chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, 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 04-AUG-2015, the patient was vaccinated with a dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis, and on 05-AUG-2016, she/he was vaccinated with a dose of GARDASIL 9 (lot number M013636; strength, dose, route and anatomical location were not provided), also for prophylaxis (interchange of vaccine products). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX, (lot #s N012134 expiry date 17-APR-2019, N000682 expiry date 06-JAN-2019, N012486 expiry date 20-APR-2019, and M045204 expiry date 11-NOV-2018) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On an unknown date, the VARIVAX vaccines were stored with a temperature excursion of 15°F to 46°F during 40 hours (incorrect product storage). The sterile diluent (STERILE DILUENT) did not undergo any temperature excursions. No adverse effects reported. The medical assistant was call because of a data logger. The outcome of incorrect product storage and no adverse event was unknown. Additional information is not expected as no information to obtain follow-up was provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # M022086 with expiration date 09-OCT-2017) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006507:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose and route were not reported), lot # M037770 and expiry date: 01-JUN-2019 for prophylaxis. The vaccine was exposed to temperature of 47 to 77 Fahrenheit for 510 minutes. There was a previous temperature excursion of 47 to 77 Fahrenheit for 6 hours. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007237: US-009507513-1707USA007238: US-009507513-1707USA007239.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patient of unknown age. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of one of the following lots of PROQUAD, but she was not sure which of the lots the unspecified patient received from lot#s (M044021, expiry: 01-MAY-2018) (N008824, expiry: 28-AUG-2018) (N002917, expiry: 24-JUL-2018) (M034692, expiry: 24-JAN-2018) (M022400, expiry: 01-NOV-2017), (dosing details not provided), for prophylaxis. No adverse effects were reported. The vaccine lots were exposed to temperature in the range -9 degree Celsius to 8 degree Celsius for 1 hour and 45 minutes. Temperature excursion was detected by digital data logger. No previous temperature excursion occurred. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005985.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 08-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M044717, expiry date: 1 dose (route, anatomical location were unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 32F to 35F for a duration of 35 minutes and 47F to 77F for a duration of 29 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007252.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Information was received from a physician via a field employee, referring to a 17 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 29-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (concentration, frequency, route, lot # and expiration date were unknown), and a dose of MENACTRA (in the opposite arm; concentration, frequency, route, lot # and expiration date were unknown), both for prophylaxis. Shortly after the vaccination, on the same day, the patient "passed out". The physician stated that the patient "came to, and was fine" The outcome of event was unknown. The causality between event and suspect therapies was not provided. Upon internal review, "passed out" was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with an unspecified amount of doses, with unspecified lot number/unspecified expiration date of ROTATEQ that underwent temperature excursions starting on 01-NOV-2016 for prophylaxis (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 47 degree Fahrenheit-77 degree Fahrenheit and time frame was 2 hours 10 mins.  Call was due to digital data logger and there was no temperature excursion before. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006922: US-009507513-1707USA006923: US-009507513-1707USA006335:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with an unspecified amount of doses, with unspecified lot number/unspecified expiration date of VAQTA that underwent temperature excursions starting on 01-NOV-2016 for prophylaxis (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 47 degree Fahrenheit-77 degree Fahrenheit and time frame was 2 hours 10 mins. Call was due to digital data logger and there was no temperature excursion before. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006335: US-009507513-1707USA006923: US-009507513-1707USA006921:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with an unspecified amount of doses, with unspecified lot number/unspecified expiration date of PNEUMOVAX 23 that underwent temperature excursions starting on 01-NOV-2016 for prophylaxis (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature was 47 degree Fahrenheit-77 degree Fahrenheit and time frame was 2 hours 10 minutes. Call was due to digital data logger and there was no temperature excursion before. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006335: US-009507513-1707USA006922: US-009507513-1707USA006921:
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB from lot # M040423 with expiry: 03-JUL-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature excursion of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. This is one of the three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA005936:
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB from lot # M040423 with expiry: 03-JUL-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature excursion of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. This is one of the three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA005936:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ from lot # M032636 with expiry: 06-APR-2018 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature excursion of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. This is one of the three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA005936:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from other health professional refers to an unspecified number of patients of unknown age. The patient's past medical history and concomitant medications were not reported. On unknown dates the patients received improperly stored PNEUMOVAX 23, lot # M037533 with expiry date 07-MAY-2018(Dose, frequency route unknown) for prophylaxis. No adverse effects reported. This is one of the 3 reports. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 11-JUL-2017 and 12-JUL-2017, unspecified number of patients were vaccinated with improperly stored doses of PROQUAD lot# M042499 with expiry date: 17-APR-2018 (dosing details, route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 1 hour. Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005971: Original Case: 1707USA005971.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB (dose and route were not reported), lot # M045207 and expiry date: 30-JUN-2019 for prophylaxis. The vaccine was exposed to temperature of 47 to 77 Fahrenheit for 510 minutes. There was a previous temperature excursion of 47 to 77 Fahrenheit for 6 hours. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA007239: US-009507513-1707USA007238: US-009507513-1707USA006714:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PROQUAD (dose and route were not reported), lot # M044719 and expiry date: 07-MAY-2018 for prophylaxis. The vaccine was exposed to temperature of 15 to 46 Fahrenheit for 75 minutes. There was a previous temperature excursion of 47 to 77 Fahrenheit for 10.5 hours. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007237: US-009507513-1707USA006714: US-009507513-1707USA007239.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with VARIVAX (dose and route were not reported), lot # M041514 and expiry date: 11-OCT-2018 for prophylaxis. The vaccine was exposed to temperature of 15 to 46 Fahrenheit for 75 minutes. There was a previous temperature excursion of 15 to 46 Fahrenheit for 53.5 hours. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same  reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA007237: US-009507513-1707USA007238: US-009507513-1707USA006714:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 08-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M044717, expiry date: 19-JUL-2019, 1 dose (route, anatomical location were unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 32F to 35F for a duration of 35 minutes and 47F to 77F for a duration of 29 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006790.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report form a contactable physician. A female patient of an unknown age and race received PREVNAR 13 single dose for immunization in the arm, on 05Jul2017. Medical history and concomitant medication were not reported. On 09Jul2017 the patient experienced arm redness, swelling and itching and chills. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported for a female patient of an unspecified age and race that received PREVNAR 13 for immunization on unknown date at single dose. Medical history and concomitant medciation were unknown. The patient get pneumonia too often. And she was hospitalized during each episode. The outcome was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Blood pressure increased
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (the patient). A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blood pressure shot sky high when he got the vaccine on an unspecified date. The outcome of the event was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a male patient of unspecified age and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient got pneumonia so bad on an unspecified date that he was hospitalized 3 times and treated with antibiotics and steroids (wound-up getting diabetic from the steroids). It took 2 months to clear his lungs. Pneumonia resolved on an unspecified date. The reported stated that it was all because of the pneumonia vaccine that was supposed to be so good. No follow up attempts possible. No further information expected.
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer reported for his/her son. A male patient of an unknown age, gender and race received the second dose of Meningococcal Group B Rlp2086 at single dose for immunization on unknown date. Medical history and concomitant medication were not reported. The patient had received the first dose of the same vaccine on unknown date and he had a sore arm. On unknown date the patient experienced arm pain, swelling redness and fever  at 102. The patient received ibuprofen (ADVIL) and paracetamol (TYLENOL). The outcome of the events was unknown. No follow-up attempts are possible. No further information expected. Pfizer is Marketing Authorization Holder of Meningococcal Group B Rlp2086 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Meningococcal Group B Rlp2086 has submitted the same report to the regulatory authorities.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Bone scan normal, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial unsolicited case received from a consumer (patient herself) on 07 Jul 2017. This case involves a 50-year-old female patient who was vaccinated with a dose of ADACEL (Batch number, expiry date, dose, dose in series, and site of administration were not reported) via intramuscularly on an unknown day in Aug 2016. The patient had no illness at time of vaccination, and no pre-existing physician diagnosed allergies, birth defects, or medical conditions. The patient concomitant medications were not reported. On an unknown day in Aug 2016, same day after the vaccination (also reported as on day of vaccination), the patient had a pain at the injection site. Pain became progressively worse and extended from the injection site down to the fingers of the left arm. Patient states that there was some redness and swelling at the injection site (vaccination site inflammation). Whole left arm became tender to touch with unbearable pain, and on an unknown date, the patient was seen by MD and orthopedic MD, and she had 4 MRIs (magnetic resonance imaging) and a bone scan both were negative, and was put on steroids for one week. Pain has subsided now is much less severe and comes and goes, and it was also reported as on an unknown date, the patient also had a loss of strength in the arm, and currently she was going to physical therapy. The patient other lab tests, and other corrective treatment was not reported. The outcome of all the events were reported as not recovered. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Initial unsolicited case received from a consumer (patient herself) on 07 Jul 2017. This case involves a 50-year-old female patient who was vaccinated with a dose of ADACEL (Batch number, expiry date, dose, dose in series, and site of administration were not reported) via intramuscularly on an unknown day in Aug 2016. The patient had no illness at time of vaccination, and no pre-existing physician diagnosed allergies, birth defects, or medical conditions. The patient concomitant medications were not reported. On an unknown day in Aug 2016, same day after the vaccination (also reported as on day of vaccination), the patient had a pain at the injection site. Pain became progressively worse and extended from the injection site down to the fingers of the left arm. Patient states that there was some redness and swelling at the injection site (vaccination site inflammation). Whole left arm became tender to touch with unbearable pain, and on an unknown date, the patient was seen by MD and orthopedic MD, and she had 4 MRIs (magnetic resonance imaging) and a bone scan both were negative, and was put on steroids for one week. Pain has subsided now is much less severe and comes and goes, and it was also reported as on an unknown date, the patient also had a loss of strength in the arm, and currently she was going to physical therapy. The patient other lab tests, and other corrective treatment was not reported. The outcome of all the events were reported as not recovered. List of documents held by sender: none.
Sex: F
Vaccine: UNK
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer, manufacturer report number 2017273915) on 10-JUL-2017. This case involves a female patient (unknown age) who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced severe allergy to tetanus vaccine. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Bone pain, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: Flu like symptoms including swollen glands: fever-swollen glands in neck and swollen and sore gland on (L) collar bone that ached to touch-achy muscles and soreness-soreness in entire left arm -tingly hands (both)-run down feeling-no energy. Besides the fever, these symptoms last over a week.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Flu like symptoms including swollen glands: fever-swollen glands in neck and swollen and sore gland on (L) collar bone that ached to touch-achy muscles and soreness-soreness in entire left arm -tingly hands (both)-run down feeling-no energy. Besides the fever, these symptoms last over a week.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms including swollen glands: fever-swollen glands in neck and swollen and sore gland on (L) collar bone that ached to touch-achy muscles and soreness-soreness in entire left arm -tingly hands (both)-run down feeling-no energy. Besides the fever, these symptoms last over a week.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: Gastrointestinal upset with vomiting.
Age: 12.0
Sex: M
Vaccine: IPV, IPV
Symptoms: Fatigue, Pyrexia, Rash, Urticaria
Clinical narrative: My son broke into hives the night after he received the vaccine. It started in his abdomen with welts that were about nickel sized and spread throughout his body. We kept a close eye on him all night to make sure it was not getting worse. He slept through the night but the next morning had a fever of 101 and was very tired. He missed his baseball camp for the day and slept all day. The rash had spread to his legs, arms, and his back. Although the next day his fever had subsided and he was feeling better (day 2 after the shot), his rash spread to his face and continued to move around his body for 10 days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, low grade fever.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria, Viral infection
Clinical narrative: Child developed urticarial within a few hours. Continued over the next 2 days until seen by this provider but additionally had evidence of a viral infection by that time (mom isn't sure if they all started around the same time or not). Was seen 10 days later and all symptoms of viral illness and urticarial had resolved.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a pharmacist regarding a 25 year old male patient. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-JUN-2017, the patient inadvertently received an expired dose (lot # L001312; expiration date 24-FEB-2017) of GARDASIL 9 intramuscularly. He also received GARDASIL 9 (lot number, expiration date not provided) on 19-APR-2017. No adverse events were reported. No further information was provided. The outcome of the events were unknown. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Hallucination
Clinical narrative: This spontaneous report was received from a physician via field representative and refers to a 14 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2017 (reported as 5 months ago), the patient was vaccinated with first dose of GARDASIL 9 (site and route of administration, lot # and expiration date were not reported). On an unknown date in 2017, the patient experienced hallucination. No treatment was given for the adverse events. It was unknown if the patient was hospitalized. The outcome of the event and the relatedness between the event and GARDASIL 9 were not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received 05-JUL-2017 via a phone call from a nurse who reported that an unknown number of patients (names and other demographics unknown to the reporter) were vaccinated with VARIVAX that had undergone a temperature excursion.  Administration dates were unspecified. The following VARIVAX lot numbers underwent the temperature excursion of 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C)  (-11 degrees C) for 144 minutes:  Lot M042495 Expiration 19-OCT-2018, Lot M046924 Expiration 28-NOV-2018, Lot M047662 Expiration 02-DEC-2018, Lot N014368 Expiration 09-MAY-2019, Lot N000683 Expiration 06-JAN-2019.  No adverse effects were reported in any patients.  No further information was available. Additional information was requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates (reported over the past year), the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration, lot# and expiration dates were not reported) as prophylaxis. The vaccines were stored between 47 degrees Fahrenheit (F) and 77F (49F) for 8 hours and 30 minutes and between 32F and 35F (32F) for 16 hours and 30 minutes. No previous temperature excursions were reported. The excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005788: US-009507513-1707USA007385.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from other health professional refers to an unspecified number of patients of an unknown age. The patient's past medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with improper stored ROTATEQ (incorrect product storage) lot # M035456 expiry date of 01-MAY-2018 (Dose, frequency, route, and start date unknown) for prophylaxis. No adverse effects reported.  This one of the 3 reports. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from other health professional (nurse) refers to an unspecified number of patients of unknown demographics. The patient's past medical history and concomitant medications were not reported. On unknown dates the patients received improperly stored GARDASIL 9 lot # M042853 expiry date 17-JUL-2019 (Dose, frequency, route unknown) for prophylaxis. No adverse effects reported. This one of the 3 reports. Additional information has been requested. .
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # m048200 with expiry date on 07-DEC-2018 (exact dose and route of administration were not reported). The doses were administered together with sterile diluent (STERILE DILUENT) and were exposed to the temperature between 6 and 14 degrees Fahrenheit for 14 hours. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report was received from a doctor of pharmacy referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis (reported as "vaccines"). On an unknown date, the patient had an anaphylactic reaction an unspecified amount of time after vaccine administration. It was unknown if the patient received any treatment.     At the time of reporting, the outcome of anaphylactic reaction was unknown. The causal relationship between the event and the M-M-R II was not reported. Upon internal review, the anaphylactic reaction was determined to be a medically significant event.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates (reported as over the past year), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route of administration, lot# and expiration dates were not reported) as prophylaxis. The vaccines were stored between 47 degrees Fahrenheit (F) and 77F (49F) for 8 hours and 30 minutes and between 32F and 35F (32F) for 16 hours and 30 minutes. No previous temperature excursions were reported. The excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005788: US-009507513-1707USA006075.
Sex: F
Vaccine: PNC13
Symptoms: Abasia, Central nervous system lupus
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Branded Concept Quant GM phase 2, from a contactable consumer. A female patient of an unspecified age, race and ethnicity  received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient developed central nervous system lupus on an unspecified date and she could not walk. Outcome of central nervous system lupus was unknown, the patient still could not walk at the time of the report. Even if the reporter though that it might not have been caused by the vaccination, this scared enough him/her to find out a lot more before getting the vaccine. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Initial unsolicited report received from physician on 07-Jul-2017. This case involves a 34 years old male patient who was vaccinated with 0.5 ml single dose of TYPHIM VI (Batch number: M15721M, expiry date and site of administration was not reported) intramuscularly on 30 June 2017. No known drug allergies, no history reactions to vaccines, no medical history other than history of anxiety/depression treated with very small dose of Zoloft. Patient received 10 mg SERTRALINE HYDROCHLORIDE (Zoloft) daily orally four years ago from depression and 400 mg dose of IBUPROFEN twice a day orally on 05 July 2017. On 05 July 2017 in the evening five days following the vaccination the patient had tactile fever. On 06 Jul 2017 in the night six days following the vaccination patient had fever including drenching sweats and chills. The patient relevant lab test was not reported. Patient received ibuprofen 400 mg at bedtime as a corrective treatment. (Self-treated with more ibuprofen). On 07 July 2017 Patient was recovered from events. (It was reported that by morning of 7 July 2017, subject was afebrile, energetic, had no other symptoms). List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Has redness, swelling and rash near injection site.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm is very sore, not able to move it well, nauseated, blurred vision, fever, joints are very pain.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Vision blurred
Clinical narrative: Arm is very sore, not able to move it well, nauseated, blurred vision, fever, joints are very pain.
Age: 19.0
Sex: F
Vaccine: ANTH, FLUX, HEPAB, SMALL
Symptoms: Altered state of consciousness, Anxiety, Appendicectomy, Arthropathy, Asthenia
Clinical narrative: Besides the immediate burning like my arm was on fire after getting each shot and having an egg shaped welt on my arm that was extremely painful. I began to have a lot of issues being outside in the sun. It felt as if I was having all the energy sucked out of me. My body would just radiate heat with in a matter of just a couple of minutes of being out in the sun. I very quickly felt as if I would pass out. As the years have gone by this issue has not gone away. I also now have anxiety issues not related to work because I did not go. This anxiety just seemed to come from out of no where. I also have degenerative disc disease and keep having positive results for arthritis but then don't show the signs for it. My joints feel weak and my muscles get really tight to where it is painful and I have to constantly be stretching. I already had to have my appendix removed and now have polyps in my gall bladder.
Age: 19.0
Sex: F
Vaccine: ANTH, FLUX, HEPAB, SMALL
Symptoms: Blood test, Burning sensation, Dermatitis contact, Drug hypersensitivity, False positive investigation result
Clinical narrative: Besides the immediate burning like my arm was on fire after getting each shot and having an egg shaped welt on my arm that was extremely painful. I began to have a lot of issues being outside in the sun. It felt as if I was having all the energy sucked out of me. My body would just radiate heat with in a matter of just a couple of minutes of being out in the sun. I very quickly felt as if I would pass out. As the years have gone by this issue has not gone away. I also now have anxiety issues not related to work because I did not go. This anxiety just seemed to come from out of no where. I also have degenerative disc disease and keep having positive results for arthritis but then don't show the signs for it. My joints feel weak and my muscles get really tight to where it is painful and I have to constantly be stretching. I already had to have my appendix removed and now have polyps in my gall bladder.
Age: 19.0
Sex: F
Vaccine: ANTH, FLUX, HEPAB, SMALL
Symptoms: Gallbladder polyp, Immediate post-injection reaction, Intervertebral disc degeneration, Muscle tightness, Myalgia
Clinical narrative: Besides the immediate burning like my arm was on fire after getting each shot and having an egg shaped welt on my arm that was extremely painful. I began to have a lot of issues being outside in the sun. It felt as if I was having all the energy sucked out of me. My body would just radiate heat with in a matter of just a couple of minutes of being out in the sun. I very quickly felt as if I would pass out. As the years have gone by this issue has not gone away. I also now have anxiety issues not related to work because I did not go. This anxiety just seemed to come from out of no where. I also have degenerative disc disease and keep having positive results for arthritis but then don't show the signs for it. My joints feel weak and my muscles get really tight to where it is painful and I have to constantly be stretching. I already had to have my appendix removed and now have polyps in my gall bladder.
Age: 19.0
Sex: F
Vaccine: ANTH, FLUX, HEPAB, SMALL
Symptoms: Pain in extremity, Photosensitivity reaction, Staphylococcus test, Urticaria
Clinical narrative: Besides the immediate burning like my arm was on fire after getting each shot and having an egg shaped welt on my arm that was extremely painful. I began to have a lot of issues being outside in the sun. It felt as if I was having all the energy sucked out of me. My body would just radiate heat with in a matter of just a couple of minutes of being out in the sun. I very quickly felt as if I would pass out. As the years have gone by this issue has not gone away. I also now have anxiety issues not related to work because I did not go. This anxiety just seemed to come from out of no where. I also have degenerative disc disease and keep having positive results for arthritis but then don't show the signs for it. My joints feel weak and my muscles get really tight to where it is painful and I have to constantly be stretching. I already had to have my appendix removed and now have polyps in my gall bladder.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Cold sweat, Erythema, Injection site nodule, Pain
Clinical narrative: Pt received vaccine in right deltoid on 7/12/17 around 0830 and states that he woke up the next day with fever, chills, and cold sweats that lasted throughout the day. Over the next 3 days, his right arm began to swell up and become red and warm to the touch with a large, firm raised knot at the injection site. Pt reported mild pain and itching and states that he was unable to raise his arm without pain.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Skin warm
Clinical narrative: Pt received vaccine in right deltoid on 7/12/17 around 0830 and states that he woke up the next day with fever, chills, and cold sweats that lasted throughout the day. Over the next 3 days, his right arm began to swell up and become red and warm to the touch with a large, firm raised knot at the injection site. Pt reported mild pain and itching and states that he was unable to raise his arm without pain.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 03-JUL-2017 from a pharmacist who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. On 29-JUN-2017, the patient was administered a dose of ZOSTAVAX (lot M032650, expiration 15-JUN-2017) (dose and site not reported) for prophylaxis that was expired. It was reconstituted with non-expired sterile diluent (unknown lot and expiration). No adverse effects were reported. No further information provided. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blindness, Blood glucose normal, Electrocardiogram normal, Full blood count, Metabolic function test
Clinical narrative: After he received the MENACTRA and ADACEL, he started to c/o nausea. Shortly after that( 3-5 min) he became pale. About 2 minutes later he said he could not see but could still hear. He was sitting in a chair while this was occurring and had oxygen being delivered at 6 liters/min. He got back on the table with a little help where an was lying down with his feet elevated. Before he got on the table his glucose was checked on the residual in the CBC tube and was found to be 74. His lips pinked back up while lying down. His heart rate was around 58-62 per Sat meter and the oxygen was turned down to 2 1/2 liters/min while maintaining his saturation. An ambulance was called to transport him to the hospital. BP while lying down was 84/50.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Pallor
Clinical narrative: After he received the MENACTRA and ADACEL, he started to c/o nausea. Shortly after that( 3-5 min) he became pale. About 2 minutes later he said he could not see but could still hear. He was sitting in a chair while this was occurring and had oxygen being delivered at 6 liters/min. He got back on the table with a little help where an was lying down with his feet elevated. Before he got on the table his glucose was checked on the residual in the CBC tube and was found to be 74. His lips pinked back up while lying down. His heart rate was around 58-62 per Sat meter and the oxygen was turned down to 2 1/2 liters/min while maintaining his saturation. An ambulance was called to transport him to the hospital. BP while lying down was 84/50.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: PATIENT STATED 8 DAYS AFTER RECEIVING VACCINE SITE BECAME ITCHY RED AND WARM TO THE TOUCH. STATED TODAY (2 DAYS AFTER ADVERSE REACTION STARTED) SITE IS NO LONGER ITCHY BUT STILL A LITTLE RED. STATED SHE THOUGHT AT FIRST IT WAS AN INSECT BITE. CALLED DRUG COMPANY AND WAS TOLD REACTION CAN TAKE PLACE UP TO 7 DAYS AFTER VACCINATION AND IT NON-LIFE THREATENING, BUT COMMON REACTION TO VACCINE. RELAYED THAT TO THE PATIENT.
Age: 78.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: PATIENT STATED 8 DAYS AFTER RECEIVING VACCINE SITE BECAME ITCHY RED AND WARM TO THE TOUCH. STATED TODAY (2 DAYS AFTER ADVERSE REACTION STARTED) SITE IS NO LONGER ITCHY BUT STILL A LITTLE RED. STATED SHE THOUGHT AT FIRST IT WAS AN INSECT BITE. CALLED DRUG COMPANY AND WAS TOLD REACTION CAN TAKE PLACE UP TO 7 DAYS AFTER VACCINATION AND IT NON-LIFE THREATENING, BUT COMMON REACTION TO VACCINE. RELAYED THAT TO THE PATIENT.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: PT C/O BODY ACHES, LEFT ARM SWELLING, REDNESS AND WARM TO TOUCH. PT'S SWELLING DEVELOPED IN THE EARLY EVENING ON THE DAY OF VACCINATION.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Skin rash, redness and itching at site of injection. 2 days later the patient has put after bite (Sodium Bicarbonate) on the site, she has been instructed to put on a cold compress and and hydrocortisone cream for the itching. If the rash did not get better in 2 days she was instructed to see a doctor and follow up with us as well.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Mom states that she dressed child the morning following vaccine administration (7/19/17) and child stated that his right arm was hurting but mom did not look at it. Later that same day as she was undressing child, she looked at arm and noticed that it was red, warm to touch and swollen. Child had temp of 100 F. Mom gave child BENADRYL and TYLENOL. Mom brought child to clinic today, 7/20/17, with complaints of continued redness, whelps and pain to upper right arm. Child was given topical BENADRYL and liquid CLARITIN to take at home. Mom instructed to follow up at ER or clinic if child has any breathing issues or reaction worsens/increases in size.