chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.21
Sex: M
Vaccine: HIBV
Symptoms: Injection site abscess, Injection site pustule, Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a healthcare worker referring to a 5 month old male patient. The patient's concurrent condition included congenital heart disease. The patient's medical history included 2 heart surgeries. The patient did not have drug reactions/allergies. On 24-JUN-2015 the patient was administered the first dose in the series of PEDVAXHIB (lot# L030868 with expiration date of 09-JUN-2018, 0.5 ml, intramuscular) in the right thigh. Concomitant therapies included amoxicillin, PULMICORT, XOPENEX and MYCOSTATIN. The patient developed a pus-filled abscess on the right thigh at the injection site on 22-SEP-2015. Then on 04-NOV-2015, the same patient was administered the second dose in the series of PEDVAXHIB (lot# L030868 with expiration date of 09-JUN-2018, 0.5 ml, intramuscular) in the left thigh. On 06-NOV-2015 (2 days later) the patient's mother called the physician's office to report "a bump broke out" at the injection site. It was reported that on an unspecified date "several weeks later" that the "bump turned to a blister and popped." The patient was recovering, but not yet completely healed. The healthcare worker also reported another AE for a different patient after administration of this same lot of PEDVAXHIB in SR#I-14178158106 (MARRS#1512USA010129). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case report was received from medical assistant regarding a patent of unknown age and gender. Patient's concurrent conditions and medical history was not reported. On 07-DEC-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 with lot number # K010016 (expiry date 08-AUG-2015) (dose number, dosing regimen, anatomical location and route were unknown). Concomitant medications of the patient were unknown. No adverse event was reported. The outcome of the event "expired vaccine used" was unknown. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (also reported as healthcare worker) referring to an adult patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-SEP-2015, the patient was vaccinated with a single first dose of pediatric formulation of RECOMBIVAX HB 5 mcg/0.5 ml, lot # J012567 with expiry date of 30-JAN-2016, intramuscular. The reporter stated that "it was outside the labeled recommendations in the RECOMBIVAX HB prescribing information". Concomitant medications were not reported. No adverse effect was reported. There was no product quality complaint involved. Follow up information has been received on 23-DEC-2015 from the healthcare worker who was requesting that no further correspondence follow up Adverse Event information was sent to her as she had no further information to provide. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an adult patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. In September 2015, the patient was inadvertently administered a pediatric dose of VAQTA (route, lot # and expiration date not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 22-DEC-2015, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 intramuscular injection (0.5 ml, once, lot# K004281 with expiration date 22-MAR-2015). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, route, lot# and expiration date were not provided). There was not concomitant medication described. On an unknown date following administration of ZOSTAVAX, the patient experienced transverse myelitis. It was reported that the patient sought an unspecified medical attention. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the event was unknown. The relatedness between the event to the suspect drug was not reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 36-year-old female patient who received TWINRIX adult (batch number 7C4Z3, expiry date 6th May 2018). This case was associated with a product complaint. On 21st December 2015, the patient received TWINRIX adult 1 ml. On 21st December 2015, less than a day after receiving TWINRIX adult, the patient experienced injection site pain. On 22nd December 2015, the patient experienced injection site swelling. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site pain, injection site swelling and pharmaceutical product complaint were unknown. The reporter considered the injection site pain and injection site swelling to be related to TWINRIX adult. Additional details provided were as follows: This case was reported by a Certified Medical Assistant. No other vaccines were administered on the vaccination day or 4 weeks prior to suspected vaccine. On 21st December 2015, at 11:00, the patient received a dose of TWINRIX adult vaccine in an unspecified deltoid. The reporter stated that, the TWINRIX adult vaccine would not re-suspend and contained chunky white matter while administration to the patient. On 21st December 2015, less than a day after vaccination, the patient experienced localized site reaction (pain). On 22 December 2015, 1 day after vaccination, the patient called the reporter and stated that she experienced a localized site reaction (swelling the size of a 2 by 2 goose egg). The reporter does not know, if the patient took anything for the pain and swelling. On 22nd December 2015, the reporter instructed the patient to go to an urgent care facility. The reporter filed a QA report and stated that, normally when the vaccine sits for a while she was able to re-suspend the vaccine in order to obtain a cloudy suspension. There were 4 vaccines left in a box that would not mix up or re-suspend. The reporter stated chunks were visible in the vaccine. The reporter discussed the appearance of the vaccine according to Package Insert. In addition, called stated the office gives this vaccine very frequently and prior to administering she normally does not see any chunky material. A wholesale credit template has been completed and submitted.
Age: 35.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to 35 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 28-FEB-2014 the patient was vaccinated with an expired dose of MMR II lot # 0425AE expiration date 27-FEB-2014 (route and dose were not provided). There was no concomitant medication described. It was unknown if the patient sought medical attention. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-DEC-2015, the patient was vaccinated with a dose of VARIVAX (dose lot # and route were not provided) instead of ZOSTAVAX. The patient had not experienced any adverse effects. She did not known why the error was made. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates since 24-OCT-2015, the patients were vaccinated with doses of GARDASIL (Lot# L033347; expiration date 23-JUL-2017) (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range. Concomitant therapies were not reported. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates since 24-OCT-2015, the patients were vaccinated with doses of VAQTA (Lot# K014696; expiration date 11-NOV-2015) (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range and expired currently but not expired at the time of administration. Concomitant therapies were not reported. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates since 24-OCT-2015, the patients were vaccinated with doses of oral, ROTATEQ (Lot# K022990; expiration date 26-JUN-2016) (dose was not reported), which were exposed to temperatures outside of the recommended range. Concomitant therapies were not reported. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unspecified dates since 24-OCT-2015, the patients were vaccinated with doses of PNEUMOVAX 23 (Lot# L029113; expiration date 27-MAR-2017) (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range. Concomitant therapies were not reported. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. No information about medical history, concurrent conditions or concomitant therapy was reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L028277, expiry date 28-JUL-2017 (dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was filed. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. No information about medical history, concurrent conditions or concomitant therapy was reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L032184, expiry date 25-NOV-2016 (dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot# L023587, expiration date: 26-JUN-2017 (dose and route of administration were not reported). There was no adverse reaction reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-DEC-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, lot # K007262, expiry date: 25-NOV-2015 (dose, strength and frequency were not reported). No concomitant medications were reported. No adverse effects have been reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information is not expected as the reporter did not wish any further contact.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report a received from an unknown reporter, as a part of market research program refers to a unspecified number of patients of unknown age and gender enrolled in a project. No information about the patients medical history or concomitant medications was reported. The concurrent conditions of the patients included Human Immunodeficiency Virus infection (HIV). On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, lot #, expiry date and route of administration were not specified). The reporter stated, that there was still conflicting evidence about PNEUMOVAX 23 efficacy in Human Immunodeficiency Virus (HIV) patients though it was still recommended by most major organizations. The reporter indicated, that at least some adult patients received PREVNAR due to less immunological reactions/ side effects to the PNEUMOVAX 23. The outcome of the events and causality assessment were not provided. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to a 15 month old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 22-DEC-2015 the patient was vaccinated with a first dose of GARDASIL (lot # K010215, expiration date unknown; route not reported) (drug administered to patient of inappropriate age). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age. On 24-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL lot # reported as K016960 (Expiration date 10-MAY-2017). No adverse effect reported. This is one of the two cases received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Nausea, Pollakiuria, Pregnancy test urine positive, Vomiting
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a 23 year old pregnant female patient with no drug reactions or allergies and no pertinent medical history. The patient's last menstrual period (LMP) was on 06-NOV-2015 and the estimated date of conception was on 20-NOV-2015. On 04-DEC-2015, the patient was inadvertently vaccinated subcutaneously with a dose of VARIVAX lot # L001330, expiration date 13-JAN-2017 (dose and frequency were not reported). The patient was not taking any concomitant medication. On 21-DEC-2015, the patient experienced nausea and increased urinary frequency, which made patient suspect pregnancy. Later, on 23-DEC-2015, the pregnancy was confirmed via urine pregnancy test. The patient was being treated with prenatal vitamins. The estimated date of delivery (EDD) would be on 12-AUG-2016. At the time of the report, the pregnancy outcome was pending. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot K007784, expiration date: 28-MAY-2016 and lot # K021936, expiration date: 10-NOV-2016. There were no adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous case report was received from a registered regarding a 45-year-old female patient. No medical history and concurrent conditions of the patient was reported. The patient's medical history included unspecified vaccination history. On an unspecified date in August 2015 (reported as early August 2015), the patient had blood work. The results of the blood test showed negative titers for Measles, Mumps, Rubella and Varicella. On 17-AUG-2015, the patient was vaccinated with PROQUAD (Merck) lot # K019100 dose 1.5ml via subcutaneous route which was outside the age indication (inappropriate schedule of drug administration). No other effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. No medical history was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L000455, expiration date 06-JAN-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On 24-DEC-2015 the patient was vaccinated with an expired third dose of GARDASIL (strength, dosage, frequency and route unspecified. The physician was not able to provide the lot#/exp. for the expired GARDASIL that was administered as well as the dates of administration of previous doses. No adverse symptoms was reported. Additional information has been requested.
Age: 1.82
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to a 21 month old patient of unknown age. On 28-DEC-2015 the patient received an expired dose of VAQTA (lot # K008254, expiration date: 12-NOV-2015, dose and route were unknown). The patient had not experienced any adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 28-DEC-2015 the patient subcutaneously received both VARIVAX (Merck) (lot# and dose were unknown) and PROQUAD (Merck) (lot# and dose were unknown) in error (overdose). No known adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose and route were not reported; lot# K021624 with expiration 07-FEB-2016; lot# K026365 with expiration 15-MAR-2016; lot L006392 with expiration 25-MAY-2016; lot# L012039 with expiration 07-JUL-2016; lot# L032184 with expiration 25-NOV-2016) (incorrect product storage). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Pain
Clinical narrative: This spontaneous case report was received from a pharmacist regarding her 55-year-old mother. The patient did not have any previous medical history, allergy and concurrent conditions. The patient was not taking any concomitant medications. On 10-DEC-2015, the patient was vaccinated with ZOSTAVAX 0.65 ml once, intramuscularly in her hip area as part of the recommended vaccination, at the physician's office. Approximately in December 2015, the patient experienced a 'knot and soreness'. No treatment was given for the events. No medical attention was sought. No laboratory studies were performed. The outcome of the events "knot and soreness" was reported as recovering. Causality assessment was not provided. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Pharmacist (R.Ph) regarding a patient of unknown age and gender. Concomitant therapies were not reported. On unspecified dates, the patient received the first and second doses of GARDASIL (Lot #, Expiration date, dose and route were not provided). On 22-DEC-2015, the patient was vaccinated with GARDASIL 9 (lot # L001312, expiration date was 24-FEB-2017( (dose and route were not reported) as the third dose in a series. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of PEDVAXHIB lot # L002867 expiration date 11-NOV-2017, and lot # L014426 expiration date 08-MAR-2018, (dose and route were not reported), were given to unspecified patients on unspecified dates. No adverse  effects were reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose and route were not reported; lot# K007974 with expiration 03-JUN-2016; lot # L000453 with expiration date 06-JAN-2017; lot # L017998 with expiration 19-MAY-2017). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age. On 24-NOV-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ lot # K022993 (Expiration date 20-JUL-2016) (incorrect product storage). No adverse effect reported. This is one of the two cases received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse (the patient's wife) referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (strength was reported as 19400PFU, dose and route were unknown). The patient's concomitant medication was not reported. On an unknown date about two years later, the patient got a small case of the shingles. The outcome of the event was unknown. The reporter considered the event to be not related to ZOSTAVAX. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Purulent discharge
Clinical narrative: Information has been received from the pharmacist referring to a 70 year old female patient. On an unknown date (reported as "over the past couple of days") the patient was vaccinated with ZOSTAVAX (dose, strength and route were unknown, lot # L029482, expiration date: 06-NOV-2016). On an unknown date the patient experienced a swollen, red, itchy area at the injection site that had pus coming out. This could be considered a rash. The patient had to see a physician on an unspecified date and got a prescription for an unspecified antibiotic. The outcome of the event was unknown. Causality was not provided. This case is one of several cases received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from the pharmacist referring to an adult female patient under the age of 60 years. On an unknown date (reported as "over the past couple of days") the patient was vaccinated with ZOSTAVAX (dose, strength and route were unknown, lot # L029482, expiration date: 06-NOV-2016). On an unknown date the patient experienced a swollen, red, itchy area at the injection site. This could be considered a rash. The patient had to see a physician on an unspecified date and got a prescription for an unspecified antibiotic. The outcome of the event was unknown. Causality was not provided. This case is one of several cases received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Rash vesicular, Scab, Skin lesion
Clinical narrative: Information has been received from a licensed nurse practitioner referring to a currently 61 years old female patient with coronary artery disease, hypertension and hypothyroidism. The patient had unspecified reactions to azithromycin, dexamethasone, dolasetron mesylate, meperidine hydrochloride, phenothiazines, quinolone, sumatriptan, VIOXX (Reference MARRS number 1510USA014690). The patient had unspecified severe reaction to COMPAZINE. Cephalosporins, penicillin and hydrocodone caused the patient rash. SULFA caused the patient a rash and facial swelling. On an unknown date the patient started therapy with benztropine mesylate (manufacturer unknown) (dose, frequency, lot# and expiration date were not reported) orally for an unknown indication. On an unknown date the patient experienced unspecified drug reaction(s)/allergy to benztropine mesylate (manufacturer unknown). Concomitant drug was not reported. Action taken with benztropine mesylate (manufacturer unknown) and outcome of the event were not reported. The reporter considered drug hypersensitivity to be related to benztropine mesylate (manufacturer unknown). This is one of the several reports from the same reporter concerning the same patient. Follow up has been received from the physician on 30-DEC-2015, refers to a 61 year old female patient. The patient was not pregnant. On 25-SEP-2015 the patient was vaccinated with .65 ml ZOSTAVAX (lot # L012476, expiry date: 10-JUL-2016) via subcutaneous route. It was reported that the suspect products listed on the form were incorrect. On 08-OCT-2015, the patient experienced rash. The patient didn't required any treatment. The outcome of rash was reported as recovered. Additional information has been requested. Patient's information, suspect product, event information and narrative were updated.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a licensed nurse practitioner referring to a currently 61 years old female patient with coronary artery disease, hypertension and hypothyroidism. The patient had unspecified reactions to azithromycin, dexamethasone, dolasetron mesylate, meperidine hydrochloride, phenothiazines, quinolone, sumatriptan, VIOXX (Reference MARRS number 1510USA014690). The patient had unspecified severe reaction to COMPAZINE. Cephalosporins, penicillin and hydrocodone caused the patient rash. SULFA caused the patient a rash and facial swelling. On an unknown date the patient started therapy with benztropine mesylate (manufacturer unknown) (dose, frequency, lot# and expiration date were not reported) orally for an unknown indication. On an unknown date the patient experienced unspecified drug reaction(s)/allergy to benztropine mesylate (manufacturer unknown). Concomitant drug was not reported. Action taken with benztropine mesylate (manufacturer unknown) and outcome of the event were not reported. The reporter considered drug hypersensitivity to be related to benztropine mesylate (manufacturer unknown). This is one of the several reports from the same reporter concerning the same patient. Follow up has been received from the physician on 30-DEC-2015, refers to a 61 year old female patient. The patient was not pregnant. On 25-SEP-2015 the patient was vaccinated with .65 ml ZOSTAVAX (lot # L012476, expiry date: 10-JUL-2016) via subcutaneous route. It was reported that the suspect products listed on the form were incorrect. On 08-OCT-2015, the patient experienced rash. The patient didn't required any treatment. The outcome of rash was reported as recovered. Additional information has been requested. Patient's information, suspect product, event information and narrative were updated.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Contusion, Full blood count, Thrombocytopenia
Clinical narrative: Bruising, Thrombocytopenia.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Anxiety, Arthralgia, Depression, Ectopic pregnancy
Clinical narrative: Multiple seizures, blackouts, near fainting episodes, frequent heart palpitations, multiple miscarriages, ectopic pregnancy and high risk pregnancies, chronic fatigue, muscle and joint pain, susceptible to illnesses (possible immune system problems), depression and anxiety resulting from illness and pregnancy loss. All of these presented after two rounds of the vaccine. I was afraid of taking the third dose because of the adverse reactions. My health has been poor since, and my fertility has been permanently affected. Many tests were done to determine the cause of my miscarriages, with no findings as to the cause. But I was very healthy and fertile until injection of the Gardasil Vaccine. I strongly suspect it is to blame.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, High risk pregnancy, Incomplete course of vaccination, Infertility female, Laboratory test
Clinical narrative: Multiple seizures, blackouts, near fainting episodes, frequent heart palpitations, multiple miscarriages, ectopic pregnancy and high risk pregnancies, chronic fatigue, muscle and joint pain, susceptible to illnesses (possible immune system problems), depression and anxiety resulting from illness and pregnancy loss. All of these presented after two rounds of the vaccine. I was afraid of taking the third dose because of the adverse reactions. My health has been poor since, and my fertility has been permanently affected. Many tests were done to determine the cause of my miscarriages, with no findings as to the cause. But I was very healthy and fertile until injection of the Gardasil Vaccine. I strongly suspect it is to blame.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Malaise, Myalgia, Palpitations, Presyncope
Clinical narrative: Multiple seizures, blackouts, near fainting episodes, frequent heart palpitations, multiple miscarriages, ectopic pregnancy and high risk pregnancies, chronic fatigue, muscle and joint pain, susceptible to illnesses (possible immune system problems), depression and anxiety resulting from illness and pregnancy loss. All of these presented after two rounds of the vaccine. I was afraid of taking the third dose because of the adverse reactions. My health has been poor since, and my fertility has been permanently affected. Many tests were done to determine the cause of my miscarriages, with no findings as to the cause. But I was very healthy and fertile until injection of the Gardasil Vaccine. I strongly suspect it is to blame.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure, Ultrasound scan
Clinical narrative: Multiple seizures, blackouts, near fainting episodes, frequent heart palpitations, multiple miscarriages, ectopic pregnancy and high risk pregnancies, chronic fatigue, muscle and joint pain, susceptible to illnesses (possible immune system problems), depression and anxiety resulting from illness and pregnancy loss. All of these presented after two rounds of the vaccine. I was afraid of taking the third dose because of the adverse reactions. My health has been poor since, and my fertility has been permanently affected. Many tests were done to determine the cause of my miscarriages, with no findings as to the cause. But I was very healthy and fertile until injection of the Gardasil Vaccine. I strongly suspect it is to blame.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Epistaxis, Rhinorrhoea
Clinical narrative: Severe bloody nose, bloody mucus draining from nose and into throat mouth.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Rash pruritic
Clinical narrative: Started getting an itchy rash around hairline and forehead. It spread to the back, both lower legs, both knees, shoulders, chest over the next several days, with intense itching. Was prescribed 7 days of steroids, antihistamine (Zyrtec), Pepcid. No relief or change with meds. Rash moved around to different areas of body and did not start to clear until 12/28/2015.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Lumbar radiculopathy, Pain in extremity
Clinical narrative: Severe lumbar pain with radiation down right leg. Lumbar radiculopathy. Lasted 7 days with use of analgesics, OTC, moist heat, ice.
Age: 18.0
Sex: M
Vaccine: HPVX
Symptoms: Eye swelling, Rash, Swelling face
Clinical narrative: Swelling of face and eyes and rash on face, arms, some on body.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Intermittent arm pain, inability to lift or use arm, sleep disruption continues to the present day. Doctors have recommended stretching and icing, which has been ineffective.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Received immunization at employee health service on 10/06/2015 as party of yearly employee check-up. The expected soreness of 1-2 days at the left deltoid injection site, never went away. No discoloration or swelling at site. Now pain of left deltoid has persisted over 2 months. Left deltoid pain is worst upon AM waking and upon elevation of left arm. Very difficult to move left arm at waking. Returned to employee health to discuss symptoms on 12/21/2015. Was give NSAID for symptoms. No significant relief with continued NSAID treatment of 5 days.
Age: 52.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea and Vomiting, muscle aches, and mid-grade fever at time of onset and continuing through submission of VAERS report.  Only treatment is pain/fever reducer/NSAID.
Age: 1.27
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Decreased appetite, Febrile convulsion, Full blood count, Pyrexia, Rash
Clinical narrative: Fever up to 105, seizure. Mother states that child had a rash on skin and had a febrile convulsion and she took him to the ER on 12/24, he had a temp of 105, He had received DTaP, Hib, PCV 13 and Flu vaccine on the 12/23 and fever started that day. He was seen here 3 days ago for an ER follow up visit. On day following shots he also had redness in the tongue and a 3 day loss of appetite. Child had a similar rash and had fever the day following his 1 yr vaccines. His fever following the his vaccines at his 1 yr visit, he received MMRV, and Hep A was not as high as this recent episode. The rash then started on the legs and spread to other areas. He also had lesions in his mouth and perioral area. He was seen in our office for that episode and diagnosed with Hand foot mouth disease. The rash seen after his recent 15 month visit is very much in keeping with a rash seen in Hand foot and mouth syndrome also.
Age: 1.27
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Seizure, Tongue discolouration
Clinical narrative: Fever up to 105, seizure. Mother states that child had a rash on skin and had a febrile convulsion and she took him to the ER on 12/24, he had a temp of 105, He had received DTaP, Hib, PCV 13 and Flu vaccine on the 12/23 and fever started that day. He was seen here 3 days ago for an ER follow up visit. On day following shots he also had redness in the tongue and a 3 day loss of appetite. Child had a similar rash and had fever the day following his 1 yr vaccines. His fever following the his vaccines at his 1 yr visit, he received MMRV, and Hep A was not as high as this recent episode. The rash then started on the legs and spread to other areas. He also had lesions in his mouth and perioral area. He was seen in our office for that episode and diagnosed with Hand foot mouth disease. The rash seen after his recent 15 month visit is very much in keeping with a rash seen in Hand foot and mouth syndrome also.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Injection site erythema, Peripheral swelling
Clinical narrative: Swollen arm very red at site heartbeat rapid woke up in eve taken to emergency room by pharmacist.
Sex: M
Vaccine: HEP
Symptoms: Nervous system disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neurological disorder nos in a male patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced neurological disorder nos. On an unknown date, the outcome of the neurological disorder nos was not recovered/not resolved. It was unknown if the reporter considered the neurological disorder nos to be related to ENGERIX B. Additional details provided were as follows: This case was reported by the patient himself. The patient reported about experiencing some reactions (neurological disorder) to ENGERIX B vaccine. No further information was available.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Erythema multiforme, Pruritus, Rash generalised
Clinical narrative: Erythema multiforme - onset of rash on feet on 12/30; progreesed to cover entire body as afternoon progressed, pruritis. Prednisone taper prescribed.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Ear pruritus, Headache, Inflammation, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer. A 64-year-old female patient received PREVNAR 13 (NDC number 0005-1971-01; lot M16258; Expiry Date 30Apr2020), on 14Dec2015 at noon on left arm at 0.5 ml. Medical history included ongoing asthma (diagnosed years before), ongoing respiratory problems (diagnosed years before, when she got a cold, she used inhaler once a year), ongoing seasonal allergy to dust, mildew, ash and elm tree pollen, reflux, joints disorder, blood cholesterol. In Sep2015 she had flu vaccine (unspecified trade name) on Right arm and right after the injection her arm was sore and she could not lift her arm up for 24 hours, event subsided after twenty four hours; at the end of Oct2015 she received shingles vaccine. Concomitant medication included CRESTOR ongoing at 10 mg 1x/day for blood cholesterol, ESTRATEST half strength, started 15 years before and ongoing as hormone therapy, SINGULAIR for about a year and ongoing for allergy, PREVACID ongoing for reflux at 15 mg 1x/day, ZYRTEC ongoing for allergies, Vitamin C taking for years and ongoing at 200 mg 1x/day for routine health maintenance, multivitamins for seniors taking for years, Primrose oil 1x/day taking for years and ongoing for skin and hair, biotin taking for years and ongoing for skin and hair, Vitamin D ongoing for bones at 1000 mg, 1x/day (2x 500 mg), Calcium + D ongoing for bones at 1000 mg, 1x/day, fish oil with krill ongoing for routine health maintenance at 1500 mg, 1x/day and glucosamine ongoing for joints 1x/day. On 15Dec2015 patient started to get sore throat, itchy throat and ears and at 8:00 am she had headache, which woke her up; she also had respiratory distress, described as labored breathing when she was walking, she felt like she had congestion. On 17Dec2015 at 6:00 AM she noticed a rash under her breast, it was inflamed and sore. Patient stated her side effects were not improving. Itchy throat and ears, respiratory distress, labored breathing, congestion and rash under her breast not recovered; sore throat not recovered and worsened; headache recovered on 16Dec2015.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Pain in extremity, Rash, Respiratory distress, Respiratory tract congestion
Clinical narrative: This is a spontaneous report from a contactable consumer. A 64-year-old female patient received PREVNAR 13 (NDC number 0005-1971-01; lot M16258; Expiry Date 30Apr2020), on 14Dec2015 at noon on left arm at 0.5 ml. Medical history included ongoing asthma (diagnosed years before), ongoing respiratory problems (diagnosed years before, when she got a cold, she used inhaler once a year), ongoing seasonal allergy to dust, mildew, ash and elm tree pollen, reflux, joints disorder, blood cholesterol. In Sep2015 she had flu vaccine (unspecified trade name) on Right arm and right after the injection her arm was sore and she could not lift her arm up for 24 hours, event subsided after twenty four hours; at the end of Oct2015 she received shingles vaccine. Concomitant medication included CRESTOR ongoing at 10 mg 1x/day for blood cholesterol, ESTRATEST half strength, started 15 years before and ongoing as hormone therapy, SINGULAIR for about a year and ongoing for allergy, PREVACID ongoing for reflux at 15 mg 1x/day, ZYRTEC ongoing for allergies, Vitamin C taking for years and ongoing at 200 mg 1x/day for routine health maintenance, multivitamins for seniors taking for years, Primrose oil 1x/day taking for years and ongoing for skin and hair, biotin taking for years and ongoing for skin and hair, Vitamin D ongoing for bones at 1000 mg, 1x/day (2x 500 mg), Calcium + D ongoing for bones at 1000 mg, 1x/day, fish oil with krill ongoing for routine health maintenance at 1500 mg, 1x/day and glucosamine ongoing for joints 1x/day. On 15Dec2015 patient started to get sore throat, itchy throat and ears and at 8:00 am she had headache, which woke her up; she also had respiratory distress, described as labored breathing when she was walking, she felt like she had congestion. On 17Dec2015 at 6:00 AM she noticed a rash under her breast, it was inflamed and sore. Patient stated her side effects were not improving. Itchy throat and ears, respiratory distress, labored breathing, congestion and rash under her breast not recovered; sore throat not recovered and worsened; headache recovered on 16Dec2015.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Sleep disorder, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer. A 64-year-old female patient received PREVNAR 13 (NDC number 0005-1971-01; lot M16258; Expiry Date 30Apr2020), on 14Dec2015 at noon on left arm at 0.5 ml. Medical history included ongoing asthma (diagnosed years before), ongoing respiratory problems (diagnosed years before, when she got a cold, she used inhaler once a year), ongoing seasonal allergy to dust, mildew, ash and elm tree pollen, reflux, joints disorder, blood cholesterol. In Sep2015 she had flu vaccine (unspecified trade name) on Right arm and right after the injection her arm was sore and she could not lift her arm up for 24 hours, event subsided after twenty four hours; at the end of Oct2015 she received shingles vaccine. Concomitant medication included CRESTOR ongoing at 10 mg 1x/day for blood cholesterol, ESTRATEST half strength, started 15 years before and ongoing as hormone therapy, SINGULAIR for about a year and ongoing for allergy, PREVACID ongoing for reflux at 15 mg 1x/day, ZYRTEC ongoing for allergies, Vitamin C taking for years and ongoing at 200 mg 1x/day for routine health maintenance, multivitamins for seniors taking for years, Primrose oil 1x/day taking for years and ongoing for skin and hair, biotin taking for years and ongoing for skin and hair, Vitamin D ongoing for bones at 1000 mg, 1x/day (2x 500 mg), Calcium + D ongoing for bones at 1000 mg, 1x/day, fish oil with krill ongoing for routine health maintenance at 1500 mg, 1x/day and glucosamine ongoing for joints 1x/day. On 15Dec2015 patient started to get sore throat, itchy throat and ears and at 8:00 am she had headache, which woke her up; she also had respiratory distress, described as labored breathing when she was walking, she felt like she had congestion. On 17Dec2015 at 6:00 AM she noticed a rash under her breast, it was inflamed and sore. Patient stated her side effects were not improving. Itchy throat and ears, respiratory distress, labored breathing, congestion and rash under her breast not recovered; sore throat not recovered and worsened; headache recovered on 16Dec2015.
Sex: U
Vaccine: PNC13
Symptoms: Hepatitis acute
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 4 patients. This is the fourth of 4 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced acute hepatic process within a few days of a PREVNAR 13 vaccine on an unspecified date with outcome of unknown.