chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Seizure, Syncope, Urinary incontinence
Clinical narrative: This spontaneous report was received from a health care worker via field representative refers to a male patient of unspecified age (reported as under the age of 15). The patient's pertinent medical history and drug allergies were unspecified. On an unknown date the patient was vaccinated with first dose of GARDASIL 9 (Lot number and expiry date not provided) intramuscularly. Concomitant medications were not reported. On an unknown date, the patient experienced convulsions, syncope and lost of bladder control. The patient sought medical attention, reported as visited office and the treatment received was unspecified. The outcome of convulsions, syncope and lost of bladder control was unknown. The relatedness of convulsions, syncope and lost of bladder control with GARDASIL 9 was not reported. Upon internal review the event convulsions was determined to be medically significant. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach cramping, diarrhea that started quickly after taking first dose.  Symptoms still occurring at time of submission of this report.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Pruritus, Skin warm, Tongue ulceration
Clinical narrative: Patient received vaccine on 6/1/15. About a week later patient developed local reacton with redness, itching and warmth. A couple days later, developed ulcerations on tongue.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Symptoms; Right arm swollen, red, tender, and warm. Pain to right arm and described by patient as burning. Treatment: Pt prescribed 5 days of KEFLEX antibiotics.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Symptoms; Right arm swollen, red, tender, and warm. Pain to right arm and described by patient as burning. Treatment: Pt prescribed 5 days of KEFLEX antibiotics.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose normal, Headache, Polyuria, Pyrexia
Clinical narrative: Vaccine administered on 6/10/15 around 4 PM. Approximately 3 hours later began experiencing polyuria, fever and headache. Reports urinating 8-10 times large volume. Awakened this AM feeing fine.No urine output yet today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Child "felt warm", complained of pain in left arm and had redness at back of left arm.  Given Tylenol.  Fever and pain resolved but still has redness.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified amount patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses improperly stored of LIQUID PEDVAXHIB lots number reported as K025005 Expiry date 21-JUL-2017 and lot number K019701 Expiration date 17-JUL-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaint (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and referred to an unspecified patient of unknown age and gender. No medical history or concurrent conditions were reported. The registered nurse reported that on 25-MAR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K007262, expiration date 25-NOV-2015) (dose, route of administration were not reported), which was improperly stored. The vaccine went below temperature excursions for over a 10 day span. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patientts of an unknown age and gender. Concurrent conditions or medical history were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to her/his mother who was an adult. No concurrent or historical conditions were reported. In approximately 2014 (reported as about a year ago), the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot# and indication unknown). There was no concomitant medication reported. On approximately 29-MAY-2015 (reported as last week), the patient started having shingle symptoms on her neck area. The outcome of the event was unknown. The relatedness of patient's adverse event and ZOSTAVAX was not 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 registered nurse refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patients of an unknown age and gender. Concurrent conditions or medical history were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Nausea
Clinical narrative: Information has been received from a registered nurse via a field representative referring to a male patient of unknown age. On an unspecified date approximately in 2015 (reported as "sometime in the last few weeks") the patient was vaccinated with GARDASIL 9, strength and dose number of the 3rd dose series unspecified, 0.5 ml once, intramuscularly as HPV Vaccination. About the same time, the patients were also given concomitant therapies included TDAP and meningococcal vaccine (unspecified). On an unspecified date in 2015 the patient experienced severe nausea after receiving GARDASIL 9 vaccine. The outcome of nausea and the causality were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (strength, dosage, frequency and route unspecified) lot # J012567 with expiration date 30-JAN-2016 since the initial temperature excursion on 15-OCT-2014. The temperature excursion for RECOMBIVAX HB was unsupported with in-house stability data. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 20 year old patient of unknown gender. On 03-JUN-2015, the patient was vaccinated with improperly stored PNEUMOVAX 23 (route of administration, dose, lot number: K012424, expiry date: 05-JUN-2016). The vaccine was exposed to -10.4 C for 2 hours on 26-MAY-2015. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (Lot# K011084 and expiration date 08-AUG-2016, strength, route and dose not reported). No adverse experiences were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (Lot # L003222 and expiration date 30-JUL-2016, strength, route and dose not reported). No adverse experiences were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 01-MAY-2015, unspecified number of VAQTA (lot # J016216, expiration date 18-AUG-2016, dose and route were unknown) which were exposed to temperature excursions of the recommended range on 01-MAY-2015 have been administered to these unspecified patients on unspecified dates. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 01-MAY-2015, unspecified number of REOCMBIVAX HB(lot # K006682, expiration date 17-DEC-2015, dose and route were unknown) which were exposed to temperature outside of the recommended range on 01-MAY-2015 have been administered to these unspecified patients on unspecified dates. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 01-MAY-2015, unspecified number of oral, ROTATEQ (lot # K003524, expiration date 29-JAN-2016, dose and route were unknown) which were exposed to temperature outside of the recommended range on 01-MAY-2015 have been administered to these unspecified patients on unspecified dates. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Nausea
Clinical narrative: Information has been received from a registered nurse via a field representative referring to two female patients of unknown ages. On unspecified dates approximately in 2015 (reported as "sometime in the last few weeks") the patients were vaccinated with GARDASIL, strength and dose number of the 3 dose series unspecified; 0.5 ml once, intramuscularly. About the same time, the patients were also give concomitant therapies included TD ap and meningococcal vaccine (unspecified). ON unspecified dates in 2015 the patients experienced severe nausea after receiving the GARDASIL vaccine. The outcome of nausea and the causality were not provided.This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 59 years old patient of unknown gender. On 29-MAY-2015, the patient was vaccinated with improperly stored PNEUMOVAX23 (route of administration, dose, lot number, expiry date). The vaccine was exposed to -10.4 C for 2 hours on 26-MAY-2015. No adverse effect was reported. This is one of several reports form the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006960, expiration date 19-FEB-2017; dose and route of administration were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. ON 01-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006960, expiration date 19-FEB-2017; dose and route of administration were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. Concurrent conditions or medical history were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored oral, ROTATEQ (route of administration default to oral, dose, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician and refers to an adult patient of unknown age and gender. No information about concomitant therapy, concurrent conditions and medical history was provided. On an unknown date, the patient was vaccinated with first dose of GARDASIL injection (route, dose, lot#, expiration date, site of vaccination were not provided). On an unknown date, also reported as after first dose of GARDASIL, the patient experienced syncope. The physician asked if the reaction likely to re-occur when the second dose would be given. The outcome of the event was not reported. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: High fever lasting 4 days. Followed by rash covering back and stomach.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling in hands & feet 36 hours after getting ZOSTAVAX, resolved within a few days.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56 years old patient of unknown gender. On 03-JUN-2015, the patient was vaccinated with improperly stored PNEUMOVAX 23 (route of administration, dose, lot number: K012424, expiry date: 05-JUN-2016). The vaccine was exposed to -10.4 C for 2 hours on 26-MAY-2015. No adverse effect was reported. This is one of several reports 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 physician refers to multiple unspecified patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the multiple patients were vaccinated with improperly stored VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19-month old child of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015 the patient was inadvertently vaccinated with a dose of ZOSTAVAX subcutaneously (dose volume, lot number were not reported) instead of the intended dose of PROQUAD (Merck). The nurse confirmed that the administration error occurred because the pharmacy dispensed ZOSTAVAX instead of PROQUAD (Merck) in error and the unspecified healthcare worker who administered ZOSTAVAX did not notice the error before she administered the dose to the patient. No product confusion was reported. No adverse effect was reported. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Bowel movement irregularity, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Lethargy
Clinical narrative: Pt administered vaccines, within 1 minute after last dose pt's breathing pattern increased, and patient appeared lethargic. Extreme diaphoresis happened within seconds. RN asked patient how he was feeling, he replied "dizzy and sweaty, and blurry vision". RN broke 1 ammonia inhalant and waved under patients nose. Immediately patient was able to sit upright and opened his eyes. Due to signs of shock, RN positioned patient with legs up in adjoining chair and then RN administered 0.3ml epinephrine in L arm and called 911. 1:50pm VS BP was not able to be recorded in L arm, pulse ox was 98% room air, HR 50. 1:55pm RN could still not get reading BP reading (dt stethoscope and pt position in chair) VS 98% pulse ox, room air HR 47.  Pt then stated, "I feel like I have to go to the bathroom", " I really have to go number 2". RN assisted patient to stand and walked patient to toilet. RN sat patient on toilet and stayed right outside door. After using toilet patient reported, "I am feeling a little better". At this time ER personnel arrived from fire dept first, then EMT's. Pt's BP at 2:01pm was 126/60; approximately 8 minutes after being administered epinephrine.
Age: 26.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Respiratory rate increased, Vision blurred
Clinical narrative: Pt administered vaccines, within 1 minute after last dose pt's breathing pattern increased, and patient appeared lethargic. Extreme diaphoresis happened within seconds. RN asked patient how he was feeling, he replied "dizzy and sweaty, and blurry vision". RN broke 1 ammonia inhalant and waved under patients nose. Immediately patient was able to sit upright and opened his eyes. Due to signs of shock, RN positioned patient with legs up in adjoining chair and then RN administered 0.3ml epinephrine in L arm and called 911. 1:50pm VS BP was not able to be recorded in L arm, pulse ox was 98% room air, HR 50. 1:55pm RN could still not get reading BP reading (dt stethoscope and pt position in chair) VS 98% pulse ox, room air HR 47.  Pt then stated, "I feel like I have to go to the bathroom", " I really have to go number 2". RN assisted patient to stand and walked patient to toilet. RN sat patient on toilet and stayed right outside door. After using toilet patient reported, "I am feeling a little better". At this time ER personnel arrived from fire dept first, then EMT's. Pt's BP at 2:01pm was 126/60; approximately 8 minutes after being administered epinephrine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a two male patients currently over 71 years old. One of the patients (unspecified which patient) had a past medical history of polymyalgia rheumatica that was being treated with chronic steroid treatment (steroid name, dose, and manufacturer were unspecified). No medication history of medical history was unspecified for the other patient. The patients had no known drug reactions or allergies. Approximately in 2007 (reported as "about 7 to 8 years ago"), the patients were vaccinated with a doses of ZOSTAVAX (lot number and expiration date were not reported), subcutaneously to prevent shingles. Secondary suspects and concomitant therapies were not reported. Approximately in 2012 (reported as "during the past 3 years") the patients experienced outbreak of shingles. Each patient was given FAMVIR, ZOVIRAX ointment, and prednisone (manufacturer unknown) on unspecified dates to resolve the shingles. There was no lab diagnostic studies performed. The outcome of herpes zoster was reported as recovering (also reported as "recovered"). The patients sought medical attention via visiting the physician. The relatedness between outbreak of shingles and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a female patient currently over 71 years old. The patient's medical history included polymyalgia rheumatica that was being treated with chronic steroid treatment (steroid name, dose, and manufacturer were unspecified). Approximately in 20077 (reported as "about 7 to 8 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date were not reported), subcutaneously to prevent shingles. Secondary suspects and concomitant therapies were not reported. Approximately in 2012 (reported as "during the past 3 years") the patient experienced outbreak of shingles. She was given FAMVIR, ZOVIRAX ointment, and prednisone (manufacturer outcome) on unspecified date to resolve the shingles. There was no lab diagnostic studies performed. The outcome of herpes zoster was reported as recovering (also reported as "recovered"). The patient sought medical attention via visiting the physician. The relatedness between outbreak of shingles and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates approximately in 2015, patients may have received RECOMBIVAX HB lot #: K006825, expiration date: 15-SEP-2016 and lot # reported as K026803, expiration date: 05-DEC-2015 (dose and route of administration were not reported) which were improperly stored at 12.9 Celsius degree for 90 hours on unspecified dates during the time frame of April 2015 to May 2015. There was no known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates approximately in 2015, patients may have received doses of VAQTA lot # K005958, expiration date 09-FEB-2017 and lot # reported as K019560, expiration date: 02-JUN-2017 (dose and route of administration were not reported) which were improperly stored at 12.9 Celsius degree for 90 hours on unspecified dates during the time frame of April 2015 to May 2015. There was no known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unspecified date in November 2014, the patient was vaccinated with the first dose of ZOSTAVAX 0.65 ml, subcutaneous (lot number, expiration date, and anatomical location were not reported). There was no concomitant medication reported. No adverse experience was reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report as received from a health professional refers to a 53 year old female patient. The patient's medical history included sicca syndrome, rheumatology issues and myalgias. The patient also experienced hives following the administration of ibuprofen, swelling following the administration of "sulfa" and vomiting following administration of LORTAB on an unspecified dates. Concomitant therapies included hydroxychloroquine sulfate, pilocarpine hydrochloride (manufacturer unknown), naproxen, LIPITOR, magnesium oxide, phentermine, loratadine (manufacturer unknown), CYMBALTA, pantoprazole, B12 injections, FLONASE, LAMICTAL, ESTRACE vaginal cream, baby aspirin, vitamin B complex, vitamin D (unspecified) and "FLINTSTONES GUMMY with OMEGA 3". On 11-MAY-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K020215, expiration date 15-MAY-2016; dose and route of administration were not reported). On 12-MAY-2015 in the evening, the patient began to experience pain at the injection site and immobility of the injected arm. It was reported that on 13-MAY-2015, the patient sought medical attention via the doctor's office visit due to the symptoms. The patient was given a steroid injection. The patient returned to the office on 15-MAY-2015 and she was still experiencing the pain and was therefore given MEDROL dose pack for treatment. No lab diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between the adverse events and the vaccination with PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and healthcare worker concerning a patient of unknown age and gender. Information about patient's medical history was not reported. On 28-MAY-215, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, frequency, route of administration and indication were not specified) (lot # was reported as K025761, expiration date: 18-JUN-2016) which was improperly stored. No adverse event was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-MAY-2015, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # reported as K016313, expiration date 31-MAY-2016, oral; dose was not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 62 year old female patient. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 20-MAY-2015, the patient was vaccinated with a dose 0.65ml of ZOSTAVAX (lot # L006381, expiry date 25-MAY-2016) subcutaneously. On an unknown date in MAY 2015, the patient experienced localized injection site reaction that consisted of swelling and a red itchy rash following the administration of ZOSTAVAX. The outcome of the events was unknown. The reporter did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a nurse referring to an 18 year old female patient with negative pregnancy status. Information about concurrent conditions and medical history was not provided. On 28-MAY-2015 the patient was vaccinated with a 0.5ml dose of PROQUAD (Merck) (lot # K025759, expire date 08-JUN-2016, subcutaneous, dose# unspecified). No information regarding concomitant therapy was provided. On 07-JUN-2015 the patient developed swollen lymph nodes and a 102F fever. On 07-JUN-2015, the patient visited an urgent care center. The fever resolved after one day (recovered on 08-JUN-2015). The swollen lymph nodes persist (not recovered). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006960, expiration date 19-FEB-2017; dose and route of administration were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 01-MAY-2015, unspecified number of GARDASIL (lot # J006850, expiration date 31-MAR-2016; lot # K006117, expiration date 14-JAN-2017, dose and route were unknown) which were exposed to temperature outside of the recommend range on 01-MAY-2015 have been administered to these unspecified patients on unspecified dates. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Myalgia
Clinical narrative: Local site rxn-redness and swelling at site. (Left arm) muscle sorness in left arm.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site movement impairment
Clinical narrative: Immediate onset pain (L) arm, deltoid area with no progression to point she has marked limitation of shoulder movement.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006960, expiration date 19-FEB-2017; dose and route of administration were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: IPV, MMRV, PPV
Symptoms: Asphyxia, Febrile convulsion, Lactose intolerance, Pyrexia, Seizure
Clinical narrative: HIGH FEVER (105) AND SEIZURE LASTING ABOUT 10 MINS, WHILE SLEEPING CAUSING SUFFOCATION. 3 MORE SEIZURES (LASTING 5 MINS) IN THE FOLLOWING 18 MONTHS WITH NO FEVER. TREATMENT WAS SOUGHT - DIAGNOSIS, FEBRILE SEIZURE.  HOWEVER, NO FEVER WAS PRESENT WITH THE LAST 3 EVENTS. WAS SEEN BY LOCAL HOSPITAL AND ANOTHER HOSPITAL NEUROLOGICAL STAFF.  EXPERIENCED SEVERE LACTOSE INTOLERANCE FOR ABOUT 2 YEARS AFTERWARDS.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site rash
Clinical narrative: Red rash and induration at vaccine site- left thigh.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV1, HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 4 month old patient was given HPV quadrivalent vaccine.  No adverse reaction noted.  Contacted CDC and advised by MD that there is no expectation to see more than a normal local reaction to injection.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV1, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: 4 month old patient was given HPV quadrivalent vaccine.  No adverse reaction noted.  Contacted CDC and advised by MD that there is no expectation to see more than a normal local reaction to injection.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Exophthalmos, Hypersensitivity, Pharyngeal oedema, Rash
Clinical narrative: Patient's mother called in today and states that she had an allergic reaction to the MCV4 vaccine. States that patient's throat started swelling, eyes started bulging, and she developed a rash, this did not occur until Saturday.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site vesicles
Clinical narrative: Pt received DTaP/IPV and MMRV to left thigh. Pt developed blister at vaccination site; blister was fluid-filled, 0.5 cm x 0.3 cm in size, and 2 cm below site of vaccination.
Age: 21.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient developed round warm raised area at the area that the varicella vaccine was given 50 x 40 mm area. Was put on antibiotics.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness & swelling at site of injection & was advised to use topical BENADRYL.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Hypersensitivity, Induration, Injection site erythema, Injection site pruritus
Clinical narrative: Mother reports (R) upper arm was red and itchy. Taken to Emergency Department-9 cm rash on (R) arm. Rash was "warm, tender, erythematous and indurated". Clinical impression: allergic reaction (Rx KEFLEX 500 Q 8 x 7 days).
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Rash, Skin warm, Tenderness
Clinical narrative: Mother reports (R) upper arm was red and itchy. Taken to Emergency Department-9 cm rash on (R) arm. Rash was "warm, tender, erythematous and indurated". Clinical impression: allergic reaction (Rx KEFLEX 500 Q 8 x 7 days).
Age: 38.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Local reaction (L) arm. Pink and swollen 4 inches by 4-5 inches. C/o area being "hot" and itching. She reports that she is taking BENADRYL and it is better than yesterday. She does not have a fever. I advised a cold compress and BENADRYL prn. If it does not resolved, call her doctor and our office.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: (R) thigh local reaction. 2cm x 1cm swelling and redness. BENADRYL given. Site monitor. Improved over next 12 hours.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt. passed out for 30 sec. check by PA and layed down for 15 min till she felt better.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding to an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unspecified dates since 03-FEB-2015, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # K007979, expiration date 03-JUN-2016, lot # K021487, expiration date 03-NOV-2016 and lot # L001335, expiration date 13-JAN-2017, subcutaneous. No concomitant medication was reported. No adverse effect was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding to an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unspecified dates since 03-FEB-2015, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD lot # L005292, expiration date 17-AUG-2016, subcutaneous. No concomitant medication was reported. No adverse effect was reported. No product quality complaint was involved. The outcome of th event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 01-JUN-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL lot # K009482 expiry dale: 06-MAR-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test, Cellulitis, Erythema, Feeling hot, Induration
Clinical narrative: Two inch diameter area of induration and redness, tender to palpation w/ localized warmth.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody, Mumps antibody test, Tenderness
Clinical narrative: Two inch diameter area of induration and redness, tender to palpation w/ localized warmth.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Skin ulcer
Clinical narrative: Patient presented with rash on forehead, that extended towards the right side of her nose. The patient denied pain, but pruritus was present. The rash was red and small sores were visiable at close proximity. They were advised to see doctor and follo-up with pharmacy.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Drug administration error, No adverse event
Clinical narrative: No adverse events. Patient received MMR however already has immunity.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Electromyogram, Hypoaesthesia
Clinical narrative: Had severe pain in left deltoid muscle where recieved vaccination associated with shooting sharp pain up my shoulders into my neck and crossed over to my right arm. Over next few days began experiencing numbness, tingling down arms which evolved into severe shooting pains from both elbows, and associated numbess in 4th and 5th fingers in my hands. Required 2 courses of steroids, was seen by neurologist, missed 3 weeks of work. I had an EMG performed at the time of the occurrence. Numbness in my hands and pain in my arms, neck continued off and on for approx 10 months. In April 2014, I started having pain in my left shoulder which progressed to my back, hips, knees. I now am being treated for possible rheumatoid arthritis, having all of the symptoms but a negative rheumatoid factor. No definitive cause has been discovered other than my symptoms started with pain in my left arm/shoulder specifically where I had that vaccine 5.5 years ago. I just started taking Humira injections. I still have discomfort in my left shoulder and can pinpoint where I recieved the vaccine 5.5 years ago. I do not
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Injection site pain, Laboratory test, Neck pain, Pain, Pain in extremity
Clinical narrative: Had severe pain in left deltoid muscle where recieved vaccination associated with shooting sharp pain up my shoulders into my neck and crossed over to my right arm. Over next few days began experiencing numbness, tingling down arms which evolved into severe shooting pains from both elbows, and associated numbess in 4th and 5th fingers in my hands. Required 2 courses of steroids, was seen by neurologist, missed 3 weeks of work. I had an EMG performed at the time of the occurrence. Numbness in my hands and pain in my arms, neck continued off and on for approx 10 months. In April 2014, I started having pain in my left shoulder which progressed to my back, hips, knees. I now am being treated for possible rheumatoid arthritis, having all of the symptoms but a negative rheumatoid factor. No definitive cause has been discovered other than my symptoms started with pain in my left arm/shoulder specifically where I had that vaccine 5.5 years ago. I just started taking Humira injections. I still have discomfort in my left shoulder and can pinpoint where I recieved the vaccine 5.5 years ago. I do not
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Paraesthesia, Rheumatoid factor negative, X-ray
Clinical narrative: Had severe pain in left deltoid muscle where recieved vaccination associated with shooting sharp pain up my shoulders into my neck and crossed over to my right arm. Over next few days began experiencing numbness, tingling down arms which evolved into severe shooting pains from both elbows, and associated numbess in 4th and 5th fingers in my hands. Required 2 courses of steroids, was seen by neurologist, missed 3 weeks of work. I had an EMG performed at the time of the occurrence. Numbness in my hands and pain in my arms, neck continued off and on for approx 10 months. In April 2014, I started having pain in my left shoulder which progressed to my back, hips, knees. I now am being treated for possible rheumatoid arthritis, having all of the symptoms but a negative rheumatoid factor. No definitive cause has been discovered other than my symptoms started with pain in my left arm/shoulder specifically where I had that vaccine 5.5 years ago. I just started taking Humira injections. I still have discomfort in my left shoulder and can pinpoint where I recieved the vaccine 5.5 years ago. I do not
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Electromyogram, Electromyogram abnormal
Clinical narrative: Had severe pain in left deltoid muscle where recieved vaccination associated with shooting sharp pain up my shoulders into my neck and crossed over to my right arm. Over next few days began experiencing numbness, tingling down arms which evolved into severe shooting pains from both elbows, and associated numbess in 4th and 5th fingers in my hands. Required 2 courses of steroids, was seen by neurologist, missed 3 weeks of work. I had an EMG performed at the time of the occurrence. Numbness in my hands and pain in my arms, neck continued off and on for approx 10 months. In April 2014, I started having pain in my left shoulder which progressed to my back, hips, knees. I now am being treated for possible rheumatoid arthritis, having all of the symptoms but a negative rheumatoid factor. No definitive cause has been discovered other than my symptoms started with pain in my left arm/shoulder specifically where I had that vaccine 5.5 years ago. I just started taking Humira injections. I still have discomfort in my left shoulder and can pinpoint where I recieved the vaccine 5.5 years ago. I do not
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Hypoaesthesia, Injection site discomfort, Injection site joint pain, Injection site pain, Musculoskeletal pain
Clinical narrative: Had severe pain in left deltoid muscle where recieved vaccination associated with shooting sharp pain up my shoulders into my neck and crossed over to my right arm. Over next few days began experiencing numbness, tingling down arms which evolved into severe shooting pains from both elbows, and associated numbess in 4th and 5th fingers in my hands. Required 2 courses of steroids, was seen by neurologist, missed 3 weeks of work. I had an EMG performed at the time of the occurrence. Numbness in my hands and pain in my arms, neck continued off and on for approx 10 months. In April 2014, I started having pain in my left shoulder which progressed to my back, hips, knees. I now am being treated for possible rheumatoid arthritis, having all of the symptoms but a negative rheumatoid factor. No definitive cause has been discovered other than my symptoms started with pain in my left arm/shoulder specifically where I had that vaccine 5.5 years ago. I just started taking Humira injections. I still have discomfort in my left shoulder and can pinpoint where I recieved the vaccine 5.5 years ago. I do not
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Neck pain, Pain, Pain in extremity, Paraesthesia, Rheumatoid factor negative
Clinical narrative: Had severe pain in left deltoid muscle where recieved vaccination associated with shooting sharp pain up my shoulders into my neck and crossed over to my right arm. Over next few days began experiencing numbness, tingling down arms which evolved into severe shooting pains from both elbows, and associated numbess in 4th and 5th fingers in my hands. Required 2 courses of steroids, was seen by neurologist, missed 3 weeks of work. I had an EMG performed at the time of the occurrence. Numbness in my hands and pain in my arms, neck continued off and on for approx 10 months. In April 2014, I started having pain in my left shoulder which progressed to my back, hips, knees. I now am being treated for possible rheumatoid arthritis, having all of the symptoms but a negative rheumatoid factor. No definitive cause has been discovered other than my symptoms started with pain in my left arm/shoulder specifically where I had that vaccine 5.5 years ago. I just started taking Humira injections. I still have discomfort in my left shoulder and can pinpoint where I recieved the vaccine 5.5 years ago. I do not
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Musculoskeletal stiffness, Pain
Clinical narrative: Patient received the vaccine on 12/18/14 and began to develop symptoms of stiff muscles and pain beginning the next day. Symptoms progressed and became more debilitating over the next few days then began to resolve in about 2 weeks.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Fever and Swelling at the injection site; Larger than a quarter.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Papular rash on back of neck.
Age: 1.0
Sex: M
Vaccine: MMRV, HEPA, MMR, PNC13, VARCEL
Symptoms: Chest X-ray, Cyanosis, Electrocardiogram, Full blood count, Pyrexia
Clinical narrative: Stopped breathing, turned blue, fever.
Age: 1.0
Sex: M
Vaccine: MMRV, HEPA, MMR, PNC13, VARCEL
Symptoms: Respiratory arrest, Urine analysis
Clinical narrative: Stopped breathing, turned blue, fever.
Age: 1.0
Sex: M
Vaccine: MMRV, HEPA, MMR, PNC13, VARCEL
Symptoms: Chest X-ray, Febrile convulsion, Full blood count, Urine analysis
Clinical narrative: Stopped breathing, turned blue, fever.