chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope. Patient counseled by administering pharmacist over the phone.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Pt. states that it is very hard and painful for him to use the arm where the vaccine was administered unable to lift it well.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Feeling abnormal, Swelling
Clinical narrative: Pt. said she had a little bump and felt "funny" I checked up on pt. 9/22 and she stated she felt better.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Oral herpes
Clinical narrative: Pt called 9/16 reported large red spot at site of injection, with no irritation. Spot was not raised or itchy. Pt reported administering valacyclovir when a herpes sore opened up post-admin.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Injection site erythema
Clinical narrative: Pt called 9/16 reported large red spot at site of injection, with no irritation. Spot was not raised or itchy. Pt reported administering valacyclovir when a herpes sore opened up post-admin.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with unspecified number of improperly stored (Oka/Merck) VARIVAX, dose and route not provided. Lot information of (Oka/Merck) VARIVAX was provided as lot # J014131, expiration date: 07-NOV-2015 and/or lot # K016132, expiration date: 24-SEP-2016. No adverse affects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse regarding unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 27-JUL-2015, the patient was vaccinated with 10 doses of improperly stored (Oka/Merck) VARIVAX lot # L003774 and expiry date 04-FEB-2017. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Incorrect route of drug administration, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist via company representative referring to a female patient of unknown age (a pharmacist). There was no medical history or concurrent condition reported) intramuscularly (incorrect route of drug administration). There was no concomitant mediation reported. The patient developed a severe unspecified rash around the injection site on an unspecified date in August 2015. The pharmacist stated that the rash from the injection site "had gone up to the patient's arm onto her chest". The patient told the pharmacist that it was not vesicular however it was red, swollen and painful. The patient also stated that she had a bad headache and had flu like symptoms on unspecified dates. At the time of the report, the outcome of the events was reported as not recovered.  Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling, Rash
Clinical narrative: Information has been received from a pharmacist via company representative referring to a female patient of unknown age (a pharmacist). There was no medical history or concurrent condition reported) intramuscularly (incorrect route of drug administration). There was no concomitant mediation reported. The patient developed a severe unspecified rash around the injection site on an unspecified date in August 2015. The pharmacist stated that the rash from the injection site "had gone up to the patient's arm onto her chest". The patient told the pharmacist that it was not vesicular however it was red, swollen and painful. The patient also stated that she had a bad headache and had flu like symptoms on unspecified dates. At the time of the report, the outcome of the events was reported as not recovered.  Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist via company representative referring to a female patient of unknown age (a pharmacist). There was no medical history or concurrent condition reported) intramuscularly (incorrect route of drug administration). There was no concomitant mediation reported. The patient developed a severe unspecified rash around the injection site on an unspecified date in August 2015. The pharmacist stated that the rash from the injection site "had gone up to the patient's arm onto her chest". The patient told the pharmacist that it was not vesicular however it was red, swollen and painful. The patient also stated that she had a bad headache and had flu like symptoms on unspecified dates. At the time of the report, the outcome of the events was reported as not recovered.  Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling, Rash, Rash erythematous, Swelling
Clinical narrative: Information has been received from a pharmacist via company representative referring to a female patient of unknown age (a pharmacist). There was no medical history or concurrent condition reported) intramuscularly (incorrect route of drug administration). There was no concomitant mediation reported. The patient developed a severe unspecified rash around the injection site on an unspecified date in August 2015. The pharmacist stated that the rash from the injection site "had gone up to the patient's arm onto her chest". The patient told the pharmacist that it was not vesicular however it was red, swollen and painful. The patient also stated that she had a bad headache and had flu like symptoms on unspecified dates. At the time of the report, the outcome of the events was reported as not recovered.  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 Licensed Vocations Nurse regarding unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 10-AUG-2015, the patients were vaccinated with 2 doses of improperly stored doses of (Merck) PROQUAD lot# L003221 and expiry date: 30-JUL-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the 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 Licensed Vocational Nurse regarding unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 28-JUL-2015, the patients were vaccinated with 4 doses of improperly stored doses of (Merck) PROQUAD lot# L003221 and expiry date: 30-JUL-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports 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 was received from registered nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2015 12:30 PM, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K004205, expiry: 12-JAN-2017), dose 2, intramuscularly in the left arm (left deltoid). No concomitant medications were reported. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, route unspecified) and (Oka/Merck) VARIVAX (strength, route unspecified) concurrently (overdose). No adverse effect reported. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse regarding 3 patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 31-AUG-2015, the patients were vaccinated with (Merck) PROQUAD lot# L005297 and expiry date: 17-AUG-2016, that was improperly exposed to defrost cycling. No adverse effect was reported. The outcome of the event was unknown. This is one of the 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 Licensed Vocational Nurse regarding 5 patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 27-AUG-2015, the patients were vaccinated with (Merck) PROQUAD lot# L005297 and expiry date: 17-AUG-2016, that was improperly exposed to defrost cycling. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports 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 was received from registered nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2015 01:00 PM, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K004205, expiry: 12-JAN-2017) dose 1, intramuscularly in the right arm (right deltoid). No concurrent medications were reported. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a male patient of unknown age referring to himself. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date the patient developed contracted shingles, the patient was reluctant to provide any additional information on his condition. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not provided. No PQC involved Additional information is not expected because there's no contact details.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: Information has been received from a male patient of unknown age referring to himself. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date the patient developed contracted shingles, the patient was reluctant to provide any additional information on his condition. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not provided. No PQC involved Additional information is not expected because there's no contact details.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: Information has been received from a male patient of unknown age referring to himself. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown). Concomitant medications were unspecified. On an unknown date the patient developed contracted shingles, the patient was reluctant to provide any additional information on his condition. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not provided. No PQC involved Additional information is not expected because there's no contact details.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse regarding an 1 patient of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 09-SEP-2015, the patient was vaccinated with improperly stored dose of (Merck) PROQUAD lot# L005297 and expiry date: 17-AUG-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 61 year old female patient. Information concerning medical history and concurrent condition was unspecified. On 20-SEP-2015 (also reported as 2 days ago) the patient was vaccinated with ZOSTAVAX (0.65 ml, lot # K018173, expiry date: 10-JAN-2016, subcutaneous). Concomitant therapies included Influenza virus vaccine inactivated (manufacturer unknown). On 22-SEP-2015 (also reported as yesterday), the patient experienced redness at the site of injection. The size of the redness was like an egg. On 22-SEP-2015, in the middle of the redness, there was also an approximately nickel size blister that was raised approximately an 1/2 inch and was filled with fluid. On the same day the redness itched a little bit. The patient had called the reporting pharmacist for medical attention. No treatment was given for the events. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with unspecified number of improperly stored VARIVAX (Merck), (dose and route not provided). Lot information of VARIVAX (Merck) was provided as lot# J014131, expiration date: 07-NOV-2015 and/or lot# K016132, expiration date: 24-SEP-2016. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been from a registered nurse referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with unspecified number of improperly stored (Oka/Merck) VARIVAX, dose and route not provided. Lot information of (Oka/Merck) VARIVAX was provided as lot # J014131, expiration date: 07-NOV-2015 and/or lot # K016132, expiration date: 24-SEP-2016. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates the patients were vaccinated with VARIVAX (Merck) (lot # L019124 and expiry date 27-MAY-2017) (dosage, strength and route were not reported) that was improperly stored. Additional doses of VARIVAX (Merck) (lot # L019124 and expiry date 27-MAY-2017) were administered to an unspecified number of patients on 16-SEP-2015. At the time of the report, no adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a female patient of unknown age. There was no medical history or drug reaction/allergies reported. In 2014, the patient received her first dose of ZOSTAVAX (dose, route and lot # were unknown). On 14-SEP-2015, the patient was inadvertently administered a second dose of ZOSTAVAX (dose, route and lot# were unknown) (extra dose administered, medication error). No concomitant medication was provided. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a unspecified number of male patients over the age of 15 years old. On an unknown date, the patients were vaccinated with GARDASIL 9 (dose and dose number and anatomical location were not reported. On an unknown date, the patients experienced inappropriate schedule of vaccine administered. No adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a pharmacist referring a 22 year old female patient who was not pregnant. On unknown dates the patient had received three doses in the series of RECOMBIVAX HB (lot#, dose and route unspecified). On an unknown date the patient had titers drawn after vaccination and the titer for Hepatitis B was 10 mIU/ml. The patient felt that this was too low and requested another series of Hepatitis B vaccine. This had not been administered to the patient yet. No adverse effect was reported. The outcome of the event was unknown. Additional information is not expected because the reporter refused additional contact.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Generalised tonic-clonic seizure, Headache
Clinical narrative: According to his medical file documentation while observing pt post immunization, pt had episode of tonic-clonic convulsion. Pt no LOC, no incontinence, no post ictal period. Pt A&O x3. C/o residual h/a. Denies dizziness, visual disturbance, ab pain. On re-examination no facial deficits. A/P post immunization reaction. Will continued for further symptoms. TYLENOL for headache. If condition worsens may 9-11.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2015 12:40 PM, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K004205, expiry: 12-JAN-2017) dose 2, intramuscularly in the left arm (left deltoid). No concomitant medications were reported. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received 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 healthcare worker in immunization official referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. Between 08-SEP-2015 and 11-SEP-2015, the patient was vaccinated with an unspecified dose in VARIVAX (Merck) ((lot # K021936, expiry date 10-NOV-2016 or lot # L018001, expiry date 19-MAY-2017) (dosage, strength and route were not reported)) that was improperly stored. Concomitant medication information was not provided. At the time of the report, no adverse effects was reported. 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 Licensed Vocational Nurse regarding unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 28-JUL-2015, the patients were vaccinated with 8 doses of improperly stored doses of VARIVAX (Merck) lot# L003774 and expiry date: 04-FEB-2017. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a unspecified number of patients of unknown age. On an unknown date, the patients started the HPV series with GARDASIL (dose and anatomical location were not reported). The reporter stated, that some of the pediatric clinics (unspecified) on an unknown date had been administering GARDASIL 9 (dose, dose number and anatomical location were not reported) to complete the HPV series. No adverse event was 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 was received from an other health professional regarding seven unspecified patients. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored (Merck) PROQUAD (lot# K025766, expiry date: 08-JUN-2016 (dose and route were unknown). No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical (vocational) nurse referring to  unspecified patients of unknown age and gender. There was no medical  history or concurrent condition reported. On an unknown date the unspecified patients were vaccinated with ROTATEQ (lot # K022993, expiry date 20-JUL-2016) (dosage, strength and route were not reported). There was a temperature excursion that resulted in the vaccinated being stored improperly. There was no concomitant medication reported. At the time of the report, no adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 02-SEP-2015 the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (dosage, strength, route and lot # were not reported) instead of ZOSTAVAX. There was no concomitant medication reported. At the time of the report, no adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2015 12:58 PM, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K004205, expiry: 12-JAN-2017) dose 2, intramuscularly in the right arm (right deltoid). No concomitant medications were reported. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.13
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Decreased appetite, Head banging, Insomnia, Pyrexia, Rash
Clinical narrative: 9/10/2015 - Patient reported that patient had fever of 102 F and rashes after 12 month shots. 9/15/2015 - Patient's returned to office with complaint of hitting head, not sleeping, not eating well and screaming out loud in sleep since vaccine given.
Age: 1.13
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Screaming
Clinical narrative: 9/10/2015 - Patient reported that patient had fever of 102 F and rashes after 12 month shots. 9/15/2015 - Patient's returned to office with complaint of hitting head, not sleeping, not eating well and screaming out loud in sleep since vaccine given.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Pallor, Unresponsive to stimuli
Clinical narrative: Patient was scheduling next appt 10-15 min after vaccine administered and started to stare. Patient unresponsive to sound and movement. Patient fell backwards into a chair because extremely pale. Patient was immediately
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received  from an other health professional regarding a patient of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K021935 expiry date 10-NOV-2016) (dose and route unknown). No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 23 month old female patient. There was no information about patient's concomitant medications and pertinent medical history reported. On 11-SEP-2015, the patient was vaccinated with a 0.5 ml dose of (Oka/Merck) VARIVAX lot # K002916, expiry date 26-FEB-2016, subcutaneously (site was not reported). On 04-SEP-2015, the patient was seen by physician and diagnosed with chickenpox. Labs were drawn during the office visit that confirmed the diagnosis of chickenpox. IT was reported that the patient had been exposed to family member who  had chickenpox on an unspecified date prior to developing chickenpox herself.  The patient seek medical attention. No treatment was given for the event. The outcome of the event was reported as recovering. The relatedness between (Oka/Merck) VARIVQAX and the event was not reported. 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 Licensed Vocational Nurse regarding 13 patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 27-AUG-2015, the patient were vaccinated with (Oka/Merck) VARIVAX lot# L005299 and expiry date: 17-FEB-2017, that was improperly exposed to defrost cycling. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse regarding 6 patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 31-AUG-2015, the patients were vaccinated with (Oka/Merck) VARIVAX lot # L00529 and expiry date: 17-FEB-2017, that was improperly exposed to defrost cycling. No adverse effect was reported. The outcome of the event was unknown. 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 as received from a Licensed Vocational Nurse regarding 4 patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 09-SEP-2015, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) lot# L012035 and expiry date: 07-APR-2017. No adverse effect was reported. The outcome of the event was unknown. 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 as received from a healthcare worker (immunization official) refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with an improperly stored VARIVAX (Merck) (lot #J013907 with expiry date 30-OCT-2015; lot # K026385 with expiry date 15-DEC-2016; dose and route of administration were not provided). Exact number of doses administered was not specified. No adverse effects were 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 was received from a healthcare worker (medical assistant) and refers to a patient of unknown age and gender. Information about the patient's relevant medical history and concomitant medications was not reported. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K020181, expiration date 24-JUN-2016, exact dose was not reported) route of administration defaulted to oral. No adverse effects reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse regarding an 1 patient of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 09-SEP-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot# L005299 and expiry date: 17-FEB-2017. No adverse effect was reported. The outcome of the event was unknown. This is one of the 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 pharmacist concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided. On 22-SEP-2015 the patient was vaccinated with ZOSTAVAX subcutaneous injection, lot # L006380 with expiration date on 25-MAY-2016 (dose and route of administration were unknown). Dose that had been improperly stored; no adverse events or product quality complaints were reported. 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 Licensed Vocational Nurse regarding an unspecified patient of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 10-AUG-2015, the patients were vaccinated with 11 doses of improperly stored doses of VARIVAX (Merck) lot# L003774 and expiry date: 04-FEB-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Muscle atrophy, Soft tissue atrophy
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding to a 60 year old female patient. The patient's pertinent medical history and drug reactions/allergies were none. On 01-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot# K023621 and expiry date: 19-FEB-2016) intramuscularly in the hip because of her age and family history of shingles. Concomitant therapies included estradiol and unspecified estrogen cream. On an unspecified date in April 2015 (reported as around the end of April), the patient noticed changes in area around the injection site. The patient sought medical attention and visited doctor's office on 13-JUL-2015 and presented with muscle and tissue atrophy at injection site. The outcome of changes in area around the injection site/muscle and tissue atrophy at injection site was reported as not recovered/not resolved. The causality of the events was not reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received a Tdap and pain swelling and redness L deltoid.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received MMRV subq and HepA IM in Rt arm. KINRIX was given IM in left deltoid. After administration of HepA and MMRV pt developed erythema in spots around where vaccines given, area warm to touch. Ice pack applied. No redness noted on Lt. arm. FNP instructed mother to give BENADRYL at home.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema, Skin reaction, Skin warm
Clinical narrative: Localized skin reaction erythema, edema, warmth. Cool compresses, TYLENOL, BENADRYL.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: 1 day after administration patient developed left arm pain, swelling, redness affecting entire arm, without dyspnea, hives, dysphagia. Saw in clinic 2 days after vaccine, swelling improving, no treatment required.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site swelling
Clinical narrative: Patient had swelling on left leg after having immunizations 2 days previously.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Full blood count normal, Haematocrit normal, Haemoglobin normal, Platelet count normal, Pyrexia
Clinical narrative: Morbilliform rash on trunk, diaper area, face, nape of neck 10 days after administration of MMR 2 #1; low grade fever, cervical LAD.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Rash, Rash morbilliform, White blood cell count decreased
Clinical narrative: Morbilliform rash on trunk, diaper area, face, nape of neck 10 days after administration of MMR 2 #1; low grade fever, cervical LAD.
Age: 5.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling at site of injection warm to touch. Mother reports applied ice pack to site and gave TYLENOL.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Peripheral swelling
Clinical narrative: Patient received vaccine at approximately 11:00 am. Patient returned to pharmacy at app. 4:00 pm complaining of arm swelling. Arm was swollen, non tender, and felt hard. Patient did not reported pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patients arm where shot was given got red, warm and had a little  hardness to area.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Evening after shot,left arm swollen from shoulder to wrist, warm to touch, exctremely red.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Pyrexia
Clinical narrative: Fever, headache, face numb - started the evening he got the Tdap vaccine. Improved the next day.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: On 8/27/2015 patient received PREVNAR 13 then 6 days later on 9/2/2015 she got large red area, hot but not painful. It's two to three inches wide and four to five inches long. The redness is on anterior of arm but not medical where the injection site was. She started BENADRYL 25mg then 50mg QID. She saw doctor on 9/4/2015 ordered cephalexin 500mg, but doctor says not cellulitis. She only took three doses and stopped due to side effect. But redness was gone. We are not sure if reaction is related to PREVNAR 13 or not.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches, fever, headache the night he got TDap.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Pyrexia, Viral infection
Clinical narrative: Pt began within an hour with a high pitch inconsolable cry that lasted 6 hours. The patient developed fever that lasted 6 days. Seen in ER and thought to have viral illness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient got a red half-dollar sized mark at injection site; she stated it was warm to touch and itchy. She came back the following day and the redness reduced significantly but the red area increased in size w/o itching. Not warm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: The patients arm became very red and warm and swelled up to the size of a baseball at the injection site, which was at the lower part of the triicep, much lower than expected administration site. The patient described it as very painful and she could not sleep at all that night. Sh eused ice treatments, motrin, and applied hydrocortisone 2.5% crm topically, six days later, she shill has pain and swelling but is feeing better.  Ultrasound done showed the swelling low in the arm (tricep) and a large knot on the muscle - diagnosis/adverse events said to be due to incorrect administration. Negative cellulitis, negative infection.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Sleep disorder, Ultrasound scan abnormal
Clinical narrative: The patients arm became very red and warm and swelled up to the size of a baseball at the injection site, which was at the lower part of the triicep, much lower than expected administration site. The patient described it as very painful and she could not sleep at all that night. Sh eused ice treatments, motrin, and applied hydrocortisone 2.5% crm topically, six days later, she shill has pain and swelling but is feeing better.  Ultrasound done showed the swelling low in the arm (tricep) and a large knot on the muscle - diagnosis/adverse events said to be due to incorrect administration. Negative cellulitis, negative infection.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Eye pain, Full blood count abnormal, Headache, Hyperhidrosis, Lethargy
Clinical narrative: Fever, headache, skin rashes 2 hrs after received TYPHIM Vi shot. Rashes all over the body included face eye pain, lethargy, body ache, sweating and fever more than 2 days. Itching on day 5th. Resolving with antihistamine BENADRYL.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Mononucleosis heterophile test negative, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Fever, headache, skin rashes 2 hrs after received TYPHIM Vi shot. Rashes all over the body included face eye pain, lethargy, body ache, sweating and fever more than 2 days. Itching on day 5th. Resolving with antihistamine BENADRYL.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Rash generalised, Stool analysis normal, Viral infection, Viral test negative
Clinical narrative: Fever, headache, skin rashes 2 hrs after received TYPHIM Vi shot. Rashes all over the body included face eye pain, lethargy, body ache, sweating and fever more than 2 days. Itching on day 5th. Resolving with antihistamine BENADRYL.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Bright red patch about 2x3 inches that lasted about 2 weeks. Skin then turned more pink and seems to be clearing jup about 3 weeks later.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ oral (lot # K016314, expiration date 05-JUN-2015) dose was not reported. No adverse effects were reported. There was not a product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unspecified dates (either 17-SEP-2015 or 18-SEP-2015), the patients were vaccinated with improperly stored PEDVAXHIB (lot # L012835, expiration date 11-MAR-2018; Lot# L002867, expiration date 11-NOV-2017; Lot# L014427, expiration date 09-MAR-2018) (dose and route of administration were not reported). No adverse effects or product quality complaint were reported. This is one of the three cases reported by the same source. Aditional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and allergies were not reported. In approximately 2013 (reported as "26 months apart"), the patient was vaccinated with a dose of ZOSTAVAX strength reported as 19.4 munit, (dose, route, anatomical location, lot number and expiration date were not reported). On 24-SEP-2015, the patient was vaccinated with a second dose of ZOSTVAX strength reported as 19.4 munit, (lot number reported as 1021612 with expiration date: 10-SEP-2016), (dose, route and anatomical location were not reported). Other suspect and concomitant therapies were not reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2015 12:30 PM, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K004205, expiry: 12-JAN-2017) dose 2, intramuscularly in the left arm (left deltoid). No concomitant medications were reported. No adverse events were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from nurse and refers to a 7 month old female patient. The patient's medical history, concurrent conditions and allergies were not reported. On 24-SEP-2015, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (lot # K020214 with expiration date: 25-MAR-2016), (strength dose, route and anatomical location were not reported), which is an inappropriate schedule of drug administration as the patient age was less than 2 years. Other suspect and concomitant therapies were not reported. No adverse  events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates since 02-SEP-2015, the patients were vaccinated with GARDASIL (two doses from lot # J003727, expiration date 07-NOV-2015; three doses from lot K016966, expiration date 10-MAY-2017; unspecified number of doses from Lot K010215, expiration date 05-MAY-2017). No adverse effect was informed. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to an unspecified number of patients unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX, (dose, frequency and route of administration were not provided). The reporter stated that (Oka/Merck) VARIVAX, lot # reported as 000375 and expiration date 04-FEB-2017 was exposed in June 2015 and (Oka/Merck) VARIVAX lot # L012036 and expiration date 07-APR-2017 was exposed in August 2015, based in office records. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a patient who ho received BOOSTRIX. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX,the patient experienced injection site redness, injection site pain, injection site induration and injection site nodule. On an unknown date, the outcome of the injection site redness, injection site ain, injection site induration and injection site nodule were unknown. It was unknown if the reporter considered the injection site redness, injection site pain, injection site induration and injection site nodule to be related to BOOSTRIX. Additional details were as follows: The patient experienced redness, soreness (pain) and a hardened knot (induration and nodule) at the injection site.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX (subcutaneous) .5 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced injection site redness, injection site induration, inappropriate route of vaccination and wrong vaccine administered. On an unknown date, the outcome of the injection site redness, injection site induration, inappropriate route of vaccination and wrong vaccine administered were unknown. It was unknown if the reporter considered the injection site redness and injection site induration to be related to BOOSTRIX. Additional details were received as follows: The patient received a dose of BOOSTRIX subcutaneously instead of shingles vaccine, which led to administration of wrong vaccine and inappropriate route of vaccination. The patient experienced injection site redness and injection site hardness. No further information was available.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of GARDASIL (route of administration, dose and frequency were not reported, lot # K010215 with expiration date: 05-MAY-2017). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.