chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose in the arm for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had redness in his/her arms where the shot was (given). The patient inquired if this was a normal case if you get a shot and had redness in the arms where the shot was (given). He/She also wanted to know if that was an injection or a reaction to pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) via a contactable nurse. A female patient of an unspecified age and ethnicity received first dose of TRUMENBA (lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date (reported as 6 months ago) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a fever of 105 degrees at the first dose of meningococcal group b rlp2086 six months ago. The outcome of the event was unknown.
Sex: F
Vaccine: PNC
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a contactable consumer. A currently 82-year-old female patient received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), 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. On an unknown date, the patient experienced allergic to it (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein)). The action taken in response to the event for pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was unknown. The clinical outcome for the event was unknown. Pfizer is marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: FLUX, MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable unspecified Healthcare professional. A female patient of unknown age and race/ethnicity received first single dose of TRUMENBA and influenza vaccine (manufacturer unknown), both for immunization. Medical history and concomitant medications were not reported. The patient had a fever of 105.0 degrees F on an unknown date. Outcome was unknown.
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Initial unsolicited report received from a patient on 29-Jun-2017. This case involves a female patient, who was vaccinated with Td (batch number, expiry date, dose, route, site of administartion and dose in series not reported) on an unknown date of 1978. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient's arm got red, sore, swollen & itchy. Patient required ER/doctor visit. No lab test done. Corrective treatment was not reported. On an unknown date, patient recovered from events'. Documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 50-year-old female patient who received BOOSTRIX (batch number 594SR, expiry date 18th July 2019). On 23rd June 2017, the patient received BOOSTRIX. On 24th June 2017, 1 days after receiving BOOSTRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. The reporter considered the chills to be possibly related to BOOSTRIX. Additional details were provided as follows: The concomitant vaccines or medications were not reported. The reporting pharmacist was the patient who experienced chills. She denied reporting any other adverse events.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Pigmentation disorder
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of spot pigmented in a infant patient who received HIBERIX. On an unknown date, the patient received HIBERIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving HIBERIX, the patient experienced spot pigmented. On an unknown date, the outcome of the spot pigmented was unknown. The reporter considered the spot pigmented to be probably related to HIBERIX. Additional details were provided as follows. This case was reported by Medical Assistant. The age at vaccination was not reported. The patient received HIBERIX in unknown thigh. It was reported that, 2 months after receiving HIBERIX, the patient returned with a black mark on thigh that they attributed to HIBERIX. The spot was looking a black tattoo, not like a blood blister or a bruise. It was unknown whether this office purchased this vaccine with private or public funds. The lot and expiration date of the vaccine was not known. The gender or age or date of birth was not provided. It was not known what other vaccines may have been administered at the same time for these two patients. This case has been linked with case US2017101776, reported by the same reporter for potentially siblings.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Pigmentation disorder
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of spot pigmented in a patient who received HIBERIX. On an unknown date, the patient received HIBERIX (intramuscular 0.5 ml. On an unknown date, less than a year after receiving HIBERIX, the patient experienced spot pigmented. On an unknown date, the outcome of the spot pigmented was unknown. The reporter considered the spot pigmented to be probably related to HIBERIX. Additional details were provided as follows: This case was reported by Medical Assistant. The age at vaccination was not reported. The patient received HIBERIX in unknown thigh. When the patient was returning 2 months after receiving HIBERIX, the patient had a black mark on thigh that they attribute to HIBERIX. The spot was looking like a black tattoo, not like a blood blister or a bruise. It was unknown whether this office purchased this vaccine with private or public funds. The lot and expiration date of the vaccine was not known. The gender or age or date of birth was not provided. It was not known what other vaccines may have been administered at the same time for these two patients. This case was one of the two cases reported by same reporter for potentially siblings.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Anxiety, Chest discomfort, Differential white blood cell count, Fatigue, Full blood count normal
Clinical narrative: Chest tightness, anxiety acutely with fatigue. Extreme feeling of panic and anxiety 1 - 2 days after receiving TRUMENBA.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Laboratory test, Metabolic function test normal, Mycoplasma test, Panic reaction, Streptococcus test
Clinical narrative: Chest tightness, anxiety acutely with fatigue. Extreme feeling of panic and anxiety 1 - 2 days after receiving TRUMENBA.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Thyroid function test normal
Clinical narrative: Chest tightness, anxiety acutely with fatigue. Extreme feeling of panic and anxiety 1 - 2 days after receiving TRUMENBA.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site swelling, Lipoma, Ultrasound scan abnormal
Clinical narrative: Large bump on the left upper thigh.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at left upper arm where shot was given.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Rash pruritic
Clinical narrative: General itchy rash on arms, legs, and trunk. Short term blisters on skin lasting approximately 1 hour each.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic
Clinical narrative: general itchy rash on arms, legs, and body. Short term blisters on skin lasting approximately one hour.
Age: 1.25
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Irritability, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Patient started with fussiness and rash on Saturday morning 7/8/2017 per mother. The rash increased from his stomach to his entire body over the course of 2 days. The rash is classic maculopapular, red and covering his entire head to toe. There is no Koplik spots noted in his oral mucosa. He was fever free at the time of examination. He was alert and calm when with his mother and grandmother.
Age: 0.5
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC13
Symptoms: Extra dose administered
Clinical narrative: Administered extra DTAP, thought I was grabbing a HIB.
Age: 0.92
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Small red dots at various places on her body: Leg, back, chest. Three dots so far. Doesn't seem to bother her at all. Raised, slightly red, not crusted or scabby or anything.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abdominal distension, Abdominal pain upper, Haematochezia, Screaming
Clinical narrative: Inconsolable screaming for 3 hours straight; Rock hard stomach for 3 hours; Stomach sensitivity/pain 3 hours; Blood in stool 24 hours after injection; Hospital used sapository to insert Tylenol.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Local reaction
Clinical narrative: SMALL AREA OF REDNESS INITIALLY WHICH GREW TO A LARGE RED INFLAMED AREA AT INJECTION SITE THAT APPEARED ABOUT 3 DAYS AFTER VACCINE ADMINISTRATION. AREA WAS LARGER THAN PALM PRINT. PHARMACIST HAD PATIENT FOLLOWUP WITH DOCTOR IMMEDIATELY. DOCTOR DETERMINED THIS TO BE A LOCALIZED REACTION AND IS HAVING PATIENT APPLY BENADRYL CREAM TO THE SITE.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received a vaccine coordinator, concerning an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 29-MAY-2017, the reporter stated that the patient received an improperly stored doses of VARIVAX lot # M003440 and expiration date 20-JAN-2018 (dose and route of administration were not provided) for prophylaxis which was reconstituted with an improperly stored of sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse event was reported. The vaccine was stored at a temperature of 9° Centigrade to 25° Centigrade (11° Centigrade), time frame of 1 hour; no previous temperature excursion was reported. Digital Data logger report was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA010114.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route, lot number, expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced an unspecified adverse reaction after receiving a dose of ZOSTAVAX. The outcome of the adverse reaction was not known at the time of reporting. The causal relationship of the adverse reaction and the ZOSTAVAX vaccine was not provided. This is one of two reports from the same source. Additional information is not expected as no contact details were provided. Sender's Comments: US-009507513-1706USA004395.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients received doses of improperly stored M-M-R II (recombinant human albumin (rHA)) lot # M034387, expiration date 19-JUL-2018 (dose and route of administration not reported) on 23-MAY-2017, 25-MAY-2017, 05-JUN-2017 and 06-JUN-2017. Between 18-MAY-2017 and 22-MAY-2017, the vaccines underwent a temperature excursion between 47 and 77 degrees Fahrenheit for 47 hours and 15 to 46 degrees Fahrenheit for 90 hours. There were no previous excursions reported. Digital data logger was used to record the excursion. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000670: US-009507513-1707USA000668: US-009507513-1707USA000669.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 10 year old female patient with prophylaxis. On 10-MAY-2017 the patient was vaccinated with VARIVAX for prophylaxis. Other suspect therapies included M-M-R II and sterile diluent (manufacturer unknown). On 17-MAY-2017, 7 days after onset of therapy the patient experienced urticaria. The outcome of urticaria was reported as recovered/resolved.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M045653 with expiration date of 03-JUL-2019 and lot# N002913 with expiration date of 23-FEB-2019, for prophylaxis (dose, route and frequency were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 hours and 20 minutes (worst case). Previous temperature excursion was reported as 47 to 77 degrees Fahrenheit for 40 minutes. The call was because of a "data logger". This one of several reports form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000697: US-009507513-1707USA000698: US-009507513-1707USA000699.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 19 year old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, as an infant, the patient was vaccinated with series of an unspecified hepatitis b vaccine (manufacturer unknown) for prevention of Hepatitis B (dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient's hepatitis B titre was negative (hepatitis b antibody negative). Therefore, the he restarted the series and, at the time of this report, he had received two doses of RECOMBIVAX HB, given four weeks apart on unspecified dates, with no adverse effects reported. The outcome of hepatitis b antibody negative was unknown at the time of this report. Causality relationship between the event and the unspecified hepatitis b vaccine (manufacturer unknown) was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated improperly stored doses of PROQUAD (dose route, frequency, lot number and expiration date were not reported) for prophylaxis. Information regarding concomitant therapies were not reported. The vaccines were stored at 39F degrees during 10 hours. This information was registered in a digital data logger. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000689:
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from healthcare worker concerning a 22 year old male patient.  The patient was a medical student. The patient did not have concurrent conditions, medical history, drug reactions or allergies, and concomitant medications to report. On an unknown date, the patient vaccinated with a dose of RECOMBIVAX HB for prophylaxis (dose and lot number were not provided). It was reported that the patient was vaccinated at birth, 1 month old, and 6.5 months old. On an unknown date (reported as "few days ago"), the patient's titers were less than 5 (negative). Per healthcare worker, physician had decided to provide a booster of RECOMBIVAX HB to patient in effort to treat the low titers (dose not yet administered). At the time of the reporting, the patient was doing fine other than low titers. The causal relationship between the adverse event and therapy with RECOMBIVAX HB was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-JUN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L040053, expiration date 10-MAY-2017, (dose, route and frequency were not reported) for prophylaxis. Information regarding concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. 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 PROQUAD. {Additional information has been requested. / Additional information is not expected.}; Sender's Comments: US-009507513-1707USA000694:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported.     On unknown dates, the patients were vaccinated with improperly stored doses GARDASIL 9 with lot # M023169 with expiration date on 13-JUN-2019, M033583 with expiration date on 04-APR-2019 and M043731 with expiration date on 22-JUN-2019 (anatomical route of vaccination was not provided) for prophylaxis. It was reported that the vaccine was exposed to a temperature of 32°F to 35°F for a 9 hours time frame. The vaccine was not exposed to any previous temperature excursion and information was provided not due to a data logger. Additionally, it was reported that no adverse effects were reported and that no product quality issue was involved. This was one of several cases by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000672:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients. On an unknown date the patients were vaccinated with multiple doses of improperly stored GARDASIL 9 lot # M023169, expiration date 13-JUN-2018 and M030380 expiration date 01-FEB-2019 for prophylaxis. The temperature was 32°F to 35°F for 72 hours. No adverse events and no product quality complaint were reported. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1707USA000692: US-009507513-1707USA000693: US-009507513-1707USA000691:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received a vaccine coordinator, concerning an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 29-MAY-2017, the reporter stated that the patient received an improperly stored doses of ZOSTAVAX lot # M032638 and expiration date 04-OCT-2017 (dose and route of administration were not provided) for prophylaxis which was reconstituted with an improperly stored of sterile diluent (manufacturer unknown) (lot # and expiration date were not provided). No adverse event was reported. The vaccine was stored at a temperature of 9° Centigrade to 25° Centigrade (11° Centigrade), time frame of 1 hour; no previous temperature excursion was reported. Digital Data logger report was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA002297.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided. On 13-JUN-2017, the patient was vaccinated with an improperly storage dose of VARIVAX (dose and route were not reported) lot number M045204, expiration date 11-NOV-2018. The temperature excursion was from -14 degrees celsius to -10 degrees celsius (-9.5 degrees celsius) in a time frame of 327 hours in total (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1707USA000678, 1707USA000679, 1707USA000680, 1707USA000681, 1707USA000682).; Sender's Comments: US-009507513-1707USA000678: US-009507513-1707USA000679: US-009507513-1707USA000680: US-009507513-1707USA000681: US-009507513-1707USA000682.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients received doses of improperly stored PROQUAD lot # M044718, expiration date 07-MAY-2018 (dose and route of administration not reported) on the following dates: 23-MAY-2017, 01-JUN-2017, 02-JUN-2017, 05-JUN-2017, 06-JUN-2017 and 07-JUN-2017. Between 18-MAY-2017 and 22-MAY-2017, the vaccines underwent a temperature excursion between 47 and 77 degrees Fahrenheit for 47 hours and 15 to 46 degrees Fahrenheit for 90 hours. There were no previous excursions reported. Digital data logger was used to record the excursion. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000669: US-009507513-1707USA000670: US-009507513-1706USA004880:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients received doses of improperly stored VARIVAX lot # M042495, expiration date 19-OCT-2018 (dose and route of administration not reported) on the following dates: 25-MAY-2017, 05-JUN-2017, 06-JUN-2017. Between 18-MAY-2017 and 22-MAY-2017, the vaccines underwent a temperature excursion between 47 and 77 degrees Fahrenheit for 47 hours and 15 to 46 degrees Fahrenheit for 90 hours. There were no previous excursions reported. Digital data logger was used to record the excursion. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004880: US-009507513-1707USA000670: US-009507513-1707USA000668:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in 2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M044718, expiration date 07-MAY-2018 (dose and route of administration were not reported) which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). On an unknown date in approximately 2017, the patient's injection site was very red, swollen and warm to touch. The outcome of the events and the relatedness between the events and PROQUAD were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000669: US-009507513-1706USA004880: US-009507513-1707USA000668:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally with lot # M029251 with expiration date on 14-MAR-2018 and lot # M044395 with expiration date on 31-MAY-2018 for prophylaxis. It was reported that the vaccine was exposed to a temperature of 32°F to 35°F for a 9 hours time frame. The vaccine was not exposed to any previous temperature excursions and information was provided not due to a data logger. Additionally, it was reported that no adverse effects were reported and that no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA009371.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided. On 14-JUN-2017, the patient was vaccinated with an improperly storage dose of VARIVAX (dose and route were not reported) lot number M045204, expiration date 11-NOV-2018. The temperature excursion was from -14 degrees Celsius to -10 degrees Celsius (-9.5 degrees Celsius) in a time frame of 327 hours in total (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1706USA010254, 1707USA000679, 1707USA000680, 1707USA000681, 1707USA000682). Sender's Comments: US-009507513-1706USA010254: US-009507513-1707USA000679: US-009507513-1707USA000680: US-009507513-1707USA000681: US-009507513-1707USA000682.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided.  On 01-JUN-2017, the patient was vaccinated with an improperly storage dose of PROQUAD (dose and route were not reported) lot number N002915, expiration date 24-JUL-2018. The temperature excursion was from -14 degrees celcius to -10 degrees celcius for 390 hours, 55 minutes and in the range -9 degrees celcius to 8 degrees celcius (-1C) for 5 minutes (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1706USA010254, 1707USA000678, 1707USA000680, 1707USA000681, 1707USA000682).; Sender's Comments: US-009507513-1706USA010254: US-009507513-1707USA000678: US-009507513-1707USA000680: US-009507513-1707USA000681: US-009507513-1707USA000682:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an Office Manager referring to two unspecified patients of unknown gender and age. The patients' medical history and concurrent conditions were not provided. On 02-JUN-2017, the patients were vaccinated with an improperly storage dose of PROQUAD (dose and route were not reported) lot number N002915, expiration date 24-JUL-2018. The temperature excursion was from -14 degrees Celsius to -10 degrees Celsius for 390 hours, 55 minutes and in the range -9 degrees Celsius to 8 degrees Celsius (-1C) for 5 minutes (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1706USA010254, 1707USA000678, 1707USA000679, 1707USA000681, 1707USA000682). Sender's Comments: US-009507513-1706USA010254: US-009507513-1707USA000678: US-009507513-1707USA000679: US-009507513-1707USA000681: US-009507513-1707USA000682.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided. On 13-JUN-2017, the patient was vaccinated with an improperly storage dose of PROQUAD (dose and route were not reported) lot number N002915, expiration date 24-JUL-2018. The temperature excursion was from -14 degrees Celsius to -10 degrees Celsius for 390 hours, 55 minutes and in the range -9 degrees Celsius to 8 degrees Celsius (-1C) for 5 minutes (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1706USA010254, 1707USA000678, 1707USA000679, 1707USA000680, 1707USA000682). Sender's Comments: US-009507513-1706USA010254: US-009507513-1707USA000678: US-009507513-1707USA000679: US-009507513-1707USA000680: US-009507513-1707USA000682.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided. On 15-JUN-2017, the patient was vaccinated with an improperly storage dose of PROQUAD (dose and route were not reported) lot number N002915, expiration date 24-JUL-2018. The temperature excursion was from -14 degrees Celsius to -10 degrees Celsius for 390 hours, 55 minutes and in the range -9 degrees Celsius to 8 degrees Celsius (-1C) for 5 minutes (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1706USA010254, 1707USA000678, 1707USA000679, 1707USA000680, 1707USA000681). Sender's Comments: US-009507513-1706USA010254: US-009507513-1707USA000678: US-009507513-1707USA000679: US-009507513-1707USA000680: US-009507513-1707USA000681.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose route, frequency, lot number and expiration date were not reported) for prophylaxis. Information regarding concomitant therapies were not reported. The vaccines were stored at 39F degrees during 10 hours. This information was registered in a digital data logger. There were no previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (MARRS#1706USA009325). Additional information has been requested. Sender's Comments: US-009507513-1706USA009325.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients. On an unknown date the patients were vaccinated with multiple doses of improperly stored LIQUID PEDVAXHIB lot # M025192, expiration date 21-MAR-2019 and M032149 expiration date 18-APR-2019 for prophylaxis. The temperature was 32°F to 35°F for 72 hours. No adverse events and no product quality complaint were reported. This is one of several reports from the same source.; Sender's Comments: US-009507513-1707USA000692: US-009507513-1707USA000693: US-009507513-1706USA010023:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients. On an unknown date the patients were vaccinated with multiple doses of improperly stored ROTATEQ  lot # M006111, expiration date 08-NOV-2017 and M026315 (also reported as N026315) expiration date 26-JAN-2018 for prophylaxis. The temperature was 32°F to 35°F for 72 hours. No adverse events and no product quality complaint were reported. This is one of several reports from the same source.; Sender's Comments: US-009507513-1706USA010023: US-009507513-1707USA000693: US-009507513-1707USA000691:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients. On an unknown date the patients were vaccinated with multiple doses of improperly stored VAQTA lot # M027879, expiration date 24-JAN-2018 and M036459 expiration date 18-JAN-2018 for prophylaxis. The temperature was 32°F to 35°F for 72 hours. No adverse events and no product quality complaint were reported. This is one of several reports from the same source.; Sender's Comments: US-009507513-1707USA000692: US-009507513-1706USA010023: US-009507513-1707USA000691:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M041080 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. 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 VARIVAX. {Additional information has been requested. / Additional information is not expected.; Sender's Comments: US-009507513-1706USA009368:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M034780 with expiration date of 15-APR-2019, for prophylaxis (dose, route and frequency were not reported).  No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 hours and 20 minutes (worst case). Previous temperature excursion was reported as 47 to 77 degrees Fahrenheit for 40 minutes. The call was because of a "data logger". This one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008789: US-009507513-1707USA000698: US-009507513-1707USA000699.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Dyskinesia, Myoclonus, Seizure like phenomena, Somnolence
Clinical narrative: Patient had a 4 month check-up at 9:30 in the morning on 07/06/2017, no problems were identified, received recommended vaccines. Patient's mother called the office in the afternoon and reported that the patient displayed "seizure-like activity". Was referred to the emergency department. Parents declined to have patient evaluated on 07/06/17 and 07/07/17. On 07/08/17 the patient was seen in the office. Mother described the event on 07/06/2017 as a "strange episode" in which he made a strange noise and moved abnormally, following the episode he was more sleepy than usual. Per parents, may have had another episode later that day. She had a video of the first episode which was viewed by the physician. Unable to determine from the video if episode was true seizure activity or benign myoclonus of infancy. Parents also reported that he had a rectal temperature of 100.4 on the evening of 07/06/17 and on the evening of 07/07/17.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Influenza like illness, Injection site pain, Pain
Clinical narrative: Site of injection very sore for 10 days. Aches and pains all over for the last 10 days...rib cage felt as if it was bursting...flu like symptoms all over.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal pain upper, Chills, Headache, Hyperventilation, Panic attack
Clinical narrative: The 2nd one listed is actually supposed to be for Meningococcal ACWY but I didn't see that as an option. Patient had a reaction involving an intense headache, uncontrollable shaking, stomach cramps, spiked a fever to 101, had chills, and was hyperventilating (panic attack). The panic attack involved loss of feeling in her hands and arms.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Sensory loss, Tremor
Clinical narrative: The 2nd one listed is actually supposed to be for Meningococcal ACWY but I didn't see that as an option. Patient had a reaction involving an intense headache, uncontrollable shaking, stomach cramps, spiked a fever to 101, had chills, and was hyperventilating (panic attack). The panic attack involved loss of feeling in her hands and arms.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose normal, Loss of consciousness, Seizure, Syncope
Clinical narrative: Within one minute of receiving the shot, my 18 year old son fainted and has a slight seizure. After he regained consciousness, his vitals were checked. Within 5 minutes, he fainted again and this time had a much worse seizure. His vitals were again check, including his blood sugar levels were good.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutropenia, Neutrophil count decreased, Ultrasound abdomen normal, Vomiting, X-ray with contrast upper gastrointestinal tract normal
Clinical narrative: 1) developed severe neutropenia on 6/14/17. 2) developed BILIOUS vomiting.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Burning sensation, Cellulitis, Contusion, Inadequate aseptic technique in use of product, Influenza like illness
Clinical narrative: Cellulitis or Arthus reaction from Tdap vaccine--Patient reported her arm was fine on 6/28 and 6/29/17, however after that date she began experiencing increased swelling, burning, bruising and flu-like symptoms. Pt. sought care through Hospital ER on 7/2/17 where she stated the ER doctor informed her the site was not cleaned properly at the time of vaccination. She stated she was taking ibuprofen every 8 hours after receiving vaccination and was prescribed Ibuprofen 600 mg every 6 hours time 3 days and Clindamycin 300 mg, 1 capsule by mouth every 6 hours x 10 days. Also stated she used cold and warm compresses, in which the cold compress helped to relieve the itching and burning.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Peripheral swelling, Pruritus, Type III immune complex mediated reaction
Clinical narrative: Cellulitis or Arthus reaction from Tdap vaccine--Patient reported her arm was fine on 6/28 and 6/29/17, however after that date she began experiencing increased swelling, burning, bruising and flu-like symptoms. Pt. sought care through Hospital ER on 7/2/17 where she stated the ER doctor informed her the site was not cleaned properly at the time of vaccination. She stated she was taking ibuprofen every 8 hours after receiving vaccination and was prescribed Ibuprofen 600 mg every 6 hours time 3 days and Clindamycin 300 mg, 1 capsule by mouth every 6 hours x 10 days. Also stated she used cold and warm compresses, in which the cold compress helped to relieve the itching and burning.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site pustule, Injection site swelling
Clinical narrative: Redness, swelling and pustule at site of injection (very itch, pustule burst 7-10-17 and redness and swelling almost gone).
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Discomfort, Erythema, Fatigue, Induration
Clinical narrative: Currently the third day of dealing with a lot of pain and discomfort due to a large rash (about 5 inches wide) that is hard and hot to the touch, red and swollen, and is causing itching and burning.  The rash does not seem to be going away yet, and the pain has spread to down my arm to my hand. Any pressure on the injection site is excruciating, and I have felt fatigued since receiving the vaccine.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Currently the third day of dealing with a lot of pain and discomfort due to a large rash (about 5 inches wide) that is hard and hot to the touch, red and swollen, and is causing itching and burning.  The rash does not seem to be going away yet, and the pain has spread to down my arm to my hand. Any pressure on the injection site is excruciating, and I have felt fatigued since receiving the vaccine.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: Currently the third day of dealing with a lot of pain and discomfort due to a large rash (about 5 inches wide) that is hard and hot to the touch, red and swollen, and is causing itching and burning.  The rash does not seem to be going away yet, and the pain has spread to down my arm to my hand. Any pressure on the injection site is excruciating, and I have felt fatigued since receiving the vaccine.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Musculoskeletal stiffness, Rash vesicular, Urticaria
Clinical narrative: Approximately 10 days after the vaccine, my spouse noticed a welt like mark on the back of my left arm. The following day it had spread more. Prior to this showing, I was having persistent unexplained left sided stiffness. I was in physical therapy during this time so I assumed it was from that. Once the rash showed and I showed the physician, he agreed it did look like a reaction similar to shingles.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Dermatitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection arm of right upper left arm. Patient went to urgent care and was given an antibiotic injection per patient. Patient presented to pharmacy with prescription for clindamycin 150 mg. Patient discharge papers diagnosed her with cellulitis/dermatitis.
Age: 4.0
Sex: M
Vaccine: TYP
Symptoms: Dysarthria, Gait disturbance, Memory impairment
Clinical narrative: Slurred speech, unsteady gait, memory impairment.
Age: 4.0
Sex: F
Vaccine: TYP
Symptoms: Dysarthria, Gait disturbance, Memory impairment
Clinical narrative: Slurred speech, unsteady gate, memory impairment.
Age: 1.58
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting during night and early morning along with constant diarrhea.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: None. Form completed to report wrong vaccine given. Hep A adult vaccine administered to 4 yr. old.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's upper left arm has an area which is swollen, warm, and red with some tender/burning to touch. No fever or other symptoms noted and appears otherwise well. The symptoms started shortly after shots were given Friday and got worse yesterday. Provider discussed given MOTRIN every 6 hrs PRN pain, BENADRYL every 6-8 hrs PRN, using ice compress to area and can apply topical Cortisone cream to the area. Follow-up if symptoms persist or get worse.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red area, warm to touch on upper right thigh at injection site. Red area was the size of a softball and swollen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness, slight swelling.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain lower, Hypoacusis, Pain, Paraesthesia, Vision blurred
Clinical narrative: Decreased hearing, blurred vision, tingling in hands/feet, sharp right lower quadrant pain - hours after vaccine. Ibuprofen for pain.