chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Blood glucose increased, Blood test, Dizziness, Fatigue, Hepatic function abnormal
Clinical narrative: A non-serious spontaneous report was received on 27JUN2016 from a consumer. On 22JUN2016, the consumer received her 12th dose of BioThrax (anthrax vaccine adsorbed). On 25JUN2016 she experienced flu-like symptoms.  On 27JUN2016, she reported experiencing fever of 102.6 F (also reported as 104 F), abdominal pain, dizziness, nausea, weakness, fatigue, and sweating. Patient went to Urgent Care and was referred to emergency room where she had blood test drawn (test names and results unknown). No other treatment given in ER, no diagnosis given. The patient left emergency room due to the long wait of 5 to 8 hours to see a doctor. The subject self-treated symptoms at home with rest, fluids, and ibuprofen. On 28JUN2016, she reported that her fever began to break and that she had vomited. She also reported that she would not be going to work for the day. On 29JUN2016 she reported that her adverse events were resolving. Additional follow-up information was received on 04JUL2016 from a consumer's roommate that contained serious criteria that upgraded case to expedited. On 03JUL2016, per report by consumer's roommate, the consumer made two trips to a local emergency room both for a migraine. It was reported that the second visit resulted in an overnight stay at the hospital for more testing. The consumer's roommate reported that the consumer's liver was not functioning as it should. The consumer was reported to have slept for about a week except for the times that she was able to make it to work. Treatments reported include Ibuprofen, fluids and rest. No medical history reported. No concomitant medication reported. Relevant laboratory tests: Alanine aminotransferase - 260; Aspartate aminotransferase - 132; Blood alkaline phosphatase - 286; Glucose - 117; Neutrophil count - 8.03; White blood cell count - 11.33; Hepatitis panel drawn - waiting results. Additional information requested.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Hepatitis viral test, Hyperhidrosis, Hypersomnia, Impaired work ability, Influenza like illness
Clinical narrative: A non-serious spontaneous report was received on 27JUN2016 from a consumer. On 22JUN2016, the consumer received her 12th dose of BioThrax (anthrax vaccine adsorbed). On 25JUN2016 she experienced flu-like symptoms.  On 27JUN2016, she reported experiencing fever of 102.6 F (also reported as 104 F), abdominal pain, dizziness, nausea, weakness, fatigue, and sweating. Patient went to Urgent Care and was referred to emergency room where she had blood test drawn (test names and results unknown). No other treatment given in ER, no diagnosis given. The patient left emergency room due to the long wait of 5 to 8 hours to see a doctor. The subject self-treated symptoms at home with rest, fluids, and ibuprofen. On 28JUN2016, she reported that her fever began to break and that she had vomited. She also reported that she would not be going to work for the day. On 29JUN2016 she reported that her adverse events were resolving. Additional follow-up information was received on 04JUL2016 from a consumer's roommate that contained serious criteria that upgraded case to expedited. On 03JUL2016, per report by consumer's roommate, the consumer made two trips to a local emergency room both for a migraine. It was reported that the second visit resulted in an overnight stay at the hospital for more testing. The consumer's roommate reported that the consumer's liver was not functioning as it should. The consumer was reported to have slept for about a week except for the times that she was able to make it to work. Treatments reported include Ibuprofen, fluids and rest. No medical history reported. No concomitant medication reported. Relevant laboratory tests: Alanine aminotransferase - 260; Aspartate aminotransferase - 132; Blood alkaline phosphatase - 286; Glucose - 117; Neutrophil count - 8.03; White blood cell count - 11.33; Hepatitis panel drawn - waiting results. Additional information requested.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Migraine, Nausea, Neutrophil count increased, Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report was received on 27JUN2016 from a consumer. On 22JUN2016, the consumer received her 12th dose of BioThrax (anthrax vaccine adsorbed). On 25JUN2016 she experienced flu-like symptoms.  On 27JUN2016, she reported experiencing fever of 102.6 F (also reported as 104 F), abdominal pain, dizziness, nausea, weakness, fatigue, and sweating. Patient went to Urgent Care and was referred to emergency room where she had blood test drawn (test names and results unknown). No other treatment given in ER, no diagnosis given. The patient left emergency room due to the long wait of 5 to 8 hours to see a doctor. The subject self-treated symptoms at home with rest, fluids, and ibuprofen. On 28JUN2016, she reported that her fever began to break and that she had vomited. She also reported that she would not be going to work for the day. On 29JUN2016 she reported that her adverse events were resolving. Additional follow-up information was received on 04JUL2016 from a consumer's roommate that contained serious criteria that upgraded case to expedited. On 03JUL2016, per report by consumer's roommate, the consumer made two trips to a local emergency room both for a migraine. It was reported that the second visit resulted in an overnight stay at the hospital for more testing. The consumer's roommate reported that the consumer's liver was not functioning as it should. The consumer was reported to have slept for about a week except for the times that she was able to make it to work. Treatments reported include Ibuprofen, fluids and rest. No medical history reported. No concomitant medication reported. Relevant laboratory tests: Alanine aminotransferase - 260; Aspartate aminotransferase - 132; Blood alkaline phosphatase - 286; Glucose - 117; Neutrophil count - 8.03; White blood cell count - 11.33; Hepatitis panel drawn - waiting results. Additional information requested.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: White blood cell count increased
Clinical narrative: A non-serious spontaneous report was received on 27JUN2016 from a consumer. On 22JUN2016, the consumer received her 12th dose of BioThrax (anthrax vaccine adsorbed). On 25JUN2016 she experienced flu-like symptoms.  On 27JUN2016, she reported experiencing fever of 102.6 F (also reported as 104 F), abdominal pain, dizziness, nausea, weakness, fatigue, and sweating. Patient went to Urgent Care and was referred to emergency room where she had blood test drawn (test names and results unknown). No other treatment given in ER, no diagnosis given. The patient left emergency room due to the long wait of 5 to 8 hours to see a doctor. The subject self-treated symptoms at home with rest, fluids, and ibuprofen. On 28JUN2016, she reported that her fever began to break and that she had vomited. She also reported that she would not be going to work for the day. On 29JUN2016 she reported that her adverse events were resolving. Additional follow-up information was received on 04JUL2016 from a consumer's roommate that contained serious criteria that upgraded case to expedited. On 03JUL2016, per report by consumer's roommate, the consumer made two trips to a local emergency room both for a migraine. It was reported that the second visit resulted in an overnight stay at the hospital for more testing. The consumer's roommate reported that the consumer's liver was not functioning as it should. The consumer was reported to have slept for about a week except for the times that she was able to make it to work. Treatments reported include Ibuprofen, fluids and rest. No medical history reported. No concomitant medication reported. Relevant laboratory tests: Alanine aminotransferase - 260; Aspartate aminotransferase - 132; Blood alkaline phosphatase - 286; Glucose - 117; Neutrophil count - 8.03; White blood cell count - 11.33; Hepatitis panel drawn - waiting results. Additional information requested.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that 6 patients received the same lot number of PNEUMOVAX 23 and all 6 patients experienced the same symptoms. She reported "2 or 3 of the patients" had hypertension and hypercholesterolemia. The nurse said that the patients included both male and female gender. (The cases were captured in MARRS # 1606USA011560 and 1607USA004050). The nurse was not aware of the patient's drug allergies. In December 2015, the patient was vaccinated with PNEUMOVAX 23 lot # L031459, expiration date: 30-APR-2017, 0.5 ml, intramuscularly. In approximately December 2015 within 24 hours of vaccination, the patient experienced low-grade fever, redness and swelling at the injection site, pain in the vaccinated arm which spread to the armpit. The patient sought medical attention by visiting the doctor's office. The patient was treated with BENADRYL, ibuprofen and other unspecified over-the-counter products. One of the 6 patients was given an unspecified steroid shot. On an unknown date 3 to 5 days after the onset of symptoms, the patient recovered from the events. The relatedness between the event and PNEUMOVAX 23 was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Pt called 7/13/16, returned call 7/14/16. Pt complains of tingling in hands, arms, fee, legs and face. Pt states began 7/9/16. Pt received vaccine 6/27/16. Advised Pt to notify his m.d. Pt states will go to clinic after work - LPN
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a medical assistant referring to a 1 year patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 05-JUL-2016 the patient was inadvertently administered a dose of VARIVAX (lot # M000757, expired on 06-JAN-2018) subcutaneously and PROQUAD (lot # L050909, expired on 14-JUN-2017, recombinant human albumin (rHA)) subcutaneously instead of VARIVAX and M-M-R II. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 10-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of VARIVAX (lot # L45953, expiration date 17-NOV-2017) subcutaneous. Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 10-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received by the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medications were not reported. No previous drug reactions/allergies were reported. On 09-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017 (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacy intern referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 08-JUL-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K009876 with expiration date 19-MAR-2016; dose and route unknown). Concomitant therapy was not provided. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Fatigue, Immediate post-injection reaction, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient's mother called on 7/13/16 and reported that immediately after the patient received the Hepatitis A Vaccine, she started having the following symptoms and they have gotten worse instead of better:  Severe pain in upper left arm, shoulder radiating toward neck.  Weak, fatigued and pale. Patient did not report any symptoms to the nurse immediately after the vaccine.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Vaccination complication
Clinical narrative: Patient's mother called on 7/13/16 and reported that immediately after the patient received the Hepatitis A Vaccine, she started having the following symptoms and they have gotten worse instead of better:  Severe pain in upper left arm, shoulder radiating toward neck.  Weak, fatigued and pale. Patient did not report any symptoms to the nurse immediately after the vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to three patients of an unknown gender and age. The patients' medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients received the first and the second dose of VARIVAX 0.5 ml (lot#, expiration date and route of administration were not reported). The physician reported that on an unknown date, during evaluation for "pre-college", varicella-zoster serology was performed and the patients had "an antibody response that was not applicable (below level)". The patients did not receive treatment for the event. Product quality complaint (PQC) was not involved. The outcome of the patients had "an antibody response that was not appropriate (below level)" was not reported. The relatedness between the patients had "an antibody response that was not applicable (below level) and VARIVAX was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Information has been received from a physician via a company representative referring to a teenage female patient. The patient's pertinent medical history and drug reactions/allergies were unknown. In approximately July 2012 (reported as "about 4 years ago") the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date not reported). It was unknown if the patient had any concomitant medication. On an unknown date the patient developed type I diabetes after administration of GARDASIL. The patient had not recovered from the event. The causality between GARDASIL and the event was not provided. Upon internal review, the event of type I diabetes was considered to be medically significant. 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 a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 06-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 06-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 24-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent or historical condition was not provided. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L042257 with expiration date 17-AUG-2018, L051124 with expiration date 14-OCT-2018, M010439 with expiration date 08-DEC-2018, dose and route unknown). Concomitant therapy was not provided. There was no previous temperature excursion. the vaccine was stored under 0 Celsius degree for 72 hours. Data logger was not involved. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. on 19-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported) (incorrect product storage). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (frequency: one, route: subcutaneous or intramuscular, lot # L022262 with expiration date 05-NOV-2016; dose was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reaction/allergies were reported. On 12-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unknown number of an unknown patients of an unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients was vaccinated with an improperly stored doses of ROTATEQ, lot# K019370 (expiry date: 16-JUL-2016) were administered to an unknown number of an unknown patients (dosage not reported). The storage temperature was 32 Fahrenheit for 24 hours. No previous excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 11-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 10-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017 (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of Gardasil 9 (lot # M003659, expiration date 20-SEP-2017) intramuscularly. Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown ages and genders.  The patients' medical histories and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L027076, expiration date 25-MAY-2017) orally. Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of M-M-R II (lot # L027591, expiration date 23-JUL-2017) subcutaneously. Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 10-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Bone pain, Dizziness, Feeling of body temperature change, Limb discomfort
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a 22 year old female patient. None pertinent medical history, drug reactions/allergies and concomitant medication. On 25-MAY-2016, the patient was vaccinated with GARDASIL 9 in the arm (lot number and dosage not reported). On 26-MAY-2016, the patient felt "woozy, my bones ache, heavy feelings in arms. The patient also was not able to lift anything over 10 pounds and had the feeling of being hot and cold". The patient sought medical attention, called the nurse. The patient received unspecified treatment for the event. None lab diagnostics studies performed. On 27-MAY-2016, patient "felt better" from the events. The reporter did not provide any causality assessment between events and GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse and a physician via company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 21-JUN-2016, the patient was vaccinated with one dose of MMR II injection (lot # L03962 (reporter has requested lot check), therapy type recombinant human albumin and Expiry date: 07-OCT-2017 subcutaneously for routine vaccination. On the same day within 3 minutes after receiving the vaccine dose, the patient experienced "a welt about the size of a nickle and redness about the size of a 50 cent piece" at the injection site (injection site urticarial and injection site erythema). The patient did not receive any treatment for the events. The outcome of the events were reported as unknown. The reporter did not provide the causality assessment for the adverse events. There was no Product Quality Complaint (PQC) involved. This is one of the several reports 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 physician referring to multiple unspecified patients of unknown age and gender. Concurrent and historical condition was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L013202 with expiration date 27-JAN-2017; dose and route unknown). Concomitant therapy was not provided. The physician reported there were no adverse effects. There was no previous excursion. The vaccine was exposed to 33.3F for 3 hours and 59.1F for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse and a physician via company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. About 3 weeks ago(approximately in May 2016), the patient was vaccinated with M-M-R II injection (lot # L043704(reporter has requested a lot check), therapy type recombinant human albumin (rHA), Expiry date: 04-NOV-2017 and dose was not reported) subcutaneously. Within 3 minutes after receiving the vaccine dose(onset approximately in May 2016), the patient experienced "a welt about the size of a nickel and redness about the size of a 50 cent piece" at the injection site. The patient did not receive any treatment for the events. The outcome of the events were reported as unknown. The reporter did not provide the causality assessment for the adverse events. There was no Product Quality Complaint (PQC) involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse and a physician via company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. About 3 weeks ago (approximately in May 2016), the patient was vaccinated with M-M-R II injection (lot # L043704 (reporter has requested a lot check), therapy type recombinant human albumin (rHA), Expiry date: 04-NOV-2017 and dose was not reported) subcutaneously. Within 3 minutes after receiving the vaccine dose (onset approximately in May 2016), the patient experienced "a welt about the size of a nickel and redness about the size of a 50 cent piece" at the injection site. The patient did not receive any treatment for the events. The outcome of the events were reported as unknown. The reporter did not provide the causality assessment for the adverse events. There was no Product Quality Complaint (PQC) involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent historical condition was not provided. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L040178 with expiration date 18-AUG-2017, L04081 with expiration date 18-AUG-2017, M000592 with expiration date 12-OCT-2017, dose and route unknown). Concomitant therapy was not reported. There was no previous temperature excursion. The vaccine was stored under 0 Celsius degree for 72 hours. Data logger was not involved. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Complex partial seizures
Clinical narrative: Complex partial seizure
Age: 17.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Chills, Injection site pain, Malaise, Mobility decreased, Pyrexia
Clinical narrative: A lot of pain at injection site.  My daughter didn't feel like she could move her arm.  A few hours later she didn't feel well, was feverish off an on all night with chills and threw up the next morning.
Age: 17.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Vomiting
Clinical narrative: A lot of pain at injection site.  My daughter didn't feel like she could move her arm.  A few hours later she didn't feel well, was feverish off an on all night with chills and threw up the next morning.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness of injection site and pain of muscle in upper arm.  After a few hrs the erythema extended to the popliteal area covering the entire upper arm. There was edema such that the circumference of the arm was 1.5 inches greater than the other arm. Intense pain and hyperemia as well as extreme warmth to the area. Improvement by day 3 but migration of erythema down arm. Swelling persists.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Redness of injection site and pain of muscle in upper arm.  After a few hrs the erythema extended to the popliteal area covering the entire upper arm. There was edema such that the circumference of the arm was 1.5 inches greater than the other arm. Intense pain and hyperemia as well as extreme warmth to the area. Improvement by day 3 but migration of erythema down arm. Swelling persists.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Swelling, fever to 100.5, redness, pain increasing in severity, pain becoming all over body.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pruritus, Injection site nodule, Injection site swelling, Pain
Clinical narrative: Pt had knot and swelling at injection site also soreness and eye itching.
Age: 11.0
Sex: M
Vaccine: YF
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Initial unsolicited report received from a nurse on 16 Jun 2016. This case is linked to 2016SA114800 (same reporter). This case involves an 11-year-old male patient (one of the two boys) who was vaccinated with first dose of Yellow Fever Vaccine (lot number: UI291AA, expiration date: 20 Apr 2018, dose, route of administration not reported) in deltoid on 13 Jun 2016. The medical history incuding any allergies, illness at time of vaccination and concomitant medications were reported as none. It was unknown if any other vaccine administered to the patient within four weeks of suspect vaccine. On 14 Jun 2016, one day after vaccination, patient experienced pain in the axilla. The patient also had lymph node swelling that was obvious to the mother. The reporter planned to advise the mother to take the patient to see their pediatrician and have them evaluated for their symptoms. It was reported that patient required doctor visit. The lab data was reported as none. Corrective treatment was not reported. The outcome for the events was reported as unknown. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Chest discomfort, Computerised tomogram thorax, Dizziness, Dyspnoea
Clinical narrative: Initial unsolicited report received from a nurse on 08 July 2016. This case involves a 60-year-old male patient who was vaccinated with a dose of FLUZONE (batch number UI523AA, expiry date was not reported) intramuscularly in left deltoid on 28 June 2016 at 1-2 PM. Patient had denied any illness at the time of vaccination. Patient had no known drug allergy (NKDA), denied birth defects and patient was taking medicine for hypertension. Concomitant medication were lisinopril 20/25, Norvasc 10 mg and duloxetine 60 mg. On 30 June 2016 at 01:00 PM, "with HA" two days following the vaccination patient had experienced fatigue, chest heaviness, dizzy, while going upsteps patient had heart palpations, anxious, shortness of breath (SOB) while going upstairs and irreg heart beat. On 30 June 2016, patient was hospitalized and patient was evaluated. Laboratory investigation included pulse 104, CT Scan-lungs. Corrective treatment was nitro. On an unspecified date, patient had recovered. On 01 July 2016, patient was discharged and patient was told to rest Saturday. List of documents held by sender: none. Sender's Comments: This is a poorly documented case of fatigue, dizzy, chest heaviness, SOB while going upstairs, heart palpations and anxious following INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. Time to onset of 2 days is compatible. Additional information regarding, patient's relevant medical history, vaccination history, etiological work-up, final diagnosis are needed for complete assessment of the case. Based on the information provided, this is a case without adequate information for causality conclusion at this time.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Heart rate irregular, Palpitations
Clinical narrative: Initial unsolicited report received from a nurse on 08 July 2016. This case involves a 60-year-old male patient who was vaccinated with a dose of FLUZONE (batch number UI523AA, expiry date was not reported) intramuscularly in left deltoid on 28 June 2016 at 1-2 PM. Patient had denied any illness at the time of vaccination. Patient had no known drug allergy (NKDA), denied birth defects and patient was taking medicine for hypertension. Concomitant medication were lisinopril 20/25, Norvasc 10 mg and duloxetine 60 mg. On 30 June 2016 at 01:00 PM, "with HA" two days following the vaccination patient had experienced fatigue, chest heaviness, dizzy, while going upsteps patient had heart palpations, anxious, shortness of breath (SOB) while going upstairs and irreg heart beat. On 30 June 2016, patient was hospitalized and patient was evaluated. Laboratory investigation included pulse 104, CT Scan-lungs. Corrective treatment was nitro. On an unspecified date, patient had recovered. On 01 July 2016, patient was discharged and patient was told to rest Saturday. List of documents held by sender: none. Sender's Comments: This is a poorly documented case of fatigue, dizzy, chest heaviness, SOB while going upstairs, heart palpations and anxious following INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. Time to onset of 2 days is compatible. Additional information regarding, patient's relevant medical history, vaccination history, etiological work-up, final diagnosis are needed for complete assessment of the case. Based on the information provided, this is a case without adequate information for causality conclusion at this time.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Death
Clinical narrative: Initial unsolicited report received from other healthcare professional on 08 July 2016. This case involves a 42-year-old female patient who was vaccinated with a dose of TENIVAC (batch number: U5411AA, expiry date, site and route of administration not reported) on 16 June 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies: none known as per reporter; Medical History: none as per reporter. Concomitant medications were not reported. Any other vaccinations within 4 weeks of vaccinations was not reported. On 30 June 2016, 14 days following the vaccination, it was reported that the patient did not have any reactions at that time. Then stated they heard from another patient that, later that night of 30 June 2016, the patient had passed away. Relevant diagnostic tests/laboratory data was not reported. The patient's corrective treatment was not reported. On 30 June 2016, the patient had died. List of documents held by sender: none. Sender's Comments: This case concerns a death in a patient who was vaccinated with DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and two other products. This case is not sufficiently documented. More information including and not limited to detailed Autopsy report and patient's medical history, laboratory tests are needed to further assess this case. Based on the information provided; the role of vaccine cannot be assessed. Reported Cause(s) of Death: passed away.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Grunting, Irritability, Vomiting, Vomiting projectile
Clinical narrative: Patient received ROTATEQ prior to receiving 6 month vaccines about 5:30pm. Patient is exclusively breastfed. Patient nursed as usual every 2-3 hours. Patient went to bed but seemed to be irritable by grunting, no fever. Projectile vomiting started at midnight 5 episodes of projectile-vomiting which turned bilious. Over the duration of 3 hours. Patient did not eat until 7:50am. Patient has spit up multiple times each day since 7/6/16.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Feeling of body temperature change, Headache, Nausea, Pyrexia
Clinical narrative: Received Tdap 7/13/16 at 11:15am. Awoke 2am 7/14/16 with headache (severe), fever, feeling hot and cold. Developed joint aches upper body, nausea. No vomiting, rash, or hives. Vaccine site not particularly sore. Seen by our site to evaluate sx - 7/14/16 at 3:30pm - consulted with ID - NAPROSYN - PHENERGAN for nausea.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Tdap received on 7/13/16 at 1:56pm. She woke up at 3am 7/14/16 with nausea, vomiting, headache. Seen for sx. at our office 7/14/16 at 4:00pm. Infectious Disease physician called - treatment was OTC NAPROSYN and if sx worsen or new sx seek emergent care.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given two doses of hib vaccine on the same visit no adverse reaction occurred.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Pyrexia, Rash vesicular
Clinical narrative: Vesicles erupted after vaccine administration approx. 5 hours later. Redness also present; worsening throughout day - spreading - body aches and pains, fever after 30 hours. Antibiotics.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching on my behind. woke up at about 2:00AM itching so bad I could not deal with it, hives on my stomach, breast, behind,groins, hands and feet itching, went to ER around 2:30AM.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Diarrhoea, Joint range of motion decreased, Nausea
Clinical narrative: Initially had fever, chills, nausea, joint pain and loose stools. Fever chills and loose stools resolved after 1 day. Joint pain persists - to shoulder, wrist and elbow with decreased range of motion. Mild nausea perists.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Initially had fever, chills, nausea, joint pain and loose stools. Fever chills and loose stools resolved after 1 day. Joint pain persists - to shoulder, wrist and elbow with decreased range of motion. Mild nausea perists.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Injection site pain, Myalgia, Nausea
Clinical narrative: Fatigue, muscle aches, nausea temp 99.0. Soreness at inj site x 2 days so far.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Immunization administered 2 days ago. Swelling and erythema present at site 1 day after administration. Large local reaction. Advised PRN antihistamines for itchiness.
Age: 1.26
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Abasia, Herpes zoster, Injection site pain, Injection site rash, Rash vesicular
Clinical narrative: Child developed unexplained pain in right leg and refusal to walk, worsened over subsequent day and then developed a dermatome-distributed herpetiform rash on the leg.  I presume this to be herpes zoster related to his varicella vaccine (simplex not ruled out but no history to suggest it).  I have started him on acyclovir today and will follow his progress.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: Redness to shot sight, swelling and pain.
Sex: M
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Foetal growth restriction, Hydrocele, Low birth weight baby, Strabismus
Clinical narrative: This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of hydrocele in a male infant exposed to BOOSTRIX (batch number 9M9AA, expiry date 23rd October 2016) in utero. The mother received the product. On 16th September 2014, the mother received BOOSTRIX. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was exposed to BOOSTRIX during the third trimester of pregnancy. The infant was born via unknown delivery and weighed 2353 grams (5lbs 3oz) at birth. The infant was diagnosed with intrauterine growth retardation (serious criteria GSK medically significant). The infant experienced low birth weight. On an unknown date, the infant experienced hydrocele (serious criteria congenital anomaly), exotropia and maternal vaccine exposure. On an unknown date, the outcome of the hydrocele was recovered/resolved and the outcome of the intrauterine growth retardation, birth weight low and maternal vaccine exposure were unknown and the outcome of the exotropia was not recovered/not resolved. It was unknown if the reporter considered the hydrocele, intrauterine growth retardation, exotropia and birth weight low to be related to BOOSTRIX. Additional information was provided as follows: The mother received BOOSTRIX vaccine during her third trimester of pregnancy and her baby did not grow from that point. Less than a year after receiving the vaccination with BOOSTRIX, the patient had hydrocele which was noted between her patient's 2nd and 6th month check-up which resolved on its own and in 2015 during the infant's first year of life, several months after vaccination, exotropia was noted.