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly and flu-like symptoms. The outcome of flu-like symptoms was reported as recovered/resolved. The outcome of the nurse reported that all patients received PNEUMOVAX 23, but that some of the patients may also have received ZOSTAVAX concomitantly was unknown. The reporter did not assess the relationship between flu-like symptoms and PNEUMOVAX 23 and ZOSTAVAX. The case is related to case: 1312USA010905, 1403USA003215, 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, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253 (same reporter link). Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Fatigue, Heart rate increased, Palpitations
Clinical narrative: Case number PHHY2014US027588 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 518495) on 06 Mar 2014. This report refers to a 56 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014, (batch number: not reported) intramuscularly in the left arm on 03 Jan 2014. On 04 Jan 2014, the patient experienced shortness of breath, rapid heartbeat, strong heart palpitations and fatigue (easily winded lasted all day). The outcome of the event was reported as complete recovery as of 06 Jan 2014. The seriousness and the causality of the events were not reported.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Fatigue, Headache, Increased viscosity of bronchial secretion, Influenza like illness
Clinical narrative: Case number PHHY2014US027617 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518728) website on 06 Mar 2014. This case refers to a 49 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13475P) intramuscularly. Two days after the vaccination, he had a mild sore throat and tiredness. As time went on, he developed flu like symptoms. On the tenth day after vaccination, he had sneezing, headache, fever, chills, congestion, congestion with thick yellow sputum. The patient did not recover from the events at the time of this report. The seriousness and causality were not reported.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Sneezing
Clinical narrative: Case number PHHY2014US027617 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518728) website on 06 Mar 2014. This case refers to a 49 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13475P) intramuscularly. Two days after the vaccination, he had a mild sore throat and tiredness. As time went on, he developed flu like symptoms. On the tenth day after vaccination, he had sneezing, headache, fever, chills, congestion, congestion with thick yellow sputum. The patient did not recover from the events at the time of this report. The seriousness and causality were not reported.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Sneezing
Clinical narrative: Case number PHHY2014US027617 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518728) website on 06 Mar 2014. This case refers to a 49 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13475P) intramuscularly. Two days after the vaccination, he had a mild sore throat and tiredness. As time went on, he developed flu like symptoms. On the tenth day after vaccination, he had sneezing, headache, fever, chills, congestion, congestion with thick yellow sputum. The patient did not recover from the events at the time of this report. The seriousness and causality were not reported.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Sputum discoloured
Clinical narrative: Case number PHHY2014US027617 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518728) website on 06 Mar 2014. This case refers to a 49 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13475P) intramuscularly. Two days after the vaccination, he had a mild sore throat and tiredness. As time went on, he developed flu like symptoms. On the tenth day after vaccination, he had sneezing, headache, fever, chills, congestion, congestion with thick yellow sputum. The patient did not recover from the events at the time of this report. The seriousness and causality were not reported.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Flushing, Immediate post-injection reaction, Injection site warmth, Nausea
Clinical narrative: Case number PHHY2014US027587 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 518842) website on 06 Mar 2014. This report refers to a 44-year-old female patient. Her medical history included ulcerative (chronic) enterocolitis and allergic to butters, coconut oil, fentanyl, neomycin, ROCEPHIN, ciprofloxacin, gabapentin, ketorolac, phenergan, REGLAN. She was vaccinated with FLUVIRIN (batch number: 1310201) into left arm on 09 Jan 2014. She complained of feeling flushed and warmth at the injection site a few seconds after the vaccination. She also experienced difficulty breathing, shortness of breath and lump in the throat. She was treated with 0.3 ml of EPI-PEN. She continued to experience the lump in the throat for additional 10 minutes. Physician was at the site and 3 mg of ZOFRAN was given orally for nausea. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Sensation of foreign body
Clinical narrative: Case number PHHY2014US027587 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 518842) website on 06 Mar 2014. This report refers to a 44-year-old female patient. Her medical history included ulcerative (chronic) enterocolitis and allergic to butters, coconut oil, fentanyl, neomycin, ROCEPHIN, ciprofloxacin, gabapentin, ketorolac, phenergan, REGLAN. She was vaccinated with FLUVIRIN (batch number: 1310201) into left arm on 09 Jan 2014. She complained of feeling flushed and warmth at the injection site a few seconds after the vaccination. She also experienced difficulty breathing, shortness of breath and lump in the throat. She was treated with 0.3 ml of EPI-PEN. She continued to experience the lump in the throat for additional 10 minutes. Physician was at the site and 3 mg of ZOFRAN was given orally for nausea. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Flushing, Injection site warmth, Nausea, Sensation of foreign body
Clinical narrative: Case number PHHY2014US027587 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 518842) website on 06 Mar 2014. This report refers to a 44-year-old female patient. Her medical history included ulcerative (chronic) enterocolitis and allergic to butters, coconut oil, fentanyl, neomycin, ROCEPHIN, ciprofloxacin, gabapentin, ketorolac, phenergan, REGLAN. She was vaccinated with FLUVIRIN (batch number: 1310201) into left arm on 09 Jan 2014. She complained of feeling flushed and warmth at the injection site a few seconds after the vaccination. She also experienced difficulty breathing, shortness of breath and lump in the throat. She was treated with 0.3 ml of EPI-PEN. She continued to experience the lump in the throat for additional 10 minutes. Physician was at the site and 3 mg of ZOFRAN was given orally for nausea. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of congenital anomaly in a foetus subject of unspecified gender who was exposed to BOOSTRIX (GlaxoSmithKline), GARDASIL (non-gsk), meningococcal B C vaccine (non-gsk) and varicella virus vaccine (non-gsk) transplacentally when the mother was vaccinated. The mother's concurrent medical conditions included depression and shellfish allergy. The fetus was also exposed to Ondansetron and Prenatal vitamins transplacentally, which the mother took concurrently. On 4 October 2013 the 16-year-old mother of the fetal subject received a dose of BOOSTRIX (.5 ml, transplacentary, unknown), unspecified dose of GARDASIL (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B C vaccine (Non-GSK) (.5 ml, transplacentary, unknown), unspecified dose of Varicella virus vaccine (Non-GSK) (.5 ml, transplacentary, unknown). The mother's last menstrual period (LMP) occurred on 20 August 2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK) at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27 May 2014. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B C vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided. At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. For the mother's case please see case A1061427A.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Ear operation, Exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of congenital anomaly in a foetus subject of unspecified gender who was exposed to BOOSTRIX (GlaxoSmithKline), GARDASIL (non-gsk), meningococcal B C vaccine (non-gsk) and varicella virus vaccine (non-gsk) transplacentally when the mother was vaccinated. The mother's concurrent medical conditions included depression and shellfish allergy. The fetus was also exposed to Ondansetron and Prenatal vitamins transplacentally, which the mother took concurrently. On 4 October 2013 the 16-year-old mother of the fetal subject received a dose of BOOSTRIX (.5 ml, transplacentary, unknown), unspecified dose of GARDASIL (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B C vaccine (Non-GSK) (.5 ml, transplacentary, unknown), unspecified dose of Varicella virus vaccine (Non-GSK) (.5 ml, transplacentary, unknown). The mother's last menstrual period (LMP) occurred on 20 August 2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK) at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27 May 2014. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B C vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided. At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. For the mother's case please see case A1061427A.