chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No concomitants were reported. On 16-MAY-2014, the patient was vaccinated with VAQTA INJ, lot K000943, expiration date 26-EP-2016 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitants were reported. On 15-MAY-2014, the patient was vaccinated with ROTATEQ inj, lot J015062, expiration date 13-OCT-2015 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 4 patients of unknown age. No concomitants were reported. On 19-MAY-2014, the patients were vaccinated with VAQTA INJ, lot K000943, expiration date 26-SEP-2016 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 at phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004835, 1406USA004837, 1405USA013338 by the same reporter link. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, Local reaction
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 1 of the five patients who experienced local reactions. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced local reactions. The outcome of local reactions was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Exposure during pregnancy
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 2 of the six patients who experienced cellulitis. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced cellulitis. The outcome of cellulitis was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Exposure during pregnancy
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 5 of the six patients who experienced cellulitis. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced cellulitis. The outcome of cellulitis was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Exposure during pregnancy
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 4 of the six patients who experienced cellulitis. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced cellulitis. The outcome of cellulitis was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, Local reaction
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 3 of the five patients who experienced local reactions. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced local reactions. The outcome of local reactions was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, Local reaction
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 4 of the five patients who experienced local reactions. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced local reactions. The outcome of local reactions was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Exposure during pregnancy
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 6 of the six patients who experienced cellulitis. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced cellulitis. The outcome of cellulitis was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, Local reaction
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 2 of the five patients who experienced local reactions. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced local reactions. The outcome of local reactions was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Exposure during pregnancy
Clinical narrative: Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 3 of the six patients who experienced cellulitis. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced cellulitis. The outcome of cellulitis was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 4 patients of unknown age. No concomitants were reported. On 19-MAY-2014, the patients were vaccinated with VAQTA INJ, lot K000943, expiration date 26-SEP-2016 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 at phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837, 1405USA013338 by the same reporter link. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein normal, Full blood count normal, Hypoaesthesia, Laboratory test normal, Muscular weakness
Clinical narrative: Case number PHHY2013US069553 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 471127) website on 03 Jul 2013 with a follow up report received from Quality Assurance Department (reference number: 240500) on 30 May 2014. This report refers to a 35-years-old female patient. Her medical history included allergic asthma, allergic rhinitis, and medication allergies to CECLOR, BACTRIM, nitrofurantoin and ALLEGRA. Her concomitant medications included sertraline 100 mg per oral once daily. She was vaccinated with FLUVIRIN (batch number: 1205501) intramuscularly in the left arm on 15 Oct 2012. On the same date, she had right lower extremity aching that progressed to bilateral lower extremity tingling and numbness with physical examination changes, in the morning following the administration of vaccine. Later that day on 16 Oct 2012, she developed weakness of right lower extremity and her numbness and tingling progressed to bilateral hands. She went to emergency room where physical examination showed right foot weakness. There were changes in sensory examination of bilateral lower extremities and it was reported that her right foot was worse than left foot. Diagnostic laboratory tests were done and she underwent complete blood count (CBC), Chem 7 test, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and lumbar x-ray and all tests were reported as normal. The outcome of the event was reported as complete recovery. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1205501 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 30 May 2014: Updated batch review report.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Red blood cell sedimentation rate normal, Sensory disturbance, Spinal X-ray
Clinical narrative: Case number PHHY2013US069553 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 471127) website on 03 Jul 2013 with a follow up report received from Quality Assurance Department (reference number: 240500) on 30 May 2014. This report refers to a 35-years-old female patient. Her medical history included allergic asthma, allergic rhinitis, and medication allergies to CECLOR, BACTRIM, nitrofurantoin and ALLEGRA. Her concomitant medications included sertraline 100 mg per oral once daily. She was vaccinated with FLUVIRIN (batch number: 1205501) intramuscularly in the left arm on 15 Oct 2012. On the same date, she had right lower extremity aching that progressed to bilateral lower extremity tingling and numbness with physical examination changes, in the morning following the administration of vaccine. Later that day on 16 Oct 2012, she developed weakness of right lower extremity and her numbness and tingling progressed to bilateral hands. She went to emergency room where physical examination showed right foot weakness. There were changes in sensory examination of bilateral lower extremities and it was reported that her right foot was worse than left foot. Diagnostic laboratory tests were done and she underwent complete blood count (CBC), Chem 7 test, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and lumbar x-ray and all tests were reported as normal. The outcome of the event was reported as complete recovery. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1205501 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 30 May 2014: Updated batch review report.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Case number PHHY2013US069553 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 471127) website on 03 Jul 2013 with a follow up report received from Quality Assurance Department (reference number: 240500) on 30 May 2014. This report refers to a 35-years-old female patient. Her medical history included allergic asthma, allergic rhinitis, and medication allergies to CECLOR, BACTRIM, nitrofurantoin and ALLEGRA. Her concomitant medications included sertraline 100 mg per oral once daily. She was vaccinated with FLUVIRIN (batch number: 1205501) intramuscularly in the left arm on 15 Oct 2012. On the same date, she had right lower extremity aching that progressed to bilateral lower extremity tingling and numbness with physical examination changes, in the morning following the administration of vaccine. Later that day on 16 Oct 2012, she developed weakness of right lower extremity and her numbness and tingling progressed to bilateral hands. She went to emergency room where physical examination showed right foot weakness. There were changes in sensory examination of bilateral lower extremities and it was reported that her right foot was worse than left foot. Diagnostic laboratory tests were done and she underwent complete blood count (CBC), Chem 7 test, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and lumbar x-ray and all tests were reported as normal. The outcome of the event was reported as complete recovery. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1205501 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 30 May 2014: Updated batch review report.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Axonal neuropathy, Blood heavy metal test, Burning sensation, Chest X-ray, Electromyogram
Clinical narrative: Case number PHHY2013US127856, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499851) website on 11 Nov 2013, with a follow-up received from Quality Assurance Department (QA, reference number: 263981) on 30 May 2014. This report refers to a 56-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1205001) on 03 Oct 2013. On 17 Oct 2013, few weeks after vaccination she had burning, tingling, electric-like feeling in both feet. Then it moved to top of feet, then ankles and calves for next few weeks and currently also in fingertips. She was diagnosed with painful small fiber axonal neuropathy. She underwent full blood tests, lung X-rays, MRI of torso, heavy metal panel urine test and EMG. She received treatment with B12 shots once a month and gabapentin. They were trying TRAMADOL in place of gabapentin. The patient visited the emergency room. The outcome of the events was reported as not recovered. The seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205001) 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: 263981) on 30 May 2014: Updated batch review report.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Nuclear magnetic resonance imaging, Paraesthesia, Urine analysis
Clinical narrative: Case number PHHY2013US127856, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499851) website on 11 Nov 2013, with a follow-up received from Quality Assurance Department (QA, reference number: 263981) on 30 May 2014. This report refers to a 56-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1205001) on 03 Oct 2013. On 17 Oct 2013, few weeks after vaccination she had burning, tingling, electric-like feeling in both feet. Then it moved to top of feet, then ankles and calves for next few weeks and currently also in fingertips. She was diagnosed with painful small fiber axonal neuropathy. She underwent full blood tests, lung X-rays, MRI of torso, heavy metal panel urine test and EMG. She received treatment with B12 shots once a month and gabapentin. They were trying TRAMADOL in place of gabapentin. The patient visited the emergency room. The outcome of the events was reported as not recovered. The seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205001) 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: 263981) on 30 May 2014: Updated batch review report.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Consciousness fluctuating, Dyspnoea, Erythema, Flushing, Gaze palsy
Clinical narrative: Case number PHHY2014US046478 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 519960) website on 14 Apr 2014 and a follow up report from the QA department received on 30 May 2014: This report refers to a 21-year-old male patient. His medical history included sulfa allergy and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13404P) in to the left arm on 17 Jan 2014. Immediately upon withdrawing the needle his eyes rolled back, face became limp to left side, face became severely red and flushed. He seemed in and out of consciousness, he was laid on floor and he became short of breath. He was immediately given EPIPEN 0.3mg in left upper thigh muscle. He was taken to the emergency room (ER) following these events. Outcome of the events was reported as complete recovery. Events were assessed as non-serious by the reporter; however the case was internally upgraded to serious by regulatory authority. No further information about causality was reported. Based on the document review for the reference number 295599, it was stated that the FLUVIRIN, batch number 13404P 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 30 May 2014: Updated batch review report.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypotonia, Immediate post-injection reaction
Clinical narrative: Case number PHHY2014US046478 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 519960) website on 14 Apr 2014 and a follow up report from the QA department received on 30 May 2014: This report refers to a 21-year-old male patient. His medical history included sulfa allergy and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13404P) in to the left arm on 17 Jan 2014. Immediately upon withdrawing the needle his eyes rolled back, face became limp to left side, face became severely red and flushed. He seemed in and out of consciousness, he was laid on floor and he became short of breath. He was immediately given EPIPEN 0.3mg in left upper thigh muscle. He was taken to the emergency room (ER) following these events. Outcome of the events was reported as complete recovery. Events were assessed as non-serious by the reporter; however the case was internally upgraded to serious by regulatory authority. No further information about causality was reported. Based on the document review for the reference number 295599, it was stated that the FLUVIRIN, batch number 13404P 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 30 May 2014: Updated batch review report.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Consciousness fluctuating, Dyspnoea, Erythema, Eye movement disorder, Flushing
Clinical narrative: Case number PHHY2014US046478 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 519960) website on 14 Apr 2014 and a follow up report from the QA department received on 30 May 2014: This report refers to a 21-year-old male patient. His medical history included sulfa allergy and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13404P) in to the left arm on 17 Jan 2014. Immediately upon withdrawing the needle his eyes rolled back, face became limp to left side, face became severely red and flushed. He seemed in and out of consciousness, he was laid on floor and he became short of breath. He was immediately given EPIPEN 0.3mg in left upper thigh muscle. He was taken to the emergency room (ER) following these events. Outcome of the events was reported as complete recovery. Events were assessed as non-serious by the reporter; however the case was internally upgraded to serious by regulatory authority. No further information about causality was reported. Based on the document review for the reference number 295599, it was stated that the FLUVIRIN, batch number 13404P 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 30 May 2014: Updated batch review report.
Age: 21.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US046478 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 519960) website on 14 Apr 2014 and a follow up report from the QA department received on 30 May 2014: This report refers to a 21-year-old male patient. His medical history included sulfa allergy and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13404P) in to the left arm on 17 Jan 2014. Immediately upon withdrawing the needle his eyes rolled back, face became limp to left side, face became severely red and flushed. He seemed in and out of consciousness, he was laid on floor and he became short of breath. He was immediately given EPIPEN 0.3mg in left upper thigh muscle. He was taken to the emergency room (ER) following these events. Outcome of the events was reported as complete recovery. Events were assessed as non-serious by the reporter; however the case was internally upgraded to serious by regulatory authority. No further information about causality was reported. Based on the document review for the reference number 295599, it was stated that the FLUVIRIN, batch number 13404P 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 30 May 2014: Updated batch review report.
Age: 83.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Transient ischaemic attack
Clinical narrative: Case number PHHY2014US047319, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521039) website on 14 Apr 2014 with a follow up report from the Quality Assurance department (QA reference number: 295462) on 30 May 2014. This report refers to an 83 year old male patient. His past medical history was not reported. His concomitant medication included of Coumadine. He was vaccinated with FLUVIRIN (batch number: 1307901) intramuscularly into his left arm on 08 Jan 2014. Since 09 Jan 2014, he had several transient ischemic attacks. He visited the emergency room on an unspecified date. He completely recovered from transient ischemic attacks. The event was reported as non-serious; however the case was internally upgraded as medically significant by the MAH. The causality of the event was not reported. Based on the review performed, it was concluded that this batch of FLUVIRIN, batch number: 1307901 was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 295462) on 30 May 2014: The batch review report was updated.
Age: 28.0
Sex: M
Vaccine: FLU3, MMR, SMALL, FLU3, MMR, SMALL
Symptoms: Discomfort, Erythema multiforme, Macule, Papule, Pruritus
Clinical narrative: Case number PHHY2014US054787, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523045) website on 06 May 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 298161) on 30 May 2014. This report refers to a 28-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13421P) intramuscularly, along with MMR II (other manufacturer, batch number: J006955) subcutaneously and ACAM2000 (other manufacturer, batch number: V04003A) intradermally on 07 Feb 2014. On 17 Feb 2014, he experienced rash on hands, dorsal and palmar surfaces, "bil" elbows and knees. Also he had concentric targetoid macules and papules associated with itching and discomfort. He had no other symptoms. It was reported that rash was consistent with erythema multiforme minor (EM-Minor). The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant by the regulatory authority. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 13421P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 298161) on 07 May 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (QA, reference number: 298161) on 30 May 2014: Updated batch review report.
Age: 28.0
Sex: M
Vaccine: FLU3, MMR, SMALL, FLU3, MMR, SMALL
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2014US054787, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523045) website on 06 May 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 298161) on 30 May 2014. This report refers to a 28-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13421P) intramuscularly, along with MMR II (other manufacturer, batch number: J006955) subcutaneously and ACAM2000 (other manufacturer, batch number: V04003A) intradermally on 07 Feb 2014. On 17 Feb 2014, he experienced rash on hands, dorsal and palmar surfaces, "bil" elbows and knees. Also he had concentric targetoid macules and papules associated with itching and discomfort. He had no other symptoms. It was reported that rash was consistent with erythema multiforme minor (EM-Minor). The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant by the regulatory authority. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 13421P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 298161) on 07 May 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (QA, reference number: 298161) on 30 May 2014: Updated batch review report.
Age: 28.0
Sex: M
Vaccine: FLU3, MMR, SMALL, FLU3, MMR, SMALL
Symptoms: Rash
Clinical narrative: Case number PHHY2014US054787, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523045) website on 06 May 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 298161) on 30 May 2014. This report refers to a 28-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13421P) intramuscularly, along with MMR II (other manufacturer, batch number: J006955) subcutaneously and ACAM2000 (other manufacturer, batch number: V04003A) intradermally on 07 Feb 2014. On 17 Feb 2014, he experienced rash on hands, dorsal and palmar surfaces, "bil" elbows and knees. Also he had concentric targetoid macules and papules associated with itching and discomfort. He had no other symptoms. It was reported that rash was consistent with erythema multiforme minor (EM-Minor). The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant by the regulatory authority. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 13421P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 298161) on 07 May 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (QA, reference number: 298161) on 30 May 2014: Updated batch review report.
Age: 54.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Throat tightness, Tuberculin test negative, Tunnel vision, Urticaria
Clinical narrative: Case number PHHY2014US054699 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 523808) website on 06 May 2014 with a follow-up information received from Quality Assurance Department (reference number: 298028) on 30 May 2014. This report refers to a 54-year-old male patient. His medical history included food allergies which required EPIPEN medically undetermined source. He was vaccinated with FLUVIRIN (batch number: 13401P) intramuscularly into left arm on 18 Feb 2014 at 1 pm. On the same day at 5:30 pm, he experienced throat tightening with progression of hives to chest and tunnel vision. He used EPIPEN on his way to medical facility then to emergency room. He was given intravenous (IV) fluids and BENADRYL as a treatment. On 20 Feb 2013 he underwent PPD skin test which was negative (no local reaction noted). These events were reported as non-serious; however the case was internally upgraded as medically significant by the regulatory authority. Outcome of the events was reported as recovered. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 13401P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The causality of the events was not reported. Follow up report received from quality assurance department on 30 May 2014: Updated batch review report.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bruxism, Computerised tomogram, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Case number PHHY2014US054780 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525293) website on 06 May 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 298154) on 30 May 2014. This report refers to 35 year old female patient. Her medical history included allergies (unspecified). Concomitant medications included CONCERTA. On 04 Mar 2014, she received FLUVIRIN (batch number: 13421P) into left arm. On the same day she experienced shaking, jaw clenching, vomiting, blurred vision, tingling in arms and legs, loss of sensation in arms and legs. Lab data included lumbar puncture, magnetic resonance imaging (MRI) head and spine, computed tomography (CT) scan the results were not reported. She was hospitalized for three days. Outcome of the events, seriousness and causality assessment was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 13421P) 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: 298154) on 30 May 2014: Updated batch review report.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Sensory loss, Tremor, Vision blurred, Vomiting
Clinical narrative: Case number PHHY2014US054780 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 525293) website on 06 May 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 298154) on 30 May 2014. This report refers to 35 year old female patient. Her medical history included allergies (unspecified). Concomitant medications included CONCERTA. On 04 Mar 2014, she received FLUVIRIN (batch number: 13421P) into left arm. On the same day she experienced shaking, jaw clenching, vomiting, blurred vision, tingling in arms and legs, loss of sensation in arms and legs. Lab data included lumbar puncture, magnetic resonance imaging (MRI) head and spine, computed tomography (CT) scan the results were not reported. She was hospitalized for three days. Outcome of the events, seriousness and causality assessment was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 13421P) 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: 298154) on 30 May 2014: Updated batch review report.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Loss of consciousness
Clinical narrative: This medically confirmed spontaneous report received by a sales representative (initial receipt 29-May-2014) concerns a female patient. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not reported) and PNEUMOVAX 23 injection (batch number not reported). On an unspecified date after receiving the vaccine, the patient was found unconscious and rushed to the emergency room. The patient was admitted in an unspecified hospital, on an unspecified date for an unspecified length of time. Outcome was not reported.
Age: 3.0
Sex: M
Vaccine: YF
Symptoms: Cough, Wheezing
Clinical narrative: Coughing, wheezing. Benadryl liquid (12.5 mg/5ml) 6.25 mg po at 4:45 pm; father is a physician, took child home to give jet neb treatment for wheezing, at 7:30 PM child was doing well, father stated "much better after breathing treatment".
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red raised area to injection site on right arm. Size of 50 cent piece. Area does have itching.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Hyperhidrosis, Malaise, Pallor
Clinical narrative: After receiving both vaccines, he told mom that he "was going to faint". Diaphoretic, pale. After 20-30 secs, became responsive - sipped at juice provided. Was observed in the office for 40 mins. 6/12/14 still not feeling well - severe headache, dizzy.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Diarrhoea, Feeling hot, Headache, Injection site pain, Nausea
Clinical narrative: Pt experienced immediate HA, had hot feeling, nausea and vomiting, diarrhea, pain at site of injection. Pt was observed for about 45 mins after injection, symptoms resolved after about 30 mins.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Pt experienced immediate HA, had hot feeling, nausea and vomiting, diarrhea, pain at site of injection. Pt was observed for about 45 mins after injection, symptoms resolved after about 30 mins.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to 42 patients of unknown age and gender. On an unknown date an improperly stored (Oka/Merck) VARIVAX had been administered to "about 42 unspecified patients". The vaccine was out of range for "about 16 hours" and exposed to a highest temperature of 25F. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain, Blood test, Headache, Pyrexia, Vomiting
Clinical narrative: Mother states via phone call that child had fever of 102.0, vomiting, headache, and abdominal pain starting at 12AM on 6/11/2014. Mother took child to urgent care in am 6/11/2014. States that doctor drew blood (no results), instructed mother to push fluids and give ibuprofen for fever.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Impaired driving ability, Injected limb mobility decreased, Local swelling, Muscle spasms
Clinical narrative: Pneumovax 23 vaccine. Was tested for antibodies to pneumococcus. Had really low immunity to a couple of the strains. Checked the vac. Phenol, Sterile Saline Solution, and inactive bacteria grown in bovine serum. Nothing screamed corn. So, did the vaccine. 24 hours after vaccine, arm swelled up, could not lift arm more than a couple inches, red patches (NOT welts or wheals, not hives) showed up, and muscles all the way up neck spasmed. 24 hours of muscle relaxers, epsom salt baths, heat, ice, and anything else I could think of here, and I can mostly move my arm again. Swelling is down. red patches are turning into bruises. Does not seem to be a typical reaction to my existing allergens.  Not sure what caused this reaction. Lost 2 days worth of work because could not turn neck enough to drive.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Rash macular
Clinical narrative: Pneumovax 23 vaccine. Was tested for antibodies to pneumococcus. Had really low immunity to a couple of the strains. Checked the vac. Phenol, Sterile Saline Solution, and inactive bacteria grown in bovine serum. Nothing screamed corn. So, did the vaccine. 24 hours after vaccine, arm swelled up, could not lift arm more than a couple inches, red patches (NOT welts or wheals, not hives) showed up, and muscles all the way up neck spasmed. 24 hours of muscle relaxers, epsom salt baths, heat, ice, and anything else I could think of here, and I can mostly move my arm again. Swelling is down. red patches are turning into bruises. Does not seem to be a typical reaction to my existing allergens.  Not sure what caused this reaction. Lost 2 days worth of work because could not turn neck enough to drive.
Age: 1.33
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: (L) thigh muscle soreness pain with knee flexion fever to 102 degrees.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pruritus generalised
Clinical narrative: Itching began 20 min after injection itching in arm, back, neck, hair and face red. Inj site warm/red. Took 25 mg BENADRYL. Symp resolved.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Areas of red induration on administered arm. Recommended BENADRYL 50 mg/25. Also, MD wrote rx for KEFLEX 500 Q8x 10d.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Cold sweat, Dizziness, Fatigue, Hearing impaired
Clinical narrative: After vaccine administration, patient left clinic room and went out to waiting room and sat down.  Upon getting up the patient felt dizzy but thought it was attributed to getting up too quickly.  Patient walked to car, accompanied by mother.  Mother described patient as becoming extremely pale while seated in the car.  Mother carried child (patient) back into clinic. Patient very pale, not very responsive but breathing.  Sat patient down on chair and elevated legs on another chair.  Applied ice pack to head.  As color came back, patient described the event as feeling very dizzy, unable to see, seeing "black spots", unable to hear "sounds were muffled", unable to really walk or remember what happened.  Patient's hands were clammy, gave water to drink.  Monitored child for almost an hour thereafter.  Gave a watermelon italian ice to put some sugar in the patient's system.  Patient also felt nauseous and had a loose bowel movement while in the office after the event.  When patient's color came back to normal, blood pressure was checked 104/82. Lungs were clear and heart rate was normal.  Mother and patient left the office at around 3:30pm.  Called the mother prior to close of the office to check on the patient.  Mother explained the child feels extremely tired and was laying down.  Advised mother if child continues to feel excessive tiredness to seek medical care. Received a call 6/12/14 from mother, child is doing better, but kept her home from school for the day.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Hyporesponsive to stimuli, Nausea, Pallor, Visual impairment
Clinical narrative: After vaccine administration, patient left clinic room and went out to waiting room and sat down.  Upon getting up the patient felt dizzy but thought it was attributed to getting up too quickly.  Patient walked to car, accompanied by mother.  Mother described patient as becoming extremely pale while seated in the car.  Mother carried child (patient) back into clinic. Patient very pale, not very responsive but breathing.  Sat patient down on chair and elevated legs on another chair.  Applied ice pack to head.  As color came back, patient described the event as feeling very dizzy, unable to see, seeing "black spots", unable to hear "sounds were muffled", unable to really walk or remember what happened.  Patient's hands were clammy, gave water to drink.  Monitored child for almost an hour thereafter.  Gave a watermelon italian ice to put some sugar in the patient's system.  Patient also felt nauseous and had a loose bowel movement while in the office after the event.  When patient's color came back to normal, blood pressure was checked 104/82. Lungs were clear and heart rate was normal.  Mother and patient left the office at around 3:30pm.  Called the mother prior to close of the office to check on the patient.  Mother explained the child feels extremely tired and was laying down.  Advised mother if child continues to feel excessive tiredness to seek medical care. Received a call 6/12/14 from mother, child is doing better, but kept her home from school for the day.