chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Headache, Meningitis aseptic, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 17 year old male patient with migraines. The patient had no drug reactions or allergies. The patient's medical history was not reported. On 17-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported) for prevention of Human Papillomavirus (HPV) and with a dose of BEXSERO (lot#, expiration date, formulation, dose and route of administration were not reported). On an unknown date in January 2017 (reported as "within a few days of receiving the vaccines"), the patient experienced headaches. On an unknown date in 2017, the patient was then sent to emergency department and on an unknown date in 2017, he was tested positive for mononucleosis (reported as mono). The patient then followed up with an unspecified neurosurgeon and he had spinal tap which resulted in being positive for aseptic meningitis, on an unknown date in 2017. On an unknown date in 2017, the patient experienced fever and was diagnosed with influenza. Product quality complaint was not involved.  The patient did make fully recovery, on an unknown date in 2017. The causality between the events and suspect therapies was not reported. Upon internal review, the event of meningitis aseptic was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Headache, Influenza, Lumbar puncture abnormal, Meningitis aseptic, Mononucleosis heterophile test positive
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 17 year old male patient with migraines. The patient had no drug reactions or allergies. The patient's medical history was not reported. On 17-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported) for prevention of Human Papillomavirus (HPV) and with a dose of BEXSERO (lot#, expiration date, formulation, dose and route of administration were not reported). On an unknown date in January 2017 (reported as "within a few days of receiving the vaccines"), the patient experienced headaches. On an unknown date in 2017, the patient was then sent to emergency department and on an unknown date in 2017, he was tested positive for mononucleosis (reported as mono). The patient then followed up with an unspecified neurosurgeon and he had spinal tap which resulted in being positive for aseptic meningitis, on an unknown date in 2017. On an unknown date in 2017, the patient experienced fever and was diagnosed with influenza. Product quality complaint was not involved.  The patient did make fully recovery, on an unknown date in 2017. The causality between the events and suspect therapies was not reported. Upon internal review, the event of meningitis aseptic was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MENB, HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 17 year old male patient with migraines. The patient had no drug reactions or allergies. The patient's medical history was not reported. On 17-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported) for prevention of Human Papillomavirus (HPV) and with a dose of BEXSERO (lot#, expiration date, formulation, dose and route of administration were not reported). On an unknown date in January 2017 (reported as "within a few days of receiving the vaccines"), the patient experienced headaches. On an unknown date in 2017, the patient was then sent to emergency department and on an unknown date in 2017, he was tested positive for mononucleosis (reported as mono). The patient then followed up with an unspecified neurosurgeon and he had spinal tap which resulted in being positive for aseptic meningitis, on an unknown date in 2017. On an unknown date in 2017, the patient experienced fever and was diagnosed with influenza. Product quality complaint was not involved.  The patient did make fully recovery, on an unknown date in 2017. The causality between the events and suspect therapies was not reported. Upon internal review, the event of meningitis aseptic was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Exposure via eye contact, Eye irrigation, Syringe issue
Clinical narrative: Information has been received from licensed practical nurse referring to a 25 year old female patient who was a certified medical assistant. The patient had no concurrent condition, concomitant therapies, relevant laboratory data or medical history. On 14-APR-2017, the certified medical assistant attempted to give a dose of PROQUAD (dose unknown, once, lot# M044018, expiration date 01-MAR-2018,) and  sterile diluent (manufacturer unknown) (strength and dose unknown, once, lot# M029234, expiration date 12-MAR-2017) (Expired drug used). But it was accidentally administered to herself topically on the ocular mucous 1 time. The certified medical assistant reconstituted the medication and drew it into the syringe. When she attempted to give the injection the area between the needle and the syringe came apart and some of the medication sprayed into certified medical assistant's eye. The eye was flushed, and the certified medical assistant reported no irrigation or eye problems at this point. At the time of 14-APR-2017, the certified medical assistant was no longer accidentally administering the PROQUAD injection to her ocular mucosa and the outcome of accidental administration was unknown. Causality between PROQUAD and "the eye was flushed" was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown date, an unspecified number of patients were vaccinated with an improperly storage doses at a temperature of 47 °F to 77 °F for 9 hours and 54 minutes of GARDASIL 9 (lot # M033583 and expiration date 14-APR-2019) (lot # M040412 and expiration date 30-JUN-2019) for prophylaxis (dose and route of administration were not reported). The vaccine did not have a previous temperature excursion and this information was provided due to the data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004698: US-009507513-1705USA004699: US-009507513-1705USA004700:
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint swelling
Clinical narrative: This spontaneous report was received from an unspecified person via company and refers to two patients 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 patients were vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not provided; lot # M038359, expiration date: 13-MAY-2018). On an unknown date, the patients experienced major swelling in their left elbow area. Both patients were given antibiotic to reduce swelling. No other medical attention was required and the patients were fine at the time of the report. The outcome of the events was not reported. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. Follow up information was received from the office manager on 11-APR-2017. The second patient was a female (initial was provided). She was vaccinated on 10-APR-2017. On an unknown date in February 2017, she experienced swelling in her elbow and redness. Therefore, on 13-FEB-2017, she visited the physician who drew a line around the swelling and redness on the patient's elbow and told her to call back if it got any worse. The patient did not call back. On an unknown date in 2017, the patient recovered.This is one of two reports received from the same reporter. Additional information is not expected as no further information is available. Sender's Comments: US-009507513-1703USA000721.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report has been received from a Pharmacist via Pfizer, concerning to a 74 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, lot # and expiration date were not reported) for prophylaxis. It was mentioned that the patient had an allergy to PNEUMOVAX 23. No further information was provided. The causality between vaccination with PNEUMOVAX 23 and the hypersensitivity was assessed as related. Additional information is not expected as no contact details were given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with multiple doses of improperly stored ROTATEQ lot # M038846 with expiration date of 26-APR-2018, orally, for prophylaxis (dose was not reported). Administered doses of vaccines experienced the temperature excursion of 32.1 degrees Fahrenheit (°F) for 12 hours. There were not previous excursions or data logger involved.  No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001619.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information had been received on 02-MAY-2017 from a nurse who reported that on 01-MAY-2017 a 12-month old female patient was inadvertently administered a dose of ZOSTAVAX with sterile diluent instead of VARIVAX (lot# M033907, expiration 20-JUL-2018). Nurse confirmed administration was the result of "human error" and not product confusion. No adverse effects reported. Nurse had requested to be contacted for all correspondence. Field employee called to confirm that the case had been reported by the physician's office. No AE/PQC reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB lot #M042322 with expiration date of 21-FEB-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 2 hours. Data logger was involved. There were not previous excursions. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002222: US-009507513-1705USA002243: US-009507513-1705USA002244.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report was received from an unspecified source, concerning to an unknown number of female patients of unreported ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown dates, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore, it was reported that vaccination with GARDASIL, was associated with a "very rare but serious condition of premature ovarian failure POF (premature menopause)". No further information was cited. The reporter considered the premature menopause to be possibly associated with GARDASIL. The premature menopause was considered by the reporter as serious. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments: US-009507513-1705USA002408: US-009507513-1705USA002407: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Premature menopause
Clinical narrative: This spontaneous report was received from an unspecified source, concerning unknown female patients from unmentioned ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore it was reported, that on unspecifed dates, there had been about 213 (Vaccine Adverse Event Reporting System) VAERS reports involving amenorrhea and premature ovarian failure (premature menopause). The outcome of the events was not known.  The relatedness between events and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given.; Sender's Comments: US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002408: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: ZA-009507513-1507ZAF012830: US-009507513-1705USA003214:
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Premature menopause
Clinical narrative: This spontaneous report was received from an unspecified source, concerning unknown female patients from unmentioned ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore it was reported, that on unspecifed dates, there had been about 213 (Vaccine Adverse Event Reporting System) VAERS reports involving amenorrhea and premature ovarian failure (premature menopause) and as reported, 88% were associated with GARDASIL vaccination . The outcome of the events was not known.  This is one of several reports received from the same source.  Additional information is not expected as no contact details were given.; Sender's Comments: US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002408: US-009507513-1705USA002410: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830: US-009507513-1705USA002393:
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Ovarian disorder
Clinical narrative: This spontaneous report was received from an unspecified source, concerning unknown female patients from unmentioned ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore it was reported, that within a few years of vaccination the patients experienced ovarian dysfunction manifested by amenorrhea and premature ovarian dysfunction. The outcome of the events was not known. The relatedness between event and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments:  US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002408: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: ZA-009507513-1507ZAF012830:  US-009507513-1705USA003214:
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from an unspecified source, concerning unknown female patients (also reported as girls) from unmentioned ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore it was reported, that since unspecified dates, dozen of girls were suffering from acute physical effects after vaccination. The relatedness between events and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given.; Sender's Comments:  US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002408: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: ZA-009507513-1507ZAF012830: US-009507513-1705USA003214:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age or gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccine was exposed to temperature of 31 Fahrenheit degrees (F) range for a time frame of 48 hours. The temperature excursion was not recorded by a data logger and no previous excursions were reported for the vaccine. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Medical assistant reported that on 30-AUG-2016, the patient received improperly stored dose of VARIVAX at a dose of 0.5 ml, subcutaneously for prophylaxis (lot number L015046 with expiration date of 29-APR-2017). Lot number and expiration date of sterile diluent could not be obtained. At the time of call. No adverse effect was reported. No further information was provided. Administered doses of vaccines experienced the temperatures of excursion from 20-AUG-2016 through 21-AUG-2016 of 47 degrees Fahrenheit to 77 degrees Fahrenheit (53 degrees Fahrenheit) for 24 hours 15 minutes and 32 degrees Fahrenheit to 35 degrees Fahrenheit (33 degrees Fahrenheit). Data logger was not involved. There were no previous excursions reported. 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 Nurse Practitioner referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX expiration date on 23-FEB-2017 (strength, dose, route, anatomical location and lot number was not provided) for prophylaxis. No adverse event reported. Additional information is not expected, since no consent to contact the reporter was provided.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. The nurse reported that on 09-MAR-2017, the patient received the first dose of GARDASIL 9(strength, dose, frequency, route of administration and expiration date were not provided) for an prophylaxis (lot # M000359 ). On 05-MAY-2017, the patient would receive the second dose of GARDASIL 9. No adverse effects were reported. No further details provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical Assistant referring to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 26-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 Intramuscularly  lot # L026602, expiration date on 19-OCT-2017 (strength and anatomical location were not provided) for prophylaxis. On 29-AUG-2016, the patient was vaccinated with an improperly stored (second dose) of GARDASIL 9. No adverse event was reported. It was stated that the vaccine was exposed to a temperature of 15°F (Fahrenheit degrees) to 46°F (22 °F) with a time frame of 24 hours and 15 minutes. It was stated that the temperature time frame between 20-AUG-2016 and 21-AUG-2016 had no data. It was reported that excursion was not noticed due to a data logger. No previous excursions were reported. A product quality complaint was not involved. Additional information is not expected, since no consent to contact the reporter was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose and route of administration were not reported, lot # M038572 with expiration date:11-MAR-2018 and M039202, 11-MAR-2018 ). No adverse effects were reported. Data logger was involved. There was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004592: US-009507513-1705USA004591: US-009507513-1705USA004590: US-009507513-1704USA004333.
Age: 22.0
Sex: M
Vaccine: FLU4, YF
Symptoms: Dizziness, Headache, Hyperhidrosis, Immediate post-injection reaction, Vision blurred
Clinical narrative: Initial unsolicited report received from a physician on 28-Apr-2017. This case involves 22-year-old male patient, who was vaccinated with one dose of FLUZONE QIV intramuscularly (Batch number: UI669AA, expiration date- 30-Jun-2017 (route, dose in series were not reported) in the left deltoid and YF VAX subcutaneously (Batch number: UI668AA, expiration date, route, dose in series were not reported) in the right tricep on 28-Apr-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none (denied). Illness at the time of vaccination was none (denied). Any other vaccinations within four weeks of vaccinations were not reported. On 28-Apr-2017, immediately following the vaccination the patient had experienced blurred, vision, dizziness, and headache and felt sweaty. Laboratory investigations and corrective treatment were not reported. It was reported that the patient was given water to drink and saltine crackers to eat. The event outcome was reported as resolving. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Initial unsolicited report received from a nurse on 27-APR-2017. This case involves a 21 years old male patient who was vaccinated with an dose of FLUZONE batch number: UI640AB, expiry date, dose and route of administration was not reported) at left deltoid on 27-APR-2017 at 02:35 PM. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was denied by the patient. It was also reported that patient had no adverse event previously. Concomitant medications was not provided. On 27-Apr-2017 at 02:45 PM, 10 minutes following the vaccination, the patient experienced metallic taste in mouth. Lab data and corrective treatment was not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Hypersomnia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Soreness at injection site (left arm) with difficulty moving arm. Chills and so tired that I slept all day.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Periarthritis
Clinical narrative: Patient called clinic and reported that she had experienced pain at the injection site on left deltoid after she received a flu vaccine. Evaluated in clinic by Dr on 5/10/17 and noted below as documented in office visit: Comment: suspect musculoskeletal following vaccine led her to not move her arm, this then has led to a frozen shoulder; there is no evidence of nerve damage or infection following the vaccine. Patient was referred to physical therapy.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006513.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. No information regarding patient's concurrent conditions, medical history and concomitant therapies was reported. On 04-APR-2017, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, lot# and expiration date were not provided). On 05-APR-2017, the patient experienced a large swollen area appeared around injection site that was warm to the touch and itchy. The pharmacist instructed the patient to put a cool compress on the area as a treatment. The outcome of the adverse events was unknown. The causality between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Arthropod bite, Rash
Clinical narrative: This information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 25-APR-2017, the patient was vaccinated with a dose of VARIVAX with lot number M041080 and expiration date on 06-OCT-2018 (dose, dose number and route of administration were not provided), administered 45 minutes after reconstitution with sterile diluent (manufacturer unknown) (lot number and expiration date were not provided) in the left arm for prophylaxis. The next day, on 26-APR-2016, the patient experienced a rash or insect bite on his calf, not at the injection site and visited the physician's office. The reporter also stated that she would call back with additional adverse event information. At the time of the report, the patient had no recovered from rash and arthropod bite and the causal relationship between VARIVAX, the sterile diluent (manufacturer unknown) and the events was unknown. Lot number M041080 has been verified to be a valid lot number for VARIVAX. 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 Licensed Practical Nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (dose, frequency and route were not reported) lot # M019232 with expiration date of 17-OCT-2017 and lot # M044018 with expiration date of 01-MAY-2018, for prophylaxis. The sterile diluents (lot # and expiration date were not reported) used to reconstitute the PROQUAD were properly stored. The temperature excursion of the PROQUAD was between 6 °F and 14 °F for a time frame of 18 hours and 15 minutes. No previous temperature incursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004704: US-009507513-1705USA004703:
Sex: U
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and known drug reactions or allergies were not reported. On unknown dates, the patient was vaccinated with an unspecified number of doses of GARDASIL injection (exact dose, route of administration, lot # and expiry date were not reported). The reported stated that since then (date not provided), the patient has been tested positive for human papillomavirus, either type 16 or 17. The outcome of the event and causality between the event and GARDASIL were not provided. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II, subcutaneously (lot # L007217 with expiration date of 03-MAR-2017; strength, dose and anatomical location were not provided) for prophylaxis. No adverse effects were known. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse and refers to an adult patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 04-MAY-2017, the patient was vaccinated with a dose of pediatric VAQTA injection, lot # M047658 with expiry date 28-OCT-2017 (exact dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Invasive lobular breast carcinoma
Clinical narrative: This spontaneous report was received from a female patient of unknown age, referring to herself. The patient's pertinent medical history, drug reactions and allergies and concomitant therapy were not reported. On an unspecified date in January 2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prevention of shingles. On an unspecified date in March 2017, the patient was diagnosed with lobular breast cancer. The outcome the adverse event was not reported. The relatedness between the adverse event and ZOSTAVAX was not reported. Upon internal review, the adverse event of lobular breast cancer was determined to be medically significant. Additional information is not expected, as there was no consent to contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. On an unknown date, the patients were orally vaccinated with improperly stored doses of ROTATEQ (dose was not reported, lot # M029919 with expiration date: 13-JUN-2018). No adverse effects were reported. Data logger was involved. There was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004592: US-009507513-1705USA004589: US-009507513-1705USA004591: US-009507513-1704USA004333.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route of administratration were not reported, lot # M031557 with expiration date: 07-ARP-2019 and M037770, 01-JUN-2019 ). No adverse effects were reported. Data logger was involved. There was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004333: US-009507513-1705USA004589: US-009507513-1705USA004590: US-009507513-1705USA004589:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose and route of administration were not reported, lot # M035487 with expiration date: 23-FEB-2019). No adverse effects were reported. Data logger was involved. There was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004591: US-009507513-1704USA004333: US-009507513-1705USA004590: US-009507513-1705USA004589.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, frequency and route were not reported) lot # M010483 with expiration date of 01-MAR-2018, lot # M040138 with expiration date of 28-SEP-2018 and lot # reported as M046005 with expiration date of 18-NOV-2018, for prophylaxis. The sterile diluents (lot # and expiration date were not reported) used to reconstitute the VARIVAX were properly stored. The temperature excursion of the VARIVAX was between 6°F and 14°F for a time frame of 18 hours and 15 minutes. No previous temperature incursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested. Sender's Comments: US-009507513-1705USA001705: US-009507513-1705USA004704.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency and route were not reported) lot # M011665 with expiration date of 17-MAY-2017 and lot # reported as M041182 with expiration date of 04-JUN-2018, for prophylaxis. The sterile diluents (lot # and expiration date were not reported) used to reconstitute the ZOSTAVAX were properly stored. The temperature excursion of the ZOSTAVAX was between 6°F and 14°F for a time frame of 18 hours and 15 minutes. No previous temperature incursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested. Sender's Comments: US-009507513-1705USA001705: US-009507513-1705USA004703.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Eating disorder, Fall, Feeding disorder, Haemorrhage
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 61-year-old male patient received PREVNAR 13 , on 30Dec2016 at single dose for immunization. Medical history included hepatitis C, two cataract surgeries and panic attacks. Patient was 100% disabled veteran. In 3 months he lost 30 pounds and he had 3 lumps on his left testicle ("one soft and spongy, the middle one was hard like a rock, and the third one was kind of soft"). The patient's concomitant medications were not reported.  Patient had a pneumonia shot about a year before (in 2016, no other details reported). Approximately 2-3 days after vaccination (in Jan2017) patient started feeling sick and it got worse and worse. It was also reported that since an unknown date, for 3 weeks, patient couldn't even eat and at the time of the report  he still wasn't eating well. He had no balance and has been falling down. He also stated that he was bouncing off the walls; he hit his head on the door jam and was bleeding.The final outcome of the events was unknown.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Head injury, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. A 61-year-old male patient received PREVNAR 13 , on 30Dec2016 at single dose for immunization. Medical history included hepatitis C, two cataract surgeries and panic attacks. Patient was 100% disabled veteran. In 3 months he lost 30 pounds and he had 3 lumps on his left testicle ("one soft and spongy, the middle one was hard like a rock, and the third one was kind of soft"). The patient's concomitant medications were not reported.  Patient had a pneumonia shot about a year before (in 2016, no other details reported). Approximately 2-3 days after vaccination (in Jan2017) patient started feeling sick and it got worse and worse. It was also reported that since an unknown date, for 3 weeks, patient couldn't even eat and at the time of the report  he still wasn't eating well. He had no balance and has been falling down. He also stated that he was bouncing off the walls; he hit his head on the door jam and was bleeding.The final outcome of the events was unknown.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Antibody test negative, Computerised tomogram, Dysphonia, Laryngitis, Product quality issue
Clinical narrative: This is a spontaneous report from a consumer reporting for herself. A 69-year-old female patient received PREVNAR 13 via an unspecified route of administration at single dose injection in left arm in Jan2017 or Feb2017 for immunization, for compromised immune system (it would give more protection), at doctor's office. Medical history included ongoing diabetes mellitus diagnosed about 10-15 years before, ongoing asthma diagnosed about 10-15 years before, ongoing bronchiectasis diagnosed about 10-15 years before, ongoing osteoporosis diagnosed about 10-15 years before, ongoing nerve injury diagnosed about 10-15 years before, ongoing sleep apnoea syndrome diagnosed about 10-15 years before, allergic to a lot of medications diagnosed about 10-15 years before, compromised immune system. She has been told those preexisting conditions will never go away. The patient's concomitant medications were not reported. She has had a pneumonia vaccine before, but this was her first PREVNAR 13 shot. She had another pneumonia shot years before, but this was the first time she got side effects. One week after her shot, she has been to a whole bunch of doctors and no one knows why, she is hoarse. She has a compromised immune system and it did not do anything for the system, she got laryngitis and it came and went and came and went. She has had laryngitis for 3 months now. States she has been to a whole bunch of doctor's and don't know why she is hoarse. She had a CAT scan and pulmonary function tests (PFT) about a month before. They were normal other than what was already there from the bronchiolectasis and asthma. The shot did not do anything for her body, she did not even get a flu shot because of her compromised immune system. The PREVNAR didn't do anything. They gave her the shot, then she had to go back within a month because her doctor did bloodwork to see if there were antibodies and there was nothing. This is a permanent stop of PREVNAR 13. Since she was allergic to a lot of medications, so she could be allergic to something in it. The outcome of the events was reported as: not recovered laryngitis/laryngitis worsened,  not recovered for hoarse, unknown  for doesn't do anything for her body/gave her the shot then she had to go back within a month because her doctor did bloodwork to see if there were antibodies and there was nothing, unknown for could be allergic to something in it. A Product Complaint was filed. The sample of the product was not available to be returned.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pulmonary function test
Clinical narrative: This is a spontaneous report from a consumer reporting for herself. A 69-year-old female patient received PREVNAR 13 via an unspecified route of administration at single dose injection in left arm in Jan2017 or Feb2017 for immunization, for compromised immune system (it would give more protection), at doctor's office. Medical history included ongoing diabetes mellitus diagnosed about 10-15 years before, ongoing asthma diagnosed about 10-15 years before, ongoing bronchiectasis diagnosed about 10-15 years before, ongoing osteoporosis diagnosed about 10-15 years before, ongoing nerve injury diagnosed about 10-15 years before, ongoing sleep apnoea syndrome diagnosed about 10-15 years before, allergic to a lot of medications diagnosed about 10-15 years before, compromised immune system. She has been told those preexisting conditions will never go away. The patient's concomitant medications were not reported. She has had a pneumonia vaccine before, but this was her first PREVNAR 13 shot. She had another pneumonia shot years before, but this was the first time she got side effects. One week after her shot, she has been to a whole bunch of doctors and no one knows why, she is hoarse. She has a compromised immune system and it did not do anything for the system, she got laryngitis and it came and went and came and went. She has had laryngitis for 3 months now. States she has been to a whole bunch of doctor's and don't know why she is hoarse. She had a CAT scan and pulmonary function tests (PFT) about a month before. They were normal other than what was already there from the bronchiolectasis and asthma. The shot did not do anything for her body, she did not even get a flu shot because of her compromised immune system. The PREVNAR didn't do anything. They gave her the shot, then she had to go back within a month because her doctor did bloodwork to see if there were antibodies and there was nothing. This is a permanent stop of PREVNAR 13. Since she was allergic to a lot of medications, so she could be allergic to something in it. The outcome of the events was reported as: not recovered laryngitis/laryngitis worsened,  not recovered for hoarse, unknown  for doesn't do anything for her body/gave her the shot then she had to go back within a month because her doctor did bloodwork to see if there were antibodies and there was nothing, unknown for could be allergic to something in it. A Product Complaint was filed. The sample of the product was not available to be returned.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer representative. A female patient of an unspecified age and race/ethnicity received PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date. This event lasted one day and resolved on an unspecified date. The reporting pharmacist said he thought maybe the plunger or tip of the cap was made with latex and the patient was allergic.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist reported through a Pfizer sales representative. A 57-year-old female patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for pneumococcal disease. The patient medical history and  concomitant medications were not reported. The patient experienced developed a golf ball size swelling on arm after injection on an unspecified date with outcome of unknown.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash macular
Clinical narrative: This is a spontaneous report from a contactable consumer (mother of patient). A 53-year-old male patient received on 02May2017 11:00 PREVNAR 13 at 0.5 ml single dose intramuscular in the left arm for prevention in the physician office. Medical history included triglycerides and cholesterol high diagnosed several years ago, back pain, heart disease, Crohn's disease, costochondritis, vitamin d deficiency, acid reflux (esophageal), thyroidectomy all from an unknown date and ongoing. The patient also had thyroid cancer in Jul2011 and a quadruple bypass in Jul2014. In 2005 the patient had a pneumococcal vaccine (manufacturer unknown) for immunization. On 30Apr2017 the patient got an unspecified allergy shot . No adverse effect occurred with prior vaccinations. Concomitant medications included ANTARA for triglycerides, AZULFIDINE EN for Crohn's disease, COLESTID for Crohn's disease, LIPITOR for high cholesterol, levothyroxine sodium since he had no thyroid, metoprolol tartrate for high blood pressure, nortriptyline for hand tremors, pantoprazole for acid reflux esophageal, ranitidine for acid reflux esophageal, tizanidine for costochondritis, vitamin D3 for vitamin D deficiency, tramadol hydrochloride for back pain, PLAVIX for blood thinner for heart stent, all ongoing since an unknown date. On 02May2017 about a half an hour after receiving vaccination, the patient his arms and back broke out and had red flat blotches that extended down to his wrist (not itching). The patient called the physician who suggested to take BENADRYL or ZYRTEC, but the patient did not take the recommended medications due to Crohn's disease. Physician suggested also to take him up the ER if the red blotches made him uncomfortable. Outcome was not recovered.