chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Abnormal behaviour, Aggression, Asocial behaviour, Asthenia
Clinical narrative: Shortly after GARDASIL vaccine, extreme mood change, depression, erratic behavior, fatigue, pain and tingling in arms/legs, painful heavy period, migraine headaches, insomnia, self harm, lack of interest in anything that she used to enjoy, isolation, very short temper, painful red veins in legs that resemble varicose veins, panic attacks, nervousness, continuous rocking motion, forgetfulness, weakness, weakened range of motion, vision problems, chest pains, severe stomach pains, diarrhea, still has issues all of the above.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Decreased interest, Depression, Diarrhoea, Dysmenorrhoea
Clinical narrative: Shortly after GARDASIL vaccine, extreme mood change, depression, erratic behavior, fatigue, pain and tingling in arms/legs, painful heavy period, migraine headaches, insomnia, self harm, lack of interest in anything that she used to enjoy, isolation, very short temper, painful red veins in legs that resemble varicose veins, panic attacks, nervousness, continuous rocking motion, forgetfulness, weakness, weakened range of motion, vision problems, chest pains, severe stomach pains, diarrhea, still has issues all of the above.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Insomnia, Joint range of motion decreased, Memory impairment, Menorrhagia
Clinical narrative: Shortly after GARDASIL vaccine, extreme mood change, depression, erratic behavior, fatigue, pain and tingling in arms/legs, painful heavy period, migraine headaches, insomnia, self harm, lack of interest in anything that she used to enjoy, isolation, very short temper, painful red veins in legs that resemble varicose veins, panic attacks, nervousness, continuous rocking motion, forgetfulness, weakness, weakened range of motion, vision problems, chest pains, severe stomach pains, diarrhea, still has issues all of the above.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Mood altered, Nervousness, Pain in extremity, Panic attack
Clinical narrative: Shortly after GARDASIL vaccine, extreme mood change, depression, erratic behavior, fatigue, pain and tingling in arms/legs, painful heavy period, migraine headaches, insomnia, self harm, lack of interest in anything that she used to enjoy, isolation, very short temper, painful red veins in legs that resemble varicose veins, panic attacks, nervousness, continuous rocking motion, forgetfulness, weakness, weakened range of motion, vision problems, chest pains, severe stomach pains, diarrhea, still has issues all of the above.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Self-injurious ideation, Stereotypy, Varicose vein, Vascular pain
Clinical narrative: Shortly after GARDASIL vaccine, extreme mood change, depression, erratic behavior, fatigue, pain and tingling in arms/legs, painful heavy period, migraine headaches, insomnia, self harm, lack of interest in anything that she used to enjoy, isolation, very short temper, painful red veins in legs that resemble varicose veins, panic attacks, nervousness, continuous rocking motion, forgetfulness, weakness, weakened range of motion, vision problems, chest pains, severe stomach pains, diarrhea, still has issues all of the above.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: Shortly after GARDASIL vaccine, extreme mood change, depression, erratic behavior, fatigue, pain and tingling in arms/legs, painful heavy period, migraine headaches, insomnia, self harm, lack of interest in anything that she used to enjoy, isolation, very short temper, painful red veins in legs that resemble varicose veins, panic attacks, nervousness, continuous rocking motion, forgetfulness, weakness, weakened range of motion, vision problems, chest pains, severe stomach pains, diarrhea, still has issues all of the above.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Feeling abnormal, Vaccination site pain, Vaccination site swelling
Clinical narrative: Approx. 48 hrs. after administration, patient reported (to PCP) approx. softball-sized raised/tender area around vacc. site. Stated she felt a little "punk-y", otherwise ok.
Age: 54.0
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Roughly 1 day post vaccination, patient reported severe soreness in all of her joints.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Bump, pain, redness. Treated with doxycycline, symptoms resolved.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Tremor
Clinical narrative: Shaking, elevated BP.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site inflammation, Injection site warmth, Nausea
Clinical narrative: Redness, inflammation, feeling of warmth at the site of injection, nausea, diarrhea the morning after administration of the vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash at injection site noticed 3 days after injection. Per patient, site is warm to touch. Patient also described feeling chills. Local rash was about 1 inch long and 3/4 inch wide.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Back pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at the site of injection. Backache, body ache, headache, pain in knee; started about 2 hours after vaccination.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Redness, swelling at the site of injection. Backache, body ache, headache, pain in knee; started about 2 hours after vaccination.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness reaction around injection site about 5 inches long and 2 inches wide, raised and warm skin going down towards elbow from upper deltoid. Pt noticed after 28 hrs after shower.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: 1 day after shot child notice a lump (small) at injection site in the afternoon. Then, it got red and itched and grandparent called HD and nurse advised to put cold compress and ice and BENADRYL and to go to Dr and call if it got worse. Child came into health dept. 8/26/16 large grapefruit size red, warm, minimal swelling, itchy to (R) deltoid. Grandparent said no BENADRYL today. Denies difficulty breathing/rash anywhere else. Grandpop offered ibuprofen and child declined last night. Referred to doctor 8/26/16 - for (R) deltoid red, warm, itchy inflamed area.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: 1 day after shot child notice a lump (small) at injection site in the afternoon. Then, it got red and itched and grandparent called HD and nurse advised to put cold compress and ice and BENADRYL and to go to Dr and call if it got worse. Child came into health dept. 8/26/16 large grapefruit size red, warm, minimal swelling, itchy to (R) deltoid. Grandparent said no BENADRYL today. Denies difficulty breathing/rash anywhere else. Grandpop offered ibuprofen and child declined last night. Referred to doctor 8/26/16 - for (R) deltoid red, warm, itchy inflamed area.
Age: 19.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Mobility decreased, Nausea, Pain in extremity, Retching
Clinical narrative: Nausea after receiving vaccines. Arm pain, unable to move the next day. Dry heaving. Treated with ice and MOTRIN.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Patient described arm post vaccination as very red, warm to the touch, swollen, hard to move the arm. Began 1 day post vaccination. Began to improve by second day post vaccination. Patient's physician told her to report to pharmacy.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Peripheral swelling, Rash, Serum sickness
Clinical narrative: Serpiginous exanthema on feet, thighs, and hands with swelling of hands onset 5 days after vaccine. Consistent w/serum-sickness.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding to 7 patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of M-M-R II (data digital logger) (lot # K016154, expiry: 24-SEP-2016). The vaccine was exposed to temperature: 54.4F for a time frame of 24 hours. No adverse effects were reported. There was no previous temperature excursion reported. This is one of 4 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 regarding to 9 patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of VAQTA (data digital logger) (lot # K019560, expiry: 02-JUN-2017). The vaccine was exposed to temperature: 54.4 F for a time frame of 24 hours. No adverse effects were reported. There was no previous temperature excursion reported. This is one of 4 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 as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored GARDASIL 9, (lots and expirations were unspecified). the vaccine was stored at a temperature of 33 F for a time frame of 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse effect reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patient were inadvertently administered with improperly stored VAQTA, (lots and expirations were unspecified) (route: intramuscular). The vaccine was stored at a temperature of 33 F for a time frame of 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse effect reported. This is one of the four 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 nurse refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored M-M-R II, (lots and expirations were unspecified) (route: subcutaneous). The vaccine was stored at a temperature of 33 F for a time frame of 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse effect reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding 3 or 4 adult patients in the 30's. The patients had a medical history of shingles. On an unknown date the nurse practitioner vaccinated "3 or 4 adult patients" who were younger than 50 years of age with ZOSTAVAX. She reports that ZOSTAVAX was administered at the patient's requests because they had a history of shingles and they wanted to receive ZOSTAVAX to prevent further outbreaks. No symptoms were reported. 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 nurse regarding to 8 patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (data digital logger) (Lot # L019127, expiry: 27-MAY-2017. The vaccine was exposed to temperature: 21.7 F for a time frame of 24 hours. No adverse effects were reported. There was no previous temperature excursion reported. This is one of 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number patient of unknown age. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (lot # M008171 and expiry date 16-FEB-2018) subcutaneous. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding to 4 patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (data digital logger)(lot # J013394, expiry date: 25-AUG-2016). The vaccine was exposed to temperature: 54.4F for a time frame of 24 hours. No adverse effects were reported. There was no previous temperature excursion reported. This is one of 4 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 as received from a certified medical assistant (also provided as nurse) refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates between 06-AUG-2016 and 09-AUG-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M005714, expiration date: 03-OCT-2017, (dose, dose number, route of administration and injection site were not provided). There were not concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 48 degrees Fahrenheit for 1 hour 6 minutes. the temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PWC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number patient of unknown age. the patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (lot # M007960, expiry date 15-AUG-2017 or lot# M011663, expiry date 08-SEP-2017) subcutaneous. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was intramuscularly vaccinated with improperly stored GARDASIL 9 (lot # L038503 and expiry date 18-DEC-2017) following a temperature excursion of 35F for 21 minutes. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. On an unknown date in July 2016 (reported as "within the last month") had an unusually large injection site reaction with redness and significant swelling. On an unspecified date, the patient sought medication attention. The patient had to apply ice packs to keep the swelling down and recovered from the events on an unknown date. The reporter did not provide the relatedness of the event with PNEUMOVAX 23. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Joint swelling, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient's pertinent medical history and drug reactions/allergies were reported as none. His concomitant medications were reported as unspecified medications. On 27-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (dose 0.5 ml/one dose, route intramuscular in the left deltoid, lot #L040181 and expiry date 18-AUG-2017) for the indication of "on protocol". On the same day evening (also reported as Wednesday), the patient's arm became swollen, itchy, red and warm to touch so the patient applied hydrocortisone cream on the affected area (the area affected was unspecified). On Thursday, the patient's symptoms did not subside so he iced the area and applied Aloe Vera. On 29-JUL-2016 (also reported as today), the patient developed a mild fever and called the pharmacist. The pharmacist stated "the injection site looked fine but the elbow was still swollen". Pharmacist recommended the patient to take TYLENOL to treat his fever. No lab diagnostic tests were performed. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient's pertinent medical history and drug reactions/allergies were reported as none. His concomitant medications were reported as unspecified medications. On 27-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (dose 0.5 ml/one dose, route intramuscular in the left deltoid, lot #L040181 and expiry date 18-AUG-2017) for the indication of "on protocol". On the same day evening (also reported as Wednesday), the patient's arm became swollen, itchy, red and warm to touch so the patient applied hydrocortisone cream on the affected area (the area affected was unspecified). On Thursday, the patient's symptoms did not subside so he iced the area and applied Aloe Vera. On 29-JUL-2016 (also reported as today), the patient developed a mild fever and called the pharmacist. The pharmacist stated "the injection site looked fine but the elbow was still swollen". Pharmacist recommended the patient to take TYLENOL to treat his fever. No lab diagnostic tests were performed. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint 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 certified medical assistant (also provided as nurse) refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates between 06-AUG-2016 and 09-AUG-2016, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # L027431, expiration date: 22-JUL-2017 and lot # L036853, expiration date; 24-SEP-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 48 degrees Fahrenheit for 1 hour 6 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 81 year old non-pregnant female patient. She had no pertinent medical history and concomitant medication. She was allergic to aspirin and codeine. On 05-AUG-2016, the patient was vaccinated with ZOSTAVAX. On 09-AUG-26, the patient experienced "hives on her body and diarrhea". The patient sought medical attention by calling the pharmacist. The outcome of the events was unknown. The reporter did not provide relatedness of the events with ZOSTAVAX. 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 refers to a patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L048452 and expiry date 01-MAR-2017), subcutaneous. The vaccine was stored at 70F for 30 minutes. No adverse effects reported. No product quality issue reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The patient received the first dose of RECOMIBVAX HB (dosing details were not reported) on 10-NOV-2014, the second dose on 17-NOV-2017 and the third dose on 01-DEC-2014. No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected, as the reporter did not wish further contact.
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. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient was vaccinated with improperly stored ROTATEQ (lot # L008054 and expiry date 30-NOV-2016) on an unknown date after 20-JUL-2016. Excursion was at temperature of 48.7 F for 5 minutes. No previous temperature excursion was noted. The call was due to digital data logger. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. The patients' pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. The patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L029306 and expiry date 26-MAR-2017) on an unknown date after 20-JUL-2016. Excursion was at temperature of 48.7 F for 5 minutes. No previous temperature excursion was noted. The call was due to digital data logger. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, current condition and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 09-AUG-2016 the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (dosing details were not reported). On an unknown date in August 2016 after the patient was vaccinated the patient was prescribed methylprednisolone and an unspecified inhaled corticosteroid for an unknown reason on 10-AUG-2016 (adverse event). The outcome of the event was unknown. The reporter did not provided the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner (also reported as nurse prescribed) refers to a 17 years old female patient of unknown age. the patient's pertinent medical history, current conditions and concomitant medications were not reported. On 09-JUL-2016, the patient was vaccinated with GARDASIL 9, (lot/batch # K014891, expiry date: 10-MAY-2017) intramuscularly, which was later found to have possibly undergone a temperature excursion due to a broken data logger. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient pertinent medical history, current conditions and concomitant medications were not reported. On 17-AUG-2016 the patient was vaccinated with ZOSTAVAX (dosing details were not reported) (lot # L006382 expiry date: 25-MAY-2016), subcutaneously, which was expired. No adverse effects reported. There was no product quality complaint involved. 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 certified medical assistant (also provided as nurse) refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates between 06-AUG-2016 and 09-AUG-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M000442, expiration date: 31-MAR-2018 and lot # L027733, expiration date: 13-SEP-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 48 degrees Fahrenheit for 1 hour 6 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L037554, expiration date 25-DEC-2017, exact dose and route of administration were not reported). the administered doses experienced a temperature excursion of 34.3 degree Fahrenheit for 15 minutes. There was a previous excursion of 34.7 degree Fahrenheit for 15 minutes. the call was because of a "data logger". No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patient were vaccinated with improperly stored doses of VAQTA INJ 25/0.5 (lot # K012457, expiration date 04-JUN-2017, exact dose and route of administration were not reported). The administered doses experienced a temperature excursion of 34.3 degree Fahrenheit for 15 minutes. There was a previous excursions of 34.7 degree Fahrenheit for 15 minutes. The call was because of a "data logger". No adverse effects were reported. This is one of the two reports received from the same reporter.  Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient's pertinent medical history included smoking. Drug reactions/allergies were reported as none. On 26-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # M009773, expiry date 17-MAY-2017) subcutaneously (strength, dosing details, anatomical location were unknown). Then on the same date the patient received PNEUMOVAX 23 on the opposite arm. On an unspecified time after vaccination (on an unknown date in JUL-2016), the patient developed a red welt, on the injection site. The patient returned to the pharmacy on 27-JUL-2016, the show the welt. She sought medical attention by speaking with the pharmacist. No treatment was given for the adverse event. No lab diagnostic tests were performed. The outcome of the event was not known. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Erythema, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient's pertinent medical history included smoking. Drug reactions/allergies were reported as none. On 26-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # M009773, expiry date 17-MAY-2017) subcutaneously (strength, dosing details, anatomical location were unknown). Then on the same date the patient received PNEUMOVAX 23 on the opposite arm. On an unspecified time after vaccination (on an unknown date in JUL-2016), the patient developed a red welt, on the injection site. The patient returned to the pharmacy on 27-JUL-2016, the show the welt. She sought medical attention by speaking with the pharmacist. No treatment was given for the adverse event. No lab diagnostic tests were performed. The outcome of the event was not known. Causality assessment was not provided. No product quality complaint was involved. 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 an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # M003659, 20-SEP-2017, lot # L017407, 15-AUG-2017. No adverse effects reported. the vaccines reached 15.5 c for 3hours. Data logger was yes. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 29-JUL-2016 the patient was vaccinated with an expired dose of ROTATEQ (lot # K022993, expiry date: 20-JUL-2016) (expired product administered). No adverse reactions were reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on trunk after 1 week. No other symptoms noted.
Age: 18.0
Sex: U
Vaccine: HPV9, MENB, MNQ
Symptoms: Rash generalised
Clinical narrative: "Rash head to toe 4 hours after vaccine", per mother.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash, Skin warm
Clinical narrative: Red spot where he got vaccines, warm to the touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red spot where he got vaccines, warm to the touch.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms, chills, body aches, severe headache.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Erythema, Generalised tonic-clonic seizure
Clinical narrative: On 8/17/2016 had first reaction swelling redness hot to touch doc said apply ice give day or two by 08/19/2016 gone. On 8/20/2016 was hospitalized after suffering a small seizure and calling 911 at hospital had a grand mal seizure.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Seizure, Skin warm, Swelling, Toxicologic test
Clinical narrative: On 8/17/2016 had first reaction swelling redness hot to touch doc said apply ice give day or two by 08/19/2016 gone. On 8/20/2016 was hospitalized after suffering a small seizure and calling 911 at hospital had a grand mal seizure.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt states that his arm immediately hurt after the injection.  It was given high on the arm so I suspect the vaccine was injected into his left bursa.  The pain was described as an 11/10 and that he could not lift or move his arm.  2 days later he called the pharmacy to report his side effect that he is still having pain not managed by acetaminophen and while the pain is better it is still present and he still has difficulty moving his arm.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events.  Patient received two Fluzone Quad 2016-17 in error.  0.5 ml in left arm and 0.5 ml in right arm.  Total vaccine dose 1.0 ml.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Abdominal discomfort, Complement factor C3, Complement factor C4 decreased, Complement factor normal, Oropharyngeal pain
Clinical narrative: Hives and pruritis, sore throat with GI upset.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and pruritis, sore throat with GI upset.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Patient has rash on injection arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Soreness of injection site. Inflammation/ red. Recommend patient to take an acetaminophen or ibuprofen. Also recommend Benadryl.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out 5 minutes after being vaccinated. She came to after a few minutes. She did not have an anaphylactic reaction.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Mild fever, headache, arms very sore, arms red/swollen from elbow to shoulder.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site was swollen and extra sensitive the next day, but patient was extremely fatigued on the 26th and 27th and just started getting better on the 28th. She also reported a fever. Sounds like a stronger than normal adverse reaction to the Pneumovax 23 (but also had the quadravalent influenza vaccine).
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: Itching and mild swelling which continued to spread over the course of 24 hours. At largest involvement patient states it covered her entire upper arm from elbow to shoulder and around entire circumference of arm. Patient had redness, swelling, and area was very warm to the touch. Patient also reported mild soreness at injection site. Symptoms lessened with oral diphenhydramine.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: About 20 seconds after being give the flu vaccine pt. slumped to the side, became very pale, sweating profusely, nauseous, weak an dizzy. Pt. began feeling better after a few minutes.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Posture abnormal
Clinical narrative: About 20 seconds after being give the flu vaccine pt. slumped to the side, became very pale, sweating profusely, nauseous, weak an dizzy. Pt. began feeling better after a few minutes.
Age: 87.0
Sex: U
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/Itching.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Injection site red swollen and painful, fever TM 102.4, body aches. Headache.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Injection site red swollen and painful, fever TM 102.4, body aches. Headache.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Joint swelling, Skin warm
Clinical narrative: Patient presented with redness and swelling around injection site. Area also swelling in elbow joint. Warm to touch. Required oral antibiotic.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Patient received vaccine on 8-22 and had sore arm that evening. Then 8-23 developed some swelling and redness near elbow but nothing around injection site. She had a low grade fever and some soreness. All symptoms resolved by 8-24. No treatment was given.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored RECOMBIVAX HB, (lots and expirations were unspecified) (route: intramuscular) (incorrect product storage). The vaccine was stored at a temperature of 33 F for a time frame of 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse effect reported. This is one of the four reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 30 year old patient of an unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (lot number/ expiry date and dose not reported) (inappropriate schedule of vaccine administration). No adverse effect reported. No Product Quality Complaint (PQC) was involved. 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 medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX lot # L029472 (06-AUG-2017) subcutaneously. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-AUG-2016, the patient was vaccinated with improperly stored VARIVAX (Lot # M023379 and expiry date 11-MAY-2018). This dose of VARIVAX had had a temperature excursion of 4 hours at 27.5 F. No adverse effects were reported. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: DTAP, FLUX, HIBV, PNC13
Symptoms: Death
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 15-month-old patient of an unspecified ethnicity and gender received on 28Oct2011 pneumococcal 13-val conj vac (dipht crm197 protein), influenza vaccine, DTAP and HIB, all via an unspecified route of administration at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient passed away on 31Oct2011. It was not reported if an autopsy was performed. No follow up attempts possible. No further information expected. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RVX
Symptoms: Death
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Social Media Activity. A contactable consumer reported that a 2-month-old patient of an unspecified ethnicity and gender received PREVNAR 13, hepatitis b vaccine, polio vaccine (IPV), rotavirus vaccine, diphtheria vaccine, pertussis vaccine, tetanus vaccine (DTAP), haemophilus influenza type b vaccine (HIB), all via an unspecified route of administration on an unspecified date at single dose and mesalazine oral. The patient medical history and the patient's concomitant medications were not reported. The patient passed away on 11Aug2011. It was not reported if an autopsy was performed. No follow up attempts possible. No further information expected.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Abdominal mass, Blood gases, Culture urine, Decreased appetite
Clinical narrative: ROTARIX vaccine administered on 6/24/16. On 7/8/16 presented to emergency room, diagnosed with intussusception, required laparotomy and some bowel resection. Recovered well.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Differential white blood cell count, Full blood count, Hyporesponsive to stimuli, Laboratory test, Lethargy
Clinical narrative: ROTARIX vaccine administered on 6/24/16. On 7/8/16 presented to emergency room, diagnosed with intussusception, required laparotomy and some bowel resection. Recovered well.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Platelet count, Ultrasound abdomen abnormal, Urine analysis, Urine output decreased
Clinical narrative: ROTARIX vaccine administered on 6/24/16. On 7/8/16 presented to emergency room, diagnosed with intussusception, required laparotomy and some bowel resection. Recovered well.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Barium enema, Enema administration, Intestinal resection, Intussusception
Clinical narrative: ROTARIX vaccine administered on 6/24/16. On 7/8/16 presented to emergency room, diagnosed with intussusception, required laparotomy and some bowel resection. Recovered well.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Laparotomy, Ultrasound abdomen
Clinical narrative: ROTARIX vaccine administered on 6/24/16. On 7/8/16 presented to emergency room, diagnosed with intussusception, required laparotomy and some bowel resection. Recovered well.
Age: 51.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Muscle spasms
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle spasm in a 51-year-old female patient who received BOOSTRIX. Concomitant products included ATIVAN. On 17th August 2016, the patient received BOOSTRIX (intramuscular) .5 ml. In August 2016, less than a week after receiving BOOSTRIX, the patient experienced muscle spasm. On 17th August 2016, the patient experienced injection site tenderness and headache. On an unknown date, the outcome of the muscle spasm, injection site tenderness and headache were not recovered/not resolved. The reporter considered the muscle spasm and headache to be possible related to BOOSTRIX. The reporter considered the injection site tenderness to be related to BOOSTRIX. Additional details were provided as follows: Immediately after vaccination, the patient experienced tenderness at injection site. Later that day, patient began experiencing a headache. The patient also experienced muscle spasms in the arm where the she received the vaccine. The exact time of onset for muscle spasms was unknown.
Age: 60.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Fatigue, Lethargy, Palpitations, Pyrexia
Clinical narrative: Constant heart palpitations for 9 hours. 9 hours after shot was administered. Fever of 100 /24 hours after shot.
Age: 60.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Palpitations, Pyrexia
Clinical narrative: Constant heart palpitations for 9 hours. 9 hours after shot was administered. Fever of 100 /24 hours after shot.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Crying, Seizure
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA, at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. 2-3 hours after the injection, the patient started having seizures, that required hospitalization. The outcome of the event was unknown.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA, at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. 2-3 hours after the injection, the patient started having seizures, that required hospitalization. The outcome of the event was unknown.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Blindness, Blood test, Computerised tomogram, Drug screen, Electrocardiogram
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA, at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. 2-3 hours after the injection, the patient started having seizures, that required hospitalization. The outcome of the event was unknown.