chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an approximately 88 year old female patient. Approximately on an unknown date in October 2008 (reported as about 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on 10-SEP-2013 (reported as 6 weeks ago), the patient developed shingles in the right side of the eye and on the top of the head to the back of the head. The patient was in extreme pain from the developed shingles. The patient sought medical attention (doctor visit). The patient had taken unspecified steroids and Gabapentin (manufacturer, dose and frequency unknown). It was unspecified if any lab tests were performed. The outcome of shingles in the right side of the eye and on the top of the head to the back of the head was reported as not resolved as the patient was in discomfort at the time of report. The relatedness for of shingles in the right side of the eye and on the top of the head to the back of the head was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an approximately a 63 year old female patient. On 02-FEB-2010, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On 14-OCT-2013, after the vaccination, the patient developed a moderate case of shingles to the front of the body that stops at the midline was unknown. The relatedness for a moderate case of shingles to the front of the body that stops at the midline was unknown for ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a second dose of PNEUMOVAX23 (lot # not reported) (start date, dose and route not reported). It was reported that the patient developed a 102F fever and had a "slight reaction" at the injection site. The patient was seen at the physician's office, on an unspecified date, regarding his symptoms. The physician reported the patient being recovered but the date of recovery was unspecified. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 52 year old female patient. The patient was allergic to NSAIDS, allergic to aspirin related medications, allergy to percocet and iodine. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date and route was unknown). On an unknown date, the patient developed rash and swelling after PNEUMOVAS23. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning five patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (lot number, expiry date, dose and route unspecified). On an unknown date, after the vaccination, the patients developed shingles. The patients sought medical attention (spoke to the physician). It was unspecified if any treatment was given or if any lab tests were performed. On an unknown date, the patients were recovered form shingles. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Convulsion, Malaise
Clinical narrative: Case number PHEH2013US022184 is an initial spontaneous report from pharmacist received on 22 Oct 2013. This case refers to 58-year-old female patient. Her medical history included penicillin allergy. She was vaccinated with FLUVIRIN (batch number: 1308001) intramuscularly in left deltoid and ZOSTAVAX (batch number: 3002868) subcutaneously in upper arm on 29 Aug 2013. Following few days after the vaccinations, "she felt under the weather with worsening symptoms". On 01 Sep 2013, 4 days after the vaccinations, the patient suffered a seizure and was treated with KEPPRA. She had required emergency room visit for the event. The seriousness of event was not reported. The outcome of event seizure was reported as recovered. The causality of event was not reported. Following internal review on 30 Oct 2013, of the information received on 22 Oct 2013, it was identified that batch number for FLUVIRIN was incorrectly captured and hence corrected to 1308001.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Convulsion, Laboratory test abnormal, Vaccination complication
Clinical narrative: Case number PHEH2013US022184 is an initial spontaneous report from pharmacist received on 22 Oct 2013. This case refers to 58-year-old female patient. Her medical history included penicillin allergy. She was vaccinated with FLUVIRIN (batch number: 1308001) intramuscularly in left deltoid and ZOSTAVAX (batch number: 3002868) subcutaneously in upper arm on 29 Aug 2013. Following few days after the vaccinations, "she felt under the weather with worsening symptoms". On 01 Sep 2013, 4 days after the vaccinations, the patient suffered a seizure and was treated with KEPPRA. She had required emergency room visit for the event. The seriousness of event was not reported. The outcome of event seizure was reported as recovered. The causality of event was not reported. Following internal review on 30 Oct 2013, of the information received on 22 Oct 2013, it was identified that batch number for FLUVIRIN was incorrectly captured and hence corrected to 1308001.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Grand mal convulsion, Injection site erythema, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHEH2013US022184 is an initial spontaneous report from pharmacist received on 22 Oct 2013. This case refers to 58-year-old female patient. Her medical history included penicillin allergy. She was vaccinated with FLUVIRIN (batch number: 1308001) intramuscularly in left deltoid and ZOSTAVAX (batch number: 3002868) subcutaneously in upper arm on 29 Aug 2013. Following few days after the vaccinations, "she felt under the weather with worsening symptoms". On 01 Sep 2013, 4 days after the vaccinations, the patient suffered a seizure and was treated with KEPPRA. She had required emergency room visit for the event. The seriousness of event was not reported. The outcome of event seizure was reported as recovered. The causality of event was not reported. Following internal review on 30 Oct 2013, of the information received on 22 Oct 2013, it was identified that batch number for FLUVIRIN was incorrectly captured and hence corrected to 1308001.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Scan brain
Clinical narrative: Case number PHEH2013US022184 is an initial spontaneous report from pharmacist received on 22 Oct 2013. This case refers to 58-year-old female patient. Her medical history included penicillin allergy. She was vaccinated with FLUVIRIN (batch number: 1308001) intramuscularly in left deltoid and ZOSTAVAX (batch number: 3002868) subcutaneously in upper arm on 29 Aug 2013. Following few days after the vaccinations, "she felt under the weather with worsening symptoms". On 01 Sep 2013, 4 days after the vaccinations, the patient suffered a seizure and was treated with KEPPRA. She had required emergency room visit for the event. The seriousness of event was not reported. The outcome of event seizure was reported as recovered. The causality of event was not reported. Following internal review on 30 Oct 2013, of the information received on 22 Oct 2013, it was identified that batch number for FLUVIRIN was incorrectly captured and hence corrected to 1308001.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blindness, Dysarthria, Feeling cold, Hyperhidrosis, Hypotension
Clinical narrative: Case number PHEH2013US022049 is an initial spontaneous report received from a consumer on 22 Oct 2013. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly on 29 Sep 2013. On the same date, 5-10 minutes after vaccination, he fainted, blacked out and experienced sweating, low blood pressure, blurred vision and chills. He went to emergency room on 29 Sep 2013. His mother stated that he had an intravenous administration (unspecified) and had his blood sugar checked. His vitals were checked by a heart monitor. The mother stated that his symptoms resolved on 29 Sep 2013. No further information was provided.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pallor
Clinical narrative: Case number PHEH2013US022049 is an initial spontaneous report received from a consumer on 22 Oct 2013. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly on 29 Sep 2013. On the same date, 5-10 minutes after vaccination, he fainted, blacked out and experienced sweating, low blood pressure, blurred vision and chills. He went to emergency room on 29 Sep 2013. His mother stated that he had an intravenous administration (unspecified) and had his blood sugar checked. His vitals were checked by a heart monitor. The mother stated that his symptoms resolved on 29 Sep 2013. No further information was provided.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose, Cardiac monitoring, Chills, Hyperhidrosis, Hypotension
Clinical narrative: Case number PHEH2013US022049 is an initial spontaneous report received from a consumer on 22 Oct 2013. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly on 29 Sep 2013. On the same date, 5-10 minutes after vaccination, he fainted, blacked out and experienced sweating, low blood pressure, blurred vision and chills. He went to emergency room on 29 Sep 2013. His mother stated that he had an intravenous administration (unspecified) and had his blood sugar checked. His vitals were checked by a heart monitor. The mother stated that his symptoms resolved on 29 Sep 2013. No further information was provided.
Age: 14.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Loss of consciousness, Syncope, Vision blurred
Clinical narrative: Case number PHEH2013US022049 is an initial spontaneous report received from a consumer on 22 Oct 2013. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly on 29 Sep 2013. On the same date, 5-10 minutes after vaccination, he fainted, blacked out and experienced sweating, low blood pressure, blurred vision and chills. He went to emergency room on 29 Sep 2013. His mother stated that he had an intravenous administration (unspecified) and had his blood sugar checked. His vitals were checked by a heart monitor. The mother stated that his symptoms resolved on 29 Sep 2013. No further information was provided.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a nurse refers to a 53 year old male patient with cephalosporins drug allergy and no pertinent medical history. On 16-OCT-2013 the patient was vaccinated with a dose of PNEUMOVAX23 injection, 0.5 ml, intramuscular (lot # J001180, expiration date 18-AUG-2014). Concomitant medication included "multiple medications". The patient that received PNEUMOVAX23 developed cellulitis in the arm that the PNEUMOVAX23 was administered "two days later" on approximately 18-OCT-2013. No lab diagnostics studies were performed. The patient was seen by the physician on 18-OCT-2013. The patient was prescribed an unspecified antibiotic on 18-OCT-2013 for the event. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood electrolytes, Blood glucose, Blood immunoglobulin E, Blood urea, Enzyme level test
Clinical narrative: This case was reported by a healthcare professional (practice manager) and described the occurrence of Guillain-Barre syndrome in a 49-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included colon polyp, hypertension and sinus infection. Concurrent medications included AUGMENTIN and lisinopril. Prior to vaccination with FLULAVAL, the subject "was being treated for a sinus condition with AUGMENTIN prior to the injection." On 19 October 2013 at 09:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 24 October 2013, 5 days after vaccination with FLULAVAL, the subject experienced Guillain-Barre syndrome, numbness of extremities and tingling of extremity. The numbness and tingling of extremities was clarified to involve the arms and legs. The subject sought medical attention with a nurse practitioner, who referred the subject to the emergency department. A neurologist "made the diagnosis of Guillain-Barre Syndrome." The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were was unknown and the subject was still in the hospital.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Full blood count, Glomerular filtration rate, Hypoaesthesia, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional (practice manager) and described the occurrence of Guillain-Barre syndrome in a 49-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included colon polyp, hypertension and sinus infection. Concurrent medications included AUGMENTIN and lisinopril. Prior to vaccination with FLULAVAL, the subject "was being treated for a sinus condition with AUGMENTIN prior to the injection." On 19 October 2013 at 09:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 24 October 2013, 5 days after vaccination with FLULAVAL, the subject experienced Guillain-Barre syndrome, numbness of extremities and tingling of extremity. The numbness and tingling of extremities was clarified to involve the arms and legs. The subject sought medical attention with a nurse practitioner, who referred the subject to the emergency department. A neurologist "made the diagnosis of Guillain-Barre Syndrome." The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were was unknown and the subject was still in the hospital.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urine analysis
Clinical narrative: This case was reported by a healthcare professional (practice manager) and described the occurrence of Guillain-Barre syndrome in a 49-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included colon polyp, hypertension and sinus infection. Concurrent medications included AUGMENTIN and lisinopril. Prior to vaccination with FLULAVAL, the subject "was being treated for a sinus condition with AUGMENTIN prior to the injection." On 19 October 2013 at 09:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 24 October 2013, 5 days after vaccination with FLULAVAL, the subject experienced Guillain-Barre syndrome, numbness of extremities and tingling of extremity. The numbness and tingling of extremities was clarified to involve the arms and legs. The subject sought medical attention with a nurse practitioner, who referred the subject to the emergency department. A neurologist "made the diagnosis of Guillain-Barre Syndrome." The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were was unknown and the subject was still in the hospital.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional (practice manager) and described the occurrence of Guillain-Barre syndrome in a 49-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included colon polyp, hypertension and sinus infection. Concurrent medications included AUGMENTIN and lisinopril. Prior to vaccination with FLULAVAL, the subject "was being treated for a sinus condition with AUGMENTIN prior to the injection." On 19 October 2013 at 09:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 24 October 2013, 5 days after vaccination with FLULAVAL, the subject experienced Guillain-Barre syndrome, numbness of extremities and tingling of extremity. The numbness and tingling of extremities was clarified to involve the arms and legs. The subject sought medical attention with a nurse practitioner, who referred the subject to the emergency department. A neurologist "made the diagnosis of Guillain-Barre Syndrome." The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events were was unknown and the subject was still in the hospital.
Age: 72.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Cellulitis
Clinical narrative: I woke up morning of October 9th with my right arm hurting. There was a solid red ring about 2 inches circling the injection site which felt hot. I called Dr.'s office and was told to come in. October 11th I saw Dr. and was started on antibiotics. I still have a soreness which comes and goes in the area of the injection.
Age: 72.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: I woke up morning of October 9th with my right arm hurting. There was a solid red ring about 2 inches circling the injection site which felt hot. I called Dr.'s office and was told to come in. October 11th I saw Dr. and was started on antibiotics. I still have a soreness which comes and goes in the area of the injection.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Heart rate increased, Pain, Pyrexia
Clinical narrative: Coughing, severe fatigue, aches, fast heartbeat, high fever (102F) all through the night. Tylenol & water. Next morning woke up without any symptoms.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase abnormal, Arthralgia, Aspartate aminotransferase abnormal, Burning sensation, Full blood count normal
Clinical narrative: Intense ache in all joints, most severe where OA is severest.  Ankle and hand swelling, red splotches around ankles, shins and calves over next 24 hours.  Unable to close fists or grab anything without shooting pain; burning sensation, numbness, electric like current running through fingers and thumbs.  Wrists tightness and sore.  Began Ibuprofen 800mg with Hydrocodone 5-325 to keep pain and swelling in check.  ER change to Indocin 50mg.  Found elevated LFT and INR.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, International normalised ratio increased, Joint stiffness, Joint swelling
Clinical narrative: Intense ache in all joints, most severe where OA is severest.  Ankle and hand swelling, red splotches around ankles, shins and calves over next 24 hours.  Unable to close fists or grab anything without shooting pain; burning sensation, numbness, electric like current running through fingers and thumbs.  Wrists tightness and sore.  Began Ibuprofen 800mg with Hydrocodone 5-325 to keep pain and swelling in check.  ER change to Indocin 50mg.  Found elevated LFT and INR.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test normal, Liver function test abnormal, Local swelling, Paraesthesia, Rash macular
Clinical narrative: Intense ache in all joints, most severe where OA is severest.  Ankle and hand swelling, red splotches around ankles, shins and calves over next 24 hours.  Unable to close fists or grab anything without shooting pain; burning sensation, numbness, electric like current running through fingers and thumbs.  Wrists tightness and sore.  Began Ibuprofen 800mg with Hydrocodone 5-325 to keep pain and swelling in check.  ER change to Indocin 50mg.  Found elevated LFT and INR.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Intense ache in all joints, most severe where OA is severest.  Ankle and hand swelling, red splotches around ankles, shins and calves over next 24 hours.  Unable to close fists or grab anything without shooting pain; burning sensation, numbness, electric like current running through fingers and thumbs.  Wrists tightness and sore.  Began Ibuprofen 800mg with Hydrocodone 5-325 to keep pain and swelling in check.  ER change to Indocin 50mg.  Found elevated LFT and INR.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Itching sensation starting 4 days after shot. Started in legs spread all over esp. in hands/feet. Has been getting worse. Patient states she hasn't changed anything (foods, soap, detergent, etc.). Only other medicines are Sertraline/has been on for a while) and Ibuprofen. Suggested BENADRYL, and to go to Urgent Care Clinic.
Sex: F
Vaccine: FLUX
Symptoms: Gout, Insomnia
Clinical narrative: This consumer report (initial receipt 23-Oct-2013) concerns a female patient who had a history of adverse reactions with many unspecified products. On an unspecified date, the patient received a flu vaccine (manufacturer and batch number not reported). The patient concomitantly received CELESTONE SOLUSPAN (batch number not reported). On an unspecified date, after receiving the flu vaccine and the CELESTONE SOLUSPAN, the patient was unable to fall asleep for 55 hours and was also diagnosed with gout. Outcome was not reported.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Rash
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research study program concerning to refers to the consumer's 13 year old daughter. On an unknown date in July 2012 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route and lot # not reported). On an unknown date in July 2012 the patient had an allergic condition to her first shot of GARDASIL ("broke out"). The patient was hospitalized to be worked up and monitored for flare-ups. The patient's outcome was reported as recovered but sequelae was unknown. The stop date of event was reported as unknown date prior to September 2012. No further incidents were monitored. Therapy of GARDASIL was reported as interrupted as the vaccines series delayed until workup. She received her second and third doses after the workup as normal. The stop date of GARDASIL was reported as January 2013. The adverse event did not re-appear after these two doses. The reporter considered the event to be related to GARDASIL. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTPIPV, HEP, HIBV
Symptoms: Antinuclear antibody negative, Blood immunoglobulin G normal, Complement factor C3, Complement factor normal, Dermatitis bullous
Clinical narrative: It was reported in a published article, that a 2-month-old female infant was vaccinated with a first dose of hepatitis B (manufacturer unknown). Suspect vaccination included a first dose of included hib (manufacturer unknown). Other concomitant vaccinations included a first dose of diphtheria toxoid and pertussis (unspecified) and tetanus toxoid. Subsequently, the patient developed bullous pemphigoid after vaccination. The patient developed bullous lesions on the palms and soles, which appeared one week after receiving the vaccinations. The patient was treated with sulphated water, dexamethasone (manufacturer unknown), and fusidic acid, and the lesions disappeared. One month later, she presented with a new, more generalized outbreak after the second dose of the same vaccines. The skin eruption completely subsided three months after treatment with deflazacort (1 mg/kg/day) was initiated. After five years of follow-up, the patient has not presented with lesions again, despite having received the rest of the vaccines on the official schedule. It has been determined that case 0605USA05337 is a duplicate of case 0507USA03414. Therefore, case 0605USA05337 is being deleted from our files and the cases consolidated into case 0507USA03414. The following information was consolidated from case 0605USA05337 into case 050703414: in case 0605USA05337, received from business partner Sanofi Pasteur, the second outbreak bullous pemphigoid was considered to be medically significant by the reporter. TETRACOQ was also a suspected medication, as well as PEDVAXHIB. The more generalized outbreak occurred three days after administration of the suspect drugs. Furthermore, this outbreak was reported to improve, but disappeared in 15 days after treatment with deflazacort (1 mg/kg/day), however, the patient had a little outbreak when the corticoids dose were decreased. Therefore, treatment with oral corticoids (0.3-1 mg/kg/day) was continued for 3 months. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTPIPV, HEP, HIBV
Symptoms: Eosinophil count increased, Eosinophilia, Immunology test normal, Pemphigoid, Rash generalised
Clinical narrative: It was reported in a published article, that a 2-month-old female infant was vaccinated with a first dose of hepatitis B (manufacturer unknown). Suspect vaccination included a first dose of included hib (manufacturer unknown). Other concomitant vaccinations included a first dose of diphtheria toxoid and pertussis (unspecified) and tetanus toxoid. Subsequently, the patient developed bullous pemphigoid after vaccination. The patient developed bullous lesions on the palms and soles, which appeared one week after receiving the vaccinations. The patient was treated with sulphated water, dexamethasone (manufacturer unknown), and fusidic acid, and the lesions disappeared. One month later, she presented with a new, more generalized outbreak after the second dose of the same vaccines. The skin eruption completely subsided three months after treatment with deflazacort (1 mg/kg/day) was initiated. After five years of follow-up, the patient has not presented with lesions again, despite having received the rest of the vaccines on the official schedule. It has been determined that case 0605USA05337 is a duplicate of case 0507USA03414. Therefore, case 0605USA05337 is being deleted from our files and the cases consolidated into case 0507USA03414. The following information was consolidated from case 0605USA05337 into case 050703414: in case 0605USA05337, received from business partner Sanofi Pasteur, the second outbreak bullous pemphigoid was considered to be medically significant by the reporter. TETRACOQ was also a suspected medication, as well as PEDVAXHIB. The more generalized outbreak occurred three days after administration of the suspect drugs. Furthermore, this outbreak was reported to improve, but disappeared in 15 days after treatment with deflazacort (1 mg/kg/day), however, the patient had a little outbreak when the corticoids dose were decreased. Therefore, treatment with oral corticoids (0.3-1 mg/kg/day) was continued for 3 months. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTPIPV, HEP, HIBV
Symptoms: Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: It was reported in a published article, that a 2-month-old female infant was vaccinated with a first dose of hepatitis B (manufacturer unknown). Suspect vaccination included a first dose of included hib (manufacturer unknown). Other concomitant vaccinations included a first dose of diphtheria toxoid and pertussis (unspecified) and tetanus toxoid. Subsequently, the patient developed bullous pemphigoid after vaccination. The patient developed bullous lesions on the palms and soles, which appeared one week after receiving the vaccinations. The patient was treated with sulphated water, dexamethasone (manufacturer unknown), and fusidic acid, and the lesions disappeared. One month later, she presented with a new, more generalized outbreak after the second dose of the same vaccines. The skin eruption completely subsided three months after treatment with deflazacort (1 mg/kg/day) was initiated. After five years of follow-up, the patient has not presented with lesions again, despite having received the rest of the vaccines on the official schedule. It has been determined that case 0605USA05337 is a duplicate of case 0507USA03414. Therefore, case 0605USA05337 is being deleted from our files and the cases consolidated into case 0507USA03414. The following information was consolidated from case 0605USA05337 into case 050703414: in case 0605USA05337, received from business partner Sanofi Pasteur, the second outbreak bullous pemphigoid was considered to be medically significant by the reporter. TETRACOQ was also a suspected medication, as well as PEDVAXHIB. The more generalized outbreak occurred three days after administration of the suspect drugs. Furthermore, this outbreak was reported to improve, but disappeared in 15 days after treatment with deflazacort (1 mg/kg/day), however, the patient had a little outbreak when the corticoids dose were decreased. Therefore, treatment with oral corticoids (0.3-1 mg/kg/day) was continued for 3 months. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Cyst, Pain
Clinical narrative: Soft tissue mass in left upper deltoid with diffuse arm pain, worse at night.  Symptoms persisting for 4 weeks after vaccination.  No cellulitis.
Age: 69.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Full blood count normal, Injection site reaction, Metabolic function test normal, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Soft tissue mass in left upper deltoid with diffuse arm pain, worse at night.  Symptoms persisting for 4 weeks after vaccination.  No cellulitis.
Age: 69.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Skin mass, Soft tissue mass, Ultrasound scan abnormal
Clinical narrative: Soft tissue mass in left upper deltoid with diffuse arm pain, worse at night.  Symptoms persisting for 4 weeks after vaccination.  No cellulitis.
Age: 1.03
Sex: M
Vaccine: FLU3, MMRV
Symptoms: Computerised tomogram head normal, Convulsion, Cyanosis, Electroencephalogram normal, Gaze palsy
Clinical narrative: Patient was noted to be seizing (T-C movements, eyes rolling) x 1 1/2 minutes. He turned blue. He remained stiff in his upper extremities for several minutes after the seizure. He was transported to the ER by EMS. No further seizure activity during the hospitalization. Fever to 103 lasted for 2 days. Rash developed on chest and abdomen on 11/1.
Age: 1.03
Sex: M
Vaccine: FLU3, MMRV
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Rash, Tonic clonic movements
Clinical narrative: Patient was noted to be seizing (T-C movements, eyes rolling) x 1 1/2 minutes. He turned blue. He remained stiff in his upper extremities for several minutes after the seizure. He was transported to the ER by EMS. No further seizure activity during the hospitalization. Fever to 103 lasted for 2 days. Rash developed on chest and abdomen on 11/1.
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a male patient of unknown age. The pertinent medical history, drug allergies and reactions were none. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date and route was unknown) 3 times a week for one whole year when he was a child. Concomitant medications were none. On an unknown date, the patient developed blisters on face and in the eye as a result of receiving VARIVAX (Merck) numerous times. The lab tests were none. The patient was recovering from the events. The patient sought medical attention. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient approaching 80 with latex allergy. on 08-OCT-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously. Patient reported to the pharmacist on 23-OCT-2013, that she had developed a vesicular bump near her injection site approximately on an unknown date in October 2013. The pharmacist stated that he had not seen the patient's bump. She told him that it was only one "bump", that it seemed to have a vesicle. He told her to go consult her physician. At the time of this call, the pharmacist was at home, and he did not have the patient's records with him. No treatment was given. Patient sought medical attention-consulted the pharmacist. He stated that she was "approaching 80." The pharmacist was agreeable to receiving the VZVIP, and it was faxed to the pharmacist's facility. The outcome of vesicular bump near her injection site was reported as not recovered. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient approaching 80 with latex allergy. on 08-OCT-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously. Patient reported to the pharmacist on 23-OCT-2013, that she had developed a vesicular bump near her injection site approximately on an unknown date in October 2013. The pharmacist stated that he had not seen the patient's bump. She told him that it was only one "bump", that it seemed to have a vesicle. He told her to go consult her physician. At the time of this call, the pharmacist was at home, and he did not have the patient's records with him. No treatment was given. Patient sought medical attention-consulted the pharmacist. He stated that she was "approaching 80." The pharmacist was agreeable to receiving the VZVIP, and it was faxed to the pharmacist's facility. The outcome of vesicular bump near her injection site was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The nurse was reporting that the patient was inadvertently administered 5 doses of GARDASIL. The first dose of 0.5 ml of GARDASIL was administered on 29-JUL-2009 intramuscularly, the second dose of GARDASIL was administered on 02-OCT-2009, the third dose of GARDASIL was administered on 25-FEB-2011, a fourth dose of GARDASIL was administered 26-JUL-2013, and a fifth dose of GARDASIL was administered on 17-OCT-2013. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning a female patient who is also a registered nurse of unknown age. On 15-OCT-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date and dose unspecified), subcutaneously in the left arm (it was unknown if this was the first dose). Approximately on an unknown date in October 2013 (reported as sometime over the weekend), following vaccination, the patient developed a couple of lesions. The patient sought medical attention (unspecified clinic physician). It was unspecified if any treatment was given or if any lab tests were performed. The patient was not recovered from couple of lesions. The relatedness for couple of lesions was unknown for VARIVAX (Merck). This is one of the two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no known drug reactions/allergies. On 17-OCT-2013 or 18-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, via for shingles vaccine int he patient's unspecified physician's office. In October 2013 the patient had an adverse event involving injection site on an unspecified date. Patient described the injection site as of 21-OCT-2013 (reported as "today"), as having a red, swollen area the size of 3 inches by 5 inches and warm to touch. Patient did not state that she was experiencing any pain. Patient was currently prescribed ENTOCORT, pantoprazole and an unspecified thyroid medicine. The patient had not sought medical attention. No treatment was given. The event outcome was reported as not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Culture, Exposure during pregnancy, Full blood count, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with allergy to KEFLEX and no pertinent medical history who on 03-MAY-2012 was vaccinated with the first dose of GARDASIL, intramuscular (dose and lot # not provided). On 18-MAY-2012, the patient had her last menstrual period (LMP). On 02-JUL-2012 the patient was vaccinated with the second dose of GARDASIL intramuscular (dose and lot # not provided). No concomitant medications were reported. The physician reproted that on July 2012 "sometime after 02-JUL-2012", the patient discovered that she was pregnant via a home pregnancy test. The estimated date (EDD) was 22-FEB-2013. On unknown dates, laboratory tests included cell blood count (CBC), "NRH", sexually transmitted disease (STD) cultures, results were not provided. The patient sought medical attention, she went to the physician's office. Follow-up information was received from the physician. She reported that this patient did not complete her OB care at this office so she has no information to share about the patient's delivery or post-partum course. She also reported that she did not have any information on the new physicians that the patient may have gone to. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer reports that an unknown number of consumers of unknown ages and genders received a dose of ZOSTAVAX (lot# not reported) of unknown dose and frequencies on unknown dated for unknown indications. The consumer's medical history, concomitant medications, and past drug history were unknown. On 26-OCT-2013, this consumer reported that her friend told her that he knows of other people who had side effects with ZOSTAVAX. Relevant laboratory testing was unknown. As of 26-OCT-2013, it was unknown if the consumers continued ZOSTAVAX and continued to experience side effects with ZOSTAVAX. The relatedness between therapy with ZOSTAVAX and side effects was not reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional via a company representative refers to an approximately 62 year old of unknown gender patient. Pertinent medical history, drug reactions or allergies were not reported. On 08-OCT-2013, the patient was vaccinated with one dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot number was not reported). Concomitant medication was not reported. The reporter stated that the ZOSTAVAX had been improperly stored in the refrigerator for an unspecified time. No adverse effect reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old male patient. On 04-Feb-2013, the patient started vaccination with the first dose of RECOMBIVAX HB (lot # not reported). On 23-OCT-2013 ("today" at the time of report) the patient was vaccinated with the third expired dose of RECOMBIVAX HB, (lot # H017802, Exp date: 06-OCT-2013), 40 mcg/ml, in the right arm, route unspecified. Dialysis patient received 40 mcg dialysis dose of RECOMBIVAX HB. No adverse effects reported at this time. Additional information has been requested.
Age: 81.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 81 year old patient. On 22-OCT-2013 the patient was vaccinated with ZOSTAVAX (19400 plague forming unit (PFU), 0.65 ml, subcutaneous, lot # H012521, exp. date: 09-OCT-2013). It was reported that the patient was administered expired dose of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant via a company representative refers to a patient of unknown age and gender. On unknown dates the patient was vaccinated with doses of GARDASIL (lot#, expiration date and route not reported) late. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy, concerning a female customer (age not reported) who on an unspecified date(s) was vaccinated with the FLU vaccine (manufacturer unspecified) and PNEUMOVAX23 and had an adverse reaction. The "date of loss" was reported as 11OCT2013. The Lot # reported for the PNEUMOVAX23 was reported to be J004080 with an expiration date of 22AUG2014. It was reported that it was unclear which vaccine she had the reaction to. Treatment and outcome of the adverse experience was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Cyanosis, Grip strength decreased, Hypoaesthesia, Pain in extremity
Clinical narrative: This spontaneous report as received from a 62 year old male consumer with no pertinent medical history and drug reactions/allergies refers to himself. On 07-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, 1 injection, under the skin of the left arm (lot# and expiration date unknown). Concomitant therapies included AFLURIA in the right arm on 07-OCT-2013. About 2 days after the patient received the ZOSTAVAX vaccine he noticed his left arm in the back was hurting very badly on 09-OCT-2013. He said a few hours later it turned a very dark black color in the entire back of his arm. He said it was very painful and it was starting to fade at the time of reporting. The patient also said that he was experiencing numbness in his left arm all the way from his elbow down into his fingers. He said it was so bad that he was not able to grasp objects or to lift anything. The patient did mention he received the flu shot on the same day 07-OCT-2013, but in the right arm and had no problems with it, only the left arm. No treatment was given for the events. No lab diagnostics studies were performed. The patient didn't seek medical attention. Outcome of left arm in the back hurting and numbness in his left arm all the way from his elbow down into his fingers was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Nerve conduction studies
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 75 year old female patient, with diabetes and drug reactions/allergies to sulfa drugs. On 30-MAY-2012, the patient was vaccinated with ZOSTAVAX(vial), 0.65 ml, subcutaneous in the left arm, lot reported as: 0241AE, expiration date: 26-APR-2013. Concomitant therapies included LEXAPRO and trazodone hydrochloride. Approximately in May 2012, reported as "shortly after receiving ZOSTAVAX", the patient developed "burning" pain in the area over the abdomen/stomach. The pharmacist did not know the exact onset time of the "burning" pain. The patient has been treated with Gabapentin, VICODIN, Tramadol and LYRICA, at different times since receiving ZOSTAVAX. Laboratory diagnostics studies performed included: Nerve conduction tests, no results provided. The patient sought medical attention, visited office. The outcome of burning pain in the area over the abdomen/stomach was reported as not recovered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 77 year old female patient with penicillin and sulfa allergy. On 22-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported) subcutaneously. No concomitant medications were reported. On 24-OCT-2013, the patient began to experience stiffness of the neck and upper arm. No treatment was given. No laboratory tests were performed. Patient sought medical attention-called pharmacy. The outcome of patient began to experience stiffness of the neck and upper arm was reported as not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 20 year old female patient with no pertinent medical history and drug reactions/allergies. On unknown dates the patient was vaccinated with the first and second doses of GARDASIL injection (dose, frequency, route, lot# and expiration date unknown). Concomitant therapies included prenatal vitamins. The patient was due for her third dose of GARDASIL however she was pregnant at reporting time. The physician stated the patient was seen in his office, on an unspecified date, at which time an unspecified diagnostic test was performed to confirm her pregnancy. The physician stated the patient was "currently in her 2nd trimester" at the time of reporting. The patient had  not received her third dose of GARDASIL. No treatment was given for the event. Additional information has been requested.