chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number patient of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored MMRII (strength, dose/frequency, lot # unspecified). Concomitant medication was not reported. No adverse effects were reported. This is one of five reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 03-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ (dose, frequency and lot# were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the 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 was received from a registered nurse refers to an unspecified patients of unknown age and gender. NO pertinent medical history was reported. On an unknown date, an unspecified patients were vaccinated with doses of (Oka/Merck) VARIVAX vial 1350 U (dose, route, lot # were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports 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 as received from a healthcare worker refers to a patient of unknown age and gender. On 26-JUN-2015 the patient was vaccinated with ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K016314 with expiration date: 05-JUN-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports 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 was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. ON an unknown date the unspecified number of patients were vaccinated with ZOSTAVAX, exposed to -6C for 2 hours and 30 minutes (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports 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 was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, an unspecified patients were vaccinated with doses of ZOSTAVAX (dose, route, and lot# were not reported) which were exposed to temperatures outside of the recommended range. No adverse experienced reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient's relevant medical history, concomitant medication and past drug history were unknown. The patient was vaccinated with (Oka/Merck) VARIVAX (lot # L002214 and expiration date on 21-JAN-2017) which was given either on 30-JUN-2015 or 01-JUL-2015. The patient was administered the (Oka/Merck) VARIVAX after it had a temperature excursion (incorrect product storage). It was unknown if there was any relevant laboratory data. At the time of this report on 02-JUL-2015, the outcome of incorrect product storage was unknown. It was also unknown if the patient would ever get the (Oka/Merck) VARIVAX again. 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 was received from a medical assistant refers to an unknown number patient of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (strength, dose/frequency, lot # unspecified) (incorrect product storage). Concomitant medication was not reported. No adverse effects were reported. This is one of the five reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, unspecified number of patients were vaccinated with improperly stored ROTATEQ (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. 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 registered nurse concerning a patient of unknown demographics. Pertinent medical history or drug reactions/allergies were unknown. On 06-JUL-2015 the patient was inadvertently vaccinated with an expired dose of GARDASIL (intramuscular, expiration date was 02-JUL-2015; dose, lot number were unspecified). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reported as received from a healthcare worker refers to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were unspecified. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose/frequency, lot # unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. This is one of the two reports 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 was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX exposed to -6C for 2 hours and 30 minutes, (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. 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 health professional, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, unspecified number of patients were vaccinated with improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medication were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. NO further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reproted. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported) and an unspecified Influenza virus vaccine (unspecified)(manufacturer unknown) (dose and route were not reported) concomitantly. On an unknown date the patient experienced pruritus that lasted between 2 and 3 months. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 09-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with improperly stored VARIVAX (strength, route unspecified) lot # L002871, expiration date 27-JAN-2017. No adverse symptoms reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to cases 1507USA008507, 1507USA004977 via same reporter link. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 18 year old female patient. There was no patient's concurrent conditions and medical history reported. Concomitant therapies included Tdap (unspecified), meningococcal vaccine (unspecified) and Hep A (unspecified). Approximately in 2015 (reported as last few weeks), the patient experienced lightheadedness, five minutes after receiving GARDASIL 9 lot # K026247, expiration date unknown, (dose was unknown) intramuscularly. The patient did not received any treatment. The patient did not seek medical attention. The outcome of event was reported as recovered on an unspecified date in 2015. The relatedness between the event and GARDASIL 9 was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 18 year old male patient. There was no patient's concurrent conditions and medical history reported. Concomitant therapies included Tdap (unspecified), meningococcal vaccine (unspecified) and Hep A vaccine (unspecified). Approximately in 2015 (reported as last few weeks), the patient experienced lightheadedness, five minutes after receiving GARDASIL 9 lot # K026247, expiration date unknown, (dose was unknown) intramuscularly. The patient did not receive treatment. The patient did not seek medical attention. The outcome of event was reported as recovered on an unspecified date in 2015. The relatedness between the event and GARDASIL 9 was not reported. 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 reprot was received from a medical assistant refers to an unknown number patient of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unspecified dates, these patients were inadvertently vaccinated with improperly stored oral, ROTATEQ (strength, dose/frequency, lot # unspecified) (incorrect product storage). Concomitant medication was not reported. No adverse effects were reported. This is one of the five reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 1.63
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 19 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 06-MAY-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 08-JUN-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 08-JUN-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 01-JUL-2015 the patient was vaccinated with oral, ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K016314 with expiration date: 05-JUN-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin exfoliation
Clinical narrative: This spontaneous report as received from a non-pregnant 54 year old female nurse refers to herself. The patient's medical history included shingles. On 07-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiration date, dose and site of administration were not reported) subcutaneous. On 09-JUL-2015 (reported as 2 days later), the patient experienced burning sensation at injection site, injection site swelling and injection site redness. The patient attempted to use ice packs after contacting her provider for advice. In approximately July 2015 (reported as later), the patient's skin began peeling and began to look more like a burn and her provider advised her to use SILVADENE cream. The event were also treated with MOTRIN and BENADRYL. The outcome of events was reported as recovering/resolving. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site swelling, Pain
Clinical narrative: Pain, there is a knot in her arm at the injection site, her shoulder to the neck is swollen but she has no difficulty breathing, her arms are now uneven.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse (also reported as Certified Medical Assistant) referring to five unspecified patients of unknown age and gender. On 11-JUL-2015, the five unspecified patients were administered MMR II which underwent a supported temperature excursion. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a Certified Nurse Practitioner referring to a patient of unknown age and gender. There was no pertinent medical history or drug reaction/allergies reported. The patient was vaccinated with the first dose of GARDASIL (0.5 ml, lot# and expired date not provided) intramuscularly on 28-JUN-2013. The patient received the second and third dose on 08-JAN-2015 and 13-MAR-2015, respectively (inappropriate schedule of drug administration). No adverse effect was reported. Lot number H020801 (expired date 05-JUL-2015) of the third dose is an invalid lot number for GARDASIL. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a 63 year old female consumer referring to herself with concurrent condition of allergic to sulfa. There was no pertinent medical history. On 07-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K023007 is an invalid lot number for ZOSTAVAX) (dosage and route were not reported) 1 time injection. No concomitant medication was reported. On the same day the patient experienced swelling and redness 2 inches below injection site. No lab diagnostic studies were performed. The patient didn't seek medical attention. There was no treatment given. At the time of the report, the outcome of the event was not provided. Additional information is not expected as there is no contact information reported.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding a 20 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 01-JUL-2015, the 20  year old patient was vaccinated with a children/adolescents dose VAQTA, 0.5 ml, intramuscular. No concomitant medication was reported. No adverse event was reported. It was reported that VAQTA, was not discontinued. The outcome of the event was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Autopsy, Blood sodium increased, Convulsion, Dehydration, Diet refusal
Clinical narrative: This spontaneous report as received from a consumer's mother who refers to her son - a 7 week old male patient. The patient's medical history and current conditions were not provided. On 22-DEC-2014, the patient was vaccinated with ROTATEQ lot # K007911, orally (dose was not provided). Secondary suspects and concomitant therapies were not reported. On 25-DEC-2014, the patient experienced vomiting and two loose stools after rolling off the bed. On 26-DEC-2014, in the morning around 5:00, the patient had a fever of 102 (units reported as "degrees") and was given a pediatric dose of baby TYLENOL. The patient was seen later that morning by Physician Assistant and was diagnosed with an ear infection and given an unspecified dose of amoxicillin. The patient was also given water due to dehydration. Unspecified tests were given and the patient's sodium level was "very high". After a second dose of amoxicillin was given around 20:00 the same evening, the patient experienced "seizures" and went to the Emergency Room around 21:30. At 23:00 the patient was given two unspecified seizure medications and was transported to hospital. Unspecified computed tomography (CAT) scans and magnetic resonance imaging (MRI) were performed (dates and results were not provided). The outcome of vomiting, loose stools, fever, ear infection, dehydration, increase blood sodium and seizures was unknown. The patient stayed in the hospital until his death on 02-JAN-2015. According to the coroner, the cause of death was unknown. The relatedness between adverse events and ROTATEQ was not reported. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Ear infection, Fall, Irritability, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a consumer's mother who refers to her son - a 7 week old male patient. The patient's medical history and current conditions were not provided. On 22-DEC-2014, the patient was vaccinated with ROTATEQ lot # K007911, orally (dose was not provided). Secondary suspects and concomitant therapies were not reported. On 25-DEC-2014, the patient experienced vomiting and two loose stools after rolling off the bed. On 26-DEC-2014, in the morning around 5:00, the patient had a fever of 102 (units reported as "degrees") and was given a pediatric dose of baby TYLENOL. The patient was seen later that morning by Physician Assistant and was diagnosed with an ear infection and given an unspecified dose of amoxicillin. The patient was also given water due to dehydration. Unspecified tests were given and the patient's sodium level was "very high". After a second dose of amoxicillin was given around 20:00 the same evening, the patient experienced "seizures" and went to the Emergency Room around 21:30. At 23:00 the patient was given two unspecified seizure medications and was transported to hospital. Unspecified computed tomography (CAT) scans and magnetic resonance imaging (MRI) were performed (dates and results were not provided). The outcome of vomiting, loose stools, fever, ear infection, dehydration, increase blood sodium and seizures was unknown. The patient stayed in the hospital until his death on 02-JAN-2015. According to the coroner, the cause of death was unknown. The relatedness between adverse events and ROTATEQ was not reported. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Blood sodium increased, Computerised tomogram, Death, Dehydration, Diarrhoea
Clinical narrative: This spontaneous report as received from a consumer's mother who refers to her son - a 7 week old male patient. The patient's medical history and current conditions were not provided. On 22-DEC-2014, the patient was vaccinated with ROTATEQ lot # K007911, orally (dose was not provided). Secondary suspects and concomitant therapies were not reported. On 25-DEC-2014, the patient experienced vomiting and two loose stools after rolling off the bed. On 26-DEC-2014, in the morning around 5:00, the patient had a fever of 102 (units reported as "degrees") and was given a pediatric dose of baby TYLENOL. The patient was seen later that morning by Physician Assistant and was diagnosed with an ear infection and given an unspecified dose of amoxicillin. The patient was also given water due to dehydration. Unspecified tests were given and the patient's sodium level was "very high". After a second dose of amoxicillin was given around 20:00 the same evening, the patient experienced "seizures" and went to the Emergency Room around 21:30. At 23:00 the patient was given two unspecified seizure medications and was transported to hospital. Unspecified computed tomography (CAT) scans and magnetic resonance imaging (MRI) were performed (dates and results were not provided). The outcome of vomiting, loose stools, fever, ear infection, dehydration, increase blood sodium and seizures was unknown. The patient stayed in the hospital until his death on 02-JAN-2015. According to the coroner, the cause of death was unknown. The relatedness between adverse events and ROTATEQ was not reported. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Ear infection, Fall, Nuclear magnetic resonance imaging, Pyrexia, Seizure
Clinical narrative: This spontaneous report as received from a consumer's mother who refers to her son - a 7 week old male patient. The patient's medical history and current conditions were not provided. On 22-DEC-2014, the patient was vaccinated with ROTATEQ lot # K007911, orally (dose was not provided). Secondary suspects and concomitant therapies were not reported. On 25-DEC-2014, the patient experienced vomiting and two loose stools after rolling off the bed. On 26-DEC-2014, in the morning around 5:00, the patient had a fever of 102 (units reported as "degrees") and was given a pediatric dose of baby TYLENOL. The patient was seen later that morning by Physician Assistant and was diagnosed with an ear infection and given an unspecified dose of amoxicillin. The patient was also given water due to dehydration. Unspecified tests were given and the patient's sodium level was "very high". After a second dose of amoxicillin was given around 20:00 the same evening, the patient experienced "seizures" and went to the Emergency Room around 21:30. At 23:00 the patient was given two unspecified seizure medications and was transported to hospital. Unspecified computed tomography (CAT) scans and magnetic resonance imaging (MRI) were performed (dates and results were not provided). The outcome of vomiting, loose stools, fever, ear infection, dehydration, increase blood sodium and seizures was unknown. The patient stayed in the hospital until his death on 02-JAN-2015. According to the coroner, the cause of death was unknown. The relatedness between adverse events and ROTATEQ was not reported. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a consumer's mother who refers to her son - a 7 week old male patient. The patient's medical history and current conditions were not provided. On 22-DEC-2014, the patient was vaccinated with ROTATEQ lot # K007911, orally (dose was not provided). Secondary suspects and concomitant therapies were not reported. On 25-DEC-2014, the patient experienced vomiting and two loose stools after rolling off the bed. On 26-DEC-2014, in the morning around 5:00, the patient had a fever of 102 (units reported as "degrees") and was given a pediatric dose of baby TYLENOL. The patient was seen later that morning by Physician Assistant and was diagnosed with an ear infection and given an unspecified dose of amoxicillin. The patient was also given water due to dehydration. Unspecified tests were given and the patient's sodium level was "very high". After a second dose of amoxicillin was given around 20:00 the same evening, the patient experienced "seizures" and went to the Emergency Room around 21:30. At 23:00 the patient was given two unspecified seizure medications and was transported to hospital. Unspecified computed tomography (CAT) scans and magnetic resonance imaging (MRI) were performed (dates and results were not provided). The outcome of vomiting, loose stools, fever, ear infection, dehydration, increase blood sodium and seizures was unknown. The patient stayed in the hospital until his death on 02-JAN-2015. According to the coroner, the cause of death was unknown. The relatedness between adverse events and ROTATEQ was not reported. Upon internal review the event of seizures was considered as medically significant. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 33 years old female patient who had a history of allergies to "other migraine medication". On 06-MAY-2015, the patient was vaccinated with a dose of (Oka-Merck) PROQUAD, lot# reported as K020752, expiration date 30-APR-2016, 0.5 ml, subcutaneously. No adverse effects were reported. The patient took concomitantly TOPOMAX for migraines. On 16-AUG-2000, the patient received a dose of MMR II (lot#, expiration date, route not provided) and the patient showed delinquent for measles and mumps component but had been reviewed for rubella at an unspecified time in the past. Also there was no varicella in her (patient's) records (capture into MARRS# 1506UsA002789). Lot number K020752 has been verified to be a valid lot number of (Oka-Merck). Follow up information has been received from the nurse concerning the patient on 13-JUL-2015. The patient was allergic to IMITREX, oxycodone, acetaminophen, PERCOCET, sumatriptan, RELPAX and ZOMIG. There was no adverse event, the reporter simply wanted to report on 06-MAY-2015 at 14:30, the vaccines, (Oka-Merck) PROQUAD at left upper arm, being administered to patient out of the age range for manufacturer recommendation. This is one of several cases linked by the same patient. Additional information is not expected as all the follow up information has been received. Patient demographic, historical drug, concomitant condition, product, adverse event and narrative were updated.
Age: 33.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 33 years old female patient who had a history of allergies to "other migraine medication". On 06-MAY-2015, the patient was vaccinated with a dose of (Oka-Merck) PROQUAD, lot# reported as K020752, expiration date 30-APR-2016, 0.5 ml, subcutaneously. No adverse effects were reported. The patient took concomitantly TOPOMAX for migraines. On 16-AUG-2000, the patient received a dose of MMR II (lot#, expiration date, route not provided) and the patient showed delinquent for measles and mumps component but had been reviewed for rubella at an unspecified time in the past. Also there was no varicella in her (patient's) records (capture into MARRS# 1506UsA002789). Lot number K020752 has been verified to be a valid lot number of (Oka-Merck). Follow up information has been received from the nurse concerning the patient on 13-JUL-2015. The patient was allergic to IMITREX, oxycodone, acetaminophen, PERCOCET, sumatriptan, RELPAX and ZOMIG. There was no adverse event, the reporter simply wanted to report on 06-MAY-2015 at 14:30, the vaccines, (Oka-Merck) PROQUAD at left upper arm, being administered to patient out of the age range for manufacturer recommendation. This is one of several cases linked by the same patient. Additional information is not expected as all the follow up information has been received. Patient demographic, historical drug, concomitant condition, product, adverse event and narrative were updated.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Nerve injury
Clinical narrative: Soreness of (lt) side neck and (rt) upper arm next day after immunization. Self treated with TYLENOL, ADVIL and heat. Approx 2/2015, tingling of (lt) arm noted and went to neurologist. Tx'd with PT, steroids, anti-inflammatory. Approx 4/15 (after 8 PT visits) no improvement and MRI of shoulder (lt) done with (+) findings and went to orthopedic diagnosis bursitis (Lt) shoulder.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
Clinical narrative: Soreness of (lt) side neck and (rt) upper arm next day after immunization. Self treated with TYLENOL, ADVIL and heat. Approx 2/2015, tingling of (lt) arm noted and went to neurologist. Tx'd with PT, steroids, anti-inflammatory. Approx 4/15 (after 8 PT visits) no improvement and MRI of shoulder (lt) done with (+) findings and went to orthopedic diagnosis bursitis (Lt) shoulder.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray limb
Clinical narrative: Soreness of (lt) side neck and (rt) upper arm next day after immunization. Self treated with TYLENOL, ADVIL and heat. Approx 2/2015, tingling of (lt) arm noted and went to neurologist. Tx'd with PT, steroids, anti-inflammatory. Approx 4/15 (after 8 PT visits) no improvement and MRI of shoulder (lt) done with (+) findings and went to orthopedic diagnosis bursitis (Lt) shoulder.
Age: 17.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Abdominal pain upper, Blood test normal, CSF test normal, Diarrhoea, Disorientation
Clinical narrative: Patient was at summer camp for the week and developed severe leg pain, headache, stomach pain, diarrhea and shortness of breath. I had to go and pick him up from camp. He then added dizziness and exhaustion to his symptoms. Wednesday he seemed to be a little better but Thursday he could barely move. He was dizzy and fell down. He could not function. He was disoriented and in terrible pain. He was rushed to urgent care where they called an ambulance to take him to the emergency room where he had the above symptoms plus a fever of 102.7, rapid heart rate (122) and low blood pressure. He underwent three attempts at a lumbar puncture before it was successful. Nothing was unusual looking. This is how my son spent his 18th birthday...in the emergency room.
Age: 17.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Dizziness, Dyspnoea, Fall, Fatigue, Headache
Clinical narrative: Patient was at summer camp for the week and developed severe leg pain, headache, stomach pain, diarrhea and shortness of breath. I had to go and pick him up from camp. He then added dizziness and exhaustion to his symptoms. Wednesday he seemed to be a little better but Thursday he could barely move. He was dizzy and fell down. He could not function. He was disoriented and in terrible pain. He was rushed to urgent care where they called an ambulance to take him to the emergency room where he had the above symptoms plus a fever of 102.7, rapid heart rate (122) and low blood pressure. He underwent three attempts at a lumbar puncture before it was successful. Nothing was unusual looking. This is how my son spent his 18th birthday...in the emergency room.
Age: 17.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Heart rate increased, Hypotension, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient was at summer camp for the week and developed severe leg pain, headache, stomach pain, diarrhea and shortness of breath. I had to go and pick him up from camp. He then added dizziness and exhaustion to his symptoms. Wednesday he seemed to be a little better but Thursday he could barely move. He was dizzy and fell down. He could not function. He was disoriented and in terrible pain. He was rushed to urgent care where they called an ambulance to take him to the emergency room where he had the above symptoms plus a fever of 102.7, rapid heart rate (122) and low blood pressure. He underwent three attempts at a lumbar puncture before it was successful. Nothing was unusual looking. This is how my son spent his 18th birthday...in the emergency room.
Age: 32.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Arthropathy, Blood test, Headache
Clinical narrative: 6/30-7/4: bad headache. 7/7: sudden onset of arthritic symptoms in fingers, knees, ankles, and toes. Tried NSAIDs for one week (ibuprofen then indomethacin), with no improvement. Now on a 6 week course of prednisone as prescribed by Drs. at Rheumatology Clinic.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Antinuclear antibody positive, Arthralgia, Arthritis, Joint swelling, Laboratory test normal
Clinical narrative: 1st Hep B vaccination on 6/2/14. No adverse event. 2nd Hep B vaccination on 7/28/14. Within one week, experienced swelling of left knee and severe joint pain. The pain and swelling got progressively worse throughout the next few months. I received the 3rd and final Hep B shot of the series in October. Within a few days of this final shot, swelling spread to my elbow and I experienced severe neck, shoulder, and hip pain. Ankle and toes on left side also swelled. These symptoms continued to get worse until I was seen by a rheumatologist. I received a steroid injection in my knee in October which relieved the knee swelling and pain for about two weeks before returning. The rheumatologist I saw in January gave me another steroid injection in the knee and put me on 20mg of oral methotrexate weekly. Also on 500mg of naproxen twice a day or as needed (usually once a day). With this treatment swelling has subsided but I still experience knee pain and can not participate in high impact activities like jogging or any kind of jumping. Rheumatologist has tentatively diagnosed me with undifferentiated arthritis as it is not following classic bilateral pattern normally seen with RA and instead presenting in asymmetrical fashion. I am getting a master's degree in genetic counseling and am no way anti-vaccination, but I largely believe that I have some genetic vulnerability which made me more sensitive to the effects of the HepB vaccination.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain, Neck pain, Rheumatoid factor negative
Clinical narrative: 1st Hep B vaccination on 6/2/14. No adverse event. 2nd Hep B vaccination on 7/28/14. Within one week, experienced swelling of left knee and severe joint pain. The pain and swelling got progressively worse throughout the next few months. I received the 3rd and final Hep B shot of the series in October. Within a few days of this final shot, swelling spread to my elbow and I experienced severe neck, shoulder, and hip pain. Ankle and toes on left side also swelled. These symptoms continued to get worse until I was seen by a rheumatologist. I received a steroid injection in my knee in October which relieved the knee swelling and pain for about two weeks before returning. The rheumatologist I saw in January gave me another steroid injection in the knee and put me on 20mg of oral methotrexate weekly. Also on 500mg of naproxen twice a day or as needed (usually once a day). With this treatment swelling has subsided but I still experience knee pain and can not participate in high impact activities like jogging or any kind of jumping. Rheumatologist has tentatively diagnosed me with undifferentiated arthritis as it is not following classic bilateral pattern normally seen with RA and instead presenting in asymmetrical fashion. I am getting a master's degree in genetic counseling and am no way anti-vaccination, but I largely believe that I have some genetic vulnerability which made me more sensitive to the effects of the HepB vaccination.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: LT arm swelled, hot, pain, hives. Dizzy chills sweats nauseated. Still remains nauseated with chills pain in back of lungs.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis, Nausea, Pain, Peripheral swelling, Urticaria
Clinical narrative: LT arm swelled, hot, pain, hives. Dizzy chills sweats nauseated. Still remains nauseated with chills pain in back of lungs.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm warm to touch, itching, painful, redness, slightly swollen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: Red rash, warm to the touch, slightly painful started day after vaccine, has progressively gotten worse over the last 24 hours.
Age: 10.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: None - wrong vaccine was given, patient was to receive a Varicella vaccine but got the Zostavax vaccine.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at injection site; tenderness, itching, mild stinging at site.  No pox or fever.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Cough, Dysphonia, Throat irritation, Wheezing
Clinical narrative: Began clearing throat, then wheezing, followed by coughing and extreme hoarseness.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (R) arm red swollen.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Headache, Hyperaesthesia, Injection site pain
Clinical narrative: 1 hr after injection she began to have bil. arm muscle pain, sympt. continued throughout the night to all joints hurt, full body musc. pains, skin sensitivity, moderate to severe HA, nausea, temp next AM was 101.1 in clinic, (L) deltoid with moderate swelling and tenderness and warmth; sympt. tx only from the clinic.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Nausea
Clinical narrative: 1 hr after injection she began to have bil. arm muscle pain, sympt. continued throughout the night to all joints hurt, full body musc. pains, skin sensitivity, moderate to severe HA, nausea, temp next AM was 101.1 in clinic, (L) deltoid with moderate swelling and tenderness and warmth; sympt. tx only from the clinic.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Lethargy
Clinical narrative: Temp of 103, lethargic.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Abdominal pain upper, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: 103.5 Fever, Nausea, stomach pain, sore muscles, vomiting. Motrin to relieve pain and reduce fever, cool cloths on forehead. Lasted for 48 hours.
Age: 48.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Blood test, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Started with what I thought were bug bites on face and neck.  Later it had spread and it was clear it wasn't bug bites.  Saw Dr. on 1st and was placed on prednisone...rash seem to get better but apx 5 days after prednisone was completed experienced severe headache and some muscle aches, two days later nausea and dizziness set in, the next day vomiting started (minimal if I didn't move I didn't vomit) a second course of prednisone started on day 7 after completing 1st course although this didn't help with nausea and vomiting.  Rash which had started to reoccur seemed to clear up with 2nd dose.  7/21 (report date) rash is still there but seems to be getting better.  Nausea has returned today but not as bad 2nd does of prednisone was just recently completed.
Age: 48.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Rash, Vomiting
Clinical narrative: Started with what I thought were bug bites on face and neck.  Later it had spread and it was clear it wasn't bug bites.  Saw Dr. on 1st and was placed on prednisone...rash seem to get better but apx 5 days after prednisone was completed experienced severe headache and some muscle aches, two days later nausea and dizziness set in, the next day vomiting started (minimal if I didn't move I didn't vomit) a second course of prednisone started on day 7 after completing 1st course although this didn't help with nausea and vomiting.  Rash which had started to reoccur seemed to clear up with 2nd dose.  7/21 (report date) rash is still there but seems to be getting better.  Nausea has returned today but not as bad 2nd does of prednisone was just recently completed.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bacterial test negative, Blood culture negative, CSF culture negative, CSF test abnormal, Computerised tomogram normal
Clinical narrative: Woke from nap with spasms/seizures lasting 5-10 seconds each, spaced apart about every 30 seconds to a minute. After a few hours, they gradually spaced to every few minutes apart. Overall duration lasted about 5 hours until spasms/seizures stopped while being transported from ER to another hospital via helicopter.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture urine negative, Electroencephalogram normal, Muscle spasms, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: Woke from nap with spasms/seizures lasting 5-10 seconds each, spaced apart about every 30 seconds to a minute. After a few hours, they gradually spaced to every few minutes apart. Overall duration lasted about 5 hours until spasms/seizures stopped while being transported from ER to another hospital via helicopter.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Seizure, Syncope
Clinical narrative: Pt collapsed approximately 5 mins after HPV4#3 and Hep A#2 injections and started to seize for about 30 seconds. BP, P and O2 were taken immediately after she became responsive, 6 mins and 10 mins after. Pt was taken to hospital via EMS for further evaluation.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Myalgia
Clinical narrative: -Inflammation, Redness, Warmth at injection site. MD suggested watch and wait. Muscle pain in arm.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Local swelling
Clinical narrative: Vaccine administered 7/9/15. Within a couple days large, swollen bruised area today 7/14/15 looks much better, resolving.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, diarrhea, joint pain began within 8 hours of Tdap administration.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Blood test normal, Seizure
Clinical narrative: My daughter had no symptoms after the vaccine. She went to bed with us cause she wasn't sleepy, right as she fell sleep I went to take a picture and the flash set off a seizure (never has had one before) we called 911 and went to ER. She had no fever and seizure was 1-2 min.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema, pain, induration at left upper arm. Started 24 hours after vaccines.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. On 16-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were unspecified). The pharmacist reported that patient was in pharmacy received the second dose of GARDASIL on 08-JUL-2015 (Inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Extra dose administered
Clinical narrative: 4th dose HPV administered in error.