chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Ultrasound kidney abnormal, Ureterocele, Ureterocelectomy
Clinical narrative: Kidney-Calyceal dilation enlarged due to rapid progression /baby has to much fluid around kidney/only one funtional kidney; the patient received GARDASIL 9 prior to pregnancy/vaccinated on 20-SEP-2016 and last menstrual period (LMP) was on 05-OCT-2016; Surgery ureterocele; Ultrasound Kidney-Calyceal dilation enlarged due to rapid progression early delivery recommended.; This spontaneous report was received from a physician referring to a male patient of unknown age. The patient's medical history, concurrent conditions, and historical drugs were not reported. Concomitant therapies included betamethasone acetate (+) betamethasone sodium phosphate(CELESTONE SOLUSPAN) and vitamins (unspecified) via transplacental.  The patients' mother was  vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for abnormal Papanicolaou (PAP) smears. She became pregnant with Last Menstrual Period (LMP) of 05-OCT-2016 and Estimated Date of Delivery (EDD) of 12-JUL-2017. The mother's history included  4 previous pregnancies and 1 live birth(s). Her concurrent conditions included mild cervical dysplasia.   On 16-JUN-2017, an ultrasound was performed to the mother of the patient and the results were that the patient had a Kidney-Calyceal dilation enlarged due to rapid progression (ultrasound kidney abnormal ) and that an early delivery was recommended. It was also reported that the patient had only one funtional kidney(renal impairment neonatal) and that at week 36 of pregancy he had too much fluid around kidneys.  The patient was born weighing 7kg 7ozs. The infant's APGAR scores were 9 at one minute and 9 at five minutes. Subsequently, on 18-JUL-2017, the new born had his first surgery on ureterocele(ureterocelectom).  At the time of the report the outcome of renal impairment neonatal, ultrasound kidney abnormal and ureterocelectomy was unknown.  The physician did not mention the causality assesment beteen the events of renal impairment neonatal, ultrasound kidney abnormal and ureterocelectomy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1612USA011465:
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL, VARCEL
Symptoms: Rash generalised, Varicella, Viral test
Clinical narrative: Patient with full body vesiculopustular rash c/w disseminated varicella disease, requiring hospitalization.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL, VARCEL
Symptoms: Disseminated varicella zoster vaccine virus infection, Rash pustular, Varicella post vaccine
Clinical narrative: Patient with full body vesiculopustular rash c/w disseminated varicella disease, requiring hospitalization.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Pain in left arm down to ring finger and pain in shoulder joint and back of neck and collar bone; can't lift left arm.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Pain in left arm down to ring finger and pain in shoulder joint and back of neck and collar bone; can't lift left arm.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Bone pain, Injected limb mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Pain in left arm down to ring finger and pain in shoulder joint and back of neck and collar bone; can't lift left arm.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain
Clinical narrative: PATIENT DESCRIBED HAVING SHOOTING PAIN FROM INJECTION SITE RADIATING TO THE BACK. PATIENT WAS  DIRECTED TO CONTACT THEIR PRIMARY CARE DOCTOR FOR TREATMENT.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia
Clinical narrative: PATIENT DESCRIBED HAVING SHOOTING PAIN FROM INJECTION SITE RADIATING TO THE BACK. PATIENT WAS  DIRECTED TO CONTACT THEIR PRIMARY CARE DOCTOR FOR TREATMENT.
Age: 88.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Injection site pain
Clinical narrative: PATIENT DESCRIBED HAVING SHOOTING PAIN FROM INJECTION SITE RADIATING TO THE BACK. PATIENT WAS  DIRECTED TO CONTACT THEIR PRIMARY CARE DOCTOR FOR TREATMENT.
Age: 18.0
Sex: F
Vaccine: FLUR3
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Woke up with extreme shoulder pain during the night that has not gone away in the days since. I have an inability to raise my arm above a certain level, and the pain is strong enough that I?m having difficulty sleeping.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Swelling
Clinical narrative: Mother called PHN and stated the morning after injection top lip and nose was swollen. After a couple of hours the swelling disappeared. There was no difficulty breathing or rash noted.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Bronchiolitis, Cough, Nasopharyngitis, Pneumonia
Clinical narrative: Bronchiolitis and pneumonia. She suddenly developed symptoms of a cold that turned into a horrible cough and bronchial tube being inflamed - bronchiolitis. Shortly after that she got pneumonia. She was given breathing treatment neublizers. Took her weeks to overcome this. Recently was hospitalized again due to Bronchiolitis.
Age: 67.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Arm sore, muscle ache still have ache as of 10/23/2017 only in left arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Loss of consciousness, Vomiting
Clinical narrative: Twelve hours after the flu shot, I had chills which lasted most of the night. Woke up to light-headedness and vomiting. Passed out once. More vomiting. Slept most of the day. Feeling much better 24 hours later.
Age: 0.33
Sex: F
Vaccine: DTAP, PNC13, RV5
Symptoms: Body temperature, Dyskinesia, Eye movement disorder, Febrile convulsion, Irritability
Clinical narrative: Information was obtained on a request by the Company from the health care professional via the Agency (HA# 404594) via a Public Case Detail concerning a 4-months-old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 16-FEB-2017, the patient was vaccinated with ROTATEQ orally (dose, lot# and expiration date were not reported) for immunization, INFANRIX injection (dose, route of administration, lot# and expiration date were not reported) for immunisation and PREVENAR 13 injection (dose, route of administration, lot# and expiration date were not reported) for immunization. On 16-FEB-2017(event onset date also reported as 17-FEB-2017), the patient experienced mild temperature and grizzliness overnight. On 17-FEB-2017, just after 07:00am (reported as today), the patient experienced small vomit followed by 40-50 seconds of seizure. The outcome of febrile convulsion, vomiting and irritability was reported as spontaneously recovered. It was reported that the patient was well in emergency department (ED). The agency considered irritability, vomiting and febrile convulsion to be possibly related to ROTATEQ. Upon internal review, the event of febrile convulsion was considered to be medically significant. Additional information is not expected as follow up information cannot be obtained from the Agency.
Age: 0.33
Sex: F
Vaccine: DTAP, PNC13, RV5
Symptoms: Seizure, Vomiting
Clinical narrative: Information was obtained on a request by the Company from the health care professional via the Agency (HA# 404594) via a Public Case Detail concerning a 4-months-old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 16-FEB-2017, the patient was vaccinated with ROTATEQ orally (dose, lot# and expiration date were not reported) for immunization, INFANRIX injection (dose, route of administration, lot# and expiration date were not reported) for immunisation and PREVENAR 13 injection (dose, route of administration, lot# and expiration date were not reported) for immunization. On 16-FEB-2017(event onset date also reported as 17-FEB-2017), the patient experienced mild temperature and grizzliness overnight. On 17-FEB-2017, just after 07:00am (reported as today), the patient experienced small vomit followed by 40-50 seconds of seizure. The outcome of febrile convulsion, vomiting and irritability was reported as spontaneously recovered. It was reported that the patient was well in emergency department (ED). The agency considered irritability, vomiting and febrile convulsion to be possibly related to ROTATEQ. Upon internal review, the event of febrile convulsion was considered to be medically significant. Additional information is not expected as follow up information cannot be obtained from the Agency.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017 (from 24-AUG-2017 to 07-SEP-2017), the patients were vaccinated with improperly stored doses of M-M-R II (recombinant human albumin) (lot # M040558, expiry date 03-OCT-2018; lot # M045401, expiry date 14-NOV-2018) (dose and route of administration were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit to 25 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA011198.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 5 year old patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-AUG-2017, the patient was vaccinated with the first dose of PROQUAD (dose, route of administration, lot # and expiry date were not provided) reconstituted with sterile diluent (STERILE DILUENT). On 27-SEP-2017, the patient was vaccinated with the second dose of PROQUAD (dose, route of administration were not provided, lot # reported as N019251, expiry date 20-DEC-2018) reconstituted with sterile diluent (STERILE DILUENT). No adverse effects were reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report has been received from a 59 year old female patient reporting on herself. Patient's concurrent condition included an "issue with a nerve in her elbow". Patient's concomitant therapies included: gabapentin, nortriptyline and Tizanidine. In 26-SEP-2017, the patient was vaccinated with ZOSTAVAX, (lot #, expiration date and concentration were not provided) dose of 0, 65 ml, route administration unknown, for prophylaxis. On the same date, about an hour later after vaccination, the patient experienced headache which "was not as bad as when it started but it was still there". The outcome of headache was reported as recovering. The causal relationship between ZOSTAVAX and the events was not reported. No product quality complaint was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacy student, regarding an adult patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB one dose (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. However, no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011207.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. In September 2017, the patient was vaccinated with PNEUMOVAX 23 lot # M038216, expiration date 09-MAY-2018, intramuscularly in the biceps muscle, for prophylaxis. On 29-SEP-2017, few hour after injection, the patient experienced redness at injection site and pain. At the time of reporting, the outcome of injection site erythema and pain was unknown. The causality assessment between injection site erythema and pain and therapy with PNEUMOVAX 23 was not provided.
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a 13 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not provided. Historical drug included a first dose of M-M-R II and varicella virus vaccine live (Oka/Merck) which were administered on 23-APR-2005 when the patient was one year of age. On 02-OCT-2017, the patient was vaccinated at the age of 13 year old of age with PROQUAD subcutaneously, lot # N019249 and expiration date 20-DEC-2018, subcutaneous (strength and frequency were not provided) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist, concerning an elderly male patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. In 2017, the patient was vaccinated with VARIVAX (dose, dose number, anatomical location, route of administration, lot number and expiration date were not provided), reconstituted with a sterile water diluent (MRK) for prophylaxis, instead of ZOSTAVAX (dose, dose number, anatomical location, route of administration, lot number and expiration date were not provided). No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored ZOSTAVAX vial 19400 PFU Lot # N020939 with expiration date on 26-OCT-2018 (dose was not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 8.2 Fahrenheit grades range for a time frame of 6 Hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA010635.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report has been received from a nurse practitioner, via a field representative, concerning a 65 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial 19400 PFU, subcutaneous injection (dose, dose number, anatomical location, lot number and expiration date were not provided), administered for prevention of herpes zoster. The reporter stated that on an unknown date, the patient had a reaction after receiving ZOSTAVAX. She had two inches of redness at injection site. It was reported that the patient sought medical attention, as she visited the physician's office, however no treatment was given for the event and no lab diagnostics or studies were performed. At the time of reporting, the patient's outcome for injection site erythema and the causal relationship between ZOSTAVAX and the event were unknown.
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a 12-month-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-AUG-2017, the patient was vaccinated with a dose of VARIVAX one time injection (dose, route of administration, lot number and expiration date were not reported) as a regular chicken pox immunization. On the same day, the patient experienced a red diffused maculopapular rash on her body, face, soles of her feet, and palms. The patient had also low grade fever. On approximately 09-AUG-2017, about one week after the onset of the events, the patient recovered. The relatedness between the events and VARIVAX was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Feeling abnormal, Lethargy, Myalgia
Clinical narrative: This spontaneous report was received from a 74 years old male patient who was a physician and reporting on himself. The patient's concurrent condition included hypertension. The patient's historical condition included stent placement. Any drug reactions or allergies were not reported. On 28-Sep-2017, approximately in September 2017, reported as "Unspecified date 6 days ago", at an unspecified pharmacy, the patient was vaccinated with ZOSTAVAX for prophylaxis, reported as "prevention of shingles" (dosage, route of administration, lot#, expiration date were unknown). Other suspect therapies included sterile diluent for unknown indication (dosage, route of administration, lot #, expiration date were unknown). Concomitant therapies included TAMIFLU, CRESTOR, sodium (unspecified) and PERCOCET. On 02-OCT-2017, the patient experienced feeling abnormal, blood pressure decreased, myalgia and lethargy. The patient received treatment due to the adverse events (also reported as received unspecified doses of TAMIFLU and PERCOCET on unspecified dates. No diagnostic tests were performed. The outcome of feeling abnormal, blood pressure decreased, myalgia and lethargy was reported as recovering/resolving, reported as "feeling much better today". Relatedness between the events and ZOSTAVAX and sterile diluent was not reported.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 78 years old male patient. The patient's concurrent conditions and medical history were reported as "a lot" but it was unspecified. No drug reactions/allergies were reported. The patient was vaccinated with PREVNAR 13 in April 2017. On 23-MAY-2017 the patient was vaccinated with ZOSTAVAX (Lot # M042854, expiration date 18-JAN-2018) with sterile diluent (MERCK) (Lot #M023895 and expiration date 18-JAN-2018) (dose was not reported) dose 1, subcutaneously in the left arm for prophylaxis. Concomitant medication included losartan potassium (manufacturer unknown) 25 mg, PROTONIX 40 mg, glyburide 3mg, pravastatin 80 mg, metoprolol 25 mg, furosemide 20 mg, amlodipine 10 mg, allopurinol 10 mg, vitamin D (unspecified) 50.000 Units, cephalexin 500 mg and LANTUS. On an unspecified date in 2017 (reported as shortly after getting ZOSTAVAX), the patient experienced a dull pain, from the shoulder to the elbow, he stated that his arm had not been the same since getting the ZOSTAVAX in May. The pain usually occurred when he laid down but went away about 5 to 10 minutes later he switched sides or get up. This seemed to be a chronic pain. The outcome of pain in extremity was reported as not recovered/not resolved. The patient did not seek for medical attention. The reporter did not assess the causal relationship between the vaccination with ZOSTAVAX and the adverse event.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-OCT-2017, the patient was vaccinated with a dose of expired VAQTA lot # M002268 with expiration date of 20-SEP-2017, intramuscularly, for prophylaxis (strength, dose and frequency were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown gender under the age of 50 years. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that the patient was administered ZOSTAVAX outside of the age recommendation from the prescribing information as on 19-SEP-2017, the patient was vaccinated with ZOSTAVAX one shot, with lot number M038864 and expiration date on 12-DEC-2017 (concentration, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent (MERCK). The reporter denied any adverse effects with the patient. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA011252.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received form a physician reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 03-OCT-2017, the patient received an expired dose of ZOSTAVAX lot # M027117, expiration date 26-JUL-2017 (dose, dose number, anatomical location and route of administration were not reported) reconstituted with diluent (manufacturer unknown) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with an improperly store dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011217: US-009507513-1710USA011216: US-009507513-1710USA011218: US-009507513-1710USA011215.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 05-OCT-2017, the patient was vaccinated with one dose of ZOSTAVAX 19400 PFU, lot # N012614 expiration date 16-MAR-2018, via the intramuscular route instead of the recommended subcutaneous route, for prophylaxis. The vaccine was reconstituted with sterile diluent (MRK) (lot # N015478 exp 28-SEP-2019). Adverse events were not reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 04-OCT-2017, the patient was vaccinated with VARIVAX (exact dose, dose number, route of administration were not reported; lot # M024683 with the expiration date of 18-MAY-2018), reconstituted with sterile diluent (lot # and expiration date were not reported), and PROQUAD (albumin status of recombinant human albumin (rHA), exact dose, dose number, route of administration were not reported; lot# M031945 with the expiration date of 21-DEC-2017), reconstituted with sterile diluent (lot # and expiration date were not reported), for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. The patient's concurrent conditions, concomitant medication and medical history were not reported. On 25-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). On 15-SEP-2017, she was vaccinated with another dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). The patient was vaccinated twice with the same vaccine. No adverse effects were reported. No product quality complaint was involved. The reporter's physician stated that the patient did not receive either of these vaccines at their office.
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date (reported as "many years ago") the patient was vaccinated with ZOSTAVAX (strength, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date the patient experienced problems with arm mobility getting vaccinated. The outcome of the event was unknown. The relatedness between the movement disorder and ZOSTAVAX was not reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-OCT-2017, the patient was vaccinated with one dose of expired ROTATEQ lot # M014318 and expiration date 30-SEP-2017. No adverse effects were reported. No causality assessment was provided by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included sterile diluent. On 09-OCT-2017, the patient was vaccinated with expired dose of ZOSTAVAX 19400 Plaque-Forming Units (PFU) lot # M042503, expiration date 18-AUG-2017 (route of administration was not reported). No adverse effect was reported. The outcome of expired product administered was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 10-OCT-2017, the patient was vaccinated with 1 dose of expired PNEUMOVAX 23 (lot # M022086, expiration date: 10-SEP-2017, dose and route of administration were not provided). No adverse events were reported. No product quality complaint was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who referred to himself. The patient concurrent condition included blood pressure abnormal. The patient pertinent medical history included a pacemaker for his heart. The patient did not have any known drug reactions or allergies. On an unknown date (reported this Monday), the patient was vaccinated with ZOSTAVAX, 1 time vaccine, in the right arm to prevent shingles (route of administration, lot # and expiration date were not reported). Concomitant medication included: blood pressure medication (unspecified). On 11-OCT-2017 (reported as for 3 days now), the patient experienced rash at the injection site. There were no lab diagnostic studies performed. The patient did not seek medical attention. At the time of the report, the outcome of the event was not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site warmth, Pain, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 36 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included unspecified flu vaccine. On 18-SEP-2017, the patient was vaccinated subcutaneously with PNEUMOVAX 23 lot # N010105, expiration date 15-NOV-2018. The patient developed pain, redness, swelling and the injection site was hot to touch later in evening of 18-SEP-2017 after administration of the vaccine. The patient went to the doctor's, and was diagnosed with cellulitis and treated with unspecified antibiotics. The outcome of cellulitis was reported as recovered on an unspecified date in 2017. The causality assessment was not provided. Upon internal review, the event of cellulitis was considered to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The patient had no drug reactions or allergies, also she did not report any medical history. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27 - 3) virus vaccine, live (manufacturer unknown) (dose route of administration and indication were not reported). The reporter was not aware which type or tradename of the vaccine it was. Concomitant therapies were not reported. On an unknown date, the patient had titers drawn, which showed that its levels were low. The patient would need to be re-vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). The outcome of the event was reported as not recovered/not resolved. The reporter did not assess relatedness between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern, and refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 16-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot number M032139, expiration date 02-OCT-2017, for prophylaxis (route of administration was not provided); reconstituted with sterile diluent (MERCK) lot number M016885, expiration date 07-DEC-2018. The reporter denied any adverse effects with the patient.
Age: 14.0
Sex: F
Vaccine: FLUX, HEPA, HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported); which was reconstituted with sterile diluent (MRK INJ) (dose, route of administration, lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion of 15 to 46 degrees Fahrenheit for 1 hour and 20 minutes. There was no previous temperature excursion. It was called because of a data logger. There was not adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist, concerning an adult patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-OCT-2017 (reported as "5 days past the expiration date"), the patient was unknowingly vaccinated with an expired dose of VARIVAX with lot # L037561 and expiration date on 29-SEP-2017 (strength, dose, route of administration, and anatomical location were not provide), for prophylaxis. The reporter was seeking professional advice about the vaccine efficacy in this case and how to proceed with re-vaccination if necessary. It was reported that VARIVAX had not previous temperature excursions prior to administration. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blood cholesterol, Headache, Injection site erythema, Injection site warmth, Thyroid function test
Clinical narrative: This spontaneous report was received from a female patient of unknown age with increased cholesterol, allergy to cephalosporin antibiotics and with no pertinent medical history who was reporting on herself. On 15-OCT-2017 (reported as "this past Sunday"), the patient was vaccinated with a dose of ZOSTAVAX injection, in the right arm, (dose, dose number, route of administration, lot number and expiration date were not provided) to prevent shingles. Concomitant therapies included unspecified statin drug to lower cholesterol and PREVACID. The patient stated that she got headache the day she got the vaccine (on 15-OCT-2017). She also reported that she developed redness at the injection site which had grown to about 4 inches in diameter on an unknown date in October 2017. It was also reported that the redness site seemed hot (on an unknown date in October 2017). The patient's laboratory diagnostic studies included blood work for cholesterol and for thyroids levels. The patient did not seek medical attention. The outcome of headache, injection site warmth and injection site erythema was unknown at the time of the report. The relatedness between the adverse events and ZOSTAVAX was not provided. Additional information is not expected as no consent was given to follow-up.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017 (from 24-AUG-2017 to 07-SEP-2017), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # N005617, expiry date 03-OCT-2018) orally (route of administration was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit to 25 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA012574.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 12 months old patient of an unknown gender. On 25-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # N013270, expiry date: 25-OCT-2018, lot # N014947 expiry date: 11-NOV-2018) (dose, route and anatomical location not reported) for prophylaxis, that was reconstituted with sterile diluent (MRK INJ) (lot#, expiration, route, dose and anatomical location not reported). The vaccine was stored at a temperature of 32 degree Fahrenheit (F) for unknown period of time (reported as "ongoing excursion"). The previous temperature excursion included multiple 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for a total of 6.5 hours. The call was because of the data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000128: US-009507513-1710USA011203: US-009507513-1710USA011202: US-009507513-1710USA011201: US-009507513-1708USA010196.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 12 months old patient of an unknown gender. On 27-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # N013270, expiry date: 25-OCT-2018, lot # N014947 expiry date: 11-NOV-2018) (dose, route and anatomical location not reported) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK INJ) (lot#, expiration, route, dose and anatomical location not reported). The vaccine was stored at a temperature of 32 degree Fahrenheit (F) for unknown period of time (reported as "ongoing excursion") (Incorrect product storage). The previous temperature excursion included multiple 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for a total of 6.5 hours. The call was because of the data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000128: US-009507513-1708USA010196: US-009507513-1710USA011199: US-009507513-1710USA011203: US-009507513-1710USA011201:
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 12 months old patient of an unknown gender. On 27-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # N013270, expiry date: 25-OCT-2018, lot # N014947 expiry date: 11-NOV-2018) (dose, route and anatomical location not reported) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK INJ) (lot#, expiration, route, dose and anatomical location not reported). The vaccine was stored at a temperature of 32 degree Fahrenheit (F) for unknown period of time (reported as "ongoing excursion") (Incorrect product storage). The previous temperature excursion included multiple 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for a total of 6.5 hours. The call was because of the data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000128: US-009507513-1708USA010196: US-009507513-1710USA011199: US-009507513-1710USA011202: US-009507513-1710USA011201:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacy student, regarding an adult patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with two pediatric doses of RECOMBIVAX HB (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. However, no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA001050.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with an improperly store dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011217: US-009507513-1710USA011216: US-009507513-1710USA011218: US-009507513-1710USA002653.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with an improperly store dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011217: US-009507513-1710USA002653: US-009507513-1710USA011218: US-009507513-1710USA011215.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 29-SEP-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA002653: US-009507513-1710USA011216: US-009507513-1710USA011218: US-009507513-1710USA011215.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011217: US-009507513-1710USA011216: US-009507513-1710USA002653: US-009507513-1710USA011215.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown gender under the age of 50 years. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that the patient was administered ZOSTAVAX outside of the age recommendation from the prescribing information as on 19-SEP-2017, the patient was vaccinated with ZOSTAVAX one shot, with lot number M038864 and expiration date on 12-DEC-2017 (concentration, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent (MERCK). The reporter denied any adverse effects with the patient. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA002538.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.