chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013206, expiry date 29-JAN-2017 and lot # K020182, expiry date 25-JUN-2016) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L035505, expiry date 16-DEC-2015) dosage regimen and route unknown).. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown date the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dosing regimen unspecified) Lot number-K006132, expiry date 29-APR-2016, Lot number-K010337, expiry date-22-JUL-2016, Lot number K021932, expiry date-10-NOV-2016, Lot number-L003777, expiry date-04-FEB-2017, Lot number-L009204, expiry date-17-MAR-2017, Lot number-L013066, expiry date-14-APR-2017, Lot number-L017146, expiry date-13-MAY-2017, Lot number-L023592, expiry date-26-JUN-2017, Lot number-L025208, expiry date-07-JUL-2017, Lot number-L032396, expiry date-26-AUG-2017, Lot number-L039093, expiry date-06-OCT-2017. The vaccines were at a temperature of -2.7 degree centigrade for a time frame of 790 hours. The call was placed as result of a data logger. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored (Oka/Merck) VARIVAX Lot number L017145 with expiration date of 13-MAY-2017, L019124 with expiration date of 20-MAY-2017 and reported lot # L044055 with expiration date of 02-MAY-2017 (dose and route were not reported), which were stored at 7.9 F for 12 hours, 10.6 F for 12 hours, 6.8 F for 12 hours and 6.8 F for 12 hours, the worse case scenario was 48 hours cumulatively. The vaccine did not have previous temperature excursion. No adverse effects reported. Lot number L044055 is an invalid lot number for (Oka/Merck) VARIVAX but was valid for (Oka-Merck) PROQUAD. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the 3rd dose of GARDASIL 9 (strength, dose, route and lot number were not reported). The patient's concomitant medication was not reported. On an unknown date, after vaccination with GARDASIL 9 vaccine the patient fainted, fell off the table and bumped her head. Additionally, she lost consciousness for 30 seconds. Then the patient was advice to go to the emergency room. It was reported that the patient received an unspecified treatment for the adverse events and she sought medical attention. At the time of the report, the outcome of loss of consciousness was recovered. The outcome of fainted, fell and bumped her head was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Blindness, Computerised tomogram head normal, Dysstasia, Electrocardiogram normal, Fall
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the 3rd dose of GARDASIL 9 (strength, dose, route and lot number were not reported). The patient's concomitant medication was not reported. On an unknown date, after vaccination with GARDASIL 9 vaccine the patient fainted, fell off the table and bumped her head. Additionally, she lost consciousness for 30 seconds. Then the patient was advice to go to the emergency room. It was reported that the patient received an unspecified treatment for the adverse events and she sought medical attention. At the time of the report, the outcome of loss of consciousness was recovered. The outcome of fainted, fell and bumped her head was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Head injury, Headache, Influenza virus test negative, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the 3rd dose of GARDASIL 9 (strength, dose, route and lot number were not reported). The patient's concomitant medication was not reported. On an unknown date, after vaccination with GARDASIL 9 vaccine the patient fainted, fell off the table and bumped her head. Additionally, she lost consciousness for 30 seconds. Then the patient was advice to go to the emergency room. It was reported that the patient received an unspecified treatment for the adverse events and she sought medical attention. At the time of the report, the outcome of loss of consciousness was recovered. The outcome of fainted, fell and bumped her head was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tachycardia, Urinary incontinence
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the 3rd dose of GARDASIL 9 (strength, dose, route and lot number were not reported). The patient's concomitant medication was not reported. On an unknown date, after vaccination with GARDASIL 9 vaccine the patient fainted, fell off the table and bumped her head. Additionally, she lost consciousness for 30 seconds. Then the patient was advice to go to the emergency room. It was reported that the patient received an unspecified treatment for the adverse events and she sought medical attention. At the time of the report, the outcome of loss of consciousness was recovered. The outcome of fainted, fell and bumped her head was unknown. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Urticaria
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a 19 month old male patient. The patient did not have any relevant medical history, drug reaction/allergies and concomitant medications. On 25-MAR-2016 the patient was vaccinated with VAQTA 25/0.5 injection, 0.5 ml intramuscularly (lot # N003011, expiry date: 15-NOV-2017). That same night the patient began having a fever, reaching 102 degrees that continued through 25-MAR-2016 and resolved on 26-MAR-2016. On 25-MAR-2016, the patient also developed hives in an unspecified location. The patient's mother (name unspecified) gave the patient BENADRYL and ZYRTEC (doses and manufacturer unspecified) on 26-MAR-2016, which did not help as stated by mother. Hence the patient visited the physician's office to seek medical attention on 29-MAR-2016 and was given ORAPRED. No laboratory diagnostic tests were performed. The reporter stated that the hives were resolving but have not completely disappeared at the time of reporting. Causality assessment was not reported. There was no product quality complaint. 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 practitioner refers to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot# and expiry date were not reported). The vaccine was exposed to 0 degree Celsius for 440 hours. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 1.67
Sex: F
Vaccine: MMRV
Symptoms: Acute lymphocytic leukaemia, Chemotherapy, Herpes simplex test negative, Neutropenia, Polymerase chain reaction positive
Clinical narrative: Admitted 2/27/2016 with widespread vesicular rash lesions positive for Varicella by DFA. Patient on AALL-1131 chemotherapy maintenance phase for ALL diagnosed in May 2014.
Age: 1.67
Sex: F
Vaccine: MMRV
Symptoms: Rash generalised, Rash pustular, Rash vesicular, Varicella virus test positive
Clinical narrative: Admitted 2/27/2016 with widespread vesicular rash lesions positive for Varicella by DFA. Patient on AALL-1131 chemotherapy maintenance phase for ALL diagnosed in May 2014.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (lot # L039093, expiry date 06-OCT-2017) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: FLUX, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15-year-old patient of unknown gender. No information about the patient's medical history and concomitant conditions were reported. On 06-JAN-2016, the patient was vaccinated with an improperly stored, the third dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the left arm (dose and route of administration were not reported). Concomitant therapy included influenza virus vaccine (unspecified). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Age: 16.0
Sex: U
Vaccine: FLU3, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the right arm (dose and route of administration were not reported). Concomitant therapy included influenza virus vaccine (unspecified). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 13-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the left arm (dose and route of administration were not reported). NO concomitant therapies were reported. The administered dose was exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 11-JAN-2016, the patient was vaccinated with an improperly stored second dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the right arm (dose and route of administration were not reported). No concomitant therapies were reported. The administered dose was exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Age: 18.0
Sex: U
Vaccine: FLU3, HPV4, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 18-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the right arm (dose and route of administration were not reported). Concomitant therapies included meningococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). Administered doses were exposed to the following condition: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated wit improperly stored doses of ROTATEQ, orally, lot #: L0000458, expiration date on 13-JUL-2015 (dose and anatomical location were not reported, which were stored in a temperature of 31F during 45 days. No previous temperature excursions was reported. Other suspect therapies included an sterile diluent (lot #: K026419, expiration date: 19-OCT-2017, lot #: L041248, expiration date: 27-JAN-2016, which were exposed with the same conditions. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reported coming from the same source. 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 pharmacist referring to unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot #: K011239, expiration date on 11-JUN-2016 (dose and anatomical location were not reported) which were stored in a temperature of 31F during 45 days. No previous temperature excursion was reported. Other suspect therapies included a sterile diluent (lot #: K026419, expiration date: 19-OCT-2017; Lot #: L041248, expiration date: 27-JAN-2018), which were exposed with the same conditions. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K005426, expiration date 15-APR-2016; lot# L023589, expiration date 26-JUN-2017; lot # L048468, expiration date 02-DEC-2017; lot # L042265, expiration date 26-OCT-2017; lot # K007784, expiration date 28-MAY-2016; dose , anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 35.1 Fahrenheit (F) for 2 hours and 48 minutes and previous temperature excursion was reported as 10.6 F for 1 hour and 45 minutes for lot # K005426 and lot # L023589/ Temperature  was 35.1 F with time frame 2  hours and 48 minutes and there was no previous temperature excursion reported for lot # L048468, lot # L042265, lot # K007784. The data logger was involved for all lot numbers. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Off label use, Product use issue
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. Since an unknown date, the patient received a series of "small doses" of PNEUMOVAX23 (anatomical site, route of administration, exact dose, lot number and expiration date were not provided) every week as a desensitization regimen, also reported as "getting it as an allergy s hot". No adverse effects reported. The pharmacist was wondering the accuracy of this information. Furthermore, no product quality issue was involved.  Additional information is not expected as no consent to contact the pharmacist was provided.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered
Clinical narrative: Information as been received from a physician via representative concerning a 7 month old patient. The concurrent condition and medical history were not reported. There was no concomitant therapy. On 28-OCT-2o15, 30-DEC-2015 and 25-FEB-2016, the patient was vaccinated with the first, second and third dose fo ROTATEQ, orally, respectively. On 19-APR-2016 the patient was administered with a fourth dose of ROTATEQ (lot # L038536, Expiration Date unknown) (extra dose administered). No treatment was given. The patient did not seek medical attention. 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 registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 04-NOV-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route of administration were not specified; lot # L019287, expiration date on 14-SEP-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent temperature excursion). No adverse effects were 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 registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 03-NOV-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route of administration were not specified; lot # L019287, expiration date on 14-SEP-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Abscess limb, Grip strength decreased, Hypoaesthesia, X-ray limb
Clinical narrative: Pt reports numbness to fingers of (L) hand and states drops things that she is holding with (L) hand. Pt states feels abscess to (L) forearm.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Activities of daily living impaired, Cough, Injection site erythema, Injection site swelling
Clinical narrative: Based on additional information received on 05 October 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 26 August 2015. This case involves a five-year-old female patient who was vaccinated with a fourth dose of DAPTACEL (batch number: C4630AA, expiration date: 28 October 2016, dose and dose number were not reported) intramuscularly in left deltoid on 09 July 2015. The patient had a medical history of milk, dust mites, tree pollen, chalk allergies and possible asthma. The patient had history of prior reaction to MMR vaccine (reaction not specified). Concomitant medication was not reported. On 09 July 2015, within 24 hours following the vaccination, the patient had swelling and redness of left arm due to which it was hard to get a shirt on. Since 09 July 2015, the patient had behavior meltdowns. On an unspecified date, the patient had seen physician for cough and cold after DAPTACEL vaccination, but not for behavior issues or local reaction. The patient required ER or doctor visit. It was reported that reporter did not know if DAPTACEL was the DTaP given for prior doses of DTaP. Laboratory investigation and corrective treatment were not reported. On an unspecified date, four days later onset, the patient was recovered from event left arm swollen, redness which was hard to get a shirt on. The patient was not recovered from event behavior meltdowns, cough and cold. Follow up report received from a physician on 05 October 2015. Patient address details updated. No other information reported. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Nasopharyngitis
Clinical narrative: Based on additional information received on 05 October 2015, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 26 August 2015. This case involves a five-year-old female patient who was vaccinated with a fourth dose of DAPTACEL (batch number: C4630AA, expiration date: 28 October 2016, dose and dose number were not reported) intramuscularly in left deltoid on 09 July 2015. The patient had a medical history of milk, dust mites, tree pollen, chalk allergies and possible asthma. The patient had history of prior reaction to MMR vaccine (reaction not specified). Concomitant medication was not reported. On 09 July 2015, within 24 hours following the vaccination, the patient had swelling and redness of left arm due to which it was hard to get a shirt on. Since 09 July 2015, the patient had behavior meltdowns. On an unspecified date, the patient had seen physician for cough and cold after DAPTACEL vaccination, but not for behavior issues or local reaction. The patient required ER or doctor visit. It was reported that reporter did not know if DAPTACEL was the DTaP given for prior doses of DTaP. Laboratory investigation and corrective treatment were not reported. On an unspecified date, four days later onset, the patient was recovered from event left arm swollen, redness which was hard to get a shirt on. The patient was not recovered from event behavior meltdowns, cough and cold. Follow up report received from a physician on 05 October 2015. Patient address details updated. No other information reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Redness of entire left arm and swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Peripheral swelling, Rash
Clinical narrative: Skin rash on abdomen looking like shingles and very painful. Local reaction at the arm, swollen/red/pain.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practitioner nurse, and refers to a 12 month old female patient. The patient's medical history included two episodes of wheezing in the past besides developing rash from amoxicillin which was not an allergic reaction. On 11-APR-2016, the patient was vaccinated with M-M-R II lot # L012482 with expiry date on 10-APR-2017 and PROQUAD (Merck) L044057 with expiry date on 02-MAY-2017, 0.5 ml each (strength, frequency, route and anatomical locations were not reported), it was reported that it was meant to give M-M-R II and Varicella virus vaccine live (manufacturer unknown). No concomitant medications were reported. No adverse event was reported and no product quality complaint was involved. It was also reported that no relevant lab work was performed. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a 58 year old male patient reporting on himself. The patient concurrent conditions included diabetes mellitus, hypertension and high cholesterol. His drug reactions/allergies included shellfish allergy and codeine hypersensitivity. On 24-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot # and expiry date were not reported). Concomitant therapies included HUMALOG, VASOTEC, LIPITOR, aspirin, Vitamin C, multivitamins, glucosamine and vitamin D. On 25-MAR-2016, the patient developed itch without rash. He sought medical attention and received a prescription for ATARAX. At the time of the report the patient had no recovered from the event. The reporter did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker regarding to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L007495, expiry date 04-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature excursion of 25.6 degrees F for a time frame of 132 hours. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis LUA s/p PREVNAR 13 injection. Started evening of injection. SXS worsened over 4 days.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 19-year-old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the 19-year-old patient was vaccinated two doses of VAQTA 0.5 ml, intramuscularly, lot# L004439, expiration date: 15-FEB-2016 and L034381, expiration date: 21-DEC-2016. There were no adverse effects reported. Follow up information has been received from the licensed practical nurse on 06-APR-2016. The patient's gender was female and her occupation was student. It was reported that the patient did not have illness at the time of the vaccination. On 10-MAR-2016, the patient was vaccinated with the first dose of VAQTA (confliction information) (lot number M003011, the expiration date was not reported) 0.5 mL instead 1 mL in the left deltoid. Relevant diagnostic test and laboratory data were not performed. It was reported that was obtained a signed informed consent form for the vaccine and that the patient recovered on an unknown date. Additional information has been requested. Product, event and the narrative were updated.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patient was vaccinated with either GARDASIL or GARDASIL 9, intramuscularly (lot#, expiration date, dose and route were not reported). The patient passed out in the physician's office after receiving the vaccine. The outcome of the event was not reported. Causality assessment was not provided. Additional information is not expected as there was no consent to contact the reporter.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram abnormal, Epilepsy, Seizure
Clinical narrative: Between August 27, 2015 and August 30, 2015 we noticed our daughter began having seizures. The seizures became more frequent and for longer periods of time over the course of a few days. I called our pediatrician each time a seizure occurred and on September 2, 2015 she recommended we bring our 2 month old to the ER. She was admitted to the hospital where she was given Keppra to stop the seizures and was hooked up to an EEG for monitoring. It was confirmed that she was having seizures and was diagnosed with epilepsy.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event, reporting for monitoring purposes since patient received vaccine while pregnant and this was not known prior to vaccine being given.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Cartilage injury, Nuclear magnetic resonance imaging abnormal, Pain, Shoulder operation
Clinical narrative: PAIN, SORENESS, IBUPROFEN DID NOT HELP.
Age: 30.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Right deltoid pain day after receiving vaccination, difficulty moving arm with pain.  No swelling, no redness, no fever.  Able to move distal fingers.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Hypersensitivity, Peripheral swelling, Pyrexia
Clinical narrative: Lt upper extremity swollen, red, hot, fever 4 hrs after PREVNAR 13 IM injection: positive cellulitis/allergic reaction.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Ultrasound scan
Clinical narrative: Lt upper extremity swollen, red, hot, fever 4 hrs after PREVNAR 13 IM injection: positive cellulitis/allergic reaction.
Age: 47.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site hypersensitivity
Clinical narrative: Cellulitis/localized allergic reaction left deltoid x 5 days - self limiting.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker regarding to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L031196, expiry date 05-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature excursion of 25.6 F for a time frame of 132 hours. It was reported there were no previous temperature excursion. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Induration
Clinical narrative: Began with erythema and induration of left leg on 4/20/16 and worsening on 4-21-16.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker regarding to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L031196, expiry date 05-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature excursion of 25.6 F for a time frame of 132 hours. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Haematoma, Local swelling, Pruritus, Sleep disorder
Clinical narrative: Localized swelling - presumed hematoma. No c/o anaphylaxis infection. Use cold compresses, NSAIDS PRN, BENADRYL PRN, for itching/sleep.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Nasal discharge discolouration, Rhinorrhoea, Scab, Skin lesion
Clinical narrative: Pt developed worsening rhinorrhea after receiving FLUMIST. On 1/7/16 developed crusted lesions around nose that spread down to lip. Clear runny nose turned to think green nasal discharge. No fever. Diagnosed with impetigo by MD on 1/8/16.
Age: 1.81
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Local reaction (swelling, erythema, induration and tenderness) to either pneumococcal or Dtap vaccine. Walking but dragging (L) leg.
Age: 1.81
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Local reaction
Clinical narrative: Local reaction (swelling, erythema, induration and tenderness) to either pneumococcal or Dtap vaccine. Walking but dragging (L) leg.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Father described pronounced swelling, pain and redness at injection site with moderate relief of S/S with ibuprofen.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L031196, expiry date 05-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature excursion of 25.6 F for a time frame of 132 hours. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not field. This report is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The physician mentioned that he recently reviewed a manuscript that reported a ZOSTAVAX-related death (dose, lot number, route, date of vaccination and date of the event were not provided). The report would be electronically published (journal unknown). The cause of death was not provided. It was unknown if autopsy was performed. The causality between the suspect drug and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker regarding to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L031196, expiry date 05-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature excursion of 25.6 F for a time frame of 132 hours. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-APR-2016, the patient was vaccinated with an improperly stored dose of VAGTA (lot # L031196, expiry date 05-FEB-2017) dosage regiment and route unknown. Concomitant medications  were not reported. The vaccine was subjected to temperature excursions.  The report is one of the 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 certified medical assistant (CMA) referring to a patient of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown). The vaccines were stored under 34.5 F (min) and 37.9 f (max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". NO adverse effects were reported. This is one of the several reports received from the same reporter.  Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to a patient (5) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On 12-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown). The vaccine were stored under 34.5 F (min) and 37.9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the 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 certified medical assistant (CMA) referring to a patient (3) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On 10-JAN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown). The vaccines were stored under 34.5 F (Min) and 36.9F (Max) for 24  hours. There was no previous temperature excursion. IT was called because of a "date logger". No adverse effects were reported. This is one of the several reports received from the same reporter.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to a patient (6) of unknown age and gender. NO information regarding patient's relevant medical history, current condition and concomitant medication was provided. On 14-JAN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34.5 F (Min) and 47.9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to a patient (4) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant  medications was provided. On 14-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34F (Min) and 37.9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to a patient (2) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant  medications was provided. On 09-DEC-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34.5 F (Min) and 37.9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Hyperhidrosis, Injection site nodule, Nausea, Pain in extremity
Clinical narrative: Severe right arm pain with chest pain on right side. Nausea and sweating. Large knot on right arm at injection site. Right arm swelling at ER. *Given TORADOL.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral swelling
Clinical narrative: Severe right arm pain with chest pain on right side. Nausea and sweating. Large knot on right arm at injection site. Right arm swelling at ER. *Given TORADOL.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L031196, expiry date 05-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature excursion of 25.6 F for a time frame of 132 hours. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This report 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 certified medical assistant (CMA) referring to a patient (7) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34.5 F (min) and 27-9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: FLU3, HIBV, PNC13, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None reported by mother.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Electrocardiogram normal, Electroencephalogram, Seizure, Tremor
Clinical narrative: Pt seen at ER on 4/24/16 for seizure at home. Father noted shaking of arms and legs, eyes rolled back in head, when he woke child in AM. Arms folded tightly into chest. No fever. Episode lasted approx. 5 min.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (which has the lot number of L040178, expiration date 15-AUG-2017)(dose and route were not provided). There were no adverse effects reported. The vaccines experienced a temperature of 13.2 C in a time frame of 1 hour and 20 minutes, there had been no previous temperature excursion. Furthermore no product quality complaint was involved. This is one of the 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 registered nurse, referring to multiple unspecified patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (which has the lot number of M003011, expiration date 15-NOV-2017, L031196, expiration date 05-FEB-2017) (dose and route were not provided). There were no adverse effects reported. The vaccines experienced a temperature of 13.2 C in a time frame of 1 hour and 20 minutes, there had been no previous temperature excursion. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.