chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Eye pain
Clinical narrative: This spontaneous report was received from a pharmacist, a 45 year old female patient refers to herself. The patient's concurrent conditions and medical history were not reported. On 25-AUG-2015 (today), while drawing up a dose of ZOSTAVAX (lot # L006392 expiry date of 25-MAY-2016) in a syringe for an unspecified patient a small amount of the vaccine may have gotten into her eye. Concomitant medications were not reported. The patient did receive a full dose of vaccine and a small amount may have gotten into the pharmacist's eye. The pharmacist flushed her affected eye with water. The pharmacist's affected eye was sore. The outcome of the event was unknown. The pharmacist was not sure if her eye was sore from the ZOSTAVAX getting into her eye or from the water she had flushed it out with. There was no product quality complaint involved. This is one of the two 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 healthcare worker concerning multiple unspecified patients (demographics unknown). On unspecified dates, the patients were administered with doses of improperly stored VARIVAX (Merck) (Lot # K003420; expiration date: 06-MAR-2016) (dose and route not provided). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner, referring to a 16 year old female patient. The patient's medical history and concurrent conditions were not reported. On 27-AUG-2015, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX lot # J007350, expiration date 13-JUN-2015 (dose and route were not reported). No concomitant therapies were reported. No adverse effect reported. It was unknown if the patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a licensed vocational nurse practitioner concerning a female patient of unknown age. The patient's pertinent medical history or concurrent conditions were not provided. In January and February 2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, doses, expiration dates, anatomical locations and routes were unspecified). Concomitant therapy was not reported. It was reported that the doses were at least 4 weeks apart. On 24-AUG-2015 (1 week ago), the patient had serology test completed 1 week ago, on 24-AUG-2015 and the result of the test showed no immunity to chicken pox (negative serologic testing, Varicella virus test negative). The outcome of Varicella virus test negative was unknown. The relatedness between the event and suspect therapy was not provided. Additional information is not expected, as there was no consent to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX, (Lot # L001325, exp. date on 13-JAN-2014) (strength, route of administration and dose were not provided). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning multiple unspecified patients (demographics unknown). On unspecified dates, the patients were administered with doses of improperly stored PROQUAD (Merck) (Lot# reported as K010212; expiration date: 17-JAN-2016) (dose and route not provided). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report has been received from a Registered Nurse refers to an adult patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 26-AUG-2015, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB, (strength, route of administration and dose were not provided), instead of an adult dose. No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker-Office Manager refers to an unspecified number of patients. The office manager reported that multiple unspecified patients received MMR II injection (confirmed Lot# K021152 and exp. 02-JAN-2016) (dose and route of administration not reported) that were improperly stored. No adverse effects reported nor PQC was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker-Office Manager refers to an unspecified number of patients. The office manager reported that multiple unspecified patients received Oral, ROTATEQ injection (confirmed Lot#K004795 and exp. 11-FEB-2016) (dose and route of administration not reported) that were improperly stored. No adverse effects reported. No adverse effects reported nor PQC was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Pneumonia, Pyrexia
Clinical narrative: This spontaneous report was received via company representative from a female patient of unknown age, regarding herself, who was a part of a Patient Assistance Program. Patient stated that she was having bad reactions to unspecified medications. Her relevant medical history was not reported. On an unspecified date in October 2013 the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot # unspecified). Concomitant therapy was not reported. Patient stated that she asked her physician to administer only half a dose PNEUMOVAX 23 to check how she would react and then decide if she would go back for the remaining the other half. She developed chills, fever, pneumonia and flu like symptoms (influenza like illness) the following day after receiving PNEUMOVAX 23. She also mentioned that these adverse experiences didn't last more than 24 hours. Causality assessment was not provided. Additional information is not expected, no contact details were provided.
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer regarding himself as a 40 year old male patient as part of marketing research titled as "ZOSTAVAX HCP competitive msg. testing" conducted by the planning shop inct. The patient medical history and current conditions were not provided. On an unknown date in May 2013, the patient was vaccinated with ZOSTAVAX (dose and lot# were not reported) subcutaneous for shingles. Secondary suspects and concomitant therapies were not reported. On an unknown date in May 2013, the patient experienced injection site pain. Action taken was not applicable. On an unknown in May 2013, the outcome of injection site pain was reported as recovered/resolved with sequelae. The reporter considered injection site pain to be related to ZOSTAVAX. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown dates, the patients were vaccinated with the unspecified doses of GARDASIL (lot #, expiration date, dose, route and site of administration were not reported). Patient just didn't show when they should to be vaccinated. There were no concomitant medications provided. No adverse symptoms were reported. There was not product quality issue involved. On 01-SEP-2015, a phone call was placed to the physician who was unavailable. The phone call was transferred to the original reporter, the medical assistant who was unable to share any lot numbers, dates of vaccination or patient identities concerning to her original phone call. The medical assistant stated that the office did not like GARDASIL because most of the kids who had received it passed out (MARRS# 1507USA012048) or fainted (MARRS# 1509USA001926) following vaccination. The medical assistant did not have any specific patient or lot number concerning this statement. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates since 01-SEP-2015, the patients were vaccinated with doses of VARIVAX (lot# K010338 and expiration date 22-JUL-2016, lot# K005428 and expiration date 15-APR-2016, lot# L010235 and expiration date 07-APR-2017, lot# L002868 and expiration date 27-JAN-2017 (dose and route were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Since 08-MAY-2015, the patient were vaccinated with improperly stored doses of MMR II (dose and route were not reported, lot # K011188, expiry date 12-AUG-2016, albumin status unknown). Concomitant medications were not reported. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection (lot# L006546, expiration date 27-NOV-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot# K021151, expiration date 02-NOV-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number patients of unknown age and gender. No information on concurrent conditions and medical history was provided. On unknown dates, the patients were vaccinated with hepatitis B (recombinant) (manufacturer unknown). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 26-AUG-2015, the patient was inadvertently vaccinated with an expired dose of MMR II lot # J010208, expiry date 26-AUG-2015. No adverse effects were reported. The outcome of the events were 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 nurse referring to an unspecified number of unspecified patients. On unspecified dates in 2015, since 06-AUG-2015 the patients were vaccinated with an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (lot # L008272, expiration ate in 11-MAR-2017) (dose and route unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. On unspecified dates in 2015, since 06-AUG-2015 the patients were vaccinated with an unspecified number of improperly stored doses of (Oka-Merck) PROQUAD (lot # L007230, expiration date 03-SEP-2016) (dose and route unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L007560, expiry date 15-JUN-2017, (dose, frequency and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same 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 nurse refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 25-AUG-2015 the patient was vaccinated with unspecified dose of VARIVAX (Merck) lot # L001324, expiration date 13-JAN-2017 that was improperly stored. No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 12-MAY-2015, multiple unspecified patients were vaccinated with unspecified doses of improperly stored PNEUMOVAX 23 (lot # K006681, expiry date 21-OCT-2015) (dosage, strength and route were not reported). At the time of the report, there was no adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ lot L004466, expiry date 02-AUG-2016 and K020181, expiry date 24-JUN-2016, (dose, frequency and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 43 year old male patient. There was no medical history or drug reaction/allergies reported. In October 2014, the patient was received the first dose of PNEUMOVAX 23 (0.5 ml, intramuscular) in his right arm (inappropriate schedule of drug administration). On 30-AUG-2015, the patient was inadvertently administered a second dose of PNEUMOVAX 23 (lot# L010598 with expired date 06-AUG-2016, 0.5 ml, intramuscular) in his right arm (inappropriate schedule of drug administration and extra dose). The reporter was trying to contact the patient for follow up. At the time of reporting, no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX23, lot # L003227, expiry date 13-OCT-2016, (dose, frequency and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. ON unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # L008353, expiration date: 11-SEP-2016 and/or lot # L002419. expiration date: 23-JUL-2016, dose, frequency and route were unknown. The patient's concomitant medication was not reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 63 year old female patient with none pertinent medical history and allergic to penicillin and KEFLEX. In March 2014 the patient was vaccinated with ZOSTAVAX (route, lot# and dose were unknown). None concomitant therapy was reported. On 28-AUG-2015, 6 days ago approximately 17 months after receiving ZOSTAVAX she now had shingles. The patient initially believed her spots were caused by poison ivy until they began to spread from an unspecified location to her buttocks. The patient did go to an unspecified dermatologist and was diagnosed with shingles. Valaciclovir (1 gram, tid, for 7 days) was given to treat the event. None lab diagnostics studies were performed. The outcome of shingles was reported as not recovered/not resolved. The causality was not 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 nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple dates, the patients were vaccinated with improperly stored GARDASIL lot # K011562, expiry date 08-APR-2017 and K011325, expiry date 08-APR-2017, (dose, frequency and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and concurrent condition were not reported. On unknown dates, the patient was vaccinated with three pneumonia shots (manufacturer unknown) (strength, lot#, expired date, dose and frequency were unknown). The last shot was administered when the patient was in her mid-40s and the patient was 62 years at the reporting time. The reporter did not know if any or all of those three pneumonia shots were PNEUMOVAX 23, therefore, this AE was being filed for PNEUMOVAX 23. No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 26-AUG-2015, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) which was expired on 18-AUG-2015. No adverse effects were reported. The outcome of the events were unknown. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unspecified dates since 14-AUG-2015, the patients were vaccinated orally with improperly stored doses of ROTATEQ oral liquid (dose, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 19-AUG-2015, the patient was vaccinated with the fourth dose of RECOMBIVAX HB (dose, strength, lot # and route were not reported). The patient's first three doses of RECOMBIVAX HB wer3e respectively administered on 12-MAY-2002, 11-JUL-2002 and 28-JAN-2003 (inappropriate schedule of vaccine administered). No adverse experience was reported. 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 nurse and refers to multiple unspecified patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with a doses of RECOMBIVAX HB lot # J000722, expiration date 17-SEP-2015 (dose, route of administration and anatomical location were not reported), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with a doses of VAQTA lot # L004743, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were inadvertently vaccinated with improperly stored ROTATEQ (lot#, expiration date, dose and frequency not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician cannot be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (lot#, expiration date, dose and frequency not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician cannot be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were inadvertently vaccinated with improperly stored M-M-R II (lot#, expiration date, dose and frequency not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician cannot be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were inadvertently vaccinated with improperly stored GARDASIL (lot#, expiration date, dose and frequency not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician cannot be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were inadvertently vaccinated with improperly stored VAQTA (lot#, expiration date, dose and frequency not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the physician cannot be contacted.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia aspiration, Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: The information has been received from a physician concerning an elderly female patient who on 24-AUG-2015 was subcutaneously vaccinated with PNEUMOVAX 23 injection drug as prophylaxis for the first time. There was no concomitant medication reported. On an unspecified date in August 2015, the patient developed vaccination site swelling. On 26-AUG-2015, the patient developed pyrexia and vomiting. On an unspecified date, the patient was hospitalized as she developed pneumonia aspiration due to vomiting. At the time of this report, the outcome of vomiting, pneumonia aspiration, vaccination site swelling and pyrexia were unknown because the patient was still hospitalized. The reporter considered that the vaccination site swelling and pyrexia were related to PNEUMOVAX 23, but vomiting is not related to PNEUMOVAX 23. Vomiting is considered as serious because the patient was hospitalized with pneumonia aspiration due to vomiting. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Chills, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for four patients via a Pfizer sales representative. This is the first of fourth reports. A 40-year-old female patient of unspecified ethnicity received a single dose of TRUMENBA (Lot # J292033; Expiration Date Jun2016), via an unspecified route of administration on an unspecified date. The patient received the vaccine, since she was working as a microbiologist. Medical history and concomitant medications were not reported. The patient experienced huge red arm, chills, body ache, headache on 18Jul2015 and skin was very bumpy on 21Jul2015. The patient was hospitalized due to the events. No treatment was received. The patient recovered from the events. Follow-up (31Aug2015): New information reported from a contactable consumer includes: patient details, vaccine details, events onset date, seriousness, treatment received and outcome.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for four patients via a Pfizer sales representative. This is the first of fourth reports. A 40-year-old female patient of unspecified ethnicity received a single dose of TRUMENBA (Lot # J292033; Expiration Date Jun2016), via an unspecified route of administration on an unspecified date. The patient received the vaccine, since she was working as a microbiologist. Medical history and concomitant medications were not reported. The patient experienced huge red arm, chills, body ache, headache on 18Jul2015 and skin was very bumpy on 21Jul2015. The patient was hospitalized due to the events. No treatment was received. The patient recovered from the events. Follow-up (31Aug2015): New information reported from a contactable consumer includes: patient details, vaccine details, events onset date, seriousness, treatment received and outcome.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Chills, Erythema, Headache, Pain, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for four patients via a Pfizer sales representative. This is the first of fourth reports. A 40-year-old female patient of unspecified ethnicity received a single dose of TRUMENBA (Lot # J292033; Expiration Date Jun2016), via an unspecified route of administration on an unspecified date. The patient received the vaccine, since she was working as a microbiologist. Medical history and concomitant medications were not reported. The patient experienced huge red arm, chills, body ache, headache on 18Jul2015 and skin was very bumpy on 21Jul2015. The patient was hospitalized due to the events. No treatment was received. The patient recovered from the events. Follow-up (31Aug2015): New information reported from a contactable consumer includes: patient details, vaccine details, events onset date, seriousness, treatment received and outcome.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Chills, Dry skin, Erythema, Headache, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for four patients via a Pfizer sales representative. This is the first of fourth reports. A 40-year-old female patient of unspecified ethnicity received a single dose of TRUMENBA (Lot # J292033; Expiration Date Jun2016), via an unspecified route of administration on an unspecified date. The patient received the vaccine, since she was working as a microbiologist. Medical history and concomitant medications were not reported. The patient experienced huge red arm, chills, body ache, headache on 18Jul2015 and skin was very bumpy on 21Jul2015. The patient was hospitalized due to the events. No treatment was received. The patient recovered from the events. Follow-up (31Aug2015): New information reported from a contactable consumer includes: patient details, vaccine details, events onset date, seriousness, treatment received and outcome.
Age: 40.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for four patients via a Pfizer sales representative. This is the first of fourth reports. A 40-year-old female patient of unspecified ethnicity received a single dose of TRUMENBA (Lot # J292033; Expiration Date Jun2016), via an unspecified route of administration on an unspecified date. The patient received the vaccine, since she was working as a microbiologist. Medical history and concomitant medications were not reported. The patient experienced huge red arm, chills, body ache, headache on 18Jul2015 and skin was very bumpy on 21Jul2015. The patient was hospitalized due to the events. No treatment was received. The patient recovered from the events. Follow-up (31Aug2015): New information reported from a contactable consumer includes: patient details, vaccine details, events onset date, seriousness, treatment received and outcome.
Age: 80.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Full blood count normal, Metabolic function test normal, Myalgia
Clinical narrative: Head congestion (48 hrs), fever on 8/6/15, 8/6 to present severe leg muscle pain, ankle to hip, both legs. Interferes with sleep, sitting, normal activities.
Age: 80.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Myoglobin urine absent, Red blood cell sedimentation rate normal
Clinical narrative: Head congestion (48 hrs), fever on 8/6/15, 8/6 to present severe leg muscle pain, ankle to hip, both legs. Interferes with sleep, sitting, normal activities.
Age: 80.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Activities of daily living impaired, Blood test normal, Insomnia, Myalgia, Pyrexia
Clinical narrative: Head congestion (48 hrs), fever on 8/6/15, 8/6 to present severe leg muscle pain, ankle to hip, both legs. Interferes with sleep, sitting, normal activities.
Age: 80.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Respiratory tract congestion
Clinical narrative: Head congestion (48 hrs), fever on 8/6/15, 8/6 to present severe leg muscle pain, ankle to hip, both legs. Interferes with sleep, sitting, normal activities.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Chest discomfort, Eye swelling, Headache, Lip swelling
Clinical narrative: This spontaneous report was received from a registered nurse refers to an 11 year old female patient. The patient current conditions included asthma and seasonal allergy. On 25-AUG-2015, the patient who had ever received was vaccinated with GARDASIL 9 (lot # L019286 and expiration date 14-SEP-2017) intramuscular. On 25-AUG-2015, on the way home the patient experienced lightheadedness and a headache which got progressively worse. In addition, she had some difficulty breathing and her eyes were swollen, most likely from crying. The patient's parents took her to the emergency room where she was given a nebulizer treatment and BENADRYL. The patient began to feel better and left the emergency room (nurse noted the patient was never admitted to the hospital). Action taken was not applicable. By the next day, on 26-AUG-2015, the patient was completely recovered. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Crying, Dizziness, Dyspnoea, Eye swelling, Headache
Clinical narrative: This spontaneous report was received from a registered nurse refers to an 11 year old female patient. The patient current conditions included asthma and seasonal allergy. On 25-AUG-2015, the patient who had ever received was vaccinated with GARDASIL 9 (lot # L019286 and expiration date 14-SEP-2017) intramuscular. On 25-AUG-2015, on the way home the patient experienced lightheadedness and a headache which got progressively worse. In addition, she had some difficulty breathing and her eyes were swollen, most likely from crying. The patient's parents took her to the emergency room where she was given a nebulizer treatment and BENADRYL. The patient began to feel better and left the emergency room (nurse noted the patient was never admitted to the hospital). Action taken was not applicable. By the next day, on 26-AUG-2015, the patient was completely recovered. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Anxiety, Chest discomfort, Chest pain, Cough, Disorientation
Clinical narrative: Vaccine given at 10:30 AM and first symptoms between 2 to 4 hours afterwards were normal for flu vaccine (sore arm, mild headache). During the 5th to 7th hours, beginning symptoms of vision changes (blurriness) and dizziness began to manifest. By 6:00 PM and onward, symptoms became strong, including extreme dizziness while sitting, inability to focus eyes, disorientation, anxiety, numbness, dry mouth, chest tightness, and mild muscle weakness. Numbness initially presented in legs, hips and spine, spreading to face and occasionally in the tongue. Water intake was normal and I was not dehydrated, yet I still experienced dry mouth. Food intake was normal. Between late afternoon (approx. 5PM) and 4:00 AM on the morning following vaccination, symptoms continued to be intense and concerning. Around midnight, during symptoms, I reported my condition to my doctor's office using the online message system. After 4:00 AM I fell asleep. Waking 6 to 7 hours later, symptoms had become mild and mainly consisted of mild occasional dizziness and vision changes. Vision changes continued throughout Friday and Saturday but did not prevent walking or driving. On Saturday evening, about 60 hours after vaccination, I began to have a mild scratchy throat. By 8:00 AM Sunday morning, the scratchy throat had become severe and required pain medication. On Monday night (09/07/2015) symptoms of chest pain, arm and shoulder discomfort, and cough were present.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dry mouth, Hypoaesthesia, Hypoaesthesia oral, Limb discomfort
Clinical narrative: Vaccine given at 10:30 AM and first symptoms between 2 to 4 hours afterwards were normal for flu vaccine (sore arm, mild headache). During the 5th to 7th hours, beginning symptoms of vision changes (blurriness) and dizziness began to manifest. By 6:00 PM and onward, symptoms became strong, including extreme dizziness while sitting, inability to focus eyes, disorientation, anxiety, numbness, dry mouth, chest tightness, and mild muscle weakness. Numbness initially presented in legs, hips and spine, spreading to face and occasionally in the tongue. Water intake was normal and I was not dehydrated, yet I still experienced dry mouth. Food intake was normal. Between late afternoon (approx. 5PM) and 4:00 AM on the morning following vaccination, symptoms continued to be intense and concerning. Around midnight, during symptoms, I reported my condition to my doctor's office using the online message system. After 4:00 AM I fell asleep. Waking 6 to 7 hours later, symptoms had become mild and mainly consisted of mild occasional dizziness and vision changes. Vision changes continued throughout Friday and Saturday but did not prevent walking or driving. On Saturday evening, about 60 hours after vaccination, I began to have a mild scratchy throat. By 8:00 AM Sunday morning, the scratchy throat had become severe and required pain medication. On Monday night (09/07/2015) symptoms of chest pain, arm and shoulder discomfort, and cough were present.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Muscular weakness, Musculoskeletal discomfort, Vision blurred
Clinical narrative: Vaccine given at 10:30 AM and first symptoms between 2 to 4 hours afterwards were normal for flu vaccine (sore arm, mild headache). During the 5th to 7th hours, beginning symptoms of vision changes (blurriness) and dizziness began to manifest. By 6:00 PM and onward, symptoms became strong, including extreme dizziness while sitting, inability to focus eyes, disorientation, anxiety, numbness, dry mouth, chest tightness, and mild muscle weakness. Numbness initially presented in legs, hips and spine, spreading to face and occasionally in the tongue. Water intake was normal and I was not dehydrated, yet I still experienced dry mouth. Food intake was normal. Between late afternoon (approx. 5PM) and 4:00 AM on the morning following vaccination, symptoms continued to be intense and concerning. Around midnight, during symptoms, I reported my condition to my doctor's office using the online message system. After 4:00 AM I fell asleep. Waking 6 to 7 hours later, symptoms had become mild and mainly consisted of mild occasional dizziness and vision changes. Vision changes continued throughout Friday and Saturday but did not prevent walking or driving. On Saturday evening, about 60 hours after vaccination, I began to have a mild scratchy throat. By 8:00 AM Sunday morning, the scratchy throat had become severe and required pain medication. On Monday night (09/07/2015) symptoms of chest pain, arm and shoulder discomfort, and cough were present.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: RASH DEVELOPED ON LOWER BACK.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Patient with progressive swelling, redness and pain at injection site which required 3 ED visits. Diagnosed initially with localized reaction and given Tylenol/Motrin. On secondary trip to ED, patient diagnosed with cellulitis and placed on topical antibiotics and clindamycin. Last visit to ED, patient received Benadryl for swelling. No respiratory distress or swelling. F/U with PCM symptoms improving.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea, Feeling abnormal, Local swelling
Clinical narrative: Patient states after about 1 and one-half hours after she left the store she started feeling odd, neck swelling trouble breathing.  She thought her diabetes might be the problem but soon ruled that out.  She was in her car and pulled over and called 911 and was transported to the hospital where she states she was given "shots".
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chills, Electrocardiogram normal
Clinical narrative: Increase in systolic BP to 158mm immediately after im injection, with fall to 136 mm in 10 minutes. Four (4) hours later, strong shivering of arms and upper body with sensation of chills. Two hours later 2 episodes nausea and vomiting occurred which required a visit to emergency room. During this time patient had a temperature of 102.2 degrees F. and complained of chest tightness. EKG, blood analysis urinanalysis and chest X-ray were unremarkable. Two 500 mg Tylenol tablets were administered in ER and one 500 mg tablet was given on return to home at 10:00 PM. Temperature was normal (98.7 degrees) at 9:30 AM the following day and none of the previous symptoms were present.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Increase in systolic BP to 158mm immediately after im injection, with fall to 136 mm in 10 minutes. Four (4) hours later, strong shivering of arms and upper body with sensation of chills. Two hours later 2 episodes nausea and vomiting occurred which required a visit to emergency room. During this time patient had a temperature of 102.2 degrees F. and complained of chest tightness. EKG, blood analysis urinanalysis and chest X-ray were unremarkable. Two 500 mg Tylenol tablets were administered in ER and one 500 mg tablet was given on return to home at 10:00 PM. Temperature was normal (98.7 degrees) at 9:30 AM the following day and none of the previous symptoms were present.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Confusional state, Dizziness, Flushing, Hypertension, Hypotension
Clinical narrative: Increase in systolic BP to 158mm immediately after im injection, with fall to 136 mm in 10 minutes. Four (4) hours later, strong shivering of arms and upper body with sensation of chills. Two hours later 2 episodes nausea and vomiting occurred which required a visit to emergency room. During this time patient had a temperature of 102.2 degrees F. and complained of chest tightness. EKG, blood analysis urinanalysis and chest X-ray were unremarkable. Two 500 mg Tylenol tablets were administered in ER and one 500 mg tablet was given on return to home at 10:00 PM. Temperature was normal (98.7 degrees) at 9:30 AM the following day and none of the previous symptoms were present.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Increased upper airway secretion, Muscle spasms, Pyrexia, Tremor
Clinical narrative: Increase in systolic BP to 158mm immediately after im injection, with fall to 136 mm in 10 minutes. Four (4) hours later, strong shivering of arms and upper body with sensation of chills. Two hours later 2 episodes nausea and vomiting occurred which required a visit to emergency room. During this time patient had a temperature of 102.2 degrees F. and complained of chest tightness. EKG, blood analysis urinanalysis and chest X-ray were unremarkable. Two 500 mg Tylenol tablets were administered in ER and one 500 mg tablet was given on return to home at 10:00 PM. Temperature was normal (98.7 degrees) at 9:30 AM the following day and none of the previous symptoms were present.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Immediate post-injection reaction, Infection, Injection site pruritus, Injection site swelling
Clinical narrative: I immediately began itching at the site of vaccination.  Mild swelling began immediately, but serious swelling occurred 3 days later by noon on August 8 to the point that I could feel the swelling moving toward my elbow.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I immediately began itching at the site of vaccination.  Mild swelling began immediately, but serious swelling occurred 3 days later by noon on August 8 to the point that I could feel the swelling moving toward my elbow.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Full blood count normal
Clinical narrative: Began as severe ankle and leg pain around 9:30 pm. Throughout night body aches, chills, headache and worsened ankle pain continued. Tuesday morning all symptoms persisted, plus stomach cramps, nausea, headache began. Later in the day on Tuesday, aches and pain moved up my body to back, neck and head. Pain was severe and relentless. Took ibuprofen throughout day, but pain did not subside. Symptoms continued throughout night. Wednesday morning (9/2/15) saw primary care physician to report symptoms and rule out other causes. All symptoms persisted throughout day and into Thursday 9/3/15. Lab results and physician confirmed no viral/bacterial infection. Friday headache and nausea eased, but joint pain worsened and focused on ankles, knees, hips and shoulders along with muscle tightness in neck, shoulders and back. As of today, 9/8/2015, no changes or improvement in joint pain. Severity of joint pain and stiffness in shoulders has prevented me from returning to work.