chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant 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 18-MAY-2017, 19-MAY-2017, 22-MAY-2017 and 23-MAY-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M040412, expiration date 30-JUN-2019 (dose and route of administration were not reported) and on unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M041212, expiration date 30-JUN-2019 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines with lot # M041212 experienced the temperature excursion of 26 degrees Fahrenheit for 15 hours and previous excursions between 32 to 35 degrees Fahrenheit for 13 hours. Administered doses of vaccines with lot # M040412 experienced the temperature excursion on 18-MAY-2017 of 32 degrees Fahrenheit for between 45 - 60 minutes, on 19-MAY-2017 of 32 degrees Fahrenheit for between 45 - 60 minutes, on 22-MAY-2017 of 35 degrees Fahrenheit for between 45 - 60 minutes and on 23-MAY-2017 of 35 degrees Fahrenheit for between 45 - 60 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1706USA008771: US-009507513-1706USA008772: US-009507513-1706USA008773:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 06-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL lot # M014929 and expiration date of 27-MAY-2017, for prophylaxis (dose and route of administration were not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-JUN-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL lot # L035105, expiration date 17-MAY-2017 (dose, dose number, route and anatomical location were not reported). No adverse effects were reported. The product quality complaint was not reported. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 14 month old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 01-JUN-2017, during the same appointment, the patient was vaccinated with a dose of M-M-R II subcutaneouslly, lot # M028130, expiration date on 03-JUN-2018(strength, dose number and anatomical location were not provided) for prophylaxis and a dose of PROQUAD lot # M041084, expiration date on 04-APR-2018. It was reported that the patient received PROQUAD in error, instead of VARIVAX, however no adverse events were reported. It was reported that no treatment was given.      Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Rash, Skin warm
Clinical narrative: This spontaneous report has been received from a pharmacist (also reported as "Dr."), concerning to a non-pregnant female patient of unknown age. The patient's concurrent conditions included allergy to codeine. The patient's medical history was not reported, and there were no concomitant medications. On 06-JUN-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 intramuscular in the left deltoid, lot # M043424 and expiration date 06-JUN-2017 (dose and frequency were not reported) for prophylaxis (reported as "indicated by the patient's doctor"). On 07-JUN-2017 (reported as the next day), the patient came back to the pharmacist and reported a rash that was on the underarm "near the armpit and the left breast" that started "3 inches" from the injection site, but was not at the injection site. In addition, it was reported that the "rash was warm to the touch and inflamed". The patient did not sought medical attention and not received any treatment for the events. There were no laboratories performed. At the time of reporting, the patient was recovering from the rash, warm to touch and inflammation.  The causal relationship between the therapy with PNEUMOVAX 23 and the events of rash, warm to touch and inflammation was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 24 year old female patient. The patient had no medical history, concurrent condition, drug and allergy history to be reported. On an unspecified date, the patient was vaccinated with a dose of GARDASIL (strength, dose, route, lot #, expiration date were not reported) for prophylaxis. On 15-MAR-2017, the patient was vaccinated with GARDASIL 9, intramuscular into her shoulder joint, (dose, lot #, expiration date were not provided) for prophylaxis.  The patient's concomitant medications were not reported. The reporter stated that after the patient received the vaccine into her shoulder joint, she felt pain immediately, and the pain continued approximately until 22-MAR-2017 (reported as for a week). It was also reported that the patient developed bursitis on an unknown date in 2017, and had to received physical therapy for an unspecified duration. None laboratories were performed. The outcome of pain and bursitis was reported as recovered.  At the time of this report, the causality between GARDASIL 9, GARDASIL and the aforementioned events was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 12-year-old female patient with chronic renal Insufficiency. She was allergic to amoxicillin. Since 14-JUN-2017, the patient was hospitalized for "an unrelated reason which was hydration for chronic renal insufficiency". On 17-JUN-2017 (while in the hospital), the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M042324, expiration date 10-JUN-2018 in the left arm (dose and route of administration were not reported), for prevention of pneumonia. Concomitant therapies included amlodipine besylate (NORVASC), calcium carbonate (TUMS), ferrous (also reported as iron) sulfate, nitrofurantoin (MACRODANTIN), sodium bicarbonate, solifenacin succinate (VESICARE), unspecified vitamin D and medication reported as "Kalcitriol". On the same day, within 2-3 hours of administration, the patient developed profound left upper arm swelling which measured 12 cm in length with a 4 cm circumference. There were no other diagnostic studies performed. The patient received oral diphenhydramine (BENADRYL), oral acetaminophen (TYLENOL) and cold packs for the swelling. There was no intervention to prevent serious criteria. The patient was discharged from the hospital on 17-JUN-2017. The outcome of the event and the relatedness between the event and the suspect therapy were not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA008485:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant 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 22-MAY-2017 and 23-MAY-2017 (also reported as prior 25-MAY-2017), the patients were vaccinated with improperly stored doses of VAQTA lot # L015460, expiration date 20-JUL-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 32 to 35 degrees Fahrenheit for 13 hours and there were no previous excursions (also reported that administered doses of vaccines with experienced the temperature excursion twice on 22-MAY-2017 of 35 degrees Fahrenheit for between 45 - 60 minutes). Digital data logger was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1705USA013714: US-009507513-1706USA008772: US-009507513-1706USA008773:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant 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 22-MAY-2017 (also reported as prior 25-MAY-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # K016964, expiration date 16-JUL-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 32 to 35 degrees Fahrenheit for 13 hours (also reported as on 22-MAY-2017 of 35 degrees Fahrenheit for between 45 - 60 minutes) and no previous excursions were reported. Digital data logger was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1705USA013714: US-009507513-1706USA008771: US-009507513-1706USA008773.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain
Clinical narrative: This spontaneous report was received from a nurse prescriber via a Company representative, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, dose, and frequency were unspecified), subcutaneously, for prevention of shingles (prophylaxis). On an unknown date, the patient experienced pain at the injection site (vaccination site pain) and then, on an unspecified date, was diagnosed with shingles in the back (herpes zoster). The patient sought for medical attention with the reporting nurse prescriber, and received an unspecified anti-viral medication. No product quality complaint was involved. At the time of the report, the outcome of herpes zoster and vaccination site pain was reported as recovered on unspecified dates. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Cardiomyopathy
Clinical narrative: Cardiomyopathy.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pallor, Syncope
Clinical narrative: Pt. was seated upright in the chair. Nurse administered one vaccine into each arm. Pt. was breathing normally, color drained from face and she fainted. Nurse and pt.'s mom lowered pt. to the floor lying her on her back with a pillow under her head and bending her knees. Her eyes were open the whole time, she came to within a couple minutes and was talking and responding to questions. Mom helped her to a seated position. Pt. stated that she felt ok and was helped to her feet by nurse and mom. Pt. ambulated out of the room without issues.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Seizure, Syncope
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of seizure in a 18-year-old male patient who received HAVRIX pediatric (batch number ZT5K4, expiry date unknown). Co-suspect products included BEXSERO (batch number 157101, expiry date unknown). Concomitant products included GARDASIL. On 9th June 2017, the patient received HAVRIX pediatric .5 ml and BEXSERO .5 ml. On 9th June 2017, less than a day after receiving HAVRIX pediatric and BEXSERO, the patient experienced seizure (serious criteria GSK medically significant) and syncope. On 9th June 2017, the outcome of the seizure and syncope were recovered/resolved. The reporter considered the seizure and syncope to be possibly related to HAVRIX pediatric and BEXSERO. Additional details were provided as follows: No hospitalization and no falling injury were reported. The patient was observed by healthcare professional (HCP). No any seriousness criteria was mentioned in the case as life threatening, death, persistent or significant disability/incapacity and congenital anomaly or birth defect. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions.
Sex: F
Vaccine: HPV9
Symptoms: Breast pain, Breast tenderness
Clinical narrative: This spontaneous report was received from an administrator via company representative and refers to a non-pregnant adolescent (age also reported as "around 16") female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patient was vaccinated with GARDASIL 9 for HPV prevention (dose, anatomical location, lot# and expiration date were not reported, route of administration was reported as injection). It was reported that the patient completed 3 dose series of the GARDASIL 9. On an unknown date, also reported as just after 3 dose series of the GARDASIL 9 completion, the patient complained that "her breast were feeling sore and tender". The outcome of the went was unknown. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 73-year-old female patient with drug reaction/allergy to penicillin (unspecified), sulfa, iodine, tetracycline, diphenhydramine hydrochloride (BENADRYL), aspirin (manufacturer unknown) (captured in MARRS # 1706USA009785), tramadol, ibuprofen (MOTRIN), diltiazem, citalopram hydrobromide (CELEXA) and erythromycin. No information regarding the patient's pertinent medical history and concomitant medications was reported. On 01-JUN-2017, the patient was administered a dose of PNEUMOVAX 23 injected intramuscularly in the right upper extremity (lot # N004564 with expiration date at 22-OCT-2018; dose and exact anatomical location were not reported), for pneumonia prevention. On 02-JUN-2017, the patient called the office reporting that she developed redness and swelling at the injection site in the right upper extremity. On the same date, the nurse practitioner instructed the patient to use warm compresses on that site and take acetaminophen (TYLENOL) as a treatment. On 03-JUN-2017, the patient was seen at unspecified emergency room, due to above noted adverse reactions. While being at the emergency room, the patient was diagnosed with cellulitis at the PNEUMOVAX 23 injection site and she was given clindamycin as a treatment. The reporter stated that the patient was not admitted to the hospital and on 03-JUN-2017, the patient was discharged from the emergency room. The outcome of redness and swelling at the injection site, as well as, cellulitis at injection site was reported as not recovered at the time of the report. The causality assessment between aforementioned events and the vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA009785:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant 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 18-MAY-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M038847, expiration date 27-APR-2018 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 32 to 35 degrees Fahrenheit for 1 hour. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013714: US-009507513-1706USA008771: US-009507513-1706USA008772:
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-AUG-2015, the patient was vaccinated with ZOSTAVAX (route, dose, lot # and expiration date were unknown) for prophylaxis; that was reconsitituted with sterile diluient (dose, lot # and expiration date were unknown). Later, on 15-JUN-2017, the patient was again vaccinated with ZOSTAVAX lot # M034766, expiration date 26-OCT-2017 (route and dose were not reported) for prophylaxis; that was reconsitituted with sterile diluient, lot # M024786, expiration date 19-FEB-2019 (dose was not reported). Information regarding concomitant medications was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Pharmacy Manager, who is also a pharmacist, 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 30-MAY-2017 and 05-JUN-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M035693, expiration date 07-NOV-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M047662, expiration date 02-DEC-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration date were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion between 9 and 25 degrees Celsius for 2 hours 16 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Fatigue, Injection site induration, Injection site pain
Clinical narrative: Initial unsolicited report received from a other non-health care professional (manufacturer) in the United States on 14-Jun-2017. This case involves a 30-year-old male patient who was vaccinated with a dose of ADACEL (batch number: C5216AB, expiry date: 06-Jun-2019, dose and route of administration was not reported), in left deltoid on 11-May-2017. Illness at time of vaccination was none and Pre-existing physician diagnosed allergies included allergy to PCN (penicillin), birth defects, medical conditions Was reported as none. Concomitant medications reported as unknown. On 11-May-2017, same day post-vaccination, since that day the patient developed pain at injection site. The patient was examine on 14-Jun-2017 by the physician assistant (PA) and PA reported that the patient had a firmness over the mid deltoid that they plan to ultrasound to rule out infection. The patient was complaining of tiredness, dizziness, nausea, diarrhea and general body aches from an unknown date. The patient required doctor visit. The patient's laboratory data reported as none. Corrective treatment was unknown. At the time of report the patient was not recovered from the events. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: Initial unsolicited report received from a other non-health care professional (manufacturer) in the United States on 14-Jun-2017. This case involves a 30-year-old male patient who was vaccinated with a dose of ADACEL (batch number: C5216AB, expiry date: 06-Jun-2019, dose and route of administration was not reported), in left deltoid on 11-May-2017. Illness at time of vaccination was none and Pre-existing physician diagnosed allergies included allergy to PCN (penicillin), birth defects, medical conditions Was reported as none. Concomitant medications reported as unknown. On 11-May-2017, same day post-vaccination, since that day the patient developed pain at injection site. The patient was examine on 14-Jun-2017 by the physician assistant (PA) and PA reported that the patient had a firmness over the mid deltoid that they plan to ultrasound to rule out infection. The patient was complaining of tiredness, dizziness, nausea, diarrhea and general body aches from an unknown date. The patient required doctor visit. The patient's laboratory data reported as none. Corrective treatment was unknown. At the time of report the patient was not recovered from the events. List of documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Flushing, Injection site reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's arm is sore and swollen. The area around the vaccination is flush compared to surrounding skin. Patient reported reaction on 6/22/17, stating it has been getting worse since vaccination. Patient has not been treating with anything.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Allergy test, Eyelid oedema, Immunology test, Swelling face
Clinical narrative: Right face and cheek and bilateral upper eyelid swelling.
Age: 26.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, refers to a 26 year-old patient of an unknown gender. The patient's medical histroy, concurrent conditions and concomitant therapies were not provided.     In approximately 2007 (reported as "when the patient was 16 year-old"), the patient was vaccinated with the 3 dose series of GARDASIL injection (strength, dose schedule, route, lot# and expiration date were not provided) for prophylaxis. It was reported that on 18-MAY-2017 (reported as "2 weeks ago at the age of 26 year-old"), the patient was vaccinated with GARDASIL 9 injection (strength, dose schedule, route, lot# and expiration date were not provided) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 77.0
Sex: U
Vaccine: HIBV, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient might have been vaccinated with a dose of one of the improperly stored vaccines: VAQTA (dose, route of administration were not reported; lot # N008823, expiration date 26-MAY-2018), LIQUID PEDVAXHIB (dose, route of administration were not reported; lot # N003698, expiration date 31-OCT-2019), GARDASIL 9 (dose, route of administration were not reported; lot # M040412, expiration date 30-JUN-2019) or PNEUMOVAX23 (dose, route of administration were not reported; lot # N004564, expiration date 22-OCT-2018). The vaccines underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot number and expiration date were not reported). Subsequently, on an unknown date, the patient received a dose of GARDASIL 9 injection (dose, route of administration, lot number and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to unspecified number of patients of unknown demographics. No information regarding the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown dates, the patients were vaccinated with doses of GARDASIL injection (dose, route of administration, lot number and expiration date were not reported). On unknown dates, the patients experienced fainting. The outcome of fainting was unknown. The relatedness between th events and GARDASIL was not reported. Additional information is not expected as there was no consent for further contact.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a 69-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-JUN-2017, the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot # and expiration date were not provided). On an unknown day after vaccination, approximately in June 2017, the patient developed a "welt" on an unknown area of the same arm that she received ZOSTAVAX injection. The the event outcome at the reporting time was unknown. The causality between the event of "welt" and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown. On an unknown date (reported as "1 to 2 years ago"), the patient was vaccinated with a dose of ZOSTAVAX vial, subcutaneously (exact dose, lot # and expiry date were not reported) to prevent shingles. Other suspect therapies included sterile diluent (STERILE DILUENT) (exact dose, lot # and expiry date were not reported), administered together with ZOSTAVAX. On an unknown date, the patient developed a severe case of shingles. They sought medical attention by contacting the office. The outcome of the event and causal relationship between the event and suspect therapies were not reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (route of administration, lot # and expiration date were not reported) for prophylaxis. The pharmacist reports that GARDASIL 9 has been "exposed to too much light". The pharmacist reported that "sometimes the full box of doses are distributed to more than one healthcare provider and then stored outside the boxes, in refrigerators with glass doors". There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: FLUN3
Symptoms: Syncope
Clinical narrative: A report has been received from a literature source concerning a patient of unknown age and gender, enrolled in an unsponsored/ non-interventional/post-marketing study. The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between 01-Sep-2003 and 31-Mar-2013. Based on prior reports and biologic plausibility, 18 medically attended health outcomes were examined, including allergic, autoimmune, neurologic, respiratory, and infectious conditions. Using self-controlled case series analyses, incident rate ratios (IRRs) were calculated for each outcome.   During 2003-2013, 396173 children received 590018 doses of LAIV. For 124529 (21. 1%) of LAIV doses, other vaccines were administered on the same day. Five outcomes (anaphylaxis, non-anaphylactic allergic reactions, Stevens-Johnson syndrome (SJS), syncope, and respiratory failure) met criteria for manual medical record review. For the remaining 13 outcomes, there was no significant increase in risk after LAIV. After manual, medical record review, most cases were excluded because diagnoses were ruled out or clearly attributable to other causes. One case of medical record-confirmed anaphylaxis was observed following LAIV (FluMist): Wheezing, facial swelling, and hives occurred 2 hours after LAIV vaccination, in someone known to be egg-allergic (observed rate 1. 7 cases per million LAIV doses). In individuals who received LAIV only, and no other same-day vaccines, two cases of medical record-confirmed syncope were observed (3.4 cases per million LAIV doses). This case belongs to one of two patients who experienced syncope (preferred term: syncope) after receiving LAIV. The outcome of syncope was unknown. The company physician considered syncope as important medical event. The reporter considered syncope to be related to LAIV. ; Sender's Comments: Syncope is not listed in the company core data sheet of FLUMIST. Due to limited information on details of syncope (type), exact onset date of event, start date of suspect drug along with its indication, underlying comorbidities, past medical history, concomitant medications, age and gender of the patient, lab details (complete blood tests, blood glucose values), detailed clinical and diagnostic workup (imaging studies), it is not possible to make a conclusive assessment of the causal relationship of syncope with FLUMIST.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Pharyngeal erythema, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse. A female patient of an unspecified age and ethnicity received single dose of PREVNAR 13 on 14Jun2017 at 0.5 ml for immunization. The patient medical history and concomitant medications were not reported. Patient experienced hives, rash, red throat, hard to breathe all on 14Jun2017 and sent to the ER following the vaccine. Nurse stated that patient was sent to the Emergency Room from the doctor's office but was unsure whether or not she was admitted to the hospital. Outcome of events was recovering.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Alopecia, Fall, Joint dislocation, Laboratory test, Surgery
Clinical narrative: This is a spontaneous report from a contactable Certified Medical Assistant calling on behalf of a patient. A 65-year-old female patient received PREVNAR 13 (Lot R45377; Expiration Date 01Dec2017), intramuscular on 28Nov2016 at 0.5 ml, single for immunization as pneumonia prevention. Medical history included ongoing diabetes mellitus, and ongoing hypertension. The patient was on several unspecified concomitant medications. The patient lost all her hair within a month of the injection. There was no treatment for the hair loss. The patient fall on Jan2017 and in 2017 had tibial fracture and dislocated shoulder. Fall, tibial fracture and dislocated shoulder were serious for hospitalization. The patient was hospitalized from 06Mar2017 to 10Mar2017 for tibial fracture surgery and had intervention for the dislocated shoulder. No testing was done for the hair loss. The patient underwent lab tests and procedures which included x-ray for the fall, but results were unknown. The outcome of all the events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Tibia fracture, X-ray
Clinical narrative: This is a spontaneous report from a contactable Certified Medical Assistant calling on behalf of a patient. A 65-year-old female patient received PREVNAR 13 (Lot R45377; Expiration Date 01Dec2017), intramuscular on 28Nov2016 at 0.5 ml, single for immunization as pneumonia prevention. Medical history included ongoing diabetes mellitus, and ongoing hypertension. The patient was on several unspecified concomitant medications. The patient lost all her hair within a month of the injection. There was no treatment for the hair loss. The patient fall on Jan2017 and in 2017 had tibial fracture and dislocated shoulder. Fall, tibial fracture and dislocated shoulder were serious for hospitalization. The patient was hospitalized from 06Mar2017 to 10Mar2017 for tibial fracture surgery and had intervention for the dislocated shoulder. No testing was done for the hair loss. The patient underwent lab tests and procedures which included x-ray for the fall, but results were unknown. The outcome of all the events was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 19May2017 as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a reaction that started about two weeks ago in Jun2017 and it was in the arm he received the injection. The arm had been getting more and more sensitive. If he went through the day moving it, it seemed to loosen up, but at night it tightens up and was quite painful and very difficult to move. He can't even reach around his body to the other arm in the early morning. Outcome of the events was not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphagia, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Place below injection site red/hot/swollen, then progressed to whole arm and then torso. Pt experienced difficulty swallowing and then was seen in ER.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Place below injection site red/hot/swollen, then progressed to whole arm and then torso. Pt experienced difficulty swallowing and then was seen in ER.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Injection site rash, Pruritus, Swelling face
Clinical narrative: Place below injection site red/hot/swollen, then progressed to whole arm and then torso. Pt experienced difficulty swallowing and then was seen in ER.
Age: 0.08
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: MD ORDERED HEPATITIS A INSTEAD OF HEPATITIS B - HEPATITIS A WAS GIVEN.
Age: 30.0
Sex: F
Vaccine: ANTH, JEVX, SMALL, TYP
Symptoms: Blood creatine phosphokinase increased, Chest X-ray abnormal, Chest pain, Chills, Diarrhoea
Clinical narrative: Headaches, myalgias, nausea, loose stools, dizziness, SOB brief left lateral chest pain. Patient states she had her usual dyspnea on exertion only when running fast (& previous since BASIC of climbing moderate stairs). Pt had chills, sweats, loose green diarrhea 3 times, myalgias, dizziness including transient spinning sensation.
Age: 30.0
Sex: F
Vaccine: ANTH, JEVX, SMALL, TYP
Symptoms: Dizziness, Dyspnoea, Dyspnoea exertional, Faeces discoloured, Headache
Clinical narrative: Headaches, myalgias, nausea, loose stools, dizziness, SOB brief left lateral chest pain. Patient states she had her usual dyspnea on exertion only when running fast (& previous since BASIC of climbing moderate stairs). Pt had chills, sweats, loose green diarrhea 3 times, myalgias, dizziness including transient spinning sensation.
Age: 30.0
Sex: F
Vaccine: ANTH, JEVX, SMALL, TYP
Symptoms: Hyperhidrosis, Myalgia, Nausea, Vertigo
Clinical narrative: Headaches, myalgias, nausea, loose stools, dizziness, SOB brief left lateral chest pain. Patient states she had her usual dyspnea on exertion only when running fast (& previous since BASIC of climbing moderate stairs). Pt had chills, sweats, loose green diarrhea 3 times, myalgias, dizziness including transient spinning sensation.
Age: 8.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Syncope, Vomiting
Clinical narrative: Client fainted for 2-3 seconds and then vomited x 3 after receiving 3rd and 4th vaccines.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Death, Respiratory failure, Rib fracture, Skeletal survey abnormal
Clinical narrative: Respiratory failure leading to death.
Age: 1.58
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 25-MAY-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # M039202, expiry date 11-MAR-2018, dose and route of administration were not provided). The vaccine was stored between 0 and 1 Celsius degree for 60minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two cases received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA014610:
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 23-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # L012838, expiry date 10-MAR-2018, dose and route of administration were not provided). The vaccine was stored between 0 and 1 Celsius degree for 60 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014603.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient received a dose of PROQUAD lot # M019232 with an expiration date of 17-OCT-2017 (exact dose, route of administration, anatomical location and albumin status were not provided), instead of M-M-R-II. Information regarding a sterile diluent was not provided. The nurse confirmed that the event was a result of human error and not a result of product confusion. The nurse stated that she did not read the package label prior to administration. No adverse effects were reported.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, who referred to an unknown number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients were administered improperly stored doses of PROQUAD recombinant human albumin (rHA) (dose, route of administration and anatomical location were not reported) as prophylaxis on the following dates: with lot# M002053 and expiration date of 11-JUL-2017 on 03-JUN-2016, 06-JUN-2016, 09-JUN-2016 and 13-JUN-2016; with lot# M011664 and expiration date of 08-SEP-2017 on 19-JUL-2016, 20-JUL-2016, 30-AUG-2016, 01-SEP-2016 and 12-SEP-2016; with lot# M012986 and expiration date of 12-SEP-2017 on 20-JUL-2016, 21-JUL-2016, 26-JUL-2016, 28-JUL-2016, 23-AUG-2016 and 29-AUG-2016; with lot# M021731 and expiration date of 29-OCT-2017 on 01-SEP-2016, 06-SEP-2016 and 08-SEP-2016; with lot# M046943 and expiration date of 27-MAY-2018 on 06-JUN-2017. It was reported that the vaccines were reconstituted with sterile diluent (DILUENT MRK) that was always stored properly with no temperature excursions. The doses of vaccine with lot# M002053 and expiration date: 11-JUL-2017 were stored at the following temperatures: on 02-JUN-2016 at -14.3 degrees Fahrenheit (F) for 8 hours, on 06-JUN-2016 at -14.6F for 7 hours, on 09-JUN-2016 at -14.1F for 8hours, on 13-JUN-2016 at -14.8F for 8 hours, on 20-JUN-2016 at -14.F for 8 hours and on 28-JUN-2016 at -3.4F at 8 hours; with lot# M011664 and expiration date: 08-SEP-2017 were stored at the following temperatures: on 19-JUL-2016 at -12.1C for 8 hours, on 20-JUL-2016 at -9.0C for 8 hours, on 30-AUG-2016 at 5.2F for 8 hours, on 01-SEP-2016 at 5.2F for 8 hours and on 12-SEP-216 at 5.2F twice for 1 hour and 7 hours; with lot# M012986 and expiration date: 12-SEP-2017 were stored at the following temperatures: on 20-JUL-2016 at -9.0 degrees Celsius (C) for 8 hours, on 21-JUL-2016 at 9F for 8hours, on 26-JUL-2016 at 7.5F for 8 hours, on 28-JUL-2016 at 6.3F for 8 hours, on 23-AUG-2016 at 5.8F for 8 hours and on 29-AUG-2016 at 9.2F for 8 hours; lot# M021731 and expiration date: 29-OCT-2017 were stored on 01-SEP-2016, 06-SEP-2016 and 08-SEP-2016 at 5.2F for 8 hours and lot# M046943 and expiration date: 27-MAY-2018 were stored on 06-JUN-2017 at 17.1F for 8 hours. All temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA006147: US-009507513-1706USA006148: US-009507513-1706USA006150: US-009507513-1706USA006151: US-009507513-1706USA006146: US-009507513-1706USA006149:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, improperly stored doses of PROQUAD lot # M038862 with expiration date 13-MAR-2018, lot # M044718 with an expiration date 07-MAY-2018, or lot # N002915 with an expiration date 24-JUL-2018, or lot# M036159 with an expiration date 12-FEB-2018 (dose, route of administration and anatomical location were not reported) were administered to the unspecified number of patients. No adverse effects were reported. It was reported that the products were exposed to temperatures between 6 and14 degrees Fahrenheit for 174 hours. No previous temperature excursion was reported. Digital data logger was involved. No product quality complaint was reported. This was one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013643: US-009507513-1706USA010087.
Sex: M
Vaccine: PPV
Symptoms: Contraindication to vaccination, Death
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a male patient, of an unknown age. The patient was diagnosed with "cancer" in an unspecified date. Concomitant medications were not mentioned.  In approximately December 2016 (reported as "about six months ago"), while the patient was in the hospital, he was vaccinated with a shot of PNEUMOVAX23, subcutaneously as a standard protocol from the hospital (dose number, anatomical location, lot # and expiration date were not reported). Subsequently, the patient was discharged from the hospital. The next day, he passed away (death), approximately in December 2016. It was unknown if an autopsy was performed. The cause of death was unknown. The reporting physician stated that he felt that the patient should not have been vaccinated due to his "weakened immune system" and he was not pleased about the hospital's conduct. He felt the hospital should have used individual judgment before vaccination.  No causal relationship between therapy with PNEUMOVAX23 and death was provided. Upon internal review, death was considered medically significant. Additional information has been requested.; Reported Cause(s) of Death: it was not known what the cause of death was.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 54 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-JUN-2017, the patient was vaccinated with an expired dose of VAQTA intramuscularly, for prophylaxis (dose not provided; lot # M034893, expiration date 26-MAY-2017). The vaccine had been properly stored. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Drug administered at inappropriate site, Local reaction
Clinical narrative: This is a spontaneous report from a contactable Nurse. This nurse reported similar events for 2 patients. This is 2nd of 2 reports. An 11-12 year-old patient (child) patient of an unspecified ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose into the thigh muscle on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient was administered TRUMENBA into the thigh muscle instead of the deltoid because the patient had less muscle mass, and experienced a larger local reactions compared to the older children given TRUMENBA in the deltoid with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017266468 same reporter, different patient, same drug/events.