chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Since 21-JUN-2017 the patients were vaccinated with improperly stored ROTATEQ(dose, lot # and expiration date were unknown, oral) for prophylaxis. No adverse effects were reported. The coldest temperature was 32 Fahrenheit, time frame was unknown. There were multiple temperature excursions previously. The call was because of a data logger. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004183: US-009507513-1708USA004184: US-009507513-1708USA003696:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Since 21-JUN-2017 the patients were vaccinated with improperly stored VAQTA (dose, lot #, expiration date and route were unknown) for prophylaxis. No adverse effects were reported. The coldest temperature was 32 Fahrenheit, time frame was unknown. There were multiple temperature excursions previously. The call was because of a data logger. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003696: US-009507513-1708USA004184: US-009507513-1708USA004182.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Since 21-JUN-2017 the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, lot #, expiration date and route were unknown) for prophylaxis. No adverse effects were reported. The coldest temperature was 32 Fahrenheit, time frame was unknown. There were multiple temperature excursions previously. The call was because of a data logger. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004183: US-009507513-1708USA003696: US-009507513-1708USA004182:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA lot # N005274, expiration date 03-APR-2018 and lot# N005796, expiration date 26-MAY-2018 (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 32 degree Fahrenheit to 35 degree Fahrenheit for 480 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA004176: US-009507513-1708USA004188: US-009507513-1708USA004189.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates,the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M032649, expiration date 11-NOV-2018 (strength,dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 32 degree fahrenheit to 35 degree fahrenheit for 480 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA004176: US-009507513-1708USA004187: US-009507513-1708USA004189:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 04-AUG-2017 the patient received an expired dose of ZOSTAVAX lot # M009773, expiry date: 17-MAY-2017 for prophylaxis (expired product administered).  Concomitant therapies included sterile diluent(STERILE DILUENT) (lot # N001534, expiry date: 30-JUL-2019).  No adverse effect reported. No Product Quality Complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician via Pfizer (MFR# 2017281821) refers to a currently 78 years old female patient. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (dose, route and lot# not reported) for prophylaxis. On an unknown date the patient experienced hives. The outcome was unknown. This is one of several reports received from the same resource.; Sender's Comments: US-009507513-1707USA009007:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unknown dates, improperly stored doses of PROQUAD (dose, strength, frequency and route were unknown, lot # N002917 with expiration date 24-JUL-2018 and lot# M041508 with expiration date 09-APR-2018) were each administered to the unspecified patients for prophylaxis. The PROQUAD was exposed from -14 Celsius to -10 Celsius for a time frame of 15 minutes. There were no previous temperature excursions. A data logger was in use. No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # M041080, expiration date 19-JAN-2019; lot #M041080, expiration date 06-OCT-2018) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). The vaccines and sterile diluent(STERILE DILUENT) were excursed under -9°C to 8°C for about 15 minutes. Digital data logger involved. No adverse events reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1707USA010624:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M014755, lot# M031802, lot# M035456, lot#M038744 (expiration dates not reported) and lot# M034799 with expiration date of 01-FEB-2018 (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA003935: US-009507513-1708USA004394: US-009507513-1708USA004392: US-009507513-1708USA004393: US-009507513-1708USA004409: US-009507513-1708USA004395:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX lot # M027342, expiration date 01-JUN-2018, and lot# M031970 (expiration date not reported) (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003935: US-009507513-1708USA004392: US-009507513-1708USA004393: US-009507513-1708USA004394: US-009507513-1708USA004395: US-009507513-1708USA004408.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX lot # M043582, expiration date 28-OCT-2018 for prophylaxis. Concomitant therapies included sterile diluent. The excursion under temperature 15 to 46 degree Fahrenheit for 5 hours. The previously excursion was 15 to 46 degree Fahrenheit for 6 hours. Digital data logger was involved. No adverse events reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA000559.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. Data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected.; Sender's Comments: US-009507513-1707USA009253:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored VAQTA (lot N005274; expiry date: 03-APR-2018). The vaccine was exposed to temperature range of 9°C to 25°C for 16 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. This is one of the reports received from the same reporter. Sender's Comments: US-009507513-1708USA004166.
Sex: F
Vaccine: UNK
Symptoms: Injection site pruritus, Vaccination site nodule
Clinical narrative: Initial unsolicited case received from a nurse (FNP) on 31 Jul 2017. This case involves a female patient (age not reported) who was vaccinated with two doses of HIB (PRP/T) VACCINE (HIB PRP-T) (Batch numbers: UH768AA, UH639AB, expiry date, dose, dose in series, route, and site of administration were not reported) on an unknown dates in Feb, and Apr 2013 respectively. The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccinations, the patient developed nodule at vaccine site that itched x 2 years. The patient relevant lab tests and corrective treatment was not reported. The outcome of the event was reported. List of documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Debridement, Injection site abscess, Nuclear magnetic resonance imaging abnormal, Wound treatment
Clinical narrative: Patient received vaccines on 7/18/17 had reaction on 7/30/17. Admitted to ER for abscess on Lt. thigh. Had MRI-Showed Intramuscular Abscess.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin irritation
Clinical narrative: Localized rash/irritation. Urgent Care prescribed Cefdinir. Patient came into clinic to see Dr. and Dr.  discontinued Cefdinir. No further adverse reaction.
Age: 2.0
Sex: M
Vaccine: TYP, VARCEL
Symptoms: Agitation, Urticaria, Vomiting
Clinical narrative: Within 5 minutes of injection, patient developed hives over entire body, agitation, resolved with benadryl after 40 minutes, some vomiting, was nearly given epinephrine but monitored with slow improvement and did not require epi.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt developed red ring around left upper arm, with warmness to the touch.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt received Vaccine on 8/8/17. Pt came today - 8/10/2017 - stating  she started having pain and swelling at site of injection that started on 8-9-17. Pt seen by provider and was given treatment plan and sent home.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Malaise, Pyrexia
Clinical narrative: Low grade fever, malaise onset 10-12 hours after dose, persisted 12 hours.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 1 year-old male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. On 23-JUN-2017, the patient was vaccinated with improperly stored first dose of VARIVAX, one unspecified dose in the left thigh (lot # M047622, expiration date and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide.; Sender's Comments:  US-009507513-1706USA009938:
Age: 2.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 2 year-old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 23-JUN-2017, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M047662 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of hepatitis a vaccine, inactivated (manufacturer: Merck Sharp & Dohme). The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 2 year-old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. On 30-JUN-2017, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M047622 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, subs on 2017-08-07.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bruxism, Glassy eyes, Hypotonia, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Seizure occurred at 12:30pm, lasted approximately 5 minutes. Parents reported that baby had been fed and was sleeping in mom's arms. Mom noticed the lips starting to quiver followed by jaws clenching and eyes flying open. Baby was not aware and not focused on mom or dad. Glassy eyed. Shortly after this, the whole body started shaking and was very stiff. Mom called 911 and dad held the baby. After a few minutes the episode was over and baby's body turned limp. She didn't move for another few minutes. Movements started again in hands, then arms and legs and later whole body. At this time EMS had arrived and they brought baby to the hospital. There was never a fever.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Seizure, Tremor
Clinical narrative: Seizure occurred at 12:30pm, lasted approximately 5 minutes. Parents reported that baby had been fed and was sleeping in mom's arms. Mom noticed the lips starting to quiver followed by jaws clenching and eyes flying open. Baby was not aware and not focused on mom or dad. Glassy eyed. Shortly after this, the whole body started shaking and was very stiff. Mom called 911 and dad held the baby. After a few minutes the episode was over and baby's body turned limp. She didn't move for another few minutes. Movements started again in hands, then arms and legs and later whole body. At this time EMS had arrived and they brought baby to the hospital. There was never a fever.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm red and swollen.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Amnesia, Electroencephalogram, Headache, Seizure
Clinical narrative: Client's mother reports that the client developed the symptoms of memory loss, severe headache, and seizures twelve hours following the vaccine administration. Client's mother reports that these symptoms are persisting now, one week after they began. The client has been evaluated at two emergency rooms and in the PCP's office with no identifiable cause of the symptoms.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Electrocardiogram normal, Injection site pain, Loss of consciousness, Pupillary light reflex tests abnormal
Clinical narrative: PT SITTING IN CHAIR BY CLINIC DESK. AFTER VACCINATION, PT TURNED TOWARDS DESK, LEANED FORWARD AND DROPPED HEAD ONTO DESK TOP. PHN LOWERED PT TO FLOOR WITH HELP OF FATHER. PT REGAINED CONSCIOUSNESS & RESTED ON FLOOR AND THEN PLACED UP ON EXAM TABLE IN SUPINE POSITION WITH ICE PACK TO BACK OF NECK. MD IN CLINIC CALLED TO CHECK PT. PT STATED HE FELT BETTER AND RAISED TO SITTING POSITION WHERE HE FELT SICK AND VOMITED X 1. PT LOWERED BACK TO SUPINE POSITION. PT FELT SLEEPY AND PHN CHECKED PUPIL REACTION WHICH SEEMED SLOW TO REACT TO LIGHT. PHN CALLED MD BACK TO ROOM TO CHECK. 911 CALLED. EMS ARRIVED AND PT CHECKED -, EKG WNL, VS WNL, PT PLACED IN SITTING POSITION TO CHECK BS WHICH WAS WNL AND PT VOMITED A SECOND TIME. EMS SUGGESTED TRANSPORT AND FATHER OF PT DECLINED. PT DISCHARGED TO HOME WITH FATHER WHO WAS ADVISED TO CALL 911 IF S/S WORSEN. PHN CALLED NEXT MORNING ON 8/10 AT 9:AM AND SPOKE WITH FATHER WHO STATED PT RESTED FOR AN HOUR UPON RETURN TO HOME THEN FELT FINE AND GOT UP AND ATE DINNER. PT WENT TO SUMMER CAMP 8/10 WITH ONLY COMPLAINT BEING SOME SORENESS AT INJECTION SITE.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pupillary reflex impaired, Vomiting
Clinical narrative: PT SITTING IN CHAIR BY CLINIC DESK. AFTER VACCINATION, PT TURNED TOWARDS DESK, LEANED FORWARD AND DROPPED HEAD ONTO DESK TOP. PHN LOWERED PT TO FLOOR WITH HELP OF FATHER. PT REGAINED CONSCIOUSNESS & RESTED ON FLOOR AND THEN PLACED UP ON EXAM TABLE IN SUPINE POSITION WITH ICE PACK TO BACK OF NECK. MD IN CLINIC CALLED TO CHECK PT. PT STATED HE FELT BETTER AND RAISED TO SITTING POSITION WHERE HE FELT SICK AND VOMITED X 1. PT LOWERED BACK TO SUPINE POSITION. PT FELT SLEEPY AND PHN CHECKED PUPIL REACTION WHICH SEEMED SLOW TO REACT TO LIGHT. PHN CALLED MD BACK TO ROOM TO CHECK. 911 CALLED. EMS ARRIVED AND PT CHECKED -, EKG WNL, VS WNL, PT PLACED IN SITTING POSITION TO CHECK BS WHICH WAS WNL AND PT VOMITED A SECOND TIME. EMS SUGGESTED TRANSPORT AND FATHER OF PT DECLINED. PT DISCHARGED TO HOME WITH FATHER WHO WAS ADVISED TO CALL 911 IF S/S WORSEN. PHN CALLED NEXT MORNING ON 8/10 AT 9:AM AND SPOKE WITH FATHER WHO STATED PT RESTED FOR AN HOUR UPON RETURN TO HOME THEN FELT FINE AND GOT UP AND ATE DINNER. PT WENT TO SUMMER CAMP 8/10 WITH ONLY COMPLAINT BEING SOME SORENESS AT INJECTION SITE.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 03-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA004691: US-009507513-1708USA004692: US-009507513-1708USA004693: US-009507513-1708USA004694: US-009507513-1708USA004695:
Sex: U
Vaccine: PPV, VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a patient of unknown demographics. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in approximately August 2015 (reported as 2 years ago), the patient got a prescription for both shingles vaccine (manufacturer unknown) and pneumonia vaccine (manufacturer unknown). On an unknown date in approximately August 2015, the patient was vaccinated with shingles vaccine (manufacturer unknown) injection (dose, route of administration, lot # and expiration date were not reported). On 03-AUG-2017, the patient went back to get the pneumonia vaccine (manufacturer unknown) injection (dose, route of administration, lot # and expiration date were not reported) and was told that they had gotten the pneumonia vaccine (manufacturer unknown) 2 years before. It could not be reliably determined whether the patient had received a dose of shingles vaccine (manufacturer unknown) or pneumonia vaccine (manufacturer unknown). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N012093 with expiration date 13-JAN-2020, lot# M024261with expiration date 30-JUL-2018, and lot# M044717 with expiration date 19-JUL-2019, for prophylaxis. No adverse event was reported. The doses of GARDASIL 9 were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. Previous temperature excursion was reported as 47 °F to 77 °F for 45 minutes. This is one of several reports from the same reporter; Sender's Comments: US-009507513-1708USA002992: US-009507513-1708USA002993: US-009507513-1708USA002994: US-009507513-1708USA002995:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient received an improperly stored dose in immunization series of GARDASIL 9 injection (lot # N013695 with expiration date at 21-MAR-2019; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 degrees Fahrenheit (F) for 168 hours. There was no previous temperature excursion. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004073: US-009507513-1708USA004071: US-009507513-1708USA004072: US-009507513-1708USA004070:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown age. On unknown dates the patients were vaccinated with single doses of improperly stored GARDASIL 9 lot # N004798, intramuscular for prophylaxis. No adverse effects were reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.    Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-year-old female patient. The patient did not have any medical history, concomitant medications and drug reactions or allergies. On 09-AUG-2017, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly lot # M040412 with expiration date on 03-JUN-2017 (the dose was not reported) as a prevention of human papilloma virus. On the same day, immediately after the administration of the vaccine, the patient passed out. An unspecified treatment was given for the event. The patient recovered from the event on the same day. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of passing out was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reported for oneself. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose on 24Jul2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got like an itch where they injected me, turned red and kind of a swelling around it on an unspecified date with outcome of unknown.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her husband. A 76-year-old male patient received the 2nd dose of PREVNAR 13, via an unspecified route of administration, on 01Aug2017 around 10:00/10:30 AM, at single dose, for immunisation. Relevant medical history included pain in knee and blood pressure abnormal (on medication since a long time). Concomitant medications included VITAMIN B 12, calcium (unspecified trade name), magnesium (unspecified trade name) and potassium (unspecified trade name). The patient previously received the 1st dose of PREVNAR 13 on an unspecified date for immunisation. The patient experienced lot of muscle pain on 01Aug2017 with outcome of unknown, chills on 01Aug2017 with outcome of not recovered, felt like he had a flu reaction on 01Aug2017 with outcome of unknown, all his joints hurt on 01Aug2017 with outcome of unknown, the pain that was in his upper arm has moved down into biceps on an unspecified date in Aug2017 with outcome of not recovered.
Sex: M
Vaccine: MENB
Symptoms: Chills
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reporting for his son reported a male patient of an unspecified age and ethnicity received the third dose of TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunization. The reporter stated that the patient got 3 doses of meningococcal group b rlp2086. The patient's medical history and concomitant medications were not reported. The patient previously took first dose and second dose of TRUMENBA both on unspecified dates. The patient experienced chills on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Vaccination site induration
Clinical narrative: This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. The healthcare professional reported similar events for 3 patients. This is the first of three reports. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date, single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported significant reactions in the area of vaccine. Large, pink, hard, wheal like lesions that lasted about 10 days. The patient did not complain about the pain or itching in the area more about the size of the rash. The outcome of the events was recovered on an unspecified date. Sender's Comments: Linked Report(s): US-PFIZER INC-2017340746 same reporter, drug and event/ different patient; US-PFIZER INC-2017340747 same reporter, drug and event/ different patient.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Vaccination site induration
Clinical narrative: This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. This healthcare professional reported similar events for three patients. This is the second of three reports. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient complained of significant reactions in the area of the vaccine. It was described as large, pink, hard, wheal like lesions that lasted about 10 days. The patient did not complain about the pain or itching in the area; it was more about the size of the rash. The outcome of the events was recovered on an unspecified date. Sender's Comments: Linked Report(s): US-PFIZER INC-2017340629 same reporter/drug/event, different patient; US-PFIZER INC-2017340747 same reporter/drug/event, different patient.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Vaccination site induration
Clinical narrative: This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. This healthcare professional reported similar events for 3 female patients. This is the third of the three reports. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date, at a single dose, for immunization. The patient's medical history and concomitant medications were not reported. The patient complained of significant reactions in the area of the vaccine described as large, pink, hard, wheal like lesions that lasted about 10 days on an unspecified date. The patient did not complain about the pain or itching in the area; it was more about the size of the rash. Outcome of the events was recovered on an unspecified date. Sender's Comments: Linked Report(s): US-PFIZER INC-2017340746 same reporter/drug/event, different patient; US-PFIZER INC-2017340629 same reporter/drug/event, different patient.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Bone pain, Myalgia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported for her daughter a female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on 02Aug2017 at single dose for immunization. The patient's medical history and concomitant medications were not reported.  It was reported that the patient got the TRUMENBA shot yesterday and was experiencing extreme muscle pain (Aug2017). It was also reported that her daughter's bones were hurting. Outcome of the adverse events were unknown.
Sex: F
Vaccine: MENB
Symptoms: Contusion, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program. The consumer reported for her daughter. A female patient of an unspecified age received second single dose of TRUMENBA, on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. Previously, on an unspecified date, the patient received the first dose of meningococcal group b rlp2086. A day after vaccination, the patient experienced fever and had bruises that lasted days. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Headache, Lacrimation increased, Nausea, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 65 year-old female patient received a single dose of PREVNAR 13 via an unspecified route of administration on 02Aug2017 for vaccination for Streptococcus pneumoniae. The patient medical history and concomitant medications were not reported. The patient started getting sore throat on 02Aug2017 soon after the shot, watery eyes in the afternoon of 02Aug2017, runny nose, nausea feeling, wasn't sleeping well and headache on 03Aug2017, on an unspecified date in Aug2017 (02Aug2017 or 03Aug2017) she felt like it was swollen in her throat, temperature was not normal anymore (99.7 degrees Fahrenheit) on 04Aug2017. She called the doctor who mentioned it could be an allergic reaction to the vaccine. The doctor asked her if she has trouble swallowing. She explained she could still swallow, but felt like it was swollen in throat. She was not wheezing. She took TYLENOL to treat headache and BENADRYL 1/4 tablet twice a day as instructed by doctor for other events. The doctor also told her to drink a lot of fluids, and if it would get worse advised her to go to urgent care. The patient was not recovered from sore throat (slightly worsened), watery eyes, runny nose, nausea feeling, felt like it was swollen in her throat, headache and abnormal temperature, she was recovering from not sleeping well.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pharyngeal oedema, Poor quality sleep, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 65 year-old female patient received a single dose of PREVNAR 13 via an unspecified route of administration on 02Aug2017 for vaccination for Streptococcus pneumoniae. The patient medical history and concomitant medications were not reported. The patient started getting sore throat on 02Aug2017 soon after the shot, watery eyes in the afternoon of 02Aug2017, runny nose, nausea feeling, wasn't sleeping well and headache on 03Aug2017, on an unspecified date in Aug2017 (02Aug2017 or 03Aug2017) she felt like it was swollen in her throat, temperature was not normal anymore (99.7 degrees Fahrenheit) on 04Aug2017. She called the doctor who mentioned it could be an allergic reaction to the vaccine. The doctor asked her if she has trouble swallowing. She explained she could still swallow, but felt like it was swollen in throat. She was not wheezing. She took TYLENOL to treat headache and BENADRYL 1/4 tablet twice a day as instructed by doctor for other events. The doctor also told her to drink a lot of fluids, and if it would get worse advised her to go to urgent care. The patient was not recovered from sore throat (slightly worsened), watery eyes, runny nose, nausea feeling, felt like it was swollen in her throat, headache and abnormal temperature, she was recovering from not sleeping well.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Cellulitis-like reaction with intense erythema and tenderness on left inner lower 2/3 of upper arm and tenderness over pectoralis muscle without erythema. Limited range of motion left shoulder. A febrile. Treated with oral antihistamine, 1%hydrocortisone topically and ice.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Tenderness
Clinical narrative: Cellulitis-like reaction with intense erythema and tenderness on left inner lower 2/3 of upper arm and tenderness over pectoralis muscle without erythema. Limited range of motion left shoulder. A febrile. Treated with oral antihistamine, 1%hydrocortisone topically and ice.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray, Full blood count, Pneumonia
Clinical narrative: Patient was diagnosed with pneumonia on 8/3/17.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Rash, Skin lesion
Clinical narrative: He woke up with a diffuse rash on his arms, legs and trunk - red, raised lesions, no blisters. No tongue swelling, difficulty swallowing or breathing. No rash on his genitals or mouth. Took benadryl approx one hour ago. Denies dysphagia, denies SOB. Reports he has joint aches.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 17-JUL-2017 from a nurse who was reporting on multiple unspecified patients (demographic were unknown). No medical history or concomitant medications were reported. The nurse reported that on unspecified dates, an unspecified number of patients were administered doses of improperly stored MMRII (lot N010426, expires 01-MAR-2018). The lot number and expiration of the sterile diluent is unknown. The nurse also reported that on unspecified dates, an unspecified number of unspecified patients were administered separate doses of improperly stored doses for the following vaccines: PEDVAXHIB (Lot L033690, expires 14-JUN-2018), GARDASIL 9 (lot N00326, expires 14-OCT-2019) and PNEUMOVAX 23 (lot N01867, expires 08-NOV-2018) (dose, injection sites and route not reported). No adverse effects were reported. No additional information was provided. The temperature excursion involved temperature range from 9 degrees C. to 25 degrees C. for 72 hours. There was no previous temperature excursion and a data logger was not involved. The nurse called back and reported that a female patient of unknown age, received a dose of improperly stored PNEUMOVAX 23 (lot N011867, expires 08-NOV-2018) vaccine on 14-JUL-2017 for prophylaxis. No medical history or concomitant medications were reported. Two male patients of unknown age also received improperly stored GARDASIL 9 (lot N000326, expires 14-OCT-2019)(MARRS# 1708USA004621 & MARRS #1708USA004622 ) on 14-JUL-2017. Follow-up information was received on 17-JUL-2017 from the nurse who reported that the actual timeframe of the temperature excursion was 96 hours. The nurse also stated that the improperly stored PEDVAXHIB and MMRII were not administered. No further adverse event information was provided. Additional information has been requested. This is one of several reports by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 76 year old male patient who is reporting on herself. The patient's concurrent conditions included pulmonary mass, cancer pain, basal cell carcinoma, metastases to spine, squamous cell carcinoma, hypercholesterolemia, drug hypersensitivity, hypertension and blood cholesterol increased. The patient's medical history included skin cancer, skin neoplasm excision, skin neoplasm excision and skin operation. The patient is an ex-tobacco user. On an unknown date (reported as 3-4 years ago), the patient received an unspecified shingles vaccine (manufacturer unknown) for prophylaxis. Then approximately on 18-MAY-2017 (reported as 2 weeks ago), he was diagnosed with shingles. He was prescribed an unspecified medication which he took for 5 days and then saw his physician for a follow-up appointment. The physician then prescribed the same unspecified medication for another 7 days. The patient stated at that time the shingles was 80-90% resolved and he felt it was a mild case (reported as "cause") of shingles. Causality assessment was unknown. This case is linked to the same patient link (MAARS ID: 1702USA009738).; Sender's Comments: US-009507513-1702USA009738:
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a other refers to a 19 year old female patient. On 24-JUL-2017 the patient was vaccinated with M-M-R II lot # M022407, intramuscular in the left deltoid for prophylaxis. Other suspect therapies included sterile diluent. On 31-JUL-2017, 8 days after onset of therapy the patient experienced rubella antibody negative and mumps antibody test negative. The outcome of rubella antibody negative and mumps antibody test negative is unknown. Additional information has been requested.
Age: 0.83
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 13 month old patient. In May 2017 (reported as "three months ago"), the patient was vaccinated with PROQUAD for prophylaxis (drug administered to patient of inappropriate age).  Concomitant therapies included sterile diluent(DILUENT MRK). No adverse event reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient received an improperly stored dose in immunization series of GARDASIL 9 injection (lot # N013695 with expiration date at 21-MAR-2019; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 degrees Fahrenheit (F) for 168 hours. There was no previous temperature excursion. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004073: US-009507513-1708USA004071: US-009507513-1708USA003345: US-009507513-1708USA004072.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient received an improperly stored dose in immunization series of PNEUMOVAX23 injection (lot # N010106 with expiration date at 15-NOV-2018; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 degrees Fahrenheit (F) for 168 hours. There was no previous temperature excursion. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004073: US-009507513-1708USA003345: US-009507513-1708USA004070: US-009507513-1708USA004072:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 02-AUG-2017, the patient received an improperly stored dose in immunization series of PNEUMOVAX 23 injection (lot # N010106 with expiration date at 15-NOV-2018; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 degrees Fahrenheit (F) for 168 hours. There was no previous temperature excursion. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003345: US-009507513-1708USA004070: US-009507513-1708USA004071: US-009507513-1708USA004073.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.On 02-AUG-2017, the patient received an improperly stored dose in immunization series of RECOMBIVAX HB injection (lot # M046373 with expiration date at 04-NOV-2018; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 degrees Fahrenheit (F) for 168 hours. There was no previous temperature excursion. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004072: US-009507513-1708USA004070: US-009507513-1708USA004071: US-009507513-1708USA003345.