chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Mobility decreased, Nausea, Neurological examination, Neutrophil percentage increased, Nuclear magnetic resonance imaging normal
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Ocular hyperaemia, Pallor, Red blood cell count normal, Syncope, Temperature intolerance
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Ultrasound Doppler normal, Visual impairment
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 30-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. 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 physician assistant refers to an unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The patient was vaccinated with GARDASIL injection on 15-MAR-2013 and 01-JUL-2013 (lot number, dose, frequency, route not reported). No concomitant medications were reported. The patient was in office on 30-JUL-2015 to receive the third dose. No adverse events were experienced. The outcome of inappropriate schedule of drug administration was unknown. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: This literature retrospective report as received from health professional refers two patients of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) (dose, route, frequency, lot# not reported). No concomitant medications reported. Background: Vaccines remain one of the most effective methods of preventing infections following transplantation. Data suggests that vaccine responses are reduced in recipients of hematopoietic stem cell (HSCT) or solid organ transplant (SOT) compared to healthy controls. There were no data on the efficacy of vaccines in combined HSCT-SOT recipients (R). Methods: As part of an IRB approved study, chimeric vs. transiently chimeric recipients of combines HSCT-kidney transplant (KT) receive vaccination with Tdap, PNEUMOVAX, HBV vaccine, polio, meningococcal, HIB and influenza vaccine consistent with current ASBMT guidelines. Revaccination data for HSCT-KTRs was retrospectively reviewed for tetanus, S. pneumonia and hepatitis B titers and compared between those maintained and failed to have durable chimerism (DC). Descriptive statistics were assessed. Results: A total of 12 combined HSCT-KTRs were vaccinated and had complete serologic follow-up. HSCT-KTRs with DC had higher rates of protective titers post-tetanus vaccination. Likewise, HSCT-KTRs with DC demonstrated higher protective response rates in 12/14 serotypes following: PNEUMOVAX. Rates of hepatitis b vaccine (manufacturer unknown) seroconversion were higher among DC HSCT-KTRs: 3/4 subjects with DC did not have protective antibodies pre-vaccination; all patients had seroprotection post vaccine. Only 1/3 of the patients without DC seroconverted. Conclusions: In his cohort of HSCT-KTRs, DC was associated with excellent seroprotection post-vaccination with Tdap, PNEUMOVAX and hepatitis b vaccine (manufacturer unknown) vaccine. On an unknown date among the three patients had seroconversion test negative without DC. The outcome of seroconversion test negative was unknown. The reporter considered seroconversion test negative to be related to hepatitis b vaccine (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 26-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 26 year old female patient. She had no pertinent medical history, no drug reactions or allergies and she was not taking concomitant medications. On 01-JUL-2015, the patient was vaccinated with a dose of M-M-R II (0.5 ml, subcutaneous, lot number reported as: K008815 and expiry: 19-JUN-2016) and with a dose of ENGERIX-B (dose, route, lot # not provided). Approximately on 15-JUL-2015 (reported as "2 weeks later"), the patient experienced "rash all over her body". Due to this event, she visited the Emergency Room on 17-JUL-2015. However, she was not admitted and was discharged on the same day. The patient recovered from rash all over her body on an unspecified date in 2015. Relatedness between the event and suspect vaccines was not specified. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Full blood count, Laboratory test, Lipids, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse regarding a 21 year old female patient. There was no information about concurrent condition. Historically on 17-MAY-2007 and 13-SEP-2007 patient was administered with GARDASIL. On 03-JUN-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, expiration date- 24-FEB-2017, dose 1. No concurrent medication was reported. The patient became pregnant. The Last Menstrual Period (LMP) and Estimated date of delivery (EDD) was not known. The pregnancy outcome was unknown. On 03-JUN-2015, the patient had a positive urine pregnancy test (exposure during pregnancy). No adverse event was reported. On 03-JUN-2015, laboratory tests PAP smear, STD testing, Lipid screening and Complete Blood Count was done and results were unkonwn. No intervention was done to prevent serious criteria. No Product quality complaint was involved. The outcome of positive urine pregnancy test was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Pregnancy test urine positive, Smear cervix
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse regarding a 21 year old female patient. There was no information about concurrent condition. Historically on 17-MAY-2007 and 13-SEP-2007 patient was administered with GARDASIL. On 03-JUN-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, expiration date- 24-FEB-2017, dose 1. No concurrent medication was reported. The patient became pregnant. The Last Menstrual Period (LMP) and Estimated date of delivery (EDD) was not known. The pregnancy outcome was unknown. On 03-JUN-2015, the patient had a positive urine pregnancy test (exposure during pregnancy). No adverse event was reported. On 03-JUN-2015, laboratory tests PAP smear, STD testing, Lipid screening and Complete Blood Count was done and results were unkonwn. No intervention was done to prevent serious criteria. No Product quality complaint was involved. The outcome of positive urine pregnancy test was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 23-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a physician of unknown age and gender. There was no information about concomitant medications, pertinent medical history, drug and allergies provided. On an unknown date, the patient was vaccinated (as a child) with unspecified dose of hepatitis B vaccine (manufacturer unknown) (reported as unspecified hepatitis B vaccine) injection (lot#, expiration date, frequency, indication, route and site of vaccination were not reported). Subsequently, on an unspecified time after receiving the hepatitis B vaccine (manufacturer unknown) the patient had titers drawn, which showed that the patient had no immunity to hepatitis B. There was no product quality complaint (PQC) involved. The outcome of the event was unknown. The relatedness between the event and hepatitis B vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about concomitant medications, pertinent medical history, drug and allergies provided. On an unknown date, the patient was vaccinated (as a child) with unspecified dose of hepatitis B vaccine (manufacturer unknown) (reported as unspecified hepatitis B vaccine) injection (lot#, expiration date, frequency, indication, route and site of vaccination were not reported). Subsequently, on an unspecified time after receiving the hepatitis B vaccine (manufacturer unknown) the patient had titers drawn, which showed that the patient had no immunity to hepatitis B. There was no product quality complaint (PQC) involved. The outcome of the event was unknown. The relatedness between the event and hepatitis B vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about concomitant medications, pertinent medical history, drug and allergies provided. On an unknown date, an unspecified number of patients were vaccinated with unspecified doses of GARDASIL (lots#, expiration dates, doses, frequency, indication, sites and routes of vaccination were not reported) or GARDASIL 9 (lot#, expiration dates, doses, frequency, indication, sites and routes of vaccination were not reported). It was not specified by the reporter, which one of the vaccines the patients received. Subsequently, on an unspecified time after receiving the GARDASIL or GARDASIL 9 the patients "passed out". The outcome of the event was unknown. The relatedness between the event and GARDASIL or GARDASIL 9 was not reported. This is one of several reports received from the same reporter. 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 registered nurse refers to a patient of unknown age and unknown gender. On 08-JUL-2008, on 05-SEP-2008 and on 16-JUN-2015 the patient was vaccinated intramuscularly with the first, the second and the third 0.5 ml dose of GARDASIL (batch #, Lot # and an expiration date were not provided), respectively. No adverse experience was reported by the nurse. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 23 years old female patient. The patient became pregnant with last menstrual period (LMP) of approximately 06-JUN-2015 and estimated delivery date (EDD) of approximately 12-MAR-2016. The patient had no concomitant medication, pertinent medical history and more known drug reactions or allergies. On 18-JUL-2015, the pregnant patient was vaccinated with the second dose of GARDASIL (strength, dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Exposure to GARDASIL occurred at 6 gestational week. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer via nurse practitioner (also reported as physician) via field employee refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. The consumer reported that there was information on the internet that stated that unspecified female patient received a three dose series of GARDASIL (dose, route of administration, lot number and expiration date not reported) or GARDASIL 9 (dose, route of administration, lot number and expiration date not reported) and that the patient experienced many unspecified  side effects (date unspecified). The outcome of the event was not reported. The relatedness between the event and the GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapy, pertinent medical history, drug reactions and allergies provided. On an unknown date, the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose, site and route of administration, indication were not reported), which had been improperly stored. No adverse effects and no product quality complaints (PQC) were reported. Additional information is not expected, as the reporter does not wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot No. and expiration date were not described). On an unspecified date in 2015, the patient was inadvertently administered with another dose of ZOSTAVAX (dose, lot #, expiration date and route were not reported) (extra dose administered). No adverse events were reported. It was unknown if the patient sought medical attention. 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 registered nurse refers to an unspecified number of patients of unknown age. On an unknown date, the unspecified number of patients were vaccinated with improperly stored oral, ROTATEQ (lot# K016263, expiry date: 14-JUL-2015, lot# K016261, expiry date: 15-JUN-2015 and lot# K023532, expiry date; 19-MAY-2015) prior to the labeled expiration. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 11-APR-2011, the patient was vaccinated with a dose of VAQTA (lot#, dose and route were not reported) by an unspecified physician. Then another dose of VAQTA was administered on 19-SEP-2011 by an unspecified physician (Inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling face
Clinical narrative: Swelling on face w/redness.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Throat tightness
Clinical narrative: Initial report was received from a health care professional on 05 October 2012. This is a cluster of two patients who received FLUZONE, lot number UH719AA, and experienced adverse events. The other patient was captured in case number 2012-09314. An 83-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH719AA, on 04 October 2012 and 10 minutes later experienced a cough followed by feeling of throat closure at 15 minutes post-vaccination. The patient was treated with BENADRYL liquid 10 mL and the symptoms resolved. The patient was not acutely ill at the time of vaccination. The patient had allergies to nonsteroidal anti-inflammatory drugs (NSAIDs) and penicillin (PCN). Past medical history (PMH) included hypertension (HTN), hyperlipidemia, coronary artery disease (CAD), aortic aneurysm, anxiety and left hip fracture. Concomitant medications included VALIUM, PLAVIX, CRESTOR, VICODIN and oxybutynin chloride. The patient's outcome was recovered. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pain, Lip swelling, Pyrexia
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The male patient, age 60, whose medical history was reported as having received treatment for low testosterone on an unspecified date and no known allergies received a dose of FLUZONE ID on 05 October 2012 (lot number UT4463AA, expiry 25 March 2013) into the left arm. Within 3 hours of vaccination, the patient developed a fever of 102.5 and redness and soreness at the injection site. The patient was seen by the physician on an unspecified date with redness on entire left arm and anterior chest and a fever. The patient was treated with BENADRYL and antibiotics, details not specified. On the day of the report (09 October 2012), the patient was seen by the physician and was experiencing swollen lips and a feeling of her "throat closing". Concomitant medications and lab results were not reported. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Initial case received from a health care professional on 09 October 2012. The male patient, age 60, whose medical history was reported as having received treatment for low testosterone on an unspecified date and no known allergies received a dose of FLUZONE ID on 05 October 2012 (lot number UT4463AA, expiry 25 March 2013) into the left arm. Within 3 hours of vaccination, the patient developed a fever of 102.5 and redness and soreness at the injection site. The patient was seen by the physician on an unspecified date with redness on entire left arm and anterior chest and a fever. The patient was treated with BENADRYL and antibiotics, details not specified. On the day of the report (09 October 2012), the patient was seen by the physician and was experiencing swollen lips and a feeling of her "throat closing". Concomitant medications and lab results were not reported. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial report received from a vaccine provider on 07 January 2013. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. The report involves a cluster of 6 children from the same reporter and same lot number UH753AB. This case captures one of the children and the other children are captured in cases 2012-11111, 2013-00527, 2013-00528, 2013-00529 and 2013-00530. A 10 year-old female patient whose illness at the time of vaccination was reported as "N/A" and past medical history was unknown had received a dose of FLUZONE (lot number UH753AB, IM) on 05 October 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on 21 November 2012. The patient's outcome was not recovered. Documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chest discomfort, Chills, Dry skin, Feeling abnormal
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 21-Aug-2013) concerns a 69 year old male patient who had a medical history of asthma and allergy to aspirin. The patient was not taking any medications at the time of vaccination. On the 03-Dec-2012 at 11:50, the patient received AFLURIA (batch number P50008) via the intramuscular route in the right arm. The patient also received PNEUMOVAX (batch number H009826) via the intramuscular route in the left arm. On the 03-Dec-2012, at 11:55 as soon as he reached the car, the patient felt funny and flushed. He laid down, his temperature was 99, blood pressure was 140/94 and pulse was 92. His skin was dry and had an occasional loose cough. He stated that he had a little bug on his chest in the morning. At 12:05 he was feeling better, and blood pressure was 148/94, temperature was 98.4. On the 04-Dec-2012, he saw the doctor in the morning, and had chilled most of the night but was sleeping. On the 11-Dec-2012, he was feeling better but felt bad for a few days. Outcome was reported as recovered. Reporter comments: the regulator reported the case as non-serious. Case correction (10-Jul-2014) - AE 9 re-coded and AE. 9 listedness. Case correction (14-Aug-2014): AE 9 re-coded and AE 9 listedness. Case correction (06-Jan-2015): Coding AE#1, case upgraded to serious. Case correction (22-Jul-2015): LLT and listedness for AE 9.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Flushing, Productive cough
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 21-Aug-2013) concerns a 69 year old male patient who had a medical history of asthma and allergy to aspirin. The patient was not taking any medications at the time of vaccination. On the 03-Dec-2012 at 11:50, the patient received AFLURIA (batch number P50008) via the intramuscular route in the right arm. The patient also received PNEUMOVAX (batch number H009826) via the intramuscular route in the left arm. On the 03-Dec-2012, at 11:55 as soon as he reached the car, the patient felt funny and flushed. He laid down, his temperature was 99, blood pressure was 140/94 and pulse was 92. His skin was dry and had an occasional loose cough. He stated that he had a little bug on his chest in the morning. At 12:05 he was feeling better, and blood pressure was 148/94, temperature was 98.4. On the 04-Dec-2012, he saw the doctor in the morning, and had chilled most of the night but was sleeping. On the 11-Dec-2012, he was feeling better but felt bad for a few days. Outcome was reported as recovered. Reporter comments: the regulator reported the case as non-serious. Case correction (10-Jul-2014) - AE 9 re-coded and AE. 9 listedness. Case correction (14-Aug-2014): AE 9 re-coded and AE 9 listedness. Case correction (06-Jan-2015): Coding AE#1, case upgraded to serious. Case correction (22-Jul-2015): LLT and listedness for AE 9.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Abscess, Blood test, Cellulitis, Injection site reaction, Mobility decreased
Clinical narrative: Initial report was received on 13 November 2012 from a healthcare professional. This case was originally part of a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients) who tested PCR positive for influenza A/H3N2. The two adolescent patients were captured in case number 2012-05659 and the ten unidentified patients (previously reported as nine patients) were captured in case numbers 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072, 2012-06073. In addition this case was previously part of the six elderly patient's case 2012-05658. The other elderly patient cases have been captured in case numbers 2012-10691, 2012-10693, 2012-10694 and 2012-10695. A 92 year-old female patient had received on 11 October 2011 a dose of FLUZONE, lot number UH454AC (route and site of administration not reported). The patient participated in an influenza surveillance program. The patient's approximate treatment date and "collection date" was 24 January 2012. According to the reporter, the type of influenza was flu A and the subtype of influenza was H3N2. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Pyrexia, Rash macular
Clinical narrative: Initial report was received on 13 November 2012 from a healthcare professional. This case was originally part of a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients) who tested PCR positive for influenza A/H3N2. The two adolescent patients were captured in case number 2012-05659 and the ten unidentified patients (previously reported as nine patients) were captured in case numbers 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072, 2012-06073. In addition this case was previously part of the six elderly patient's case 2012-05658. The other elderly patient cases have been captured in case numbers 2012-10691, 2012-10693, 2012-10694 and 2012-10695. A 92 year-old female patient had received on 11 October 2011 a dose of FLUZONE, lot number UH454AC (route and site of administration not reported). The patient participated in an influenza surveillance program. The patient's approximate treatment date and "collection date" was 24 January 2012. According to the reporter, the type of influenza was flu A and the subtype of influenza was H3N2. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction positive
Clinical narrative: Initial report was received on 13 November 2012 from a healthcare professional. This case was originally part of a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients) who tested PCR positive for influenza A/H3N2. The two adolescent patients were captured in case number 2012-05659 and the ten unidentified patients (previously reported as nine patients) were captured in case numbers 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072, 2012-06073. In addition this case was previously part of the six elderly patient's case 2012-05658. The other elderly patient cases have been captured in case numbers 2012-10691, 2012-10693, 2012-10694 and 2012-10695. A 92 year-old female patient had received on 11 October 2011 a dose of FLUZONE, lot number UH454AC (route and site of administration not reported). The patient participated in an influenza surveillance program. The patient's approximate treatment date and "collection date" was 24 January 2012. According to the reporter, the type of influenza was flu A and the subtype of influenza was H3N2. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Activities of daily living impaired, Burning sensation, Chest pain, Confusional state, Disorientation
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 66-year old female patient. The patient had no current illness. The patient never drank or smoked anything in her life. On 03-Oct-2014, the patient received AFLURIA injection (batch number T57505) in the left arm and PNEUMOVAX injection (batch number J010396) in the right arm. On 03-Oct-2014, the patient went home and felt bad and her right arm was hurting very bad. Her right arm was swollen, red and burning. The pain was shooting through arm and chest. That night, she felt dizzy, nauseous, had pain everywhere, shaking, was confused and disoriented. She went to the hospital. On the day she took the shots, she had to go the ER (emergency room) at Medical Centre. The patient reported that to this day, she felt really awful. Her body ached all over. Her left hand hurt so badly that she could not pick things up. It was hard at times to walk and she was quite disoriented at times. Her head and neck hurt, for which she took EXCEDRIN and ibuprofen 600 every day. Her eyes kept getting red and burning. Her ears were ringing constantly and loud. The patient reported that 'it hurts to write this letter from her right hand'. She could not type well anymore either. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as serious (life-threatening). The patient stated that she did know that it was caused from pneumonia shot and had no doubt about it. She reported that she was not perfect but was going through many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dizziness, Erythema, Eye irritation, Feeling abnormal, Gait disturbance
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 66-year old female patient. The patient had no current illness. The patient never drank or smoked anything in her life. On 03-Oct-2014, the patient received AFLURIA injection (batch number T57505) in the left arm and PNEUMOVAX injection (batch number J010396) in the right arm. On 03-Oct-2014, the patient went home and felt bad and her right arm was hurting very bad. Her right arm was swollen, red and burning. The pain was shooting through arm and chest. That night, she felt dizzy, nauseous, had pain everywhere, shaking, was confused and disoriented. She went to the hospital. On the day she took the shots, she had to go the ER (emergency room) at Medical Centre. The patient reported that to this day, she felt really awful. Her body ached all over. Her left hand hurt so badly that she could not pick things up. It was hard at times to walk and she was quite disoriented at times. Her head and neck hurt, for which she took EXCEDRIN and ibuprofen 600 every day. Her eyes kept getting red and burning. Her ears were ringing constantly and loud. The patient reported that 'it hurts to write this letter from her right hand'. She could not type well anymore either. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as serious (life-threatening). The patient stated that she did know that it was caused from pneumonia shot and had no doubt about it. She reported that she was not perfect but was going through many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Nausea, Neck pain, Ocular hyperaemia, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 66-year old female patient. The patient had no current illness. The patient never drank or smoked anything in her life. On 03-Oct-2014, the patient received AFLURIA injection (batch number T57505) in the left arm and PNEUMOVAX injection (batch number J010396) in the right arm. On 03-Oct-2014, the patient went home and felt bad and her right arm was hurting very bad. Her right arm was swollen, red and burning. The pain was shooting through arm and chest. That night, she felt dizzy, nauseous, had pain everywhere, shaking, was confused and disoriented. She went to the hospital. On the day she took the shots, she had to go the ER (emergency room) at Medical Centre. The patient reported that to this day, she felt really awful. Her body ached all over. Her left hand hurt so badly that she could not pick things up. It was hard at times to walk and she was quite disoriented at times. Her head and neck hurt, for which she took EXCEDRIN and ibuprofen 600 every day. Her eyes kept getting red and burning. Her ears were ringing constantly and loud. The patient reported that 'it hurts to write this letter from her right hand'. She could not type well anymore either. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as serious (life-threatening). The patient stated that she did know that it was caused from pneumonia shot and had no doubt about it. She reported that she was not perfect but was going through many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Tinnitus, Tremor
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 66-year old female patient. The patient had no current illness. The patient never drank or smoked anything in her life. On 03-Oct-2014, the patient received AFLURIA injection (batch number T57505) in the left arm and PNEUMOVAX injection (batch number J010396) in the right arm. On 03-Oct-2014, the patient went home and felt bad and her right arm was hurting very bad. Her right arm was swollen, red and burning. The pain was shooting through arm and chest. That night, she felt dizzy, nauseous, had pain everywhere, shaking, was confused and disoriented. She went to the hospital. On the day she took the shots, she had to go the ER (emergency room) at Medical Centre. The patient reported that to this day, she felt really awful. Her body ached all over. Her left hand hurt so badly that she could not pick things up. It was hard at times to walk and she was quite disoriented at times. Her head and neck hurt, for which she took EXCEDRIN and ibuprofen 600 every day. Her eyes kept getting red and burning. Her ears were ringing constantly and loud. The patient reported that 'it hurts to write this letter from her right hand'. She could not type well anymore either. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as serious (life-threatening). The patient stated that she did know that it was caused from pneumonia shot and had no doubt about it. She reported that she was not perfect but was going through many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Grip strength decreased, Headache, Nausea, Neck pain, Ocular hyperaemia
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 66-year old female patient. The patient had no current illness. The patient never drank or smoked anything in her life. On 03-Oct-2014, the patient received AFLURIA injection (batch number T57505) in the left arm and PNEUMOVAX injection (batch number J010396) in the right arm. On 03-Oct-2014, the patient went home and felt bad and her right arm was hurting very bad. Her right arm was swollen, red and burning. The pain was shooting through arm and chest. That night, she felt dizzy, nauseous, had pain everywhere, shaking, was confused and disoriented. She went to the hospital. On the day she took the shots, she had to go the ER (emergency room) at Medical Centre. The patient reported that to this day, she felt really awful. Her body ached all over. Her left hand hurt so badly that she could not pick things up. It was hard at times to walk and she was quite disoriented at times. Her head and neck hurt, for which she took EXCEDRIN and ibuprofen 600 every day. Her eyes kept getting red and burning. Her ears were ringing constantly and loud. The patient reported that 'it hurts to write this letter from her right hand'. She could not type well anymore either. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as serious (life-threatening). The patient stated that she did know that it was caused from pneumonia shot and had no doubt about it. She reported that she was not perfect but was going through many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Tinnitus, Tremor
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 66-year old female patient. The patient had no current illness. The patient never drank or smoked anything in her life. On 03-Oct-2014, the patient received AFLURIA injection (batch number T57505) in the left arm and PNEUMOVAX injection (batch number J010396) in the right arm. On 03-Oct-2014, the patient went home and felt bad and her right arm was hurting very bad. Her right arm was swollen, red and burning. The pain was shooting through arm and chest. That night, she felt dizzy, nauseous, had pain everywhere, shaking, was confused and disoriented. She went to the hospital. On the day she took the shots, she had to go the ER (emergency room) at Medical Centre. The patient reported that to this day, she felt really awful. Her body ached all over. Her left hand hurt so badly that she could not pick things up. It was hard at times to walk and she was quite disoriented at times. Her head and neck hurt, for which she took EXCEDRIN and ibuprofen 600 every day. Her eyes kept getting red and burning. Her ears were ringing constantly and loud. The patient reported that 'it hurts to write this letter from her right hand'. She could not type well anymore either. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as serious (life-threatening). The patient stated that she did know that it was caused from pneumonia shot and had no doubt about it. She reported that she was not perfect but was going through many physical things that last too long.
Age: 56.0
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Back pain, Chronic inflammatory demyelinating polyradiculoneuropathy, Fall, Muscular weakness, Neuralgia
Clinical narrative: Within 4 wks of Flu shot; symptoms of leg weakness, back pain and multiple falls. Within 6 wks: wheelchair bound and terrible bilateral thigh pain. Numerous ER/doctor visits and medical tests. Within 3 months a CIDP diagnosis, hospitalization and monthly IVIG's infusions which have continued. Physical therapy 1 year. Now ambulatory with shoe braces. Permanent nerve damage in bilateral ankles.
Age: 56.0
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity
Clinical narrative: Within 4 wks of Flu shot; symptoms of leg weakness, back pain and multiple falls. Within 6 wks: wheelchair bound and terrible bilateral thigh pain. Numerous ER/doctor visits and medical tests. Within 3 months a CIDP diagnosis, hospitalization and monthly IVIG's infusions which have continued. Physical therapy 1 year. Now ambulatory with shoe braces. Permanent nerve damage in bilateral ankles.
Age: 56.0
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Back pain, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram abnormal, Electromyogram abnormal, Fall
Clinical narrative: Within 4 wks of Flu shot; symptoms of leg weakness, back pain and multiple falls. Within 6 wks: wheelchair bound and terrible bilateral thigh pain. Numerous ER/doctor visits and medical tests. Within 3 months a CIDP diagnosis, hospitalization and monthly IVIG's infusions which have continued. Physical therapy 1 year. Now ambulatory with shoe braces. Permanent nerve damage in bilateral ankles.
Age: 56.0
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Immunoglobulin therapy, Lumbar puncture abnormal, Muscular weakness, Nerve injury, Nuclear magnetic resonance imaging normal
Clinical narrative: Within 4 wks of Flu shot; symptoms of leg weakness, back pain and multiple falls. Within 6 wks: wheelchair bound and terrible bilateral thigh pain. Numerous ER/doctor visits and medical tests. Within 3 months a CIDP diagnosis, hospitalization and monthly IVIG's infusions which have continued. Physical therapy 1 year. Now ambulatory with shoe braces. Permanent nerve damage in bilateral ankles.
Age: 56.0
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity, Wheelchair user
Clinical narrative: Within 4 wks of Flu shot; symptoms of leg weakness, back pain and multiple falls. Within 6 wks: wheelchair bound and terrible bilateral thigh pain. Numerous ER/doctor visits and medical tests. Within 3 months a CIDP diagnosis, hospitalization and monthly IVIG's infusions which have continued. Physical therapy 1 year. Now ambulatory with shoe braces. Permanent nerve damage in bilateral ankles.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Blood culture, Culture urine, Electrocardiogram, Electroencephalogram, Headache
Clinical narrative: Fever, Headaches, Chills, SYNCOPE initially lasted over 2.5 hours and then intermittent for about 6 hours.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Loss of consciousness
Clinical narrative: Fever, Headaches, Chills, SYNCOPE initially lasted over 2.5 hours and then intermittent for about 6 hours.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Blood test, Chills, Computerised tomogram head, Electrocardiogram, Electroencephalogram
Clinical narrative: Fever, Headaches, Chills, SYNCOPE initially lasted over 2.5 hours and then intermittent for about 6 hours.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Headache, Pyrexia, Syncope
Clinical narrative: Fever, Headaches, Chills, SYNCOPE initially lasted over 2.5 hours and then intermittent for about 6 hours.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Dizziness postural, Loss of consciousness, Nausea, Unresponsive to stimuli
Clinical narrative: Fever, Headaches, Chills, SYNCOPE initially lasted over 2.5 hours and then intermittent for about 6 hours.
Age: 27.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Bone pain, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: My arm is in constant pain. I can not lift it at all or touch in the area where the shot was given. I can not lay on the side where the shot was given. I am experiencing pain all the way from the injection site now up to my collar bone. The pain is at a 7 when resting and at a 10 when raising the arm or touching/applying minimal amounts of pressure.
Age: 22.0
Sex: M
Vaccine: JEV1
Symptoms: Local swelling
Clinical narrative: Minor localized swelling on right deltoid.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Condition aggravated, Seizure
Clinical narrative: Mother states the patient had a seizure about 4 hours after the vaccine, but that this was not unexpected, as she was "due" to have a seizure related to her epilepsy.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Pharyngeal oedema, Retching, Swollen tongue
Clinical narrative: Swelling of tongue and throat, gagging, difficulty breathing. Treated at E.R. With Benadryl and prednisone. Dr. also noted same reaction could be from Lisinopril, so Lisinopril replaced with Cozaar.