chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored GARDASIL (Lot # K009482 with expiration date of 06-MAR-2017), (dose and route were not reported), which were stored at 1.8 C for 1 hour and 45 minutes. The vaccines did not have previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report has been received from a registered nurse, via a company representative, referring to a child of unknown age and gender. Information regarding medical history and concurrent conditions was not reported. According to the reporter, on an unknown date, the patient was vaccinated with either a dose of VARIVAX (Merck) (dose, frequency, lot #, and expiration date were not provided) or PROQUAD (Merck) (dose, frequency, lot# and expiration date were not provided) (the reporter could not determinate which of the vaccines was administered). Concomitant therapies were not provided. In March 2016, the nurse stated that she was notified of a case of breakthrough varicella in this child who was vaccinated with VARIVAX (Merck) or PROQUAD (Merck). At the time of reporting the outcome of breakthrough varicella was unknown. The relatedness between the event and VARIVAX (Merck) or PROQUAD (Merck), was not reported. This is one of two cases received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Rhesus antigen negative
Clinical narrative: This spontaneous prospective pregnancy report has been received from a registered nurse via a company representative referring to a 25 year old female patient. The patient had 27 weeks of gestation, her last menstrual period (LMP) was approximately on 29-SEP-2015, estimated date of conception was calculated to be on 13-OCT-2015 and due date to be on 05-JUL-2016; her medical history included that she was Rh negative and also a vaginal bleeding on 25-DEC-2015, when she went to the emergency department and confirmed that she was pregnant. Information regarding drug reactions or allergies were not known. On 05-APR-2016 the patient was mistakenly vaccinated with GARDASIL, intramuscular, (dose and frequency were not provided) lot # L039066 and expiration date 19-MAR-2017. The nurse reported that it was due to human error. Concomitant therapies included RHOGAM. No adverse effect reported or product quality complains involved. The nurse stated that the patient went to the office to seek medical attention and moreover, laboratory test were not specified by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a child of unknown age and gender. Information regarding medical history and concurrent conditions was not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, frequency, lot #, and expiration date were not provided). Concomitant therapies were not provided. In January 2016, the nurse stated that she was notified of a case of breakthrough varicella in this child who was vaccinated with VARIVAX (Merck). At the time of reporting, the outcome of breakthrough varicella was unknown. The relatedness between the event and VARIVAX (Merck), was not reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 12-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 26-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 27-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes simplex, Ophthalmic herpes zoster
Clinical narrative: Information was received on 07-APR-2016 from a letter and pharmacy records received from a 73 year old consumer who is reporting on herself with a history of an allergy to Keflex. No other medical history or concomitant medications were reported. ON 30-AUG-2007, the patient received a dose of ZOSTAVAX (lot, dose and injections site not reported). In March 2014, the patient developed shingles on the right side of her head and they got in her right. After about a month, became of the weakened state of her eye, the herpes simplex also got in it. She states "it has been a battle ever since." She reports that her eye is still in "bad shape" and she requires 4 different drops daily and also takes pills to keep the shingles from returning. Pharmacy records indicate that that patient filled the following treatment medications on the following dates: acyclovir 400 mg 18-APR-14, 18-NOV-2014; acyclovir 800 mg: 02-JUN-2014, 30-SEP-2015; timolol maleate 0.5% ophthalmic 09-JUN-2014; trifluridine 1% ophthalmic 12-JUN-2014, 27-APR-2015, 11-AUG-2015, prednisolone AC 1% ophthalmic 09-JUN-2014, 18-SEP-2015, 05-JAN-2016; Besivance 0.6% ophthalmic 05-JAN-2016, Valsartan 160 mg 25-MAR-2015, levofloxacin 500 mg 02-FEB-2015; erythromycin ophthalmic ointment 29-MAY-2014, 12-JUN-2014; Gentak 0.3% ophthalmic 13-MAR-2014. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored VARIVAX (Merck) (Lot # L006383 with expiration date of 25-FEB-2017), (dose and route were not reported), which were stored at -9.7 C for 12 hours and 47 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to 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 unknown dates, the patients were administered improperly stored PROQUAD (Merck) (Lot # L007231 with expiration date of 03-SEP-2016), (dose and route were not reported), which were stored at -9.7 C for 12 hours and 47 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored RECOMBIVAX HB (Lot # L045117 with expiration date of 16-OCT-2018), (dose and route were not reported), which were stored 1.8 C for 1 hour and 45 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to 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 unknown dates, the patients were administered improperly stored ROTATEQ orally (Lot # L029617 with expiration date of 19-MAY-2017), (dose not reported), which were stored at 1.8 C for 1 hour and 45 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored GARDASIL 9 (Lot # L020015 with expiration date of 16-AUG-2017), (dose and route were not reported), which were stored at 1.8 C for 1 hour and 45 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: FLU3, HPV4, TDAP, FLU3, HPV4, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 year old patient of unknown gender. On 25-JAN-2016, the patient was vaccinated with a dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the right arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Concomitant therapies included Tdap and influenza virus vaccine (unspecified). Additional information is not expected, as all required correspondence was received.
Age: 15.0
Sex: U
Vaccine: FLU3, HPV4, TDAP, FLU3, HPV4, TDAP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 year old patient of unknown gender. On 25-JAN-2016, the patient was vaccinated with a dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the right arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Concomitant therapies included Tdap and influenza virus vaccine (unspecified). Additional information is not expected, as all required correspondence was received.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL, VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 12 month old female patient. The patient did not have any pre-existing allergies, birth defects or medical conditions. The patient's illness at the time of vaccination included an ear infection without fever. On 14-MAR-2016, the patient was vaccinated with a dose of (Merck) VARIVAX subcutaneously, on left thigh, which had a lot # L041206 (expiration date and dose were not reported). On the same date, the patient was also vaccinated with a dose of MMR II subcutaneously in the right thigh, lot # L034730 (expiration date and dose were not reported). Additionally, she was vaccinated with a dose of VAQTA intramuscular on the left thigh, which has a lot # L045713 (expiration date and dose were not reported). Concomitant therapies included amoxicillin. On 16-MAR-2016, a rash erupted, involving the extremities and trunk which progressed from 10 - 12 lesions to 200 or more lesions before it started to resolved. The patient sought for medical attention with a doctor visit but no it was not reported if any treatment was given, however, lab diagnostics were not performed. On 28-MAR-16, the patient was still recovering from the event and was getting better (also reported as "recovered") nevertheless it was reported that it had taken some time. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL, VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 12 month old female patient. The patient did not have any pre-existing allergies, birth defects or medical conditions. The patient's illness at the time of vaccination included an ear infection without fever. On 14-MAR-2016, the patient was vaccinated with a dose of (Merck) VARIVAX subcutaneously, on left thigh, which had a lot # L041206 (expiration date and dose were not reported). On the same date, the patient was also vaccinated with a dose of MMR II subcutaneously in the right thigh, lot # L034730 (expiration date and dose were not reported). Additionally, she was vaccinated with a dose of VAQTA intramuscular on the left thigh, which has a lot # L045713 (expiration date and dose were not reported). Concomitant therapies included amoxicillin. On 16-MAR-2016, a rash erupted, involving the extremities and trunk which progressed from 10 - 12 lesions to 200 or more lesions before it started to resolved. The patient sought for medical attention with a doctor visit but no it was not reported if any treatment was given, however, lab diagnostics were not performed. On 28-MAR-16, the patient was still recovering from the event and was getting better (also reported as "recovered") nevertheless it was reported that it had taken some time. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL, VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 12 month old female patient. The patient did not have any pre-existing allergies, birth defects or medical conditions. The patient's illness at the time of vaccination included an ear infection without fever. On 14-MAR-2016, the patient was vaccinated with a dose of (Merck) VARIVAX subcutaneously, on left thigh, which had a lot # L041206 (expiration date and dose were not reported). On the same date, the patient was also vaccinated with a dose of MMR II subcutaneously in the right thigh, lot # L034730 (expiration date and dose were not reported). Additionally, she was vaccinated with a dose of VAQTA intramuscular on the left thigh, which has a lot # L045713 (expiration date and dose were not reported). Concomitant therapies included amoxicillin. On 16-MAR-2016, a rash erupted, involving the extremities and trunk which progressed from 10 - 12 lesions to 200 or more lesions before it started to resolved. The patient sought for medical attention with a doctor visit but no it was not reported if any treatment was given, however, lab diagnostics were not performed. On 28-MAR-16, the patient was still recovering from the event and was getting better (also reported as "recovered") nevertheless it was reported that it had taken some time. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Burning sensation, Hyperaesthesia, Musculoskeletal pain, Pain, Paraesthesia
Clinical narrative: 11-03-15 arm pain. 11-04-15 poor gait, back pain, abdominal pain. Hydrocodone-acetaminophen prescribed, ibuprofen for pain and increased gabapentin. 11-23-15 abdominal CT negative for cause of abdominal pain. Hospitalization for torso pain starting from shoulders down to his back and abdomen. Lumbar puncture 12-14-15 abnormal spinal fluid. Opiate dependence. Dx: Chronic inflammatory demyelinating polyradiculoneuropathy.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Abdominal pain, Back pain, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram abdomen normal, Drug dependence
Clinical narrative: 11-03-15 arm pain. 11-04-15 poor gait, back pain, abdominal pain. Hydrocodone-acetaminophen prescribed, ibuprofen for pain and increased gabapentin. 11-23-15 abdominal CT negative for cause of abdominal pain. Hospitalization for torso pain starting from shoulders down to his back and abdomen. Lumbar puncture 12-14-15 abnormal spinal fluid. Opiate dependence. Dx: Chronic inflammatory demyelinating polyradiculoneuropathy.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Gait disturbance, Lumbar puncture abnormal, Musculoskeletal pain, Nuclear magnetic resonance imaging brain, Pain in extremity
Clinical narrative: 11-03-15 arm pain. 11-04-15 poor gait, back pain, abdominal pain. Hydrocodone-acetaminophen prescribed, ibuprofen for pain and increased gabapentin. 11-23-15 abdominal CT negative for cause of abdominal pain. Hospitalization for torso pain starting from shoulders down to his back and abdomen. Lumbar puncture 12-14-15 abnormal spinal fluid. Opiate dependence. Dx: Chronic inflammatory demyelinating polyradiculoneuropathy.
Age: 26.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old non-pregnant female patient. The patient was a smoker and had allergies (details were not specified). No information about the patient's concomitant therapies was provided. On 13-APR-2016, the patient was vaccinated with PNEUMOVAX23 intramuscularly, in the arm, lot # L040181, expiry date 18-AUG-2017 (dose was not specified). On 14-APR-2016, the patient experienced small red patches on her arm where the PNEUMOVAX23 was administered. The patient sought medical attention and called the reporting pharmacist on 15-APR-2016, in the morning. The pharmacist suggested she placed ice on the small red patches and took some ibuprofen. The outcome of the events was reported as not recovered. The reporter did not provided the causality assessment. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 54 year old female consumer with high blood pressure, allergies, depressions, drug hypersensitivity to sulfonamide and doxycycline, refers to herself. On 08-APR-2016, the patient was vaccinated subcutaneously with ZOSTAVAX (refrigerated vial 19400 plaque-forming unit (PFU)) (dose, lot number and expiration date were unknown) at her pharmacist's suggestion. Concomitant therapies included CYMBALTA, lisinopril (manufacturer unknown), omeprazole (manufacturer unknown), CELEXA and SINGULAIR. On 09-APR-2016 (Saturday), the patient experienced a slight reaction at the injection site. It was a little red and swollen, just like the pharmacist told her it may be. On 10-APR-2016 (Sunday), the redness and swelling were a little larger. On 11-APR-2016, the area that was red and swollen was as large as her hand stretched out from the tip of her middle finger to her thumb. The upper arm was also hot to the touch and sore. The patient also was not feeling well and was tired. No treatment was given for the events and no lab diagnostic studies were performed. The outcome of the events was not reported. The patient sought medical attention via calling a physician, but as of the time of the report, he had not yet responded. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Malaise, Pain in extremity
Clinical narrative: This spontaneous report as received from a 54 year old female consumer with high blood pressure, allergies, depressions, drug hypersensitivity to sulfonamide and doxycycline, refers to herself. On 08-APR-2016, the patient was vaccinated subcutaneously with ZOSTAVAX (refrigerated vial 19400 plaque-forming unit (PFU)) (dose, lot number and expiration date were unknown) at her pharmacist's suggestion. Concomitant therapies included CYMBALTA, lisinopril (manufacturer unknown), omeprazole (manufacturer unknown), CELEXA and SINGULAIR. On 09-APR-2016 (Saturday), the patient experienced a slight reaction at the injection site. It was a little red and swollen, just like the pharmacist told her it may be. On 10-APR-2016 (Sunday), the redness and swelling were a little larger. On 11-APR-2016, the area that was red and swollen was as large as her hand stretched out from the tip of her middle finger to her thumb. The upper arm was also hot to the touch and sore. The patient also was not feeling well and was tired. No treatment was given for the events and no lab diagnostic studies were performed. The outcome of the events was not reported. The patient sought medical attention via calling a physician, but as of the time of the report, he had not yet responded. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a 54 year old female consumer with high blood pressure, allergies, depressions, drug hypersensitivity to sulfonamide and doxycycline, refers to herself. On 08-APR-2016, the patient was vaccinated subcutaneously with ZOSTAVAX (refrigerated vial 19400 plaque-forming unit (PFU)) (dose, lot number and expiration date were unknown) at her pharmacist's suggestion. Concomitant therapies included CYMBALTA, lisinopril (manufacturer unknown), omeprazole (manufacturer unknown), CELEXA and SINGULAIR. On 09-APR-2016 (Saturday), the patient experienced a slight reaction at the injection site. It was a little red and swollen, just like the pharmacist told her it may be. On 10-APR-2016 (Sunday), the redness and swelling were a little larger. On 11-APR-2016, the area that was red and swollen was as large as her hand stretched out from the tip of her middle finger to her thumb. The upper arm was also hot to the touch and sore. The patient also was not feeling well and was tired. No treatment was given for the events and no lab diagnostic studies were performed. The outcome of the events was not reported. The patient sought medical attention via calling a physician, but as of the time of the report, he had not yet responded. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program refers to a 14 year old female patient. The patient had no concurrent condition. On an unknown date the patient was vaccinated with her first dose of GARDASIL (dose and route were not reported). There was no concomitant therapy. On an unknown date in 2009 the patient experience dizziness. The patient did not faint but had to lie down. Blood pressure was normal in 10-15 minutes and she went home. No diagnostic test was performed. The outcome of dizziness was reported as recovering. The event did not present administration of second and third dose of GARDASIL. The reporter considered dizziness to be related to GARDASIL. Additional information is not expected since the physician does not wish to be contacted.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Condition aggravated, Joint swelling, Lethargy, Lip swelling, Migraine
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient experienced arthralgia after received the dose of GARDASIL 9. The outcome of arthralgia was unknown. The reporter did not assess the relatedness between the event and suspect therapy. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient experienced arthralgia after received the dose of GARDASIL 9. The outcome of arthralgia was unknown. The reporter did not assess the relatedness between the event and suspect therapy. No product quality complaint was involved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This is an update to previous form. Pt had a stroke and was hospitalized.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: This is an update to previous form. Pt had a stroke and was hospitalized.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria, Echocardiogram
Clinical narrative: This is an update to previous form. Pt had a stroke and was hospitalized.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Headache, Hemiparesis, Hypoaesthesia, Nuclear magnetic resonance imaging
Clinical narrative: This is an update to previous form. Pt had a stroke and was hospitalized.
Age: 1.01
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: SEVERE SWELLING AT INJECTION SITE IN THIGH. RED RING AROUND INJECTION SITE APPROX 3 IN IN DIAMETER. HOT TO TOUCH. PAINFUL FOR CHILD TO WALK X5 DAYS.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Pain at site of injection and radiating down arm--became worse as night progressed. Also pain in all joints and weakness of legs.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Abdominal pain lower, Bacterial test negative, Blood potassium normal, Clostridium test negative
Clinical narrative: Initial unsolicited report received from the literature on 18-Apr-2016.  This case involves 31-year-old male patient who was vaccinated with intramuscular injection of Influenza vaccine quadrivalent (batch number, dose, dose in series and site of administration were not reported) on an unspecified date. The patient had no significant medical history, no known risk factors and concomitant medications were not reported. On an unspecified date, 12 weeks after the vaccination, the patient experienced severe myalgia, low grade fever, headache, cough and on an unspecified date, patient also experienced abdominal cramps, right lower quadrant abdominal pain and moderate bloody diarrhea. It was a case of vaccination failure. On an unspecified date, the patient was hospitalized. Laboratory investigations included hemoglobin 11.5 g/dL, leukocyte count 10,500 /mm3 and borderline low potassium level 3.7 mmol/L. Abdominopelvic CT scan showed moderately severe right sided colitis. Bacterial cultures of stool, stool examination for ova and parasites and polymerase chain reaction assay for C. difficile toxin did not reveal enteric pathogens. A rapid diagnostic test showed positive influenza A. patient had received oseltamivir 75 mg orally twice daily for influenza A as a corrective treatment. On an unspecified date, patient recovered from the events with conservative therapy including discontinuation of oseltamivir at the onset of abdominal symptoms, IV hydration and electrolyte repletion. On an unknown date, patient was discharged 5 days after the hospitalization. Documents held by sender: Yes. Sender's Comments: As with any vaccine, vaccination with INFLUENZA QUADRIVAL A-B VACCINE may not protect all recipients. A 31 years old patient experienced influenza type A, 12 weeks after vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Patient was treated with oseltamivir and two days later patient experienced ischemic colitis. In this particular case, Vaccination Failure for INFLUENZA QUADRIVAL A-B VACCINE leading to the event influenza type A cannot be ruled out, whereas, the causality for Ischemic colitis can be ruled out, because Ischemic colitis is more likely due to treatment with oseltamivir. As the symptoms of Ischemic colitis improved rapidly on discontinuation of Oseltamivir along with conservative therapy.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Colitis, Colitis ischaemic, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis, Cough
Clinical narrative: Initial unsolicited report received from the literature on 18-Apr-2016.  This case involves 31-year-old male patient who was vaccinated with intramuscular injection of Influenza vaccine quadrivalent (batch number, dose, dose in series and site of administration were not reported) on an unspecified date. The patient had no significant medical history, no known risk factors and concomitant medications were not reported. On an unspecified date, 12 weeks after the vaccination, the patient experienced severe myalgia, low grade fever, headache, cough and on an unspecified date, patient also experienced abdominal cramps, right lower quadrant abdominal pain and moderate bloody diarrhea. It was a case of vaccination failure. On an unspecified date, the patient was hospitalized. Laboratory investigations included hemoglobin 11.5 g/dL, leukocyte count 10,500 /mm3 and borderline low potassium level 3.7 mmol/L. Abdominopelvic CT scan showed moderately severe right sided colitis. Bacterial cultures of stool, stool examination for ova and parasites and polymerase chain reaction assay for C. difficile toxin did not reveal enteric pathogens. A rapid diagnostic test showed positive influenza A. patient had received oseltamivir 75 mg orally twice daily for influenza A as a corrective treatment. On an unspecified date, patient recovered from the events with conservative therapy including discontinuation of oseltamivir at the onset of abdominal symptoms, IV hydration and electrolyte repletion. On an unknown date, patient was discharged 5 days after the hospitalization. Documents held by sender: Yes. Sender's Comments: As with any vaccine, vaccination with INFLUENZA QUADRIVAL A-B VACCINE may not protect all recipients. A 31 years old patient experienced influenza type A, 12 weeks after vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Patient was treated with oseltamivir and two days later patient experienced ischemic colitis. In this particular case, Vaccination Failure for INFLUENZA QUADRIVAL A-B VACCINE leading to the event influenza type A cannot be ruled out, whereas, the causality for Ischemic colitis can be ruled out, because Ischemic colitis is more likely due to treatment with oseltamivir. As the symptoms of Ischemic colitis improved rapidly on discontinuation of Oseltamivir along with conservative therapy.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea haemorrhagic, Haemoglobin decreased, Headache, Influenza, Influenza A virus test positive
Clinical narrative: Initial unsolicited report received from the literature on 18-Apr-2016.  This case involves 31-year-old male patient who was vaccinated with intramuscular injection of Influenza vaccine quadrivalent (batch number, dose, dose in series and site of administration were not reported) on an unspecified date. The patient had no significant medical history, no known risk factors and concomitant medications were not reported. On an unspecified date, 12 weeks after the vaccination, the patient experienced severe myalgia, low grade fever, headache, cough and on an unspecified date, patient also experienced abdominal cramps, right lower quadrant abdominal pain and moderate bloody diarrhea. It was a case of vaccination failure. On an unspecified date, the patient was hospitalized. Laboratory investigations included hemoglobin 11.5 g/dL, leukocyte count 10,500 /mm3 and borderline low potassium level 3.7 mmol/L. Abdominopelvic CT scan showed moderately severe right sided colitis. Bacterial cultures of stool, stool examination for ova and parasites and polymerase chain reaction assay for C. difficile toxin did not reveal enteric pathogens. A rapid diagnostic test showed positive influenza A. patient had received oseltamivir 75 mg orally twice daily for influenza A as a corrective treatment. On an unspecified date, patient recovered from the events with conservative therapy including discontinuation of oseltamivir at the onset of abdominal symptoms, IV hydration and electrolyte repletion. On an unknown date, patient was discharged 5 days after the hospitalization. Documents held by sender: Yes. Sender's Comments: As with any vaccine, vaccination with INFLUENZA QUADRIVAL A-B VACCINE may not protect all recipients. A 31 years old patient experienced influenza type A, 12 weeks after vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Patient was treated with oseltamivir and two days later patient experienced ischemic colitis. In this particular case, Vaccination Failure for INFLUENZA QUADRIVAL A-B VACCINE leading to the event influenza type A cannot be ruled out, whereas, the causality for Ischemic colitis can be ruled out, because Ischemic colitis is more likely due to treatment with oseltamivir. As the symptoms of Ischemic colitis improved rapidly on discontinuation of Oseltamivir along with conservative therapy.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Parasite stool test negative, Polymerase chain reaction, Pyrexia, Vaccination failure
Clinical narrative: Initial unsolicited report received from the literature on 18-Apr-2016.  This case involves 31-year-old male patient who was vaccinated with intramuscular injection of Influenza vaccine quadrivalent (batch number, dose, dose in series and site of administration were not reported) on an unspecified date. The patient had no significant medical history, no known risk factors and concomitant medications were not reported. On an unspecified date, 12 weeks after the vaccination, the patient experienced severe myalgia, low grade fever, headache, cough and on an unspecified date, patient also experienced abdominal cramps, right lower quadrant abdominal pain and moderate bloody diarrhea. It was a case of vaccination failure. On an unspecified date, the patient was hospitalized. Laboratory investigations included hemoglobin 11.5 g/dL, leukocyte count 10,500 /mm3 and borderline low potassium level 3.7 mmol/L. Abdominopelvic CT scan showed moderately severe right sided colitis. Bacterial cultures of stool, stool examination for ova and parasites and polymerase chain reaction assay for C. difficile toxin did not reveal enteric pathogens. A rapid diagnostic test showed positive influenza A. patient had received oseltamivir 75 mg orally twice daily for influenza A as a corrective treatment. On an unspecified date, patient recovered from the events with conservative therapy including discontinuation of oseltamivir at the onset of abdominal symptoms, IV hydration and electrolyte repletion. On an unknown date, patient was discharged 5 days after the hospitalization. Documents held by sender: Yes. Sender's Comments: As with any vaccine, vaccination with INFLUENZA QUADRIVAL A-B VACCINE may not protect all recipients. A 31 years old patient experienced influenza type A, 12 weeks after vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Patient was treated with oseltamivir and two days later patient experienced ischemic colitis. In this particular case, Vaccination Failure for INFLUENZA QUADRIVAL A-B VACCINE leading to the event influenza type A cannot be ruled out, whereas, the causality for Ischemic colitis can be ruled out, because Ischemic colitis is more likely due to treatment with oseltamivir. As the symptoms of Ischemic colitis improved rapidly on discontinuation of Oseltamivir along with conservative therapy.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: White blood cell count increased
Clinical narrative: Initial unsolicited report received from the literature on 18-Apr-2016.  This case involves 31-year-old male patient who was vaccinated with intramuscular injection of Influenza vaccine quadrivalent (batch number, dose, dose in series and site of administration were not reported) on an unspecified date. The patient had no significant medical history, no known risk factors and concomitant medications were not reported. On an unspecified date, 12 weeks after the vaccination, the patient experienced severe myalgia, low grade fever, headache, cough and on an unspecified date, patient also experienced abdominal cramps, right lower quadrant abdominal pain and moderate bloody diarrhea. It was a case of vaccination failure. On an unspecified date, the patient was hospitalized. Laboratory investigations included hemoglobin 11.5 g/dL, leukocyte count 10,500 /mm3 and borderline low potassium level 3.7 mmol/L. Abdominopelvic CT scan showed moderately severe right sided colitis. Bacterial cultures of stool, stool examination for ova and parasites and polymerase chain reaction assay for C. difficile toxin did not reveal enteric pathogens. A rapid diagnostic test showed positive influenza A. patient had received oseltamivir 75 mg orally twice daily for influenza A as a corrective treatment. On an unspecified date, patient recovered from the events with conservative therapy including discontinuation of oseltamivir at the onset of abdominal symptoms, IV hydration and electrolyte repletion. On an unknown date, patient was discharged 5 days after the hospitalization. Documents held by sender: Yes. Sender's Comments: As with any vaccine, vaccination with INFLUENZA QUADRIVAL A-B VACCINE may not protect all recipients. A 31 years old patient experienced influenza type A, 12 weeks after vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Patient was treated with oseltamivir and two days later patient experienced ischemic colitis. In this particular case, Vaccination Failure for INFLUENZA QUADRIVAL A-B VACCINE leading to the event influenza type A cannot be ruled out, whereas, the causality for Ischemic colitis can be ruled out, because Ischemic colitis is more likely due to treatment with oseltamivir. As the symptoms of Ischemic colitis improved rapidly on discontinuation of Oseltamivir along with conservative therapy.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Information has been received from a physician via a company representative, referring to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (subcutaneous; dose, lot# and expiration date were not reported). Approximately one week after the vaccination, the patient experienced hearing loss. He contacted the physician to seek medical attention. The outcome of the event was not reported. Causality assessment was not reported. Upon internal review, the event hearing loss is considered to be medically significant. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: DTAPIPV
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Patient in office for 6 mnth WCC, administered KINRIX in error. S/H/B DTaP, IPV, Hib (PENTACEL). No known adverse symptoms in patient.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: Pt developed a red rash/reaction after getting her MENVEO vaccine. Site was the Lt upper arm, area was red, swollen, patient said it itches and burns.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, soreness at injection site.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt. c/o itching, and redness at injection site.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Injection site discolouration, Injection site pruritus, Peripheral swelling, Pruritus
Clinical narrative: 4-26-16, 7:40 pm Patient said his left arm was itchy and swollen, redness 3 inches by 4 inches. 4/27/16 4:45 pm Mom reports area is now pink 3" diameter, skin color at injection site. Slightly itchy. BENADRYL 2 tsps. given 4-26-16. Ice pack with good effect.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 year old patient of unknown gender. On 20-JAN-2016, the patient was vaccinated with a second dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) (dose, route and site of administration were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all required correspondence was received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients might have received unspecified doses of RECOMBIVAX HB injection (route of administration, lot# and expiration date were not reported) that were left out of the refrigerator for up to four hours prior to administration. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
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 08-FEB-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). Concomitant therapy included meningococcal vaccine and Tdap. 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: 12.0
Sex: U
Vaccine: DTP, HPV4, MEN
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 15-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, (dose and route of administration were not reported). Concomitant therapy included meningococcal vaccine (unspecified) and diphtheria (+) tetanus (+) pertussis 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.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-MAY-2015, the patient was vaccinated with GARDASIL (dose, route of administration, lot# and expiration date were not reported). On 18-APR-2016, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) (interchange of vaccine products). No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients might had been vaccinated with improperly stored PEDVAXHIB (lot # K001124, expiration date: 22-OCT-2016; lot # L012838, expiration date: 10-MAR-2018; dose and route of administration were not provided). The vaccines were exposed to temperature of 30 degrees Fahrenheit for 3 months. No previous temperature excursion was reported. No adverse symptoms were reported. Administration of vaccine was possible. There was no product quality complaint. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in March 2016 (reported as about a month ago), the adult patient was inadvertently administered a pediatric dose of RECOMBIVAX HB (route and site of administration, dose, lot number and expiration date were not reported). There was no adverse effects reported. Additional information has been requested.