chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of weakness in extremity in a female patient who received dTpa vaccine. On 11th March 2015, the patient received dTpa vaccine. On 11th March 2015, less than a day after receiving dTpa vaccine, the patient experienced chills, injection site erythema, injection site pain, joint pain, general body pain, leg pain and nocturnal awakening. On 12th March 2015, the patient experienced weakness in extremity and tiredness. In March 2015, the patient experienced weight bearing difficulty. The patient was treated with Ice Pack (Nos), heat therapy, MOTRIN, Acupuncture and TYLENOL. On an unknown date, the outcome of the weakness in extremity, tiredness and weight bearing difficulty were not recovered/not resolved and the outcome of the chills, injection site erythema, injection site pain, joint pain, general body pain, leg pain and nocturnal awakening were unknown. It was unknown if the reporter considered the weakness in extremity, chills, injection site erythema, injection site pain, joint pain, general body pain, leg pain, nocturnal awakening, tiredness and weight bearing difficulty to be related to dTpa vaccine. Additional information: The patient received a dose of TDAP on 11 March 2015 at about 5 p.m. She developed chills, redness and pain around the injection site. She also developed pain and body aches. It was very painful when she received the shot. By 8:30-9 p.m. her legs were achy. She was up for 2-3 hours during the night because of this. The next morning, she had achy and weak legs. She went to work for only the morning and then came home and slept until 9 p.m. got up for a few minutes and went back to bed. She was down all weekend. She had weakness in arms the first 2-3 weeks. It was heavy to pick up her purse, lunch, gallon of milk, etc. She have continued to have the same achy, very weak legs through the present. It has affected the patient during her daily living and work. She told her doctor about it about a month ago and he said it would probably just have to run its course. Nothing helps. She tried ice, heat, MOTRIN, elevation, acupuncture, chiropractic and TYLENOL.
Sex: F
Vaccine: TDAP
Symptoms: Middle insomnia, Muscular weakness, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: This case was reported by a consumer and described the occurrence of weakness in extremity in a female patient who received dTpa vaccine. On 11th March 2015, the patient received dTpa vaccine. On 11th March 2015, less than a day after receiving dTpa vaccine, the patient experienced chills, injection site erythema, injection site pain, joint pain, general body pain, leg pain and nocturnal awakening. On 12th March 2015, the patient experienced weakness in extremity and tiredness. In March 2015, the patient experienced weight bearing difficulty. The patient was treated with Ice Pack (Nos), heat therapy, MOTRIN, Acupuncture and TYLENOL. On an unknown date, the outcome of the weakness in extremity, tiredness and weight bearing difficulty were not recovered/not resolved and the outcome of the chills, injection site erythema, injection site pain, joint pain, general body pain, leg pain and nocturnal awakening were unknown. It was unknown if the reporter considered the weakness in extremity, chills, injection site erythema, injection site pain, joint pain, general body pain, leg pain, nocturnal awakening, tiredness and weight bearing difficulty to be related to dTpa vaccine. Additional information: The patient received a dose of TDAP on 11 March 2015 at about 5 p.m. She developed chills, redness and pain around the injection site. She also developed pain and body aches. It was very painful when she received the shot. By 8:30-9 p.m. her legs were achy. She was up for 2-3 hours during the night because of this. The next morning, she had achy and weak legs. She went to work for only the morning and then came home and slept until 9 p.m. got up for a few minutes and went back to bed. She was down all weekend. She had weakness in arms the first 2-3 weeks. It was heavy to pick up her purse, lunch, gallon of milk, etc. She have continued to have the same achy, very weak legs through the present. It has affected the patient during her daily living and work. She told her doctor about it about a month ago and he said it would probably just have to run its course. Nothing helps. She tried ice, heat, MOTRIN, elevation, acupuncture, chiropractic and TYLENOL.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Nasal congestion, Pruritus, Rash, Sinusitis, Wheezing
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a 44-year-old female patient who received ENGERIX B adult. The patient's past medical history included blood pressure high, arthritis and drug allergy (allergy to amoxicillin). Concomitant products included atenolol and diclofenac. In May 2010, the patient received ENGERIX B adult. In May 2011, 1 year after receiving ENGERIX B adult, the patient experienced rash, itching, nasal congestion, wheezing and sinus infection. On an unknown date, the outcome of the rash, itching, nasal congestion, wheezing and sinus infection were not recovered/not resolved. It was unknown if the reporter considered the rash, itching, nasal congestion, wheezing and sinus infection to be related to ENGERIX B adult. Additional information received: Patient reported that after a complete series of ENGERIX-B vaccinations, she began to develop rashes. The patient said that the rash starts every year around the same time as when she was injected in May 2010. There were no events that occurred at time of injection. The patient reports that every year around this time, when the weather gets warmer, she experiences rash that begins on her arms and spreads to her back. The rash is also itchy. The patient reports that she has nasal congestion and wheezing around the same time of year as well.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications were not reported. On 11-APR-2015, the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (dose, route of administration, lot number were not reported). No adverse events were reported. This is one of several cases reported by the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician via a company representative referring to 2 patients of unknown age and gender. Pertinent medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with PNEUMOVAX 23 injection (strength, dose, route and lot # not reported). No concomitant therapies were reported. On unknown dates, the patients experienced injection site swelling after receiving PNEUMOVAX 23. Both of the patients were in the doctor's office. The outcome of injection site swelling was unknown. Causality was not reported. Additional information is not expected because the reporter was not consented to be contacted.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Induration, Swelling
Clinical narrative: Indurated, erythema, warmth, swelling. Treated with OTC TYLENOL and topical triamcinolone cream.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Pain, Pyrexia, Swelling
Clinical narrative: Swelling, pain, fever, body-weakness and tiredness
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 5/1-itching, pain, swelling, redness at injection site tx-OTC IBU, BENADRYL. Lasted 3-4 days. 5/7-still red but no pain or itching. 2.5 inches long 1.5 inches wide.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: 4/17/15 office visit seen for redness, swelling, warmth and pain. Treated for cellulitis.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Office visit 4/17/15 treated for cellulitis.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: MCV4 required liquid/powder (dual) vaccination. Only liquid was given incomplete vaccination. Needs to go revaccinate 8wks from 2/20/15.
Age: 12.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Wrong age group given.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse refers to a 24 year old no pregnant female patient without any pertinent medical history or drug reactions/allergies. The vaccination history was unknown. On 08-APR-2015, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, subcutaneously, (strength, frequency and anatomical location were not reported), (lot # K014833, expiration date: 14-SEP-2016). Other suspect therapies were not reported. There was not concomitant therapy. On approximately 25-APR-2015, the patient experienced rash, which began on her fingers and spread to the inside of her elbows, hips bilaterally and the front and back of her knees bilaterally. The patient sought medical attention on 28-APR-2015 through office visit. No treatment was given for the adverse event and no lab diagnostics studies were performed. The outcome of rash was reported as not recovered/not resolved. The relatedness between rash and therapy with M-M-R II was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity, Syncope
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning a current 11 year old female patient. On an unknown date the patient was vaccinated with a dose of hepatitis A vaccine (manufacturer unknown) (dose, route and lot# not provided). On an unknown date the patient experienced "an allergic reaction". At the time of the report, the patient's outcome was unknown. It was also reported that in late April 2015, the patient experienced syncope after received her first dose of GARDASIL (MARRS # 1505USA002375). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 0.5 ml, intramuscular, (dose number was not reported). No adverse event was reported. Product quality complaints (PQC) were not involved. At the time of the report the outcome for the improperly stored GARDASIL was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with unspecified doses of ROTATEQ (Lot # K013661 and expiration date: 26-APR-2016), PEDVAXHIB (reported as K004541 and expiration date: 04-DEC-2016) and GARDASIL (K006960 and expiration date: 19-FEB-2017) on unspecified dates. No adverse effects were reported. Follow up information has been received on 06-MAY-2015. The information stated that the ROTATEQ was administered was improperly stored. This is one of several reports received from the same source. Additional information has been requested. Events and narrative were updated.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with unspecified doses of PEDVAXHIB (Lot No. K004541 and expiration date: 04-DEC-2016) (dose and route were not provided) on unspecified dates. No adverse effects were reported. The information stated that the PEDVAXHIB administered was improperly stored. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. In 2009, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not reported). On 06-MAY-2015 the patient received the second dose of GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications were not reported. On 13-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose, route of administration, lot number were not reported). No adverse event were reported. This is one of several cases reported by the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a few patients of unknown age and gender. No relevant medical history was reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # K016965, expiration date 20-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of patients of unkonwn age and gender. No current or historical conditions were reported. Since unknown dates from 01-APR-2015, the patients were vaccinated with PROQUAD (Merck) (route, dose, Lot# and expiration date not reported), the vaccines were exposed to temperatures outside of the recommended range on 01-APR-2015. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with unspecified doses of GARDASIL (K006960 and expiration date: 19-FEB-2017) (dose and route were not provided) on unspecified dates. No adverse effects were reported. The information stated that the GARDASIL which was administered, was improperly stored. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products
Clinical narrative: Information has been received from a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date in March 2015 the patient was vaccinated with the first dose of GARDASIL (lot number, expiration date, dose and route were not reported). On an unknown date in May 2015 the patient was vaccinated with the following dose of GARDASIL 9 (lot number, expiration date, dose and route not reported). The outcome of the event was unknown. Additional information is not expected due to lack of contact information.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a certified medical assistant via a company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number were not reported). The patient's concomitant therapies were not reported. On an unknown date, the patient development cellulitis at the injection site after administration of PNEUMOVAX 23; the patient was evaluated at unspecified hospital but it was unknown if the patient was admitted. At the time of the report, the outcome for cellulitis at the injection site was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse on 07-MAY-2015, referring to unspecified patients of unknown age and gender. The nurse reported that on unspecified dates in 2015 (since 31-MAR-2015) these unspecified patients had been administered doses of VARIVAX (Merck) (dose, route not reported, lot# K003422 with expiration date 06-MAR-2016), which had been exposed to temperatures outside of the recommended range. No adverse experience had been observed or reported. This is one of two reports received from the same reporter (other linked MARRS# 1504USA000335). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Discomfort, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, one time vaccination (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she was vaccinated, since on an unknown day in September 2014, she started to experienced prickling, tingly, burning stabbing all over her body. She stated that it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, at first it lasted for 2 weeks and she recovered, however since on an unknown day in November 2014, it came back with a vengeance and the only time she had relief was at night when she used less clothing. During the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results were not provided). The patient was prescribed DOXEPIN 10 mg capsule for the adverse event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. The relatedness between the events and ZOSTAVAX was not reported. Follow up information was received from a 60 year old female patient concerning herself. The patient stated that she was still having the side effects from a shot of the ZOSTAVAX. She reported that she was very uncomfortable some days and the medicine she had did not seem to work. She had good and bad days. She asked for help. She also mentioned that some days she lost hope that she would ever be normal again. The outcome of the event described as "the medicine did not seem to work" was not reported. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, knee surgery was considered to be medically significant. Additional information has been requested. Adverse events and correspondence contact details were added, and narrative was updated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, one time vaccination (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she was vaccinated, since on an unknown day in September 2014, she started to experienced prickling, tingly, burning stabbing all over her body. She stated that it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, at first it lasted for 2 weeks and she recovered, however since on an unknown day in November 2014, it came back with a vengeance and the only time she had relief was at night when she used less clothing. During the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results were not provided). The patient was prescribed DOXEPIN 10 mg capsule for the adverse event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. The relatedness between the events and ZOSTAVAX was not reported. Follow up information was received from a 60 year old female patient concerning herself. The patient stated that she was still having the side effects from a shot of the ZOSTAVAX. She reported that she was very uncomfortable some days and the medicine she had did not seem to work. She had good and bad days. She asked for help. She also mentioned that some days she lost hope that she would ever be normal again. The outcome of the event described as "the medicine did not seem to work" was not reported. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, knee surgery was considered to be medically significant. Additional information has been requested. Adverse events and correspondence contact details were added, and narrative was updated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Knee operation, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, one time vaccination (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she was vaccinated, since on an unknown day in September 2014, she started to experienced prickling, tingly, burning stabbing all over her body. She stated that it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, at first it lasted for 2 weeks and she recovered, however since on an unknown day in November 2014, it came back with a vengeance and the only time she had relief was at night when she used less clothing. During the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results were not provided). The patient was prescribed DOXEPIN 10 mg capsule for the adverse event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. The relatedness between the events and ZOSTAVAX was not reported. Follow up information was received from a 60 year old female patient concerning herself. The patient stated that she was still having the side effects from a shot of the ZOSTAVAX. She reported that she was very uncomfortable some days and the medicine she had did not seem to work. She had good and bad days. She asked for help. She also mentioned that some days she lost hope that she would ever be normal again. The outcome of the event described as "the medicine did not seem to work" was not reported. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, knee surgery was considered to be medically significant. Additional information has been requested. Adverse events and correspondence contact details were added, and narrative was updated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urine analysis
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, one time vaccination (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she was vaccinated, since on an unknown day in September 2014, she started to experienced prickling, tingly, burning stabbing all over her body. She stated that it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, at first it lasted for 2 weeks and she recovered, however since on an unknown day in November 2014, it came back with a vengeance and the only time she had relief was at night when she used less clothing. During the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results were not provided). The patient was prescribed DOXEPIN 10 mg capsule for the adverse event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. The relatedness between the events and ZOSTAVAX was not reported. Follow up information was received from a 60 year old female patient concerning herself. The patient stated that she was still having the side effects from a shot of the ZOSTAVAX. She reported that she was very uncomfortable some days and the medicine she had did not seem to work. She had good and bad days. She asked for help. She also mentioned that some days she lost hope that she would ever be normal again. The outcome of the event described as "the medicine did not seem to work" was not reported. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, knee surgery was considered to be medically significant. Additional information has been requested. Adverse events and correspondence contact details were added, and narrative was updated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Discomfort, Feeling abnormal, Knee operation
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, one time vaccination (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she was vaccinated, since on an unknown day in September 2014, she started to experienced prickling, tingly, burning stabbing all over her body. She stated that it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, at first it lasted for 2 weeks and she recovered, however since on an unknown day in November 2014, it came back with a vengeance and the only time she had relief was at night when she used less clothing. During the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results were not provided). The patient was prescribed DOXEPIN 10 mg capsule for the adverse event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. The relatedness between the events and ZOSTAVAX was not reported. Follow up information was received from a 60 year old female patient concerning herself. The patient stated that she was still having the side effects from a shot of the ZOSTAVAX. She reported that she was very uncomfortable some days and the medicine she had did not seem to work. She had good and bad days. She asked for help. She also mentioned that some days she lost hope that she would ever be normal again. The outcome of the event described as "the medicine did not seem to work" was not reported. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, knee surgery was considered to be medically significant. Additional information has been requested. Adverse events and correspondence contact details were added, and narrative was updated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Paraesthesia, Urine analysis
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reporting on herself. The patient drug reactions/allergies included codeine allergy. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, one time vaccination (route, lot number and expiration date were not provided). Concomitant therapies included hydrocodone and ibuprofen. Consumer reported that, after she was vaccinated, since on an unknown day in September 2014, she started to experienced prickling, tingly, burning stabbing all over her body. She stated that it was on her legs, behind her legs, her back, face, all over. At first, it was pin pricks which she could not remember when that started, it could have been right away but since it had been going through so much. She reported that, at first it lasted for 2 weeks and she recovered, however since on an unknown day in November 2014, it came back with a vengeance and the only time she had relief was at night when she used less clothing. During the day when she had clothes on it got worse, therefore, she had not recovered. She also stated that, on an unknown day in November 2014, the patient underwent a blood and urine test (results were not provided). The patient was prescribed DOXEPIN 10 mg capsule for the adverse event. Consumer also had a knee surgery on approximately 28-JAN-2015 (reported as 2 weeks and a day ago). At the time of the report, the outcome of a knee surgery was not provided. The relatedness between the events and ZOSTAVAX was not reported. Follow up information was received from a 60 year old female patient concerning herself. The patient stated that she was still having the side effects from a shot of the ZOSTAVAX. She reported that she was very uncomfortable some days and the medicine she had did not seem to work. She had good and bad days. She asked for help. She also mentioned that some days she lost hope that she would ever be normal again. The outcome of the event described as "the medicine did not seem to work" was not reported. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, knee surgery was considered to be medically significant. Additional information has been requested. Adverse events and correspondence contact details were added, and narrative was updated.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Acute disseminated encephalomyelitis, Choreoathetosis, Decreased eye contact, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Increase in fussiness, decreased ability to PO feed and increased agitation followed by loss of developmental milestones over the next several days. She was admitted to a hospital for acute evaluation and neurologic work-up.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Posture abnormal, Somnolence, Visual impairment, White matter lesion
Clinical narrative: Increase in fussiness, decreased ability to PO feed and increased agitation followed by loss of developmental milestones over the next several days. She was admitted to a hospital for acute evaluation and neurologic work-up.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Agitation, Crying, Decreased activity, Decreased appetite, Depressed mood
Clinical narrative: Increase in fussiness, decreased ability to PO feed and increased agitation followed by loss of developmental milestones over the next several days. She was admitted to a hospital for acute evaluation and neurologic work-up.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Dyskinesia, Gaze palsy, Hyperhidrosis, Irritability, Posture abnormal
Clinical narrative: Increase in fussiness, decreased ability to PO feed and increased agitation followed by loss of developmental milestones over the next several days. She was admitted to a hospital for acute evaluation and neurologic work-up.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Somnolence
Clinical narrative: Increase in fussiness, decreased ability to PO feed and increased agitation followed by loss of developmental milestones over the next several days. She was admitted to a hospital for acute evaluation and neurologic work-up.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Agitation, Anti-NMDA antibody positive, Childhood disintegrative disorder, Encephalitis autoimmune, Hypophagia
Clinical narrative: Increase in fussiness, decreased ability to PO feed and increased agitation followed by loss of developmental milestones over the next several days. She was admitted to a hospital for acute evaluation and neurologic work-up.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Irritability
Clinical narrative: Increase in fussiness, decreased ability to PO feed and increased agitation followed by loss of developmental milestones over the next several days. She was admitted to a hospital for acute evaluation and neurologic work-up.
Age: 0.61
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Anti-NMDA antibody positive, Dyskinesia, Encephalitis autoimmune, Encephalopathy
Clinical narrative: Increase in fussiness, decreased ability to PO feed and increased agitation followed by loss of developmental milestones over the next several days. She was admitted to a hospital for acute evaluation and neurologic work-up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient with no known allergies. On 20-APR-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot# K023623, expiration date: 20-FEB-2015, 0.65 ml, subcutaneous in the left arm. Concomitant medicines included unspecified medications. In April 2015 the patient experienced injection site red, hot to touch and ten centimeter wide raised swelling at the left arm. The patient came to the pharmacy for medical attention. There was no treatment given for the adverse event. The outcome of the adverse events was reported as not recovered/not resolved. The relationship of the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Local swelling
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient with no known allergies. On 20-APR-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot# K023623, expiration date: 20-FEB-2015, 0.65 ml, subcutaneous in the left arm. Concomitant medicines included unspecified medications. In April 2015 the patient experienced injection site red, hot to touch and ten centimeter wide raised swelling at the left arm. The patient came to the pharmacy for medical attention. There was no treatment given for the adverse event. The outcome of the adverse events was reported as not recovered/not resolved. The relationship of the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervical dysplasia, Colposcopy, Human papilloma virus test positive, Loop electrosurgical excision procedure, Papilloma viral infection
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a currently (at the time of the report) 23 years old female patient. The patient's medical history and concurrent conditions were not reported. The concomitant therapy included "multi vitamins" (manufacturer, dose, frequency, route of administration unknown). In approximately 2008 (reported as at the age 16), the patient completed the shot series of GARDASIL (intramuscular; dose, frequency, lot # and expiration date unknown). it was reported that the patient was a virgin when she completed the GARDASIL shot series and that she always uses condoms during sex. In 2011, the patient had the Papanicolaou test (reported as paps)- the result started to be abnormal. On an unknown date, the patient had a cervical intraepithelial neoplasia test (CIN) with the result 2 and 3 (units not provided) (coded as cervical dysplasia). In 2014, the patient had the next one Papanicolaou test and she had a low grade for type 18. In 2015, the patient had a high grade for type 18 in the Papanicolaou test. In 2015, the patient tested positive for HPV for type 18 (coded as papilloma viral infection). On 27-APR-2015, the patient had a colonoscopy and she was scheduled to have Loop Electrosurgical Excision Procedure (LEEP) on an unspecified date. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with GARDASIL was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a currently (at the time of the report) 23 years old female patient. The patient's medical history and concurrent conditions were not reported. The concomitant therapy included "multi vitamins" (manufacturer, dose, frequency, route of administration unknown). In approximately 2008 (reported as at the age 16), the patient completed the shot series of GARDASIL (intramuscular; dose, frequency, lot # and expiration date unknown). it was reported that the patient was a virgin when she completed the GARDASIL shot series and that she always uses condoms during sex. In 2011, the patient had the Papanicolaou test (reported as paps)- the result started to be abnormal. On an unknown date, the patient had a cervical intraepithelial neoplasia test (CIN) with the result 2 and 3 (units not provided) (coded as cervical dysplasia). In 2014, the patient had the next one Papanicolaou test and she had a low grade for type 18. In 2015, the patient had a high grade for type 18 in the Papanicolaou test. In 2015, the patient tested positive for HPV for type 18 (coded as papilloma viral infection). On 27-APR-2015, the patient had a colonoscopy and she was scheduled to have Loop Electrosurgical Excision Procedure (LEEP) on an unspecified date. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with GARDASIL was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervical dysplasia, Colonoscopy, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a currently (at the time of the report) 23 years old female patient. The patient's medical history and concurrent conditions were not reported. The concomitant therapy included "multi vitamins" (manufacturer, dose, frequency, route of administration unknown). In approximately 2008 (reported as at the age 16), the patient completed the shot series of GARDASIL (intramuscular; dose, frequency, lot # and expiration date unknown). it was reported that the patient was a virgin when she completed the GARDASIL shot series and that she always uses condoms during sex. In 2011, the patient had the Papanicolaou test (reported as paps)- the result started to be abnormal. On an unknown date, the patient had a cervical intraepithelial neoplasia test (CIN) with the result 2 and 3 (units not provided) (coded as cervical dysplasia). In 2014, the patient had the next one Papanicolaou test and she had a low grade for type 18. In 2015, the patient had a high grade for type 18 in the Papanicolaou test. In 2015, the patient tested positive for HPV for type 18 (coded as papilloma viral infection). On 27-APR-2015, the patient had a colonoscopy and she was scheduled to have Loop Electrosurgical Excision Procedure (LEEP) on an unspecified date. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with GARDASIL was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity, X-ray normal
Clinical narrative: Possible nerve damage, pain in left arm, shoulder, wrist, and hand.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia, Streptococcus test positive
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown dates, the patient received four doses of pneumococcal vaccine, at least one dose was PNEUMOVAX 23 (dose, route and lot# was not reported). On an unspecified dates after vaccination, the patient had two cases of pneumonia. In approximately 2015, the patient developed a third case of pneumonia, for which the patient was hospitalized at the time of reporting. The patient received an unspecified treatment for the event. On an unknown date, the patient was tested for pneumococcal pathogen serotypes (units were not provided): serotype 1: less than 0.1, serotype 3: 0.3, serotype 4: 0.4, serotype 5: less than 0.1, serotype 8: 2.2, serotype 9N: 0.6, serotype 12: less than 0.1, serotype 14: 2.3, serotype 19: 2.3, serotype 23: 1.0, serotype 26: 0.2, serotype 51: less than 0.1, serotype 56: 1.3, serotype 68: less than 0.1. At the time of reporting, the patient had not recovered from a third case of pneumonia. The outcome of the previous episodes of pneumonia was not reported. The relatedness between all three episodes of pneumonia and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: This is a spontaneous report from a contactable pediatrician and nurse via a Pfizer sales representative. A 13-year-old male patient received first dose (three dose series) of TRUMENBA (Lot# J29203, Exp date 01Jun2016), intramuscular in right arm, on 27Apr2015 at approximately 03:15 pm, at 0.5ml single. He left the reporter's office at 3:30 pm feeling fine. The patient was otherwise healthy, no other medical conditions. Concomitant medication included first dose (three dose series) of HPV vaccine (Lot# L004601, Exp date 04Nov2016), intramuscular in the left arm, on 27Apr2015 at approximately 03:15 pm, at unspecified dose and frequency. On 27Apr2015 the patient experienced pain at the injection site, headache, fatigue, nausea, extreme dizziness, right arm feeling sore or painful, pallor and chills. The patient came back to see the doctor on 28Apr2015 at 11:45 am for extreme dizziness and other side effects. At doctor's visit he could barely lift his right arm. The patient was running into corners of the wall when he had the dizziness. Patient stated he felt like blood rushing through him fast (Apr2015). On 29Apr2015 the patient experienced trouble walking: needed to go down stairs on his back, and could not walk down the stairs because of weakness in legs. On an unspecified date the patient experienced fever. The patient was completely checked out and examined at hospital and was diagnosed with convulsion disorder, for which received treatment. He was brought to the emergency room (ER), where full neurological work up was performed. Outcome of events trouble walking, weakness in legs and extreme dizziness was not recovered at the time of this report. Outcome of the other mentioned events was unknown. The reporting physician did not think side effects had anything to do with the HPV vaccine, he thought they were from TRUMENBA. Follow-up (05May2015): new information received from a contactable pediatrician via a Pfizer sales representative includes: event "Convulsion disorder" added, lab data added.
Age: 13.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Muscular weakness, Nausea
Clinical narrative: This is a spontaneous report from a contactable pediatrician and nurse via a Pfizer sales representative. A 13-year-old male patient received first dose (three dose series) of TRUMENBA (Lot# J29203, Exp date 01Jun2016), intramuscular in right arm, on 27Apr2015 at approximately 03:15 pm, at 0.5ml single. He left the reporter's office at 3:30 pm feeling fine. The patient was otherwise healthy, no other medical conditions. Concomitant medication included first dose (three dose series) of HPV vaccine (Lot# L004601, Exp date 04Nov2016), intramuscular in the left arm, on 27Apr2015 at approximately 03:15 pm, at unspecified dose and frequency. On 27Apr2015 the patient experienced pain at the injection site, headache, fatigue, nausea, extreme dizziness, right arm feeling sore or painful, pallor and chills. The patient came back to see the doctor on 28Apr2015 at 11:45 am for extreme dizziness and other side effects. At doctor's visit he could barely lift his right arm. The patient was running into corners of the wall when he had the dizziness. Patient stated he felt like blood rushing through him fast (Apr2015). On 29Apr2015 the patient experienced trouble walking: needed to go down stairs on his back, and could not walk down the stairs because of weakness in legs. On an unspecified date the patient experienced fever. The patient was completely checked out and examined at hospital and was diagnosed with convulsion disorder, for which received treatment. He was brought to the emergency room (ER), where full neurological work up was performed. Outcome of events trouble walking, weakness in legs and extreme dizziness was not recovered at the time of this report. Outcome of the other mentioned events was unknown. The reporting physician did not think side effects had anything to do with the HPV vaccine, he thought they were from TRUMENBA. Follow-up (05May2015): new information received from a contactable pediatrician via a Pfizer sales representative includes: event "Convulsion disorder" added, lab data added.