chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to about 5 patients of unknown age. The patient were vaccinated with a dose of GARDASIL (lot # not reported) stored as low as 31 F for an unknown period of time. No adverse effect was reported. Attempts are being made in order to obtain additional information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event, Rubella antibody positive
Clinical narrative: Information has been received from a pharmacist a patient who on 18-MAY-2012 was vaccinated with a dose of MMR (Lot# 667319/0408Z, dose and route not reported), that had an expiration date of 18-MAR-2012. No symptoms reported. It was unspecified whether the patient sought attention or not. Follow up information was received from the pharmacist reported that the 26 years old female patient who at 14:14 on 18-MAY-2012 was vaccinated on the right arm with the first dose of MMR (Lot# 667319/0408Z). There was no illness at time of vaccination. The concomitant therapies included MIRENA. On 06-JUL-2012 the patient's rubella antibodies test revealed 108 IU/mL which indicate immune. No adverse events reported. No further follow up was planned. Additional information is not expected.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eye swelling, Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 88 years old female patient with drug allergic to aspirin and AVELOX and a medical history of shingles 48 years ago. The patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot # 664634/0742Y, Exp Date 23-NOV-2010) on 10-DEC-1999. There was no concomitant medication. On 09-JUL-2012 the patient experienced shingles which were red, swollen and painful in her right eye area. Patient sought medical attention via contacting physician. She was referred to an ophthalmologist for further evaluation. There was no lab diagnostics performed. The patient received treatment of VALTREX and DEPO-MEDROL. At the time of report, the outcome of shingles was reported as not recovered/not resolved. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with ROTATEQ (2 MLS, orally, Lot:1807AA, Exp:24-Aug-2013) on 16-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-JUL-2012 the nurse called to report that ROTATEQ that was stored under conditions that merck could not support and was administered that day and no adverse effects reported. No treatment information was reported. It was not reported whether the patient had sought medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age. The patient was vaccinated with ZOSTAVAX on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles on flank sides of his body after receiving ZOSTAVAX. No treatment information was reported. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with the third dose of GARDASIL (lot number unknown). No other co-suspects were reported. No concomitant medications were reported. The patient was administered the third dose of GARDASIL 4 weeks after the second dose of GARDASIL. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. The patients were vaccinated with a dose of MMR II on unspecified date (lot number, dose and route not reported). The medical assistant reported that the office did not monitor the temperature of the freezer and refrigerator from 18-JUN-2012 through 01-JUL-2012 so the office did not know for sure if their vaccines were stored at the proper temperature. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response, Vaccination failure
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 56 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated IM with the first 3 doses series of RECOMBIVAX HB on 09-APR-2011, 21-MAY-2011 and 22-SEP-2011 and the second 3 doses series of RECOMBIVAX HB on 24-OCT-2011, 22-MAR-2012 and 14-MAY-2012. The dosage information was 10 microgram each dose. No other co-suspects were reported. There was no concomitant therapy. The nurse reported that the patient did not respond to the first series of RECOMBIVAX HB, and anti-HBs titers levels were less than 0.1 on 22-OCT-2011. The second series of the vaccine was given, but anti-HIBs titers levels were still low at less than 0.26 on 11-JUL-2012. The patient contacted the nurse for medical attention. At the time of the report, the outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient was vaccinated with first and second dose of GARDASIL on 02-AUG-2011 and 02-JUL-2012 respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Induration, Skin warm
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age who on 06-JUL-2012, was vaccinated with a dose of ZOSTAVAX (Dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient developed a cellulitis infection on their arm which was hard and warm to the touch. CIPRO was given as a treatment for the experience. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for patient developed a cellulitis infection on their arm which was hard and warm to the touch was unknown for ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Foetal disorder, Maternal exposure during pregnancy
Clinical narrative: Information has been received from the patient's mother, a Medical Assistant and a practice administrator concerning an 18 year old female patient with asthma, dyslexia and drug intolerance to BENADRYL and to AUGMENTIN who on 20-MAY-2011 was vaccinated with her first dose of GARDASIL (lot number 666597/0768Z) (dose, route and site not provided). On the same day the patient also received a dose of VARIVAX (lot number, dose, route and site not provided), a dose of MENACTRA and a dose of diphtheria toxoid (+) pertussis acellular vaccine (manufacturer unspecified) (+) tetanus toxoid. On 22-JUL-2011, the patient received the second dose of GARDASIL (lot # 0819Z; lot not valid for GARDASIL (dose, route and site not provided). The patient did not receive any other vaccinations that day. On 23-DEC-2011, the patient received the third dose of GARDASIL (lot # 670048/0963AA0 (dose, route and site not provided). The patient did not receive any other vaccinations that day. The patient was pregnant at the time she received her third and last dose of GARDASIL. It was reported that the office was not aware that the patient was pregnant when she received the third dose of GARDASIL, The patient had told the physician before the third dose of GARDASIL was administered that she was not sexually active. On 28-MAY-2012 the patient delivered a baby. The baby had hydrocephalia. The baby's events were captured in WAES# 1206USA02525B1. On 12-JUN-2012, the patient was in the office due to ear pain., The patient did not provide any information about her baby at that time. Follow-up information was received from office worker who reported that office had details for adverse event for the fetus that developed severe brain damage related to the patients vaccination with GARDASIL (WAES# 1206USA02525B1). Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient who on 13-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#: 672675/0068AE, exp. date 03-APR-2012) after being stored at room temperature for 12 to 24 hours. It was unknown if the patient sought medical attention. No adverse symptoms noted. Follow-up information was received from a physician who stated that the 64 year old female patient on 13-JUN-2012, was vaccinated SQ in the right arm with a dose of ZOSTAVAX (lot# 672675/0068AE). The physician stated that the patient did not have any adverse event. The patient received a dose of ZOSTAVAX that had not been properly frozen due to a building BLDG power failure. The patient did not sought medical attention. No further information is available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a currently 76 years old male patient. The patient was vaccinated with a dose of lot # (670986/0730AA; 17-AUG-2012) ZOSTAVAX on 06-DEC-2011 (dose and route not reported). No other co-suspects and no concomitant medications were reported. The pharmacist reported that the patient has had two cases of shingles following vaccination with ZOSTAVAX. The date of the first case of shingles was unspecified and the date of resolution was also unspecified. At the time of the report the patient currently had the second case of shingles (Start date unspecified). The patient sought medical attention by contacting the pharmacist. No treatment information was reported. At the time of the report the outcome of shingles was reported as not recovered. The relatedness shingles was not reported for ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site pruritus, Injection site urticaria, Injection site vesicles
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 63 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (Lot#671596/1056AA, expiration date 05-OCT-2012) on 12-JUL-2012 for "shingles prevention". No concomitant medications were reported. In July-2012, "over this past weekend", the patient experienced redness, itching, bruising, welts, hives and blisters around the injection site area. No treatment was given for adverse events. The outcome of patient was reported as not recovered/not resolved. No lab diagnostic study was performed. The patient sought medical attention via contacted pharmacist. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that on an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported) that had been expired by a month. He was enquiring if there was any health risk the patient needed to worry about as well as do they need to be revaccinated. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender, who on an unknown date was vaccinated with a third dose of GARDASIL, (dose, route and Lot# not reported) 6 weeks from the dose 2. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician referred to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced shingles. No treatment information was reported. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medicine assistant refers to a patient of unknown age. The patient was vaccinated with 0.65 ml VARIVAX (Merck) (lot number unknown) subcutaneously on 16-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-JUL-2012 the patient was inadvertently administered VARIVAX instead of ZOSTAVAX. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles on upper arm after receiving ZOSTAVAX, No treatment information was reported. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin burning sensation, Skin discolouration
Clinical narrative: Information has been received from a 91 year old female consumer reporting on herself with drug reactions or allergies to morphine and anxiety and osteoporosis who in approximately September 2011 ("last fall") was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, lot number not reported). Concomitant therapy included THYROXIN and DEPLIN. In approximately September 2011 ("last fall"), shortly after receiving ZOSTAVAX (Merck) the patient experienced itching and burning on her right side and buttock. The patient described her skin as brown spots and she had told her doctor about the reaction. Steroid ointment and cream were given as  a treatment for itching and burning on her right side and buttock and her skin described as brown spots. At the time of the report the patient not recovered. Blood tests were performed, results not provided. The patient sought unspecified medical attention. Follow up information has been received from the consumer stating that she had used many products for the itchy brown spots on her buttocks. She advised that she would be seeing her dermatologist regarding this matter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a female nurse of unknown age refers to herself. On an unspecified date the patient was vaccinated with ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse mentioned that when she received ZOSTAVAX, the injection was painful. No treatment information was reported. At the time of the report, the patient's status was unknown. This is one of the several reports received from the same source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient "in her 70's". The patient was vaccinated with ZOSTAVAX (lot # not reported) on 05-JUN-2012. On 24-JUN-2012 the patient experienced rash after the vaccination and the patient had spots that itch but do not blister. Per the pharmacist, the rash was all over the patient's body. The patient prescribed her an oral steroid to take but as of 2 days before the time of report (09-JUL-2012) it was still not helping the rash. And the patient sought for medical attention by seeing her physician. It was reported that the pharmacist did not believe this is due to ZOSTAVAX but the patient did feel it was due to the vaccine. The outcome was not recovered. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a female physician reporting on herself, who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot#, dose and route not reported). Physician reported that in approximately 1995 ("approximately 17 years ago") she developed chicken pox following vaccination with VARIVAX (Merck) and on unspecified date she recovered. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX on 30-JUN-2012 (expiration date 01-MAY-2012; lot number, dose and route not reported). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of unspecified patients. the patients were vaccinated with ZOSTAVAX (lot number unknown) and experienced injection site reactions with reactions affecting the whole arm which subsided in about 5 days at an unspecified time. Pharmacist stated that he reported this a number of years ago to VAERS. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Food allergy, Functional gastrointestinal disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a 5 years old male patient. The patient was vaccinated with ROTATEQ (lot #, dose and route not reported). No other co-suspects and no concomitant medications were reported. The consumer reported that since an unknown date while on ROTATEQ the patient (her son) did not eat eggs any longer. The patient also had unspecified bowel issues. The patient visited the doctor and no treatment was given for the reported events. The outcome of the events was reported as not recovered. The relatedness for the reported events was not provided for ROTATEQ. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Alopecia, Hair texture abnormal, Photophobia
Clinical narrative: This spontaneous report as received from a consumer refers to her 11 years old daughter with penicillin allergy and no pertinent medical history. The patient was vaccinated with a dose of VAQTA. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that while on VAQTA, her daughter's behaviour toward her siblings changed. Her hair became dry. Her hair was still dry. She cannot tolerate flashing or bright light in her eyes. She lost some hair on her head and began pulling hair out around her ear. She visited the doctor for medical attention. No treatment was given for the events. No lab diagnostics studied were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Vaccination error
Clinical narrative: The spontaneous report as received from a Medical Assistant refers to a patient of unknown age. The patient was vaccinated with VARIVAX (Merck) (dose, lot# and expired date were not reported) in error on 13-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. No further information is available. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Burning sensation, Cough, Deafness
Clinical narrative: This case was reported by a consumer and described the occurrence of loss of hearing in a 76-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included heart attack in 1994 and sinus problems for 40 years. Concurrent medications included Omeprazole, Lisinopril and an unclear medication of Ascorbic Nitrate. On 17 September 2010 at 15:00 the subject received unspecified dose of FLULAVAL in the left arm. On 21 or 22 September 2010, 4 days after vaccination with FLULAVAL, the subject experienced burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees) and coughing. He was treated in the emergency room on 24 September 2010. The subject was treated with TYLENOL and prescribed Dicyclomine. The subject returned to the emergency room on 25 September 2010 sick to his stomach. The antibiotic was discontinued. Additional symptoms reported with onset September 2010 included vomiting, dizziness, and double vision. His symptoms continued and he was admitted to the hospital at midnight on 01 October 2010 and released on 04 October 2010. The subject was diagnosed with vertigo and pneumonia on 04 October 2010. Loss of hearing was also discovered during his hospital stay. On 13 October 2010, the subject experienced severe pain in his upper back and his hips. He went back to the emergency room where he was given a shot of morphine and a prescription for PERCOCET which he took for the next 4 to 5 days. The pain was not controlled with pain medication and the subject was admitted to the hospital again on 18 October 2010. He was discharged 4 days later with inconclusive diagnosis. On 25 October 2010 the subject saw his physician for his sinuses and had unspecified tests done that came back with no problems. All of the pain symptoms continued. On 31 October 2010, the subject experienced severe pain in both eyes, especially below the right eye. He also had blurred vision in both eyes. The subject also reported being numb from the center of his face to the right eye, including his upper lip (facial numbness, eye numbness, lip numbness). He described it as feeling like he was at the dentist. He said that it felt swollen. He was told that it may be a loss of the myelin sheath. The subject reported biting his lip when eating due to the numbness which caused to his lip. He also reported drooling due to the numbness. At the time of reporting, hearing loss was unresolved. Events of burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees). coughing, vomiting, dizziness and double vision were resolved at the time of reporting. The outcome of the remaining was not specifically noted.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Diplopia, Dizziness, Drooling, Eye pain, Hypoaesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of loss of hearing in a 76-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included heart attack in 1994 and sinus problems for 40 years. Concurrent medications included Omeprazole, Lisinopril and an unclear medication of Ascorbic Nitrate. On 17 September 2010 at 15:00 the subject received unspecified dose of FLULAVAL in the left arm. On 21 or 22 September 2010, 4 days after vaccination with FLULAVAL, the subject experienced burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees) and coughing. He was treated in the emergency room on 24 September 2010. The subject was treated with TYLENOL and prescribed Dicyclomine. The subject returned to the emergency room on 25 September 2010 sick to his stomach. The antibiotic was discontinued. Additional symptoms reported with onset September 2010 included vomiting, dizziness, and double vision. His symptoms continued and he was admitted to the hospital at midnight on 01 October 2010 and released on 04 October 2010. The subject was diagnosed with vertigo and pneumonia on 04 October 2010. Loss of hearing was also discovered during his hospital stay. On 13 October 2010, the subject experienced severe pain in his upper back and his hips. He went back to the emergency room where he was given a shot of morphine and a prescription for PERCOCET which he took for the next 4 to 5 days. The pain was not controlled with pain medication and the subject was admitted to the hospital again on 18 October 2010. He was discharged 4 days later with inconclusive diagnosis. On 25 October 2010 the subject saw his physician for his sinuses and had unspecified tests done that came back with no problems. All of the pain symptoms continued. On 31 October 2010, the subject experienced severe pain in both eyes, especially below the right eye. He also had blurred vision in both eyes. The subject also reported being numb from the center of his face to the right eye, including his upper lip (facial numbness, eye numbness, lip numbness). He described it as feeling like he was at the dentist. He said that it felt swollen. He was told that it may be a loss of the myelin sheath. The subject reported biting his lip when eating due to the numbness which caused to his lip. He also reported drooling due to the numbness. At the time of reporting, hearing loss was unresolved. Events of burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees). coughing, vomiting, dizziness and double vision were resolved at the time of reporting. The outcome of the remaining was not specifically noted.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia eye, Hypoaesthesia oral, Laboratory test normal, Lip injury, Lip swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of loss of hearing in a 76-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included heart attack in 1994 and sinus problems for 40 years. Concurrent medications included Omeprazole, Lisinopril and an unclear medication of Ascorbic Nitrate. On 17 September 2010 at 15:00 the subject received unspecified dose of FLULAVAL in the left arm. On 21 or 22 September 2010, 4 days after vaccination with FLULAVAL, the subject experienced burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees) and coughing. He was treated in the emergency room on 24 September 2010. The subject was treated with TYLENOL and prescribed Dicyclomine. The subject returned to the emergency room on 25 September 2010 sick to his stomach. The antibiotic was discontinued. Additional symptoms reported with onset September 2010 included vomiting, dizziness, and double vision. His symptoms continued and he was admitted to the hospital at midnight on 01 October 2010 and released on 04 October 2010. The subject was diagnosed with vertigo and pneumonia on 04 October 2010. Loss of hearing was also discovered during his hospital stay. On 13 October 2010, the subject experienced severe pain in his upper back and his hips. He went back to the emergency room where he was given a shot of morphine and a prescription for PERCOCET which he took for the next 4 to 5 days. The pain was not controlled with pain medication and the subject was admitted to the hospital again on 18 October 2010. He was discharged 4 days later with inconclusive diagnosis. On 25 October 2010 the subject saw his physician for his sinuses and had unspecified tests done that came back with no problems. All of the pain symptoms continued. On 31 October 2010, the subject experienced severe pain in both eyes, especially below the right eye. He also had blurred vision in both eyes. The subject also reported being numb from the center of his face to the right eye, including his upper lip (facial numbness, eye numbness, lip numbness). He described it as feeling like he was at the dentist. He said that it felt swollen. He was told that it may be a loss of the myelin sheath. The subject reported biting his lip when eating due to the numbness which caused to his lip. He also reported drooling due to the numbness. At the time of reporting, hearing loss was unresolved. Events of burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees). coughing, vomiting, dizziness and double vision were resolved at the time of reporting. The outcome of the remaining was not specifically noted.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Pneumonia, Pyrexia, Swelling face, Vertigo
Clinical narrative: This case was reported by a consumer and described the occurrence of loss of hearing in a 76-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included heart attack in 1994 and sinus problems for 40 years. Concurrent medications included Omeprazole, Lisinopril and an unclear medication of Ascorbic Nitrate. On 17 September 2010 at 15:00 the subject received unspecified dose of FLULAVAL in the left arm. On 21 or 22 September 2010, 4 days after vaccination with FLULAVAL, the subject experienced burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees) and coughing. He was treated in the emergency room on 24 September 2010. The subject was treated with TYLENOL and prescribed Dicyclomine. The subject returned to the emergency room on 25 September 2010 sick to his stomach. The antibiotic was discontinued. Additional symptoms reported with onset September 2010 included vomiting, dizziness, and double vision. His symptoms continued and he was admitted to the hospital at midnight on 01 October 2010 and released on 04 October 2010. The subject was diagnosed with vertigo and pneumonia on 04 October 2010. Loss of hearing was also discovered during his hospital stay. On 13 October 2010, the subject experienced severe pain in his upper back and his hips. He went back to the emergency room where he was given a shot of morphine and a prescription for PERCOCET which he took for the next 4 to 5 days. The pain was not controlled with pain medication and the subject was admitted to the hospital again on 18 October 2010. He was discharged 4 days later with inconclusive diagnosis. On 25 October 2010 the subject saw his physician for his sinuses and had unspecified tests done that came back with no problems. All of the pain symptoms continued. On 31 October 2010, the subject experienced severe pain in both eyes, especially below the right eye. He also had blurred vision in both eyes. The subject also reported being numb from the center of his face to the right eye, including his upper lip (facial numbness, eye numbness, lip numbness). He described it as feeling like he was at the dentist. He said that it felt swollen. He was told that it may be a loss of the myelin sheath. The subject reported biting his lip when eating due to the numbness which caused to his lip. He also reported drooling due to the numbness. At the time of reporting, hearing loss was unresolved. Events of burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees). coughing, vomiting, dizziness and double vision were resolved at the time of reporting. The outcome of the remaining was not specifically noted.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of loss of hearing in a 76-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included heart attack in 1994 and sinus problems for 40 years. Concurrent medications included Omeprazole, Lisinopril and an unclear medication of Ascorbic Nitrate. On 17 September 2010 at 15:00 the subject received unspecified dose of FLULAVAL in the left arm. On 21 or 22 September 2010, 4 days after vaccination with FLULAVAL, the subject experienced burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees) and coughing. He was treated in the emergency room on 24 September 2010. The subject was treated with TYLENOL and prescribed Dicyclomine. The subject returned to the emergency room on 25 September 2010 sick to his stomach. The antibiotic was discontinued. Additional symptoms reported with onset September 2010 included vomiting, dizziness, and double vision. His symptoms continued and he was admitted to the hospital at midnight on 01 October 2010 and released on 04 October 2010. The subject was diagnosed with vertigo and pneumonia on 04 October 2010. Loss of hearing was also discovered during his hospital stay. On 13 October 2010, the subject experienced severe pain in his upper back and his hips. He went back to the emergency room where he was given a shot of morphine and a prescription for PERCOCET which he took for the next 4 to 5 days. The pain was not controlled with pain medication and the subject was admitted to the hospital again on 18 October 2010. He was discharged 4 days later with inconclusive diagnosis. On 25 October 2010 the subject saw his physician for his sinuses and had unspecified tests done that came back with no problems. All of the pain symptoms continued. On 31 October 2010, the subject experienced severe pain in both eyes, especially below the right eye. He also had blurred vision in both eyes. The subject also reported being numb from the center of his face to the right eye, including his upper lip (facial numbness, eye numbness, lip numbness). He described it as feeling like he was at the dentist. He said that it felt swollen. He was told that it may be a loss of the myelin sheath. The subject reported biting his lip when eating due to the numbness which caused to his lip. He also reported drooling due to the numbness. At the time of reporting, hearing loss was unresolved. Events of burning sensation from knee joint down leg and pain both lower legs and feet as well as a slight temperature (fever to 101 or 102 degrees). coughing, vomiting, dizziness and double vision were resolved at the time of reporting. The outcome of the remaining was not specifically noted.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Flank pain, Pain, Urticaria
Clinical narrative: 9 days after pt received vaccine; pt developed rash on right torso towards the back. A Few days later it developed into a Shingles Rash diagnosed by her doctor.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: 9 days after pt received vaccine; pt developed rash on right torso towards the back. A Few days later it developed into a Shingles Rash diagnosed by her doctor.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Burning sensation, Drug ineffective, Joint stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Tenderness
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio, Alpha 1 globulin, Alpha 2 globulin, Amylase normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Angiotensin converting enzyme, Anti-SS-A antibody positive, Anti-SS-B antibody positive, Antinuclear antibody, Antinuclear antibody negative
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Aspartate aminotransferase normal, Basophil count normal, Basophil percentage, Beta globulin normal, Biopsy lip abnormal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Biopsy peripheral nerve, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood folate normal, Blood glucose normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Blood homocysteine normal, Blood iron normal, Blood lactate dehydrogenase normal, Blood magnesium normal, Blood potassium normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Blood sodium decreased, Blood thyroid stimulating hormone decreased, Blood triglycerides normal, Blood urea normal, Burning sensation
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: C-reactive protein normal, CSF cell count increased, CSF culture negative, CSF glucose increased, CSF lymphocyte count increased
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: CSF monocyte count decreased, CSF neutrophil count increased, CSF protein increased, CSF test abnormal, CSF white blood cell count increased
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Carbon dioxide normal, Demyelination, Double stranded DNA antibody, Electromyogram abnormal, Eosinophil count normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Eosinophil percentage, Fibrosis, Gamma-glutamyltransferase normal, Glycosylated haemoglobin normal, Haematocrit normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Haemoglobin normal, High density lipoprotein increased, Histone antibody, Hypoaesthesia, Immunoglobulins
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Immunology test normal, Inflammation, Intervertebral disc degeneration, Iron binding capacity total normal, Low density lipoprotein increased
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell volume normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Mean platelet volume normal, Monocyte count normal, Monocyte percentage, Nerve conduction studies abnormal, Neuropathy peripheral
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Neutrophil count normal, Neutrophil percentage, Neutrophil percentage increased, Nuclear magnetic resonance imaging spinal cord abnormal, Platelet count normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Protein total normal, Red blood cell count decreased, Red blood cell sedimentation rate increased, Red blood cells CSF positive, Red cell distribution width normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Serum ferritin normal, Spinal osteoarthritis, Treponema test, Treponema test negative, Vitamin B12 normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 44.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: White blood cell count normal, X-ray limb normal
Clinical narrative: Pt describes onset of burning, numbness in hands and feet that has not resolved and continued to steadily get worse even with medications.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: She fainted almost hit a wall hurt her chin and knee. She was sweating and her lips and face were pale and her skin was cold and clammy. It lasted for about 4 minutes (faint spell) and took her about 5 minutes to get her color back and stop being dizzy.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cold sweat, Dizziness, Face injury, Hyperhidrosis, Joint injury
Clinical narrative: She fainted almost hit a wall hurt her chin and knee. She was sweating and her lips and face were pale and her skin was cold and clammy. It lasted for about 4 minutes (faint spell) and took her about 5 minutes to get her color back and stop being dizzy.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Pallor, Syncope
Clinical narrative: She fainted almost hit a wall hurt her chin and knee. She was sweating and her lips and face were pale and her skin was cold and clammy. It lasted for about 4 minutes (faint spell) and took her about 5 minutes to get her color back and stop being dizzy.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Intussusception, Ultrasound scan
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 11 weeks old male patient. The patient had no pertinent medical history or drug reactions/allergies. The patient was vaccinated with ROTATEQ oral on 26-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-JUL-2012 the patient experienced intussusception, 21 days after onset of therapy. He was admitted to hospital for medical attention on 17-JUL-2012 and he received an air enema. The patient was performed with ultrasound (result unknown). The patient recovered and was discharged from the hospital on 18-JUL-2012. The reporter considered intussusception as life threatening. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Joint stiffness, Mobility decreased, Pain, Pyrexia
Clinical narrative: Within a couple of hours pt said shoulder stiffened and was too painful to move, by evening chills & fever. That night shaking uncontrollably. After several hours chills & shaking stopped. Saturday morning fever gone, Pt refused to come in but said he was much better still didn't have full use of arm.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Within a couple of hours pt said shoulder stiffened and was too painful to move, by evening chills & fever. That night shaking uncontrollably. After several hours chills & shaking stopped. Saturday morning fever gone, Pt refused to come in but said he was much better still didn't have full use of arm.
Age: 19.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Activities of daily living impaired, Asthenia, Bacterial test negative, Fatigue, Herpes simplex serology positive
Clinical narrative: Patient in 5th week of training developed widespread vesicular rash preceded by 10 URI with fever, fatigue and weakness. Rash virtually over entire body including scalp and mouth. Pruritic for the 1st 2 days, in various stages, nausea. 2 days after onset felt better, returned to training on 7/13 with some short term limitations on physical activity. Hospitalized only to achieve isolation. Bacterial and viral cultures neg.
Age: 19.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Nausea, Pyrexia, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: Patient in 5th week of training developed widespread vesicular rash preceded by 10 URI with fever, fatigue and weakness. Rash virtually over entire body including scalp and mouth. Pruritic for the 1st 2 days, in various stages, nausea. 2 days after onset felt better, returned to training on 7/13 with some short term limitations on physical activity. Hospitalized only to achieve isolation. Bacterial and viral cultures neg.
Age: 19.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Varicella virus test negative, Viral test negative
Clinical narrative: Patient in 5th week of training developed widespread vesicular rash preceded by 10 URI with fever, fatigue and weakness. Rash virtually over entire body including scalp and mouth. Pruritic for the 1st 2 days, in various stages, nausea. 2 days after onset felt better, returned to training on 7/13 with some short term limitations on physical activity. Hospitalized only to achieve isolation. Bacterial and viral cultures neg.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: Patient complained of nausea and dizziness 5 minutes after vaccinations given. She was pale, clammy and quickly vomited. She was laid down with legs elevated. BP. was 91/61, HR 82. RR 20. She was monitored for 10 more minutes on recheck, BP was 98/68, HR 84, RR 18, she was placed on a chair and observed for an additional 10 minutes. Patient said she now felt "fine".