chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Expired drug administered, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a non-healthcare professional (patient's mother) on 23 May 2013. A 10-year-old male patient, whose medical history and concomitant medications were not reported, had received dose of MENACTRA (batch number: U4021AE, route of administration was not reported, expiry date: 10 May 2013) on the right arm on 14 May 2013, also received Tdap and Varicella vaccine (unknown manufacture, route and site of administration were not reported) both on 14 May 2013. It was stated that after vaccination, the patient experiences redness and swelling at the site on the right arm and presented dizziness, headache and nausea. It was reported that the patient received expired MENACTRA vaccine. Complementary investigations and laboratory data were not reported. As of 23 May 2013 it was reported that, swelling and redness at injection site has resolved and had not any further dizziness, headaches and nausea. Documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Nausea
Clinical narrative: Initial report received from a non-healthcare professional (patient's mother) on 23 May 2013. A 10-year-old male patient, whose medical history and concomitant medications were not reported, had received dose of MENACTRA (batch number: U4021AE, route of administration was not reported, expiry date: 10 May 2013) on the right arm on 14 May 2013, also received Tdap and Varicella vaccine (unknown manufacture, route and site of administration were not reported) both on 14 May 2013. It was stated that after vaccination, the patient experiences redness and swelling at the site on the right arm and presented dizziness, headache and nausea. It was reported that the patient received expired MENACTRA vaccine. Complementary investigations and laboratory data were not reported. As of 23 May 2013 it was reported that, swelling and redness at injection site has resolved and had not any further dizziness, headaches and nausea. Documents held by sender: none.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2012US110985 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number: 466156) on 04 Dec 2012 with a follow-up received from Quality Assurance Department (reference number: 210122) on 11 Jun 2013. This case refers to a 15-year-old male patient. The patient was vaccinated with MENVEO (batch number: X10034) intramuscularly in arm on 22 Jul 2011. On 15 Sep 2011, after the vaccination, the patient experienced Guillain-Barre syndrome. The patient was treated in hospital for the event in Sep 2011. The outcome of the event was reported as complete recovery as of 24 Sep 2012. The causality of the event was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: X10034) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance department on 11 Jun 2013: Batch review report was updated.
Age: 38.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Dizziness, Oedema peripheral, Pyrexia
Clinical narrative: Case number PHHY2012US110831, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 467774) web site on 04 Dec 2012 with a follow-up received from Quality Assurance department (reference number: 209662) on 10 Jun 2013. This report refers to 38 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1205001), MENVEO (batch number: M11078) and PNEUMOVAX (batch number: 1947AA) intramuscularly on 02 Oct 2012. On the same day the patient went to emergency room with dizziness, fever 104.3 degree F, arm swollen to the size of "softball". The outcome of the event was recovered. Seriousness and causality assessment was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: M11078) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 209662) on 11 Feb 2013: Updated QA reference number only. Follow-up received from the Quality Assurance department on 10 Jun 2013: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2013US032470 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480990) website on 04 Apr 2013 with a follow-up received from Quality Assurance department (reference number: 220660) on 11 Jun 2013: This report refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number: M10133 and expiry date: Feb 2013) and ADACEL (other manufacturer, batch number: C3974AA) into the left arm on 26 Dec 2012. On the same date, he was also vaccinated with FLUZONE (other manufacturer, batch number: UH745AB) and GARDASIL (other manufacturer, batch number: H013977) into the right arm. On 27 Dec 2012, one day after vaccinations he experienced acute swelling of left deltoid area with erythema. He visited the emergency room and was diagnosed with cellulitis. He was treated with clindamycin orally for one week. The outcome of the events was reported as recovered as of 10 Jan 2013. The seriousness and causality of the events were not reported. No further information was available. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: M10133) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance department on 11 Jun 2013: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2013US032470 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480990) website on 04 Apr 2013 with a follow-up received from Quality Assurance department (reference number: 220660) on 11 Jun 2013: This report refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number: M10133 and expiry date: Feb 2013) and ADACEL (other manufacturer, batch number: C3974AA) into the left arm on 26 Dec 2012. On the same date, he was also vaccinated with FLUZONE (other manufacturer, batch number: UH745AB) and GARDASIL (other manufacturer, batch number: H013977) into the right arm. On 27 Dec 2012, one day after vaccinations he experienced acute swelling of left deltoid area with erythema. He visited the emergency room and was diagnosed with cellulitis. He was treated with clindamycin orally for one week. The outcome of the events was reported as recovered as of 10 Jan 2013. The seriousness and causality of the events were not reported. No further information was available. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: M10133) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance department on 11 Jun 2013: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Anti-ganglioside antibody, Asthenia, Benign intracranial hypertension, Blood immunoglobulin G, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Case number PHHY2013US032529, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 482851) web site on 04 Apr 2013 with a follow-up received from Quality Assurance department (reference number: 220653) on 11 Jun 2013. This report refers to 16-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M10061 and expiry date Jan 2013) and fifth dose of BOOSTRIX (batch number: AC52B075AA) on 10 Apr 2012. Two weeks after vaccination, on 28 Apr 2012 the patient developed tingling in feet and sides of hands. She went to the local hospital and was treated with IVIG and sent home on 10 May 2012 with steroids. In Jun 2012, she experienced progressive weakness and was admitted in the hospital with Guillain Barre Syndrome. She was admitted in the hospital around 19 times. In Jul 2012, she was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). On 02 Nov 2012, had G01B IGG antibody and EIA serum. She was diagnosed with pseudo tumor of brain from steroids. Magnetic Resonance Imaging (MRI),  Magnetic resonance venography (MRV), Neuro work up, spinal tap and Electromyography (EMG) were performed but the results were not reported. The reporter assessed the events as serious (life threatening). Outcome of the events was condition unchanged. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: M10061) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance department on 11 Jun 2013: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy, Immunology test, Lumbar puncture
Clinical narrative: Case number PHHY2013US032529, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 482851) web site on 04 Apr 2013 with a follow-up received from Quality Assurance department (reference number: 220653) on 11 Jun 2013. This report refers to 16-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M10061 and expiry date Jan 2013) and fifth dose of BOOSTRIX (batch number: AC52B075AA) on 10 Apr 2012. Two weeks after vaccination, on 28 Apr 2012 the patient developed tingling in feet and sides of hands. She went to the local hospital and was treated with IVIG and sent home on 10 May 2012 with steroids. In Jun 2012, she experienced progressive weakness and was admitted in the hospital with Guillain Barre Syndrome. She was admitted in the hospital around 19 times. In Jul 2012, she was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). On 02 Nov 2012, had G01B IGG antibody and EIA serum. She was diagnosed with pseudo tumor of brain from steroids. Magnetic Resonance Imaging (MRI),  Magnetic resonance venography (MRV), Neuro work up, spinal tap and Electromyography (EMG) were performed but the results were not reported. The reporter assessed the events as serious (life threatening). Outcome of the events was condition unchanged. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: M10061) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance department on 11 Jun 2013: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Neurological examination, Nuclear magnetic resonance imaging, Paraesthesia, Venogram
Clinical narrative: Case number PHHY2013US032529, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 482851) web site on 04 Apr 2013 with a follow-up received from Quality Assurance department (reference number: 220653) on 11 Jun 2013. This report refers to 16-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M10061 and expiry date Jan 2013) and fifth dose of BOOSTRIX (batch number: AC52B075AA) on 10 Apr 2012. Two weeks after vaccination, on 28 Apr 2012 the patient developed tingling in feet and sides of hands. She went to the local hospital and was treated with IVIG and sent home on 10 May 2012 with steroids. In Jun 2012, she experienced progressive weakness and was admitted in the hospital with Guillain Barre Syndrome. She was admitted in the hospital around 19 times. In Jul 2012, she was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). On 02 Nov 2012, had G01B IGG antibody and EIA serum. She was diagnosed with pseudo tumor of brain from steroids. Magnetic Resonance Imaging (MRI),  Magnetic resonance venography (MRV), Neuro work up, spinal tap and Electromyography (EMG) were performed but the results were not reported. The reporter assessed the events as serious (life threatening). Outcome of the events was condition unchanged. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: M10061) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance department on 11 Jun 2013: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Antibody test, Asthenia, Benign intracranial hypertension, Blood immunoglobulin G, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Case number PHHY2013US032529, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 482851) web site on 04 Apr 2013 with a follow-up received from Quality Assurance department (reference number: 220653) on 11 Jun 2013. This report refers to 16-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M10061 and expiry date Jan 2013) and fifth dose of BOOSTRIX (batch number: AC52B075AA) on 10 Apr 2012. Two weeks after vaccination, on 28 Apr 2012 the patient developed tingling in feet and sides of hands. She went to the local hospital and was treated with IVIG and sent home on 10 May 2012 with steroids. In Jun 2012, she experienced progressive weakness and was admitted in the hospital with Guillain Barre Syndrome. She was admitted in the hospital around 19 times. In Jul 2012, she was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). On 02 Nov 2012, had G01B IGG antibody and EIA serum. She was diagnosed with pseudo tumor of brain from steroids. Magnetic Resonance Imaging (MRI),  Magnetic resonance venography (MRV), Neuro work up, spinal tap and Electromyography (EMG) were performed but the results were not reported. The reporter assessed the events as serious (life threatening). Outcome of the events was condition unchanged. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: M10061) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance department on 11 Jun 2013: Updated batch review report.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, VARCEL
Symptoms: Erythema, Injection site pruritus, Skin warm, Somnolence
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 13 year old patient with none pertinent medical history. The patient had drug reaction allergies including: sulfa antibiotics caused hives and rash, erythromycin caused hives and rash. On 28-JUN-2001 the patient was vaccinated with the first dose of VARIVAX (lot # not reported (dose 0.5 ml, subcutaneous route). On 14-MAY-2013 the patient was vaccinated with the second dose of VARIVAX (lot # H018791, exp date 15-OCT-2014) (dose 0.5 ml, subcutaneous route). Concomitant therapies included RITALIN. On 16-MAY-2013, the patient experienced a swollen right arm painful, hot to touch, more fatigued than normal, and the injection site there were areas that started to look like "pin point blisters". The patient came in for an office visit on 16-MAY-2013 and the injection site was itchy, redness was 7mm in size, warm to touch, and a few places that looked like blister could erupt. On 17-MAY-2013, the office did a status call to the patient and the patient's mother said that arm was bigger, a lump that was getting harder, the patient was sleeping a lot, really fatigued and redness that was now 8mm in size. On 17-MAY-2013 another status call was done on the same day to the patient and BENADRYL was prescribed with BENADRYL for 10 days cool wash cloth as needed. The patient had an office visit 20-MAY-2013 and the patient was much better, some redness, swelling decreased, and itching stopped. The patient was instructed to continue antibiotics for only 7 days since initial start of therapy instead of 10 days as initially prescribed. The patient's swelling right arm was recovering and the remaining events were recovered. Laboratory diagnostic studies were not performed. Medical assistant requested a lot check on lot number H018791. this case is linked to MARRS # 1305USA013823, 1305USA013819, 1305USA103839. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, VARCEL
Symptoms: Fatigue, Hypersomnia, Induration, Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 13 year old patient with none pertinent medical history. The patient had drug reaction allergies including: sulfa antibiotics caused hives and rash, erythromycin caused hives and rash. On 28-JUN-2001 the patient was vaccinated with the first dose of VARIVAX (lot # not reported (dose 0.5 ml, subcutaneous route). On 14-MAY-2013 the patient was vaccinated with the second dose of VARIVAX (lot # H018791, exp date 15-OCT-2014) (dose 0.5 ml, subcutaneous route). Concomitant therapies included RITALIN. On 16-MAY-2013, the patient experienced a swollen right arm painful, hot to touch, more fatigued than normal, and the injection site there were areas that started to look like "pin point blisters". The patient came in for an office visit on 16-MAY-2013 and the injection site was itchy, redness was 7mm in size, warm to touch, and a few places that looked like blister could erupt. On 17-MAY-2013, the office did a status call to the patient and the patient's mother said that arm was bigger, a lump that was getting harder, the patient was sleeping a lot, really fatigued and redness that was now 8mm in size. On 17-MAY-2013 another status call was done on the same day to the patient and BENADRYL was prescribed with BENADRYL for 10 days cool wash cloth as needed. The patient had an office visit 20-MAY-2013 and the patient was much better, some redness, swelling decreased, and itching stopped. The patient was instructed to continue antibiotics for only 7 days since initial start of therapy instead of 10 days as initially prescribed. The patient's swelling right arm was recovering and the remaining events were recovered. Laboratory diagnostic studies were not performed. Medical assistant requested a lot check on lot number H018791. this case is linked to MARRS # 1305USA013823, 1305USA013819, 1305USA103839. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, VARCEL
Symptoms: Injection site vesicles, Injection site warmth, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 13 year old patient with none pertinent medical history. The patient had drug reaction allergies including: sulfa antibiotics caused hives and rash, erythromycin caused hives and rash. On 28-JUN-2001 the patient was vaccinated with the first dose of VARIVAX (lot # not reported (dose 0.5 ml, subcutaneous route). On 14-MAY-2013 the patient was vaccinated with the second dose of VARIVAX (lot # H018791, exp date 15-OCT-2014) (dose 0.5 ml, subcutaneous route). Concomitant therapies included RITALIN. On 16-MAY-2013, the patient experienced a swollen right arm painful, hot to touch, more fatigued than normal, and the injection site there were areas that started to look like "pin point blisters". The patient came in for an office visit on 16-MAY-2013 and the injection site was itchy, redness was 7mm in size, warm to touch, and a few places that looked like blister could erupt. On 17-MAY-2013, the office did a status call to the patient and the patient's mother said that arm was bigger, a lump that was getting harder, the patient was sleeping a lot, really fatigued and redness that was now 8mm in size. On 17-MAY-2013 another status call was done on the same day to the patient and BENADRYL was prescribed with BENADRYL for 10 days cool wash cloth as needed. The patient had an office visit 20-MAY-2013 and the patient was much better, some redness, swelling decreased, and itching stopped. The patient was instructed to continue antibiotics for only 7 days since initial start of therapy instead of 10 days as initially prescribed. The patient's swelling right arm was recovering and the remaining events were recovered. Laboratory diagnostic studies were not performed. Medical assistant requested a lot check on lot number H018791. this case is linked to MARRS # 1305USA013823, 1305USA013819, 1305USA103839. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, VARCEL
Symptoms: Upper extremity mass
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 13 year old patient with none pertinent medical history. The patient had drug reaction allergies including: sulfa antibiotics caused hives and rash, erythromycin caused hives and rash. On 28-JUN-2001 the patient was vaccinated with the first dose of VARIVAX (lot # not reported (dose 0.5 ml, subcutaneous route). On 14-MAY-2013 the patient was vaccinated with the second dose of VARIVAX (lot # H018791, exp date 15-OCT-2014) (dose 0.5 ml, subcutaneous route). Concomitant therapies included RITALIN. On 16-MAY-2013, the patient experienced a swollen right arm painful, hot to touch, more fatigued than normal, and the injection site there were areas that started to look like "pin point blisters". The patient came in for an office visit on 16-MAY-2013 and the injection site was itchy, redness was 7mm in size, warm to touch, and a few places that looked like blister could erupt. On 17-MAY-2013, the office did a status call to the patient and the patient's mother said that arm was bigger, a lump that was getting harder, the patient was sleeping a lot, really fatigued and redness that was now 8mm in size. On 17-MAY-2013 another status call was done on the same day to the patient and BENADRYL was prescribed with BENADRYL for 10 days cool wash cloth as needed. The patient had an office visit 20-MAY-2013 and the patient was much better, some redness, swelling decreased, and itching stopped. The patient was instructed to continue antibiotics for only 7 days since initial start of therapy instead of 10 days as initially prescribed. The patient's swelling right arm was recovering and the remaining events were recovered. Laboratory diagnostic studies were not performed. Medical assistant requested a lot check on lot number H018791. this case is linked to MARRS # 1305USA013823, 1305USA013819, 1305USA103839. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy gingival, Biopsy site unspecified abnormal, Fungal skin infection, Oral lichen planus
Clinical narrative: This spontaneous report as received from a 73 years old registered nurse concerning on herself. The patient's medical history included high blood pressure, high cholesterol, gastroesophageal reflux (GERD) and allergy and rash to NIASPAN. The patient's medical history included a case of shingles in approximately December 2009 (two years prior to receiving the vaccine). The patient requested to be vaccinated and received on 05-DEC-2011 a vaccination with a dose of ZOSTAVAX (dose, via, lot number and expiration date not reported). Concomitant therapies included NEXIUM, CORGARD, CELEXA, NASONEX, ZETIA, PRAVACHOL, NORVASC and aspirin. The patient stated that after receiving ZOSTAVAX, she began to experience skin and urinary tract infections around the beginning of January 2012 on an unspecified day. Shortly after that time, she began to notice (in approximately 2012) that her gums would bleed when she brushed her teeth on an unspecified date. The patient consulted her primary physician, who sent her for lab work, a consultation with a dermatologist and a consultation with an oral surgeon on unspecified dates. The lab work, along with the dermatologist consultation, revealed that the source of the infections were yeast. The consultation with the oral surgeon revealed, after a gum biopsy, a diagnosis of lichen planus, an autoimmune disease. All of her treating physicians agreed that she should be put on a tapering dose of prednisone (manufacturer unknown) to control her symptoms. The patient reported that she was experiencing relief of her symptoms since being placed on the tapering dose of prednisone on an unspecified date. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy gingival, Biopsy site unspecified abnormal, Fungal skin infection, Gingival bleeding, Laboratory test abnormal
Clinical narrative: This spontaneous report as received from a 73 years old registered nurse concerning on herself. The patient's medical history included high blood pressure, high cholesterol, gastroesophageal reflux (GERD) and allergy and rash to NIASPAN. The patient's medical history included a case of shingles in approximately December 2009 (two years prior to receiving the vaccine). The patient requested to be vaccinated and received on 05-DEC-2011 a vaccination with a dose of ZOSTAVAX (dose, via, lot number and expiration date not reported). Concomitant therapies included NEXIUM, CORGARD, CELEXA, NASONEX, ZETIA, PRAVACHOL, NORVASC and aspirin. The patient stated that after receiving ZOSTAVAX, she began to experience skin and urinary tract infections around the beginning of January 2012 on an unspecified day. Shortly after that time, she began to notice (in approximately 2012) that her gums would bleed when she brushed her teeth on an unspecified date. The patient consulted her primary physician, who sent her for lab work, a consultation with a dermatologist and a consultation with an oral surgeon on unspecified dates. The lab work, along with the dermatologist consultation, revealed that the source of the infections were yeast. The consultation with the oral surgeon revealed, after a gum biopsy, a diagnosis of lichen planus, an autoimmune disease. All of her treating physicians agreed that she should be put on a tapering dose of prednisone (manufacturer unknown) to control her symptoms. The patient reported that she was experiencing relief of her symptoms since being placed on the tapering dose of prednisone on an unspecified date. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lichen planus, Urinary tract infection
Clinical narrative: This spontaneous report as received from a 73 years old registered nurse concerning on herself. The patient's medical history included high blood pressure, high cholesterol, gastroesophageal reflux (GERD) and allergy and rash to NIASPAN. The patient's medical history included a case of shingles in approximately December 2009 (two years prior to receiving the vaccine). The patient requested to be vaccinated and received on 05-DEC-2011 a vaccination with a dose of ZOSTAVAX (dose, via, lot number and expiration date not reported). Concomitant therapies included NEXIUM, CORGARD, CELEXA, NASONEX, ZETIA, PRAVACHOL, NORVASC and aspirin. The patient stated that after receiving ZOSTAVAX, she began to experience skin and urinary tract infections around the beginning of January 2012 on an unspecified day. Shortly after that time, she began to notice (in approximately 2012) that her gums would bleed when she brushed her teeth on an unspecified date. The patient consulted her primary physician, who sent her for lab work, a consultation with a dermatologist and a consultation with an oral surgeon on unspecified dates. The lab work, along with the dermatologist consultation, revealed that the source of the infections were yeast. The consultation with the oral surgeon revealed, after a gum biopsy, a diagnosis of lichen planus, an autoimmune disease. All of her treating physicians agreed that she should be put on a tapering dose of prednisone (manufacturer unknown) to control her symptoms. The patient reported that she was experiencing relief of her symptoms since being placed on the tapering dose of prednisone on an unspecified date. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy gingival, Condition aggravated, Fungal infection, Fungal skin infection, Fungal test positive
Clinical narrative: This spontaneous report as received from a 73 years old registered nurse concerning on herself. The patient's medical history included high blood pressure, high cholesterol, gastroesophageal reflux (GERD) and allergy and rash to NIASPAN. The patient's medical history included a case of shingles in approximately December 2009 (two years prior to receiving the vaccine). The patient requested to be vaccinated and received on 05-DEC-2011 a vaccination with a dose of ZOSTAVAX (dose, via, lot number and expiration date not reported). Concomitant therapies included NEXIUM, CORGARD, CELEXA, NASONEX, ZETIA, PRAVACHOL, NORVASC and aspirin. The patient stated that after receiving ZOSTAVAX, she began to experience skin and urinary tract infections around the beginning of January 2012 on an unspecified day. Shortly after that time, she began to notice (in approximately 2012) that her gums would bleed when she brushed her teeth on an unspecified date. The patient consulted her primary physician, who sent her for lab work, a consultation with a dermatologist and a consultation with an oral surgeon on unspecified dates. The lab work, along with the dermatologist consultation, revealed that the source of the infections were yeast. The consultation with the oral surgeon revealed, after a gum biopsy, a diagnosis of lichen planus, an autoimmune disease. All of her treating physicians agreed that she should be put on a tapering dose of prednisone (manufacturer unknown) to control her symptoms. The patient reported that she was experiencing relief of her symptoms since being placed on the tapering dose of prednisone on an unspecified date. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gingival bleeding, Herpes zoster, Laboratory test abnormal, Oral lichen planus, Pain
Clinical narrative: This spontaneous report as received from a 73 years old registered nurse concerning on herself. The patient's medical history included high blood pressure, high cholesterol, gastroesophageal reflux (GERD) and allergy and rash to NIASPAN. The patient's medical history included a case of shingles in approximately December 2009 (two years prior to receiving the vaccine). The patient requested to be vaccinated and received on 05-DEC-2011 a vaccination with a dose of ZOSTAVAX (dose, via, lot number and expiration date not reported). Concomitant therapies included NEXIUM, CORGARD, CELEXA, NASONEX, ZETIA, PRAVACHOL, NORVASC and aspirin. The patient stated that after receiving ZOSTAVAX, she began to experience skin and urinary tract infections around the beginning of January 2012 on an unspecified day. Shortly after that time, she began to notice (in approximately 2012) that her gums would bleed when she brushed her teeth on an unspecified date. The patient consulted her primary physician, who sent her for lab work, a consultation with a dermatologist and a consultation with an oral surgeon on unspecified dates. The lab work, along with the dermatologist consultation, revealed that the source of the infections were yeast. The consultation with the oral surgeon revealed, after a gum biopsy, a diagnosis of lichen planus, an autoimmune disease. All of her treating physicians agreed that she should be put on a tapering dose of prednisone (manufacturer unknown) to control her symptoms. The patient reported that she was experiencing relief of her symptoms since being placed on the tapering dose of prednisone on an unspecified date. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urinary tract infection fungal
Clinical narrative: This spontaneous report as received from a 73 years old registered nurse concerning on herself. The patient's medical history included high blood pressure, high cholesterol, gastroesophageal reflux (GERD) and allergy and rash to NIASPAN. The patient's medical history included a case of shingles in approximately December 2009 (two years prior to receiving the vaccine). The patient requested to be vaccinated and received on 05-DEC-2011 a vaccination with a dose of ZOSTAVAX (dose, via, lot number and expiration date not reported). Concomitant therapies included NEXIUM, CORGARD, CELEXA, NASONEX, ZETIA, PRAVACHOL, NORVASC and aspirin. The patient stated that after receiving ZOSTAVAX, she began to experience skin and urinary tract infections around the beginning of January 2012 on an unspecified day. Shortly after that time, she began to notice (in approximately 2012) that her gums would bleed when she brushed her teeth on an unspecified date. The patient consulted her primary physician, who sent her for lab work, a consultation with a dermatologist and a consultation with an oral surgeon on unspecified dates. The lab work, along with the dermatologist consultation, revealed that the source of the infections were yeast. The consultation with the oral surgeon revealed, after a gum biopsy, a diagnosis of lichen planus, an autoimmune disease. All of her treating physicians agreed that she should be put on a tapering dose of prednisone (manufacturer unknown) to control her symptoms. The patient reported that she was experiencing relief of her symptoms since being placed on the tapering dose of prednisone on an unspecified date. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Cellulitis, Erythema, Herpes zoster, Injection site reaction
Clinical narrative: Left arm red, burning, itching - 6/7/13 at 9:10 AM patient said started stinging right after injection and it steadily got worse returned to clinic dx with cellulitis and shingles [vesicular rash] of area where injection was given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Left arm red, burning, itching - 6/7/13 at 9:10 AM patient said started stinging right after injection and it steadily got worse returned to clinic dx with cellulitis and shingles [vesicular rash] of area where injection was given.
Age: 1.32
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection of PREVNAR 13 and VARICELLA in left thigh became noticeable swollen. Initially believed to be normal reaction. Noticeable edema, erythema, and warmth to the area. Area the size of half-dollar. When measured on second visit doctors believed to be MRSA or super-infection and prescribed Clindamycin. Patient is undergoing antibiotic treatment and resting as of this submission.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Insomnia, Pyrexia, Rash generalised, Skin irritation
Clinical narrative: Major outbreak of chicken pox rash covering entire body following vaccination. Fever around 101. Extreme irritation, loss of appetite, sleeplessness. Oatmeal baths, calamine lotion to treat.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Major outbreak of chicken pox rash covering entire body following vaccination. Fever around 101. Extreme irritation, loss of appetite, sleeplessness. Oatmeal baths, calamine lotion to treat.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a female patient of unknown age. Approximately on an unknown date in 2010 (approximately 2 to 3 years ago), the patient was vaccinated with the first dose of GARDISIL (lot number, expiry date, dose and route unspecified). On an unknown date (reported as approximately 2 to 3 years ago), the patient was vaccinated with the second dose of GARDISIL (lot number, expiry date, dose and route unspecified) and the patient wanted to schedule to receive her third dose as soon as possible. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex, Herpes simplex ophthalmic
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 79 year old male patient. No medical history or drug allergies was reported. On 30-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). Concomitant therapies included simvastatin. On 10-JUN-2013, the patient was diagnosed by his eye physician with "shingles" in the patient's right eye. On 11-Jun-2013, the pharmacist called back to report that the physician determined the adverse event was not related to ZOSTAVAX and it was a herpes simplex infection, dendritic keratitis simplex. Patient received treatment with acyclovir and Zirgan. Patient sought medical attention (saw eye physician). The outcome of herpes simplex infection, dendritic keratitis herpes simplex was reported as not recovered. The reporter considered herpes simplex infection, dendritic keratitis herpes simplex to be not related to ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist (pharmacy manager) refers to a 66 year old female patient. The patient had none pertinent medical history. The patient had none drug allergies. On 31-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000495, expiry date 14-APR-2014) (strength and total daily dose not reported). The vaccine was administered by the pharmacist. Concomitant medications were reported as none. The pharmacist reported that on 06-JUN-2013, he received a phone call from the patient's physician stating that patient had an active case of shingles when patient received the ZOSTAVAX vaccination on 31-MAY-2013. Pharmacist reported that physician stated that patient had "full blown shingles" at the time of reporting. The patient sought for medical attention by visiting physician. Lab diagnostics studies performed were reported as none. The patient was not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to an unspecified number of patients of unknown age and gender. No medical history was provided. It was reported the patients had received their first two doses of GARDASIL from another health care professional, "approximately one year ago" (2012), and they want to receive the third dose of GARDASIL from the reporting health care professional. No concomitant medications were reported. No adverse effect was reported. No outcome was reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Anti-NMDA antibody negative, Antinuclear antibody negative, Balance disorder, Blood electrolytes normal, Blood immunoglobulin G normal
Clinical narrative: PAC Contacts Vaccine Call Ctr on 01OCT12 re 21 y/o right hand dominant male with onset of gait/balance problems on (16APR11) and subsequent onset of slurred speech/handwriting problems (20-30th MAY 2011) s/p receipt of required MMR #2 on (07FEB11). NP conducts in-depth long-distance (LD) phone interview with patient on 04OCT12. Symptoms: Lack of coordination, Disturbance, speech NEC, Dizziness.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Blood magnesium normal, Blood thyroid stimulating hormone normal, C-reactive protein normal, CSF glucose normal, CSF protein normal
Clinical narrative: PAC Contacts Vaccine Call Ctr on 01OCT12 re 21 y/o right hand dominant male with onset of gait/balance problems on (16APR11) and subsequent onset of slurred speech/handwriting problems (20-30th MAY 2011) s/p receipt of required MMR #2 on (07FEB11). NP conducts in-depth long-distance (LD) phone interview with patient on 04OCT12. Symptoms: Lack of coordination, Disturbance, speech NEC, Dizziness.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: CSF white blood cell count negative, Chest X-ray normal, Computerised tomogram head normal, Coordination abnormal, Differential white blood cell count normal
Clinical narrative: PAC Contacts Vaccine Call Ctr on 01OCT12 re 21 y/o right hand dominant male with onset of gait/balance problems on (16APR11) and subsequent onset of slurred speech/handwriting problems (20-30th MAY 2011) s/p receipt of required MMR #2 on (07FEB11). NP conducts in-depth long-distance (LD) phone interview with patient on 04OCT12. Symptoms: Lack of coordination, Disturbance, speech NEC, Dizziness.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Drug screen negative, Dysarthria, Dysgraphia, Electromyogram normal
Clinical narrative: PAC Contacts Vaccine Call Ctr on 01OCT12 re 21 y/o right hand dominant male with onset of gait/balance problems on (16APR11) and subsequent onset of slurred speech/handwriting problems (20-30th MAY 2011) s/p receipt of required MMR #2 on (07FEB11). NP conducts in-depth long-distance (LD) phone interview with patient on 04OCT12. Symptoms: Lack of coordination, Disturbance, speech NEC, Dizziness.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Full blood count normal, Gait disturbance, HIV test negative, Haematocrit decreased, Haemoglobin normal
Clinical narrative: PAC Contacts Vaccine Call Ctr on 01OCT12 re 21 y/o right hand dominant male with onset of gait/balance problems on (16APR11) and subsequent onset of slurred speech/handwriting problems (20-30th MAY 2011) s/p receipt of required MMR #2 on (07FEB11). NP conducts in-depth long-distance (LD) phone interview with patient on 04OCT12. Symptoms: Lack of coordination, Disturbance, speech NEC, Dizziness.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Immunology test, Laboratory test normal, Lumbar puncture normal, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: PAC Contacts Vaccine Call Ctr on 01OCT12 re 21 y/o right hand dominant male with onset of gait/balance problems on (16APR11) and subsequent onset of slurred speech/handwriting problems (20-30th MAY 2011) s/p receipt of required MMR #2 on (07FEB11). NP conducts in-depth long-distance (LD) phone interview with patient on 04OCT12. Symptoms: Lack of coordination, Disturbance, speech NEC, Dizziness.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Nuclear magnetic resonance imaging spinal normal, Platelet count normal, Protein total normal, Red blood cell sedimentation rate normal, Staphylococcus test negative
Clinical narrative: PAC Contacts Vaccine Call Ctr on 01OCT12 re 21 y/o right hand dominant male with onset of gait/balance problems on (16APR11) and subsequent onset of slurred speech/handwriting problems (20-30th MAY 2011) s/p receipt of required MMR #2 on (07FEB11). NP conducts in-depth long-distance (LD) phone interview with patient on 04OCT12. Symptoms: Lack of coordination, Disturbance, speech NEC, Dizziness.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Treponema test negative, Ultrasound Doppler, Ultrasound Doppler normal, Vitamin B12 normal
Clinical narrative: PAC Contacts Vaccine Call Ctr on 01OCT12 re 21 y/o right hand dominant male with onset of gait/balance problems on (16APR11) and subsequent onset of slurred speech/handwriting problems (20-30th MAY 2011) s/p receipt of required MMR #2 on (07FEB11). NP conducts in-depth long-distance (LD) phone interview with patient on 04OCT12. Symptoms: Lack of coordination, Disturbance, speech NEC, Dizziness.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: 65 y/o medical transcriptionist presents with h/o pain left upper extremity (LUE) since receipt of influenza vaccine at Flu Drive on 01OCT12. Since then, she c/o a dull, persistent ache in deltoid muscle which has limited her range of motion and ability to raise her left arm laterally above her left shoulder.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Severe fatigue, aches, pain from vaccination site and fever. Noticed fatigue and aches 12Jun at 0500. Symptoms worsened as the day progressed. Took temperature when able (12Jun13 1700) and it was 103. Called vaccination hotline they recommended 800mg ibuprofen, fever and all symptoms decreased significantly.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: On Tuesday morning school noticed redness on injection site of (L) arm contact mom and applied ice. Tuesday afternoon mom noticed redness spreading down arm. Patient was seen in Dr. office on Thursday AM treated for cellulitis. Prescribed SEPTRA for 5 days and prednisone for 3 days. Advise to use MOTRIN and cool compress.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia areata
Clinical narrative: This spontaneous report as received from a physician (Dermatologist) refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL (0.5 ml, intramuscular) (lot number and expiry date were not provided). No concomitant medications were reported. The physician stated that the patient experienced alopecia areata after receiving her third dose of GARDASIL. She stated that this began "four to five years ago" (exact date not provided). The physician stated that the patient was vaccinated at another office and was seen in her dermatology office for the alopecia areata. The physician reported that the alopecia areata had not completely resolved at the time of this report (outcome of event was not recovered/not resolved). No reporter causality was provided. No further information was available. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test abnormal
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) 1350U (dose, route and lot number not reported). The reporter stated that on an unknown date, the patient's titer came back as 0.91. The outcome of the adverse event was unknown. Additional information has been requested.
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Headache, Pain, Pyrexia, Swelling
Clinical narrative: Fever. Headaches. Aches in body. Swelling.