chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Posture abnormal
Clinical narrative: Case number PHHY2013US020841, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480371) on 04 Mar 2013 with a follow up report received from the Quality Assurance Department (QA reference number: 227390) on 01 Jul 2014. This report refers to 27 year old male patient. His current condition included runny nose and cough and his concomitant medication was not reported. His vaccination history included an unspecified vaccine long time ago with which he experienced fainting. He was vaccinated with FLUVIRIN (batch number: 1205601) and ADACEL (other manufacturer, batch number: C4332AA) into left arm on 29 Dec 2012. On the same day post vaccination, when he tried to get up, he sat down and passed out. His head rolled back and he became red and rigid. He was stiff for approximately 30 seconds and then he slowly started labored breathing. Emergency medical team came and took blood pressure multiple times and stayed with him for 20 to 30 minutes then released him home with the father. He was not given any drugs like epinephrine. The outcome of the events was complete recovery. The seriousness and causality of the events was not reported. Based on the batch review performed, it was concluded that the FLUVIRIN batch number 1205601 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received from the QA department on 01 Jul 2014: Updated batch review report.
Age: 69.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abdominal pain, Blood creatinine increased, Blood urea increased, Diarrhoea, Nausea
Clinical narrative: Case number PHHY2013US120455 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 481484) website on 15 Oct 2013, with a follow-up received from Quality Assurance Department (QA, reference number: 260770) on 01 Jul 2014. This report refers to a 69-year-old female patient. Her medical history included atrial fibrillation (AFIB), chronic back pain, frequent UTI (urinary tract infection), enlarged heart and borderline diabetes. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1205401) intramuscularly into left arm and TDAP vaccine (manufacturer and batch number: unknown) on 13 Nov 2012. On 14 Nov 2012, she woke up with fever, nausea, vomiting and some abdominal pain. She also had some mild diarrhea and had mild acute renal failure as well. She went to emergency room and underwent some lab tests which revealed her body temperature as 38.8, white blood count as 15.6, blood pressure as 129/59, oxygen saturation was 88% on room air, BUN (blood urea) was 43 and creatinine was 1.54 (units and normal range unknown). Outcome of the events was reported as recovered. No seriousness and causality was reported for the events. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205401) 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: 260770) on 01 Jul 2014: Updated batch review report.
Age: 69.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Renal failure acute, Vomiting, White blood cell count increased
Clinical narrative: Case number PHHY2013US120455 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 481484) website on 15 Oct 2013, with a follow-up received from Quality Assurance Department (QA, reference number: 260770) on 01 Jul 2014. This report refers to a 69-year-old female patient. Her medical history included atrial fibrillation (AFIB), chronic back pain, frequent UTI (urinary tract infection), enlarged heart and borderline diabetes. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1205401) intramuscularly into left arm and TDAP vaccine (manufacturer and batch number: unknown) on 13 Nov 2012. On 14 Nov 2012, she woke up with fever, nausea, vomiting and some abdominal pain. She also had some mild diarrhea and had mild acute renal failure as well. She went to emergency room and underwent some lab tests which revealed her body temperature as 38.8, white blood count as 15.6, blood pressure as 129/59, oxygen saturation was 88% on room air, BUN (blood urea) was 43 and creatinine was 1.54 (units and normal range unknown). Outcome of the events was reported as recovered. No seriousness and causality was reported for the events. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205401) 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: 260770) on 01 Jul 2014: Updated batch review report.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Impaired work ability, Intensive care, Lumbar puncture
Clinical narrative: Case number PHHY2013US110747, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497838) website on 04 Oct 2013 and a follow-up information was received from Quality Assurance Department (reference number: 257011) on 01 Jul 2014. This report refers to a 32-year-old female patient. Her current condition included severe pain and ovarian cysts. Her medical history included Von Willebrand's disease. Her concomitant medications included glucagon, glucose, and lidocaine topical. She was vaccinated with FLUVIRIN (batch number: 1206801, expiry date: 30 Jun 2013) intramuscularly on 17 Jan 2013. On 12 Feb 2013, she experienced severe tingling from hips to feet. She was taken to the emergency room of the physician. By the time she reached the hospital, tingling reached her arms. She was sent to the ICU and the symptoms recovered after 48 hours. It was also reported that she was very weak. She experienced vomiting and migraine due to intravenous drip (unspecified) for five days. She was in the hospital for six days and could not work for 5 days. It was reported that she lost 26 pounds weight and she could not work for five weeks. She started her job in the beginning of May 2013. She was dismissed as a patient from the physician on 15 May 2013. On unknown date, she was hospitalized for the second time for Guillain-Barre syndrome. A lumbar puncture was performed (details not specified). The patient recovered as of 28 Jul 2013. The causality was not reported. Batch review report (reference number: 257011) received from quality assurance department 01 Jul 2014. Based on the batch review performed, it was stated that FLUVIRIN (batch number: 1206801) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from Quality Assurance Department (reference number: 257011) on 01 Jul 2014: Updated batch review report and expiry date of vaccine.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Paraesthesia, Vomiting, Weight decreased
Clinical narrative: Case number PHHY2013US110747, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497838) website on 04 Oct 2013 and a follow-up information was received from Quality Assurance Department (reference number: 257011) on 01 Jul 2014. This report refers to a 32-year-old female patient. Her current condition included severe pain and ovarian cysts. Her medical history included Von Willebrand's disease. Her concomitant medications included glucagon, glucose, and lidocaine topical. She was vaccinated with FLUVIRIN (batch number: 1206801, expiry date: 30 Jun 2013) intramuscularly on 17 Jan 2013. On 12 Feb 2013, she experienced severe tingling from hips to feet. She was taken to the emergency room of the physician. By the time she reached the hospital, tingling reached her arms. She was sent to the ICU and the symptoms recovered after 48 hours. It was also reported that she was very weak. She experienced vomiting and migraine due to intravenous drip (unspecified) for five days. She was in the hospital for six days and could not work for 5 days. It was reported that she lost 26 pounds weight and she could not work for five weeks. She started her job in the beginning of May 2013. She was dismissed as a patient from the physician on 15 May 2013. On unknown date, she was hospitalized for the second time for Guillain-Barre syndrome. A lumbar puncture was performed (details not specified). The patient recovered as of 28 Jul 2013. The causality was not reported. Batch review report (reference number: 257011) received from quality assurance department 01 Jul 2014. Based on the batch review performed, it was stated that FLUVIRIN (batch number: 1206801) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from Quality Assurance Department (reference number: 257011) on 01 Jul 2014: Updated batch review report and expiry date of vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Aldolase, Aspartate aminotransferase normal, Blood cholesterol increased, Blood creatine phosphokinase, C-reactive protein
Clinical narrative: Case number PHHY2013US127921, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501875) website on 11 Nov 2013 with a follow-up received from Quality Assurance department (QA Ref no. 263753) department on 01 Jul 2014. This report refers to 66-year-old female patient. Her medical history included hypertension, hypercholesterolemia, glucose intolerance, carotid artery stenosis, TIA (transient ischemic attack), Cushing's syndrome post trans-sphenoidal surgery, hypoparathyroidism post resection, colonic polyps with tubular adenomas. Her concomitant medications included hydrochlorothiazide, calcium, vitamin D, and aspirin. She was vaccinated with FLUVIRIN (batch number: 1205401, expiry date: 30 Jun 2013) intramuscularly in the right arm on 10 Dec 2012. The patient started using CRESTOR on an unknown date. On 25 Dec 2012, she experienced myositis, myalgia after starting CRESTOR and it was reported that it was discontinued on an unspecified date. She also experienced difficulty in walking, achiness in muscles of the lower extremity and red rash on the chest. She visited the emergency room. Lab test such as creatinine kinase (result: not available), Aldolase (result: not available), sedimentation rate (result: not available), C-reactive protein (result: not available), MRI muscles (result: not available), AST (result: 33), cholesterol (result: 231). The patient was diagnosed with allergy to statins (statin induced myositis). The patient recovered completely as of 09 Sep 2013. The events were assessed as life threatening. The causality was not reported. Batch review report concluded that, based on the document review, it was stated that the concerned FLUVIRIN (batch number: 1205401) 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 Quality Assurance department on 01 Jul 2014: Updated batch review report and expiry date of the product.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Drug hypersensitivity, Gait disturbance, Myalgia, Myositis, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2013US127921, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501875) website on 11 Nov 2013 with a follow-up received from Quality Assurance department (QA Ref no. 263753) department on 01 Jul 2014. This report refers to 66-year-old female patient. Her medical history included hypertension, hypercholesterolemia, glucose intolerance, carotid artery stenosis, TIA (transient ischemic attack), Cushing's syndrome post trans-sphenoidal surgery, hypoparathyroidism post resection, colonic polyps with tubular adenomas. Her concomitant medications included hydrochlorothiazide, calcium, vitamin D, and aspirin. She was vaccinated with FLUVIRIN (batch number: 1205401, expiry date: 30 Jun 2013) intramuscularly in the right arm on 10 Dec 2012. The patient started using CRESTOR on an unknown date. On 25 Dec 2012, she experienced myositis, myalgia after starting CRESTOR and it was reported that it was discontinued on an unspecified date. She also experienced difficulty in walking, achiness in muscles of the lower extremity and red rash on the chest. She visited the emergency room. Lab test such as creatinine kinase (result: not available), Aldolase (result: not available), sedimentation rate (result: not available), C-reactive protein (result: not available), MRI muscles (result: not available), AST (result: 33), cholesterol (result: 231). The patient was diagnosed with allergy to statins (statin induced myositis). The patient recovered completely as of 09 Sep 2013. The events were assessed as life threatening. The causality was not reported. Batch review report concluded that, based on the document review, it was stated that the concerned FLUVIRIN (batch number: 1205401) 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 Quality Assurance department on 01 Jul 2014: Updated batch review report and expiry date of the product.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Red blood cell sedimentation rate
Clinical narrative: Case number PHHY2013US127921, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501875) website on 11 Nov 2013 with a follow-up received from Quality Assurance department (QA Ref no. 263753) department on 01 Jul 2014. This report refers to 66-year-old female patient. Her medical history included hypertension, hypercholesterolemia, glucose intolerance, carotid artery stenosis, TIA (transient ischemic attack), Cushing's syndrome post trans-sphenoidal surgery, hypoparathyroidism post resection, colonic polyps with tubular adenomas. Her concomitant medications included hydrochlorothiazide, calcium, vitamin D, and aspirin. She was vaccinated with FLUVIRIN (batch number: 1205401, expiry date: 30 Jun 2013) intramuscularly in the right arm on 10 Dec 2012. The patient started using CRESTOR on an unknown date. On 25 Dec 2012, she experienced myositis, myalgia after starting CRESTOR and it was reported that it was discontinued on an unspecified date. She also experienced difficulty in walking, achiness in muscles of the lower extremity and red rash on the chest. She visited the emergency room. Lab test such as creatinine kinase (result: not available), Aldolase (result: not available), sedimentation rate (result: not available), C-reactive protein (result: not available), MRI muscles (result: not available), AST (result: 33), cholesterol (result: 231). The patient was diagnosed with allergy to statins (statin induced myositis). The patient recovered completely as of 09 Sep 2013. The events were assessed as life threatening. The causality was not reported. Batch review report concluded that, based on the document review, it was stated that the concerned FLUVIRIN (batch number: 1205401) 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 Quality Assurance department on 01 Jul 2014: Updated batch review report and expiry date of the product.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Hypotension, Loss of consciousness, Pallor, Peripheral coldness, Somnolence
Clinical narrative: Case number PHHY2013US140330 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 505093) web site on 03 Dec 2013, with a follow-up received from Quality Assurance Department (QA, reference number: 269304) on 01 Jul 2014. This report refers to an 11-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly in to the left arm on 29 Sep 2013. On the same day within seconds after vaccination, he passed out as he tried to get up (out about 7 seconds). He woke up when the vaccine provider spoke to him and passed out (3 seconds) again and he awakened very groggy. Blood pressure (BP) was noted as 121/85. Paramedics were called, he was not feverish. BP was low when they took it. The reaction was assessed as a possible vasovagal response. He was very pale and his skin was cool. He was taken to the ER following these events. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309201) 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: 269304) on 01 Jul 2014: Updated batch review report.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Barium swallow, Cerebrovascular accident, Computerised tomogram, Hemiplegia, Neurological examination
Clinical narrative: Case number PHHY2014US000982, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 510601) website on 06 Jan 2014 with follow-up received from the Quality Assurance Department (reference number: 274136) on 13 Jan 2014 and 01 Jul 2014. This report refers to a 78-year-old male patient. Past medical history included food allergies, seasonal allergies and manageable enlarged prostate. This polymedicated patient was vaccinated with FLUVIRIN(batch number: 1308601) intramuscularly in the left arm on 19 Sep 2013. On 24 Sep 2013, he experienced stroke and his left side was not functioning. It was reported that between 05:00 to 07:00 AM, he woke up to go to the bathroom and he could not locate his left slipper. He was hospitalized and they could not determine if he would fit in the 3 hour window to receive the blood clot medicine, so they did not administer it. He underwent computed tomography scan (CT), magnetic resonance imaging (MRI), sonogram, neurological examinations and swallow tests, however no results were provided. He was kept in the hospital and was observed. Later he was moved to rehabilitation. The outcome of the events was reported as condition unchanged as of 31 Oct 2013. The reporter considered the seriousness as disability and causality of the events was not reported. Based on the investigation performed by the QA department, it was confirmed that FLUVIRIN batch number 1308601, 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: 274136) on 13 Jan 2014: Updated QA reference number. Follow-up received from the Quality Assurance Department (reference number:274136) on 01 Jul 2014: Updated batch review report.                    Adjudication Data Entry
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Ultrasound scan
Clinical narrative: Case number PHHY2014US000982, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 510601) website on 06 Jan 2014 with follow-up received from the Quality Assurance Department (reference number: 274136) on 13 Jan 2014 and 01 Jul 2014. This report refers to a 78-year-old male patient. Past medical history included food allergies, seasonal allergies and manageable enlarged prostate. This polymedicated patient was vaccinated with FLUVIRIN(batch number: 1308601) intramuscularly in the left arm on 19 Sep 2013. On 24 Sep 2013, he experienced stroke and his left side was not functioning. It was reported that between 05:00 to 07:00 AM, he woke up to go to the bathroom and he could not locate his left slipper. He was hospitalized and they could not determine if he would fit in the 3 hour window to receive the blood clot medicine, so they did not administer it. He underwent computed tomography scan (CT), magnetic resonance imaging (MRI), sonogram, neurological examinations and swallow tests, however no results were provided. He was kept in the hospital and was observed. Later he was moved to rehabilitation. The outcome of the events was reported as condition unchanged as of 31 Oct 2013. The reporter considered the seriousness as disability and causality of the events was not reported. Based on the investigation performed by the QA department, it was confirmed that FLUVIRIN batch number 1308601, 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: 274136) on 13 Jan 2014: Updated QA reference number. Follow-up received from the Quality Assurance Department (reference number:274136) on 01 Jul 2014: Updated batch review report.                    Adjudication Data Entry
Age: 11.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 year old patient of unknown gender. On 13-JUN-2014, the patient was vaccinated with ZOSTAVAX (strength reported as dose, route and lot# not reported). No symptoms were reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 year old patient of unknown gender. On 13-JUN-2014, the patient was vaccinated with ZOSTAVAX (strength reported as dose, route and lot# not reported). No symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Headache, Loss of consciousness, Photophobia
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as secretary) regarding a female patient (Age at onset of event unknown). The patient had a medical history of osteomyelitis of the hip at four years of age (approximately in 2002). On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, frequency, product lot/Exp date not reported). The reporter stated that patient had an unspecified local reaction after receiving VARIVAX (Merck) on an unspecified date. The patient subsequently experienced syncope on 27-JUN-2014 while on therapy with GARDASIL (captured in MARRS # 1406US014097). The patient's present status was unspecified by reporter. The outcome and causality of event was unknown. No product quality complaint ((PQC) was reported. Additional information has been requested. This is one of report received from the same source.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Local reaction
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as secretary) regarding a female patient (Age at onset of event unknown). The patient had a medical history of osteomyelitis of the hip at four years of age (approximately in 2002). On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, frequency, product lot/Exp date not reported). The reporter stated that patient had an unspecified local reaction after receiving VARIVAX (Merck) on an unspecified date. The patient subsequently experienced syncope on 27-JUN-2014 while on therapy with GARDASIL (captured in MARRS # 1406US014097). The patient's present status was unspecified by reporter. The outcome and causality of event was unknown. No product quality complaint ((PQC) was reported. Additional information has been requested. This is one of report received from the same source.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Confusional state, Decreased appetite, Emotional disorder, Gait disturbance
Clinical narrative: Limping with a stiff leg Fever of 101 Loss of appetite Loss of sleep Irritable and emotional Nonsensical and confused
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Insomnia, Irritability, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Limping with a stiff leg Fever of 101 Loss of appetite Loss of sleep Irritable and emotional Nonsensical and confused
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient recieved PNA vaccine on day of discharge from hospital, returned next am with pain and swelling at the site.  Advancement of Red line marked and during stay in ED the redness expanded beyond the border drawn.  Pt was admitted and MRI obtained.  Pt given Vancomycin and then discharged the next day when pain and swelling had reduced.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: White blood cell count normal
Clinical narrative: Patient recieved PNA vaccine on day of discharge from hospital, returned next am with pain and swelling at the site.  Advancement of Red line marked and during stay in ED the redness expanded beyond the border drawn.  Pt was admitted and MRI obtained.  Pt given Vancomycin and then discharged the next day when pain and swelling had reduced.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient recieved PNA vaccine on day of discharge from hospital, returned next am with pain and swelling at the site.  Advancement of Red line marked and during stay in ED the redness expanded beyond the border drawn.  Pt was admitted and MRI obtained.  Pt given Vancomycin and then discharged the next day when pain and swelling had reduced.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Urinary tract infection, White blood cell count increased
Clinical narrative: Patient was given the pneumonia vaccine, the next day complaining of redness and pain at the site.  According to patient the symptoms lasted 5 days and has now resolved.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bacterial test negative, Blood culture negative, CSF white blood cell count increased, Cough, Culture urine negative
Clinical narrative: He developed a cough and grunting - seen with fever and irritability. Diagnosed as meningitis. Treated empirically with antibiotics. All cultures were negative. Discharged home.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Grunting, Irritability, Meningitis, Pyrexia, Red blood cells CSF positive
Clinical narrative: He developed a cough and grunting - seen with fever and irritability. Diagnosed as meningitis. Treated empirically with antibiotics. All cultures were negative. Discharged home.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Viral test negative
Clinical narrative: He developed a cough and grunting - seen with fever and irritability. Diagnosed as meningitis. Treated empirically with antibiotics. All cultures were negative. Discharged home.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased appetite, Faeces discoloured, Intensive care, Intestinal obstruction, Intussusception
Clinical narrative: This 4 month old has increased sleepiness and decreased appetite followed by onset of bright red blood per rectum. He than had 2 bowel movements, which were described as melanotic or very dark stool that was heme-positive. At an outside hospital, he had 2 episodes of emesis, which had bilious tinge. He was transfered to ICU at the hospital. KUB and ultrasound were obtained. KUB was suggestive of bowel obstruction. Ultrasound was notable for intussusception. The patient did undergo a hydrostatic reduction and was found to have an ilecolonic intussuseption to the level of the splenic flexure. Parents report no fever or diarrhea. Patient did receive the Rotarix vaccine on June 30, 2014. The patient is shedding virus in the stool. The child is otherwise well grown and healthy without any signficant clinical symptoms prior to the hours, according to the parents.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Occult blood positive, Rectal haemorrhage, Somnolence, Ultrasound abdomen abnormal, Urinary system x-ray abnormal
Clinical narrative: This 4 month old has increased sleepiness and decreased appetite followed by onset of bright red blood per rectum. He than had 2 bowel movements, which were described as melanotic or very dark stool that was heme-positive. At an outside hospital, he had 2 episodes of emesis, which had bilious tinge. He was transfered to ICU at the hospital. KUB and ultrasound were obtained. KUB was suggestive of bowel obstruction. Ultrasound was notable for intussusception. The patient did undergo a hydrostatic reduction and was found to have an ilecolonic intussuseption to the level of the splenic flexure. Parents report no fever or diarrhea. Patient did receive the Rotarix vaccine on June 30, 2014. The patient is shedding virus in the stool. The child is otherwise well grown and healthy without any signficant clinical symptoms prior to the hours, according to the parents.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: This 4 month old has increased sleepiness and decreased appetite followed by onset of bright red blood per rectum. He than had 2 bowel movements, which were described as melanotic or very dark stool that was heme-positive. At an outside hospital, he had 2 episodes of emesis, which had bilious tinge. He was transfered to ICU at the hospital. KUB and ultrasound were obtained. KUB was suggestive of bowel obstruction. Ultrasound was notable for intussusception. The patient did undergo a hydrostatic reduction and was found to have an ilecolonic intussuseption to the level of the splenic flexure. Parents report no fever or diarrhea. Patient did receive the Rotarix vaccine on June 30, 2014. The patient is shedding virus in the stool. The child is otherwise well grown and healthy without any signficant clinical symptoms prior to the hours, according to the parents.
Sex: U
Vaccine: TYP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: This case was received from a physician from Center for Disease Control and Prevention and forwarded by Crucell Medical Affairs. An initial spontaneous report was received on 26-JUN-2014 and concerns an unidentified patient of unspecified age and gender, who received a dose of VIVOTIF (batch number not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unknown date, 1-2 hours after receiving VIVOTIF, the patient experienced hives and difficulty breathing. At the time of this report, the outcome of the events was unknown. Action taken with VIVOTIF course was unknown. The events were assessed as serious (medically significant). No additional information was reported.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Unevaluable event, X-ray
Clinical narrative: Medical record from hospitalization will be provided. Proof of vaccination record will be provided by mail.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, itching and mild swelling along entire underside of upper left arm (approximately 11 inches long and 6 inches wide beginning day after administration. Patient received Keflex after doctor visit and patient has recovered.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood cholesterol, Burning sensation, Fatigue, Herpes zoster, Laboratory test abnormal
Clinical narrative: This spontaneous report as received from a consumer refers to a 71 year old (currently 78 year old) female patient refers to herself. The patient's concurrent condition included hypertension. On 05-MAR-2007, the patient was vaccinated with ZOSTAVAX, 1 injection, subcutaneous (lot # and expired date were not reported). Concomitant therapies included TOPROL XL tablets, metoprolol, and LIPITOR. The patient had continuously been getting breakouts of shingles, somewhere around 2 months (approximately in May 2007) after receiving the ZOSTAVAX injection of 05-MAR-2007 she was administered with the vaccine by Nurse (now retired). She was experiencing pain, burning and itching and it was always on the left side above where her knee bends, all the way up to the buttocks. Her primary physician diagnosed her first rash as shingles after he received her lab work back "about 2 months" (calculated on 05-MAR-2007) after the ZOSTAVAX vaccine was received. Lab diagnostics study was performed: lipid and cholesterol (result not provided). She said that that week she had experienced 29 instances of shingles. She always knew when she would have another episode of shingles because she felt fatigue, and very sleepy before an outbreak. The patient sought medical attention. The patient was treated with VALTREX. When she weared pants during a shingles outbreak, her pants felt like sandpaper against her skin. She said the shingles outbreaks were affecting her lifestyle. The outcome of adverse event was reported as not recovered/no resolved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lipids, Pain, Pruritus, Quality of life decreased, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 71 year old (currently 78 year old) female patient refers to herself. The patient's concurrent condition included hypertension. On 05-MAR-2007, the patient was vaccinated with ZOSTAVAX, 1 injection, subcutaneous (lot # and expired date were not reported). Concomitant therapies included TOPROL XL tablets, metoprolol, and LIPITOR. The patient had continuously been getting breakouts of shingles, somewhere around 2 months (approximately in May 2007) after receiving the ZOSTAVAX injection of 05-MAR-2007 she was administered with the vaccine by Nurse (now retired). She was experiencing pain, burning and itching and it was always on the left side above where her knee bends, all the way up to the buttocks. Her primary physician diagnosed her first rash as shingles after he received her lab work back "about 2 months" (calculated on 05-MAR-2007) after the ZOSTAVAX vaccine was received. Lab diagnostics study was performed: lipid and cholesterol (result not provided). She said that that week she had experienced 29 instances of shingles. She always knew when she would have another episode of shingles because she felt fatigue, and very sleepy before an outbreak. The patient sought medical attention. The patient was treated with VALTREX. When she weared pants during a shingles outbreak, her pants felt like sandpaper against her skin. She said the shingles outbreaks were affecting her lifestyle. The outcome of adverse event was reported as not recovered/no resolved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discomfort, Somnolence
Clinical narrative: This spontaneous report as received from a consumer refers to a 71 year old (currently 78 year old) female patient refers to herself. The patient's concurrent condition included hypertension. On 05-MAR-2007, the patient was vaccinated with ZOSTAVAX, 1 injection, subcutaneous (lot # and expired date were not reported). Concomitant therapies included TOPROL XL tablets, metoprolol, and LIPITOR. The patient had continuously been getting breakouts of shingles, somewhere around 2 months (approximately in May 2007) after receiving the ZOSTAVAX injection of 05-MAR-2007 she was administered with the vaccine by Nurse (now retired). She was experiencing pain, burning and itching and it was always on the left side above where her knee bends, all the way up to the buttocks. Her primary physician diagnosed her first rash as shingles after he received her lab work back "about 2 months" (calculated on 05-MAR-2007) after the ZOSTAVAX vaccine was received. Lab diagnostics study was performed: lipid and cholesterol (result not provided). She said that that week she had experienced 29 instances of shingles. She always knew when she would have another episode of shingles because she felt fatigue, and very sleepy before an outbreak. The patient sought medical attention. The patient was treated with VALTREX. When she weared pants during a shingles outbreak, her pants felt like sandpaper against her skin. She said the shingles outbreaks were affecting her lifestyle. The outcome of adverse event was reported as not recovered/no resolved. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 47 year old male patient. On 16-JUN-2014, the patient inadvertently received 0.5ml, intramuscularly, a dose of GARDASIL (strength and lot # not reported). The nurse stated that that was related to staff error and not product confusion. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients (unknown age and gender). In unknown date in 2014 the patients were vaccinated with RECOMBIVAX HB dose, route of administration and lot# were not reported. On 23-MAY-2014 doses of RECOMBIVAX HB was exposed to -1C for 2 hours. Reporter stated that there other excursions that were below 2C, and she did not have that information organized presently in order to report it. Reporter would "run a report" of the patients who received these improperly stored doses and she would provide the full details of the excursions. There were no adverse experience to report at the time of the report. This case is linked with MARRS # 1406USA008824 (Same Reporter Link(. Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-JUN-2014, the patient was inadvertently vaccinated with a dose of PEDVAXHIB (lot#, expiration date, dose, route, strength and indication not reported). Additional vaccines that were given during the same visit were PENTACEL (lot#, expiration date, dose, route, strength and indication not reported), PREVNAR and ROTATEQ. Medical assistant said that the patient should not have received the PEDVAXHIB because the PENTACEL had a similar indication (Hib immunization). No symptoms reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Chest pain, Electrocardiogram normal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 16 year old male patient with asthma. On 06-JUN-2014 the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not reported). Other suspect therapies included VARIVAX (Merck) (lot#, dose, route not reported) vaccinated as a second dose on the same day. Concomitant therapies included albuterol (manufacturer unknown). On 06-JUN-2014, when being observed while lying down for 10 minutes after receiving the two vaccines, the patient started having chest pains, sweating and vomiting. The physician sent the patient to the Emergency Room (unidentified name and location) and the Emergency Room physician diagnosed him with "chest pains". No treatment was given. Electrocardiogram (EKG) was performed and the result was normal. Symptoms gradually went away. Outcome of the event was reported as recovered on 07-JUN-2014. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site infection, Injection site streaking
Clinical narrative: This spontaneous report as received from an administrator (also mentioned as representative and healthcare worker) refers to a female patient of unknown age. No pertinent medical history and drug reactions/allergies were reported. On 09-JUN-2014, the patient was vaccinated with PNEUMOVAX 23 Lot # J011799, 09-FEB-2015, subcutaneous in the arm. On an unspecified date in June 2014 the patient experienced skin surface infection below the injection site and streaking down her arm. On 11-JUN-2014, the patient sought medical attention by visiting the office. No lab diagnostics studies were performed. The patient was treated with Cephalexin (also reported as ephalexin. The outcome of skin surface infection streaking down her arm was not reported. Relatedness between skin surface infection below the injection site and streaking down her arm and therapy with PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients (unknown age and gender). In unknown date in 2014 the patients were vaccinated with GARDASIL dose, route of administration and lot# were not reported. On 23-MAY-2014 doses of GARDASIL was exposed to -1C for 2 hours. Reporter stated that there other excursions that were below 2C, and she did not have that information organized presently in order to report it. Reporter would "run a report" of the patients who received these improperly stored doses and she would provide the full details of the excursions. There were no adverse experience to report at the time of report. Case linked with MARRS # 1406USA010046 (Same Reporter Link). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Blood test normal, Chest X-ray normal, Convulsion, Electrocardiogram normal, Grand mal convulsion
Clinical narrative: Initial case received from a consumer (the patient's parent) via Novartis on 03 July 2014. A 13-year-old female patient, with no reported medical history, developed grand mal seizure after she received a shot of MCV4 on an unspecified date (manufacturer, lot number, route and site of administration not reported). The reporter stated that the patient was transferred from the local health unit to the ER via ambulance after having a grand mal seizure. She received a urine test, blood test, chest X-Ray and EKG. All these tests were normal. When the patient was dismissed to return home, she stood to get dressed and had another seizure. She was kept longer and given fluids. She was admitted overnight. She was then transferred to another hospital where she was observed and then released with orders for outpatient tests. Outcome was not reported. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Urine analysis normal
Clinical narrative: Initial case received from a consumer (the patient's parent) via Novartis on 03 July 2014. A 13-year-old female patient, with no reported medical history, developed grand mal seizure after she received a shot of MCV4 on an unspecified date (manufacturer, lot number, route and site of administration not reported). The reporter stated that the patient was transferred from the local health unit to the ER via ambulance after having a grand mal seizure. She received a urine test, blood test, chest X-Ray and EKG. All these tests were normal. When the patient was dismissed to return home, she stood to get dressed and had another seizure. She was kept longer and given fluids. She was admitted overnight. She was then transferred to another hospital where she was observed and then released with orders for outpatient tests. Outcome was not reported. Documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding a 14 year old female patient. No information about medical history, drug reactions and allergies was specified. On 21-AUG-2012, patient was vaccinated with GARDASIL (Lot # 04758E, No expiration date provided) dose 1, 0.5 ml, intramuscular. On 19-OCT-2013, the patient was vaccinated with GARDASIL (Lot # H015863, No expiration date provided) dose 2, 0.5 ml, intramuscular. On 26-JUN-2014 the patient was vaccinated with GARDASIL (Lot K001502, Expiration 06-AUG-2015) dose 3, 0.5 ml, intramuscular outside of prescribing information dosage and administration recommended schedule. No concomitant medications were reported. The lot numbers were confirmed with the nurse. There was no product quality complaint. No adverse effects noted to patient. Lot number 04758E is an invalid lot number for GARDASIL. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as secretary) regarding multiple unspecified male patients of unknown age. The reporter stated that on an unknown dates multiple unspecified male patients were vaccinated with GARDASIL (dose, frequency, product lot/expiry date not reported) in their office and have passed out after receiving the dose. The causality and outcome of the event was unknown. Additional information has been requested. This is one of report received from the same source.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and swelling, redness. pain to injection site.
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to three patients of unknown age and gender. On an unknown date patients were vaccinated with GARDASIL (dose and lot number were not reported) 1 intramuscular injection, for prevention of HPV. Concomitant medications were not reported. Physician reported that on an unknown date, the patients "passed out" after being injected with GARDASIL. The outcome of passed out was not reported. The relationship between GARDASIL and the event was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever and injection site pain.
Age: 45.0
Sex: F
Vaccine: DTP
Symptoms: Rash
Clinical narrative: Rash.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via publicis representative refers to a over 60 year old female patient. On 02-JUL-2014, the patient was vaccinated with ZOSTAVAX (lot #, route and dose were not reported) for vaccination. On 02-JUL-2014, the patient developed an injection site rash after administration of ZOSTAVAX. The patient stated that "the rash did not bother her". No treatment was given for the adverse event. No lab diagnostics studies were performed. On an unknown date, the patient sought medical attention by calling the pharmacy. The outcome of injection site rash after administration of ZOSTAVAX was reported as recovering/resolving. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Antinuclear antibody increased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Dermatomyositis, Fatigue
Clinical narrative: 9-13-2011 Appearance of "rash" - on face and chest treated with oral steroids and antihistamine. 9-25-2011 Rash still present. Treated with more prednisone. Nov - Dec 2011 - Treated with topicals; Jan 2012 more topicals. June 2012 muscle contractures, rash, fatigue, muscle weakness. July 2012 - Dermatomyositis - prednisone, SOLUMEDROL, IVIG, CELLCEPT.