chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 79-year-old male patient. The patient's concurrent conditions included reflux, elevated prostate-specific antigen (PSA) and elevated cholesterol. The patient's concomitant medications were not provided. The patient had no drug reactions or allergies. The patient had a pneumococcal shot in the past, but not specified as PREVNAR 13 or PNEUMOVAX 23. On 31-OCT-2017, the patient received from an unspecified local pharmacy a dose of PNEUMOVAX 23, lot # N013521 with expiration date on 23-JAN-2019 (dose and route of administration were not reported). At the same time when the PNEUMOVAX 23 was administered, the patient received high dose FLUZONE (exact dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2017, the patient experienced a cellulitis type reaction: extremely red that was streaking down arm below injection site, swollen, hot to touch. On 02-NOV-2017 (reported as "today"), the patient came to urgent care. At the time of this report, no treatment was given for the events. The reporter stated she planned to treat the events with warm compresses and unspecified antibiotics. On an unknown date, a complete blood count (CBC) was completed. The outcome of the events was reported as not recovered at the time of this report. The relatedness between the events, PNEUMOVAX 23 and FLUZONE was not assessed by the reporter.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Extra dose administered, Mobility decreased, Pain, Pain in extremity, Vaccination site joint movement impairment
Clinical narrative: Patient complaining of arm pain lasting over 2 weeks and the inability to lift her arm above her shoulder.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complaining of arm pain lasting over 2 weeks and the inability to lift her arm above her shoulder.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Axillary pain, Erythema, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse via medical records, refers to a 58 year old female patient with allergy to atorvastatin, codeine and sulfa (sulfonamide antibiotics), shortness of air, severe, chronic obstructive pulmonary disease (COPD), respiratory distress, wheezing, adenocarcinoma of the right lung, skin cyst on the scalp toward the back (posterior) and anaemia. The patient's medical history included right upper lobe (RUL) lobectomy. Illnesses at the time of vaccination included cellulitis of right upper extremity (twice). Historical drugs included an unspecified flu vaccine, atorvastatin, codeine and sulfa (sulfonamide antibiotics). Concomitant therapies included amitriptyline hydrochloride(ELAVIL), budesonide, formoterol fumarate(SYMBICORT), pantoprazole sodium(PROTONIX), propranolol hydrochloride(INDERAL), gabapentin(NEURONTIN), tiotropium bromide(SPIRIVA), tramadol hydrochloride(ULTRAM), albuterol sulfate(ACCUNEB), albuterol sulfate(PROVENTIL), albuterol(VENTOLIN), albuterol sulfate(PROAIR), acetaminophen(TYLENOL), triamcinolone acetonide(KENALOG), influenza virus split virion 4v vaccine inactivated(FLULAVAL), buspirone hydrochloride(BUSPAR), citalopram hydrobromide(CELEXA), doxycycline hyclate(VIBRAMYCIN) and fluticasone propionate(FLONASE). On 17-OCT-2017,  the patient was vaccinated with an expired and improperly stored first dose of PNEUMOVAX 23 with lot # M005287 and expiration date of 08-OCT-2017, intramuscularly in the left deltoid (strength and dose were unknown) for prophylaxis. It was reported that the expired vaccine was transported from one office to home office and did not maintain proper temperature (the temperature excursions were not detected by a data logger; the temperature and the time frame of storage were unknown) and it was being expired. The nurse from satellite office placed in vaccine fridge. A medical assistant pulled the expired vaccine and it was administered without checking the expiration date. She realized the vaccine was expired when she attempted to place it in the computer and was unable to select the vaccine. The doctor, the patient and the manufacturer were notified. Then, a bin was placed in fridge for expired vaccines. No adverse events were reported. All available medical records will be provided upon request.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse via medical records, refers to a 58 year old female patient with allergy to atorvastatin, codeine and sulfa (sulfonamide antibiotics), shortness of air, severe, chronic obstructive pulmonary disease (COPD), respiratory distress, wheezing, adenocarcinoma of the right lung, skin cyst on the scalp toward the back (posterior) and anaemia. The patient's medical history included right upper lobe (RUL) lobectomy. Illnesses at the time of vaccination included cellulitis of right upper extremity (twice). Historical drugs included an unspecified flu vaccine, atorvastatin, codeine and sulfa (sulfonamide antibiotics). Concomitant therapies included amitriptyline hydrochloride(ELAVIL), budesonide, formoterol fumarate(SYMBICORT), pantoprazole sodium(PROTONIX), propranolol hydrochloride(INDERAL), gabapentin(NEURONTIN), tiotropium bromide(SPIRIVA), tramadol hydrochloride(ULTRAM), albuterol sulfate(ACCUNEB), albuterol sulfate(PROVENTIL), albuterol(VENTOLIN), albuterol sulfate(PROAIR), acetaminophen(TYLENOL), triamcinolone acetonide(KENALOG), influenza virus split virion 4v vaccine inactivated(FLULAVAL), buspirone hydrochloride(BUSPAR), citalopram hydrobromide(CELEXA), doxycycline hyclate(VIBRAMYCIN) and fluticasone propionate(FLONASE). On 17-OCT-2017,  the patient was vaccinated with an expired and improperly stored first dose of PNEUMOVAX 23 with lot # M005287 and expiration date of 08-OCT-2017, intramuscularly in the left deltoid (strength and dose were unknown) for prophylaxis. It was reported that the expired vaccine was transported from one office to home office and did not maintain proper temperature (the temperature excursions were not detected by a data logger; the temperature and the time frame of storage were unknown) and it was being expired. The nurse from satellite office placed in vaccine fridge. A medical assistant pulled the expired vaccine and it was administered without checking the expiration date. She realized the vaccine was expired when she attempted to place it in the computer and was unable to select the vaccine. The doctor, the patient and the manufacturer were notified. Then, a bin was placed in fridge for expired vaccines. No adverse events were reported. All available medical records will be provided upon request.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse via medical records, refers to a 58 year old female patient with allergy to atorvastatin, codeine and sulfa (sulfonamide antibiotics), shortness of air, severe, chronic obstructive pulmonary disease (COPD), respiratory distress, wheezing, adenocarcinoma of the right lung, skin cyst on the scalp toward the back (posterior) and anaemia. The patient's medical history included right upper lobe (RUL) lobectomy. Illnesses at the time of vaccination included cellulitis of right upper extremity (twice). Historical drugs included an unspecified flu vaccine, atorvastatin, codeine and sulfa (sulfonamide antibiotics). Concomitant therapies included amitriptyline hydrochloride(ELAVIL), budesonide, formoterol fumarate(SYMBICORT), pantoprazole sodium(PROTONIX), propranolol hydrochloride(INDERAL), gabapentin(NEURONTIN), tiotropium bromide(SPIRIVA), tramadol hydrochloride(ULTRAM), albuterol sulfate(ACCUNEB), albuterol sulfate(PROVENTIL), albuterol(VENTOLIN), albuterol sulfate(PROAIR), acetaminophen(TYLENOL), triamcinolone acetonide(KENALOG), influenza virus split virion 4v vaccine inactivated(FLULAVAL), buspirone hydrochloride(BUSPAR), citalopram hydrobromide(CELEXA), doxycycline hyclate(VIBRAMYCIN) and fluticasone propionate(FLONASE). On 17-OCT-2017,  the patient was vaccinated with an expired and improperly stored first dose of PNEUMOVAX 23 with lot # M005287 and expiration date of 08-OCT-2017, intramuscularly in the left deltoid (strength and dose were unknown) for prophylaxis. It was reported that the expired vaccine was transported from one office to home office and did not maintain proper temperature (the temperature excursions were not detected by a data logger; the temperature and the time frame of storage were unknown) and it was being expired. The nurse from satellite office placed in vaccine fridge. A medical assistant pulled the expired vaccine and it was administered without checking the expiration date. She realized the vaccine was expired when she attempted to place it in the computer and was unable to select the vaccine. The doctor, the patient and the manufacturer were notified. Then, a bin was placed in fridge for expired vaccines. No adverse events were reported. All available medical records will be provided upon request.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Echocardiogram normal, Electrocardiogram normal, Full blood count normal, Syncope
Clinical narrative: Fainted suddenly day after; no other symptoms before or after incident.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient develops red, welling right upper arm.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site discomfort, Lymph node pain, Lymphadenopathy
Clinical narrative: Beyond the expected normal discomfort at the injection site, in the left arm. The nearby armpit lymph glands developed a painful and pronounced swelling that began overnight and lasted for five days! The other glands at hips and other armpit had some Normal and Minor inflammation. But I have never had a reaction like this to a shot. It was worth reporting. Treated with EXCEDRIN tablets, and topical pain relieving cream, and extra fluids.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: At site of flu shot pt has red, hot, hard lump 5 days after administration.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and information about concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with PROQUAD injection (therapy type, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to 2 patients of unknown age and gender. The patients did not have any concomitant medication, pertinent medical history, drug reactions or allergies. On unknown dates, the patients were vaccinated with a ZOSTAVAX injection (dose, route of administration, lot # and expiry date were not provided). On unknown dates in September 2017(reported as "sometime within the past month"), the patients experienced mild case of shingles. The outcome of the events was unknown. Causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous initial report was received from a nurse referring a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The Nurse reported that on in 11-NOV-2016 the patient was vaccinated with PROQUAD lot # L032761, expiration date 24-FEB-2017 (strength, dose and route of administration were not reported) for prophylaxis. (Product use issue). The nurse also informed that the sterile diluent (MERCK) (unknown lot number and expiration date) used to reconstitute PROQUAD did not undergo a temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a female patient of unknown age reporting on herself. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. According to the physician's office records, on an unspecified date 2012 (reported as 5 years ago), the patient received an unspecified dose of ZOSTAVAX for prophylaxis (anatomical location, route of administration, lot number and expiration date were not reported). Then, on an unspecified date in 2014 (reported as 3 years ago), the patient received another unspecified dose of ZOSTAVAX (anatomical location, route of administration, lot number and expiration date were not reported). Nevertheless, the patient believed that it was only administered once. No side effects were reported.
Age: 2.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, regarding to a 30 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 30-OCT-2017, the patient was accidentally vaccinated with GARDASIL 9 which had a lot # N010497 with expiration date on 15-JAN-2020 (dose, strength and route were not reported) for prophylaxis. However, at the reporting time no adverse events were reported.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist reporting on an 84 year old female patient. The patient had no drug reactions/allergies, pertinent medical history or concomitant medication. On 12-JAN-2017, the patient received an unspecified dose of PNEUMOVAX 23 intramuscular, right arm, lot # M038359, expiration date 13-MAY-2018 for prophylaxis (strength not reported). On an unspecified date in 2017, the patient developed pain in the right arm. The pharmacist reported that the patient still experienced pain at times when lying in bed at night. No lab diagnostics/studies were performed; the patient did not seek medical attention and it was unknown by the reporter if treatment given for the adverse event. The outcome of the event pain in extremity was reported as not resolved. The causal relationship between the event and therapy with PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent (MERCK) lot # N021894 with expiration date 28-NOV-2019. On 30-OCT-2017, the patient was vaccinated with a dose of PROQUAD lot # N015623 with expiration date 15-NOV-2018 and a dose of VARIVAX lot # N015477 with expiration date 18-MAY-2019, both for prophylaxis (dose, route of administration were not reported for the suspect therapies). No adverse effect was reported.
Sex: M
Vaccine: FLUA3, PNC13, PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In 2015 (reported as "two years ago"), the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for prophylaxis or with PREVNAR 13. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 as a booster and with FLUAD.     On an unknown date, the patient felt ill (malaise), the reporter stated that it could just been malaise from the flu vaccine. The outcome of malaise was unknown. The reporter considered malaise to be not related to PNEUMOVAX 23.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Laparoscopy, Menstruation irregular, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse referring to a 15 year old non pregnant female patient. The patient's concurrent conditions were not reported. No allergic reactions were known for the patient. Concomitant therapies included an unspecified birth control pill. On 29-AUG-2017, the patient was vaccinated with the first dose of intramuscular GARDASIL 9 0.5 ml, with a non-valid lot number of N003702 with an expiration date of 29-OCT-2019, as vaccination (strength and anatomical location were not reported). On an unspecified date in September 2017 (reported as ''one month ago''), the patient experienced menstruation irregular and due to it she underwent a laparoscopic procedure.   On 30-OCT-2017, the patient was vaccinated with the second dose of intramuscular GARDASIL 9 0.5 ml, with the same previously non valid lot number (strength and anatomical location were not reported), as vaccination. On 31-OCT-2017, the patient experienced dizziness and nausea while attending school and on the same date, she sought medical attention and she was evaluated in the office. No medical treatment was prescribed and no laboratory diagnostics studies were performed. The outcome of menstruation irregular was unknown and the outcome of dizziness and nausea was reported as not resolved by the time of reporting. The patient would continue to be monitored. No further information provided. The causal relationship of the events and the GARDASIL 9 vaccine was not provided. Upon internal review the event of menstruation irregular was considered to be medically significant due to a laparoscopic procedure performed.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Cheilitis, Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 15 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.    On 26-OCT-2017, the patient was vaccinated with a dose of VARIVAX for regular routine vaccination (strength, dose, route, frequency, lot/batch # and expiration date were not reported). Other suspect therapies included sterile diluent (manufacturer unknown). It was reported that the VARIVAX dose got on the patient's leg while it was being administered. On an unknown date in October 2017, the patient developed a rash on the back of both of her hands and on her face under her eyes (rash) and on the bottom of lip (cheilitis). The pharmacist reported that "the patient had no fever and felt fine."  The patient did not seek medical attention and did not received treatment for the events, the events did not cause significant disability or incapacity, the patient did not required hospitalization and the events were not life threatening events. The outcome of cheilitis and rash was reported as recovering/resolving.  The causality between cheilitis and rash with VARIVAX was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Varicella virus test
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date (reported as "one year old), the patient was vaccinated with VARIVAX subcuteanous injection (dose, lot# and expiry date were not provided) for prevention of Varicella (Chickenpox). On an unknown date (reported as " and subsequently at eight months old"), the patient developed rash. The rash was later tested for "Chickenpox" but the results were unknown. The outcome of rash is unknown. Causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 08-NOV-2017, the patient was vaccinated with an expired dose of PROQUAD with lot number M021427 and expiration date on 29-OCT-2017, administered for prophylaxis (dose, dose number, route of administration and anatomical location were not provided). The reporter stated that the vaccine did not have any temperature excursions prior to administration. No adverse symptoms reported.
Sex: M
Vaccine: HPV4
Symptoms: Anogenital dysplasia
Clinical narrative: Information has been received from a physician via a company medical science liaison referring to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not reported. The physician reported that on unspecified dates, the patient received two doses of GARDASIL (lots #, expiration dates, dose and route were not reported) for prophylaxis, respectively. On a separate unspecified date after receiving the two doses of GARDASIL, the patient developed anal dysplasia. It was unknown whether treatment was given to the patient for the adverse event. The outcome of the event was not reported. The reported did not provide the causality between the event and GARDASIL. Upon internal review, the event of anal dysplasia was considered to be medically significant.
Age: 0.25
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 3 months old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 14-NOV-2017, the patient was vaccinated with an expired dose of PROQUAD with lot # M022399 and expiration date on 01-NOV-2017 (strength, dose, route of administration, and anatomical location were not reported), administered for prophylaxis; and was reconstituted with a not expired sterile diluent (manufacturer unknown). No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Barrett's oesophagus, Biopsy site unspecified abnormal, Cholecystectomy, Cholecystitis chronic
Clinical narrative: A spontaneous report with was received on 26OCT2017 from a male consumer. Additional information was received in the form of the completed Adverse Event Data Collection Form and medical records on 01NOV2017. A 35 year-old patient reported that he received BIOTHRAX, "the full series, in 2002-2005, and then again after my medical record was lost in 2006, and then again after my medical record was lost in 2009." "I was given/forced the initial dose of Anthrax in 2002, 2006, 2009." My records "indicate that I was given more than the recommended dose on several occasions". He inquired about the overuse of the Anthrax Vaccine and the "possible" health consequences. From the "incomplete" vaccination record shared by the consumer: 03JAN2003, third dose, FAV066, 17SEP2003, fourth dose, FAV066, 30MAY2007, third dose, FAV103, 12APR2009, second dose, FAV177, 20NOV2009, fifth dose, FAV217. The consumer reported the following adverse events were facing him at the time of the report or in the past. He reports Fatty Liver Disease identified when gallbladder was removed 8/2016, Barrett's Esophagus without dysplasia identified on EGD 9/28/2016, Celiac Disease diagnosed by biopsy on 9/28/2016 and Gallbladder removal 8/2016 with pathology report indicating Mild Benign Papillary Epithelial Hyperplasia. Fibromyalgia was diagnosed 1/14/2016. He additionally reports Joint Pain, Chronic Fatigue, PTSD, TBI, Depressive Disorder, Moderate Osteoarthritis right knee, Osteoarthritis Bilateral Hips, Osteoarthritis Lower Back, Feet Problems, Throat swelling, Chronic Otomastoiditis, Painful urination, Sexual dysfunction, and Chronic Diarrhea. He reports Chronic kidney stones and had a CT 9/2014 revealing punctate nonobstructing calcifications bilat perinephric fat stranding - poss inflammatory changes related to pyelonephritis, Kidney infection. He reports Rhabdomyolysis at some time in the years after immunization, though medical records indicate diagnosis was in 2001 after 7 days of working out in a row. On 10/20/2017 he experienced a Seizure after playing with PlayDoh; subject assumes this was related to his gluten allergies as PlayDoh contains wheat. The subject additionally self-reports a right shoulder injury - slap tear, torn biceps tendon, and torn rotator cuff. The consumer added in his update to the Adverse Event Data Collection Form that the onset of the reported adverse events was "2004?". The individual onset date for each medical complaint noted in the medical records was recorded when available. Allergies: Penicillin, sulfa drugs, KEFLEX, BIAXIN, clindamycin, PAXIL, WELLBUTRIN, nicotine and glutens. Active medication list:  cholestyramine, cyclobenzaprine, lansoprazole, methylphenidate, naproxen, nicotine gum, pregabalin, marijuana. Additional medical records available upon request. Compete immunization record has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Coeliac disease, Computerised tomogram kidney abnormal, Craniocerebral injury, Depression, Diarrhoea
Clinical narrative: A spontaneous report with was received on 26OCT2017 from a male consumer. Additional information was received in the form of the completed Adverse Event Data Collection Form and medical records on 01NOV2017. A 35 year-old patient reported that he received BIOTHRAX, "the full series, in 2002-2005, and then again after my medical record was lost in 2006, and then again after my medical record was lost in 2009." "I was given/forced the initial dose of Anthrax in 2002, 2006, 2009." My records "indicate that I was given more than the recommended dose on several occasions". He inquired about the overuse of the Anthrax Vaccine and the "possible" health consequences. From the "incomplete" vaccination record shared by the consumer: 03JAN2003, third dose, FAV066, 17SEP2003, fourth dose, FAV066, 30MAY2007, third dose, FAV103, 12APR2009, second dose, FAV177, 20NOV2009, fifth dose, FAV217. The consumer reported the following adverse events were facing him at the time of the report or in the past. He reports Fatty Liver Disease identified when gallbladder was removed 8/2016, Barrett's Esophagus without dysplasia identified on EGD 9/28/2016, Celiac Disease diagnosed by biopsy on 9/28/2016 and Gallbladder removal 8/2016 with pathology report indicating Mild Benign Papillary Epithelial Hyperplasia. Fibromyalgia was diagnosed 1/14/2016. He additionally reports Joint Pain, Chronic Fatigue, PTSD, TBI, Depressive Disorder, Moderate Osteoarthritis right knee, Osteoarthritis Bilateral Hips, Osteoarthritis Lower Back, Feet Problems, Throat swelling, Chronic Otomastoiditis, Painful urination, Sexual dysfunction, and Chronic Diarrhea. He reports Chronic kidney stones and had a CT 9/2014 revealing punctate nonobstructing calcifications bilat perinephric fat stranding - poss inflammatory changes related to pyelonephritis, Kidney infection. He reports Rhabdomyolysis at some time in the years after immunization, though medical records indicate diagnosis was in 2001 after 7 days of working out in a row. On 10/20/2017 he experienced a Seizure after playing with PlayDoh; subject assumes this was related to his gluten allergies as PlayDoh contains wheat. The subject additionally self-reports a right shoulder injury - slap tear, torn biceps tendon, and torn rotator cuff. The consumer added in his update to the Adverse Event Data Collection Form that the onset of the reported adverse events was "2004?". The individual onset date for each medical complaint noted in the medical records was recorded when available. Allergies: Penicillin, sulfa drugs, KEFLEX, BIAXIN, clindamycin, PAXIL, WELLBUTRIN, nicotine and glutens. Active medication list:  cholestyramine, cyclobenzaprine, lansoprazole, methylphenidate, naproxen, nicotine gum, pregabalin, marijuana. Additional medical records available upon request. Compete immunization record has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Dysuria, Fatigue, Fibromyalgia, Hepatic steatosis, Hyperplasia
Clinical narrative: A spontaneous report with was received on 26OCT2017 from a male consumer. Additional information was received in the form of the completed Adverse Event Data Collection Form and medical records on 01NOV2017. A 35 year-old patient reported that he received BIOTHRAX, "the full series, in 2002-2005, and then again after my medical record was lost in 2006, and then again after my medical record was lost in 2009." "I was given/forced the initial dose of Anthrax in 2002, 2006, 2009." My records "indicate that I was given more than the recommended dose on several occasions". He inquired about the overuse of the Anthrax Vaccine and the "possible" health consequences. From the "incomplete" vaccination record shared by the consumer: 03JAN2003, third dose, FAV066, 17SEP2003, fourth dose, FAV066, 30MAY2007, third dose, FAV103, 12APR2009, second dose, FAV177, 20NOV2009, fifth dose, FAV217. The consumer reported the following adverse events were facing him at the time of the report or in the past. He reports Fatty Liver Disease identified when gallbladder was removed 8/2016, Barrett's Esophagus without dysplasia identified on EGD 9/28/2016, Celiac Disease diagnosed by biopsy on 9/28/2016 and Gallbladder removal 8/2016 with pathology report indicating Mild Benign Papillary Epithelial Hyperplasia. Fibromyalgia was diagnosed 1/14/2016. He additionally reports Joint Pain, Chronic Fatigue, PTSD, TBI, Depressive Disorder, Moderate Osteoarthritis right knee, Osteoarthritis Bilateral Hips, Osteoarthritis Lower Back, Feet Problems, Throat swelling, Chronic Otomastoiditis, Painful urination, Sexual dysfunction, and Chronic Diarrhea. He reports Chronic kidney stones and had a CT 9/2014 revealing punctate nonobstructing calcifications bilat perinephric fat stranding - poss inflammatory changes related to pyelonephritis, Kidney infection. He reports Rhabdomyolysis at some time in the years after immunization, though medical records indicate diagnosis was in 2001 after 7 days of working out in a row. On 10/20/2017 he experienced a Seizure after playing with PlayDoh; subject assumes this was related to his gluten allergies as PlayDoh contains wheat. The subject additionally self-reports a right shoulder injury - slap tear, torn biceps tendon, and torn rotator cuff. The consumer added in his update to the Adverse Event Data Collection Form that the onset of the reported adverse events was "2004?". The individual onset date for each medical complaint noted in the medical records was recorded when available. Allergies: Penicillin, sulfa drugs, KEFLEX, BIAXIN, clindamycin, PAXIL, WELLBUTRIN, nicotine and glutens. Active medication list:  cholestyramine, cyclobenzaprine, lansoprazole, methylphenidate, naproxen, nicotine gum, pregabalin, marijuana. Additional medical records available upon request. Compete immunization record has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, Injection site injury, Kidney infection, Limb discomfort
Clinical narrative: A spontaneous report with was received on 26OCT2017 from a male consumer. Additional information was received in the form of the completed Adverse Event Data Collection Form and medical records on 01NOV2017. A 35 year-old patient reported that he received BIOTHRAX, "the full series, in 2002-2005, and then again after my medical record was lost in 2006, and then again after my medical record was lost in 2009." "I was given/forced the initial dose of Anthrax in 2002, 2006, 2009." My records "indicate that I was given more than the recommended dose on several occasions". He inquired about the overuse of the Anthrax Vaccine and the "possible" health consequences. From the "incomplete" vaccination record shared by the consumer: 03JAN2003, third dose, FAV066, 17SEP2003, fourth dose, FAV066, 30MAY2007, third dose, FAV103, 12APR2009, second dose, FAV177, 20NOV2009, fifth dose, FAV217. The consumer reported the following adverse events were facing him at the time of the report or in the past. He reports Fatty Liver Disease identified when gallbladder was removed 8/2016, Barrett's Esophagus without dysplasia identified on EGD 9/28/2016, Celiac Disease diagnosed by biopsy on 9/28/2016 and Gallbladder removal 8/2016 with pathology report indicating Mild Benign Papillary Epithelial Hyperplasia. Fibromyalgia was diagnosed 1/14/2016. He additionally reports Joint Pain, Chronic Fatigue, PTSD, TBI, Depressive Disorder, Moderate Osteoarthritis right knee, Osteoarthritis Bilateral Hips, Osteoarthritis Lower Back, Feet Problems, Throat swelling, Chronic Otomastoiditis, Painful urination, Sexual dysfunction, and Chronic Diarrhea. He reports Chronic kidney stones and had a CT 9/2014 revealing punctate nonobstructing calcifications bilat perinephric fat stranding - poss inflammatory changes related to pyelonephritis, Kidney infection. He reports Rhabdomyolysis at some time in the years after immunization, though medical records indicate diagnosis was in 2001 after 7 days of working out in a row. On 10/20/2017 he experienced a Seizure after playing with PlayDoh; subject assumes this was related to his gluten allergies as PlayDoh contains wheat. The subject additionally self-reports a right shoulder injury - slap tear, torn biceps tendon, and torn rotator cuff. The consumer added in his update to the Adverse Event Data Collection Form that the onset of the reported adverse events was "2004?". The individual onset date for each medical complaint noted in the medical records was recorded when available. Allergies: Penicillin, sulfa drugs, KEFLEX, BIAXIN, clindamycin, PAXIL, WELLBUTRIN, nicotine and glutens. Active medication list:  cholestyramine, cyclobenzaprine, lansoprazole, methylphenidate, naproxen, nicotine gum, pregabalin, marijuana. Additional medical records available upon request. Compete immunization record has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Limb injury, Mastoiditis, Nephrolithiasis, Oesophagogastroduodenoscopy abnormal, Osteoarthritis
Clinical narrative: A spontaneous report with was received on 26OCT2017 from a male consumer. Additional information was received in the form of the completed Adverse Event Data Collection Form and medical records on 01NOV2017. A 35 year-old patient reported that he received BIOTHRAX, "the full series, in 2002-2005, and then again after my medical record was lost in 2006, and then again after my medical record was lost in 2009." "I was given/forced the initial dose of Anthrax in 2002, 2006, 2009." My records "indicate that I was given more than the recommended dose on several occasions". He inquired about the overuse of the Anthrax Vaccine and the "possible" health consequences. From the "incomplete" vaccination record shared by the consumer: 03JAN2003, third dose, FAV066, 17SEP2003, fourth dose, FAV066, 30MAY2007, third dose, FAV103, 12APR2009, second dose, FAV177, 20NOV2009, fifth dose, FAV217. The consumer reported the following adverse events were facing him at the time of the report or in the past. He reports Fatty Liver Disease identified when gallbladder was removed 8/2016, Barrett's Esophagus without dysplasia identified on EGD 9/28/2016, Celiac Disease diagnosed by biopsy on 9/28/2016 and Gallbladder removal 8/2016 with pathology report indicating Mild Benign Papillary Epithelial Hyperplasia. Fibromyalgia was diagnosed 1/14/2016. He additionally reports Joint Pain, Chronic Fatigue, PTSD, TBI, Depressive Disorder, Moderate Osteoarthritis right knee, Osteoarthritis Bilateral Hips, Osteoarthritis Lower Back, Feet Problems, Throat swelling, Chronic Otomastoiditis, Painful urination, Sexual dysfunction, and Chronic Diarrhea. He reports Chronic kidney stones and had a CT 9/2014 revealing punctate nonobstructing calcifications bilat perinephric fat stranding - poss inflammatory changes related to pyelonephritis, Kidney infection. He reports Rhabdomyolysis at some time in the years after immunization, though medical records indicate diagnosis was in 2001 after 7 days of working out in a row. On 10/20/2017 he experienced a Seizure after playing with PlayDoh; subject assumes this was related to his gluten allergies as PlayDoh contains wheat. The subject additionally self-reports a right shoulder injury - slap tear, torn biceps tendon, and torn rotator cuff. The consumer added in his update to the Adverse Event Data Collection Form that the onset of the reported adverse events was "2004?". The individual onset date for each medical complaint noted in the medical records was recorded when available. Allergies: Penicillin, sulfa drugs, KEFLEX, BIAXIN, clindamycin, PAXIL, WELLBUTRIN, nicotine and glutens. Active medication list:  cholestyramine, cyclobenzaprine, lansoprazole, methylphenidate, naproxen, nicotine gum, pregabalin, marijuana. Additional medical records available upon request. Compete immunization record has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Pathology test, Pharyngeal oedema, Post-traumatic stress disorder, Pyelonephritis, Rhabdomyolysis
Clinical narrative: A spontaneous report with was received on 26OCT2017 from a male consumer. Additional information was received in the form of the completed Adverse Event Data Collection Form and medical records on 01NOV2017. A 35 year-old patient reported that he received BIOTHRAX, "the full series, in 2002-2005, and then again after my medical record was lost in 2006, and then again after my medical record was lost in 2009." "I was given/forced the initial dose of Anthrax in 2002, 2006, 2009." My records "indicate that I was given more than the recommended dose on several occasions". He inquired about the overuse of the Anthrax Vaccine and the "possible" health consequences. From the "incomplete" vaccination record shared by the consumer: 03JAN2003, third dose, FAV066, 17SEP2003, fourth dose, FAV066, 30MAY2007, third dose, FAV103, 12APR2009, second dose, FAV177, 20NOV2009, fifth dose, FAV217. The consumer reported the following adverse events were facing him at the time of the report or in the past. He reports Fatty Liver Disease identified when gallbladder was removed 8/2016, Barrett's Esophagus without dysplasia identified on EGD 9/28/2016, Celiac Disease diagnosed by biopsy on 9/28/2016 and Gallbladder removal 8/2016 with pathology report indicating Mild Benign Papillary Epithelial Hyperplasia. Fibromyalgia was diagnosed 1/14/2016. He additionally reports Joint Pain, Chronic Fatigue, PTSD, TBI, Depressive Disorder, Moderate Osteoarthritis right knee, Osteoarthritis Bilateral Hips, Osteoarthritis Lower Back, Feet Problems, Throat swelling, Chronic Otomastoiditis, Painful urination, Sexual dysfunction, and Chronic Diarrhea. He reports Chronic kidney stones and had a CT 9/2014 revealing punctate nonobstructing calcifications bilat perinephric fat stranding - poss inflammatory changes related to pyelonephritis, Kidney infection. He reports Rhabdomyolysis at some time in the years after immunization, though medical records indicate diagnosis was in 2001 after 7 days of working out in a row. On 10/20/2017 he experienced a Seizure after playing with PlayDoh; subject assumes this was related to his gluten allergies as PlayDoh contains wheat. The subject additionally self-reports a right shoulder injury - slap tear, torn biceps tendon, and torn rotator cuff. The consumer added in his update to the Adverse Event Data Collection Form that the onset of the reported adverse events was "2004?". The individual onset date for each medical complaint noted in the medical records was recorded when available. Allergies: Penicillin, sulfa drugs, KEFLEX, BIAXIN, clindamycin, PAXIL, WELLBUTRIN, nicotine and glutens. Active medication list:  cholestyramine, cyclobenzaprine, lansoprazole, methylphenidate, naproxen, nicotine gum, pregabalin, marijuana. Additional medical records available upon request. Compete immunization record has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Rotator cuff syndrome, Seizure, Sexual dysfunction, Tendon rupture
Clinical narrative: A spontaneous report with was received on 26OCT2017 from a male consumer. Additional information was received in the form of the completed Adverse Event Data Collection Form and medical records on 01NOV2017. A 35 year-old patient reported that he received BIOTHRAX, "the full series, in 2002-2005, and then again after my medical record was lost in 2006, and then again after my medical record was lost in 2009." "I was given/forced the initial dose of Anthrax in 2002, 2006, 2009." My records "indicate that I was given more than the recommended dose on several occasions". He inquired about the overuse of the Anthrax Vaccine and the "possible" health consequences. From the "incomplete" vaccination record shared by the consumer: 03JAN2003, third dose, FAV066, 17SEP2003, fourth dose, FAV066, 30MAY2007, third dose, FAV103, 12APR2009, second dose, FAV177, 20NOV2009, fifth dose, FAV217. The consumer reported the following adverse events were facing him at the time of the report or in the past. He reports Fatty Liver Disease identified when gallbladder was removed 8/2016, Barrett's Esophagus without dysplasia identified on EGD 9/28/2016, Celiac Disease diagnosed by biopsy on 9/28/2016 and Gallbladder removal 8/2016 with pathology report indicating Mild Benign Papillary Epithelial Hyperplasia. Fibromyalgia was diagnosed 1/14/2016. He additionally reports Joint Pain, Chronic Fatigue, PTSD, TBI, Depressive Disorder, Moderate Osteoarthritis right knee, Osteoarthritis Bilateral Hips, Osteoarthritis Lower Back, Feet Problems, Throat swelling, Chronic Otomastoiditis, Painful urination, Sexual dysfunction, and Chronic Diarrhea. He reports Chronic kidney stones and had a CT 9/2014 revealing punctate nonobstructing calcifications bilat perinephric fat stranding - poss inflammatory changes related to pyelonephritis, Kidney infection. He reports Rhabdomyolysis at some time in the years after immunization, though medical records indicate diagnosis was in 2001 after 7 days of working out in a row. On 10/20/2017 he experienced a Seizure after playing with PlayDoh; subject assumes this was related to his gluten allergies as PlayDoh contains wheat. The subject additionally self-reports a right shoulder injury - slap tear, torn biceps tendon, and torn rotator cuff. The consumer added in his update to the Adverse Event Data Collection Form that the onset of the reported adverse events was "2004?". The individual onset date for each medical complaint noted in the medical records was recorded when available. Allergies: Penicillin, sulfa drugs, KEFLEX, BIAXIN, clindamycin, PAXIL, WELLBUTRIN, nicotine and glutens. Active medication list:  cholestyramine, cyclobenzaprine, lansoprazole, methylphenidate, naproxen, nicotine gum, pregabalin, marijuana. Additional medical records available upon request. Compete immunization record has been requested.
Sex: U
Vaccine: TD
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 10-Oct-2017. This case is linked to case 2017SA199735 (same reporter). This case involves a patient (onset age and gender not reported) who was vaccinated with a 0.5 ml single intramuscular dose of TENIVAC (batch number, expiry date and site of administration were not reported) on 27-Sep-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, two weeks following the vaccination, the patient developed extreme muscle weakness and pain in the arm of vaccination. The patient's laboratory data and corrective treatment were not reported. At the time of report the patient was not recovered from the events. List of documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Muscular weakness, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 11-Oct-2017. This case involves an 81 year old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH-DOSE (Batch number- UI871AC) (expiry date, site and dose in series not reported) intramuscularly on 27-Sep-2017. The patient's medical history was not reported. Concomitant medications was not reported. On 27-Sep-2017, same day following the vaccination, the patient had fever, fatigue and muscle weakness. It was unknown if went to doctor. Lab data were not reported. Patient did not receive any treatment. The outcome of the events were unknown. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a pharmacist on 03-Nov-2017. This case involves a 68 year old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH-DOSE (Batch number- UI883AB) in deltoid left and PREVENAR 13 (batch number and site not reported) (expiry date and dose in series not reported for both the vaccines) intramuscularly on 26-Oct-2017. The patient's medical history was not reported. Concomitant medications was not reported. On an unspecified date (also reported as today), following the vaccination, the patient diagnosed with a cellulitis the site is red and the size of a baseball it's in the lower deltoid area and down no swelling at site visualized, not palpated by reporter. Lab data were not reported. She was given BACTRIM and Prednisone as corrective treatment to taper but she didn't tell when she would be going back for a recheck. The outcome of the event was not recovered. Upon internal review the company decided to consider the case as serious due to Important Medical Events: cellulitis and redness. List of documents held by sender: none. Sender's Comments: The patient experienced cellulitis and the site was red post vaccination with FLUZONE HD and PREVENAR 13. Time to onset was not reported. Patient's medical history was not reported. Cellulitis could be due to alternate infectious etiologies. Since the site of vaccination was not specified as vaccination site it could not be concluded if it was due to improper aseptic technique at the time of vaccination. Additional information regarding patient's medical condition at the time of vaccination, site of event should be requested. Based upon reported information the role of one vaccine cannot be assessed.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Laboratory test normal, Malaise, Muscle twitching, Myalgia, Nasopharyngitis
Clinical narrative: On June 8, 2017 patient received her ADACEL and MENACTRA shots. She had been a healthy girl only missing 2 days of school that year. 48 hours after the shots she developed a fever (101) with sore throat and upper respiratory cold. The fever, sore throat, and cold resolved in about a week, but she still reported "not feeling well". She describes it as the feeling right before you get sick - you feel a little sick and know you aren't 100% well. She describes it as feeling 85%. She has muscle aches and twitching. She has had these symptoms for 5 months, and it all started 48 hours after the shots. We have visited out primary care physician. She ordered the attached labs, but all came back normal. After 5 months, we visited our neurologist, but only supplement recommendations were given. My daughter has not been the same since her shots. She still complains of feeling 85% with muscle aches and twitching.