chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-SEP-2017, the patient was vaccinated with an improperly stored dose of PROQUAD first dose, lot # M033612, expiration date 14-JAN-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (MERCK). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 12.4 degrees Fahrenheit for 5 hours 50 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and vaccine coordinator and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038717 with expiration date on 24-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 1 degree Celsius for 3 minutes and 56 seconds. Data logger was involved in recording of the temperature excursions. There was a previous excursion of 1 degree Celsius for 1 hour and 22 minutes reported.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a field representative and refers to an infant patient of unspecified age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with the second dose of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (dose, route of administration, lot# and expiration date were not provided), at one month of age. On an unknown date, the patient received the third dose of RECOMBIVAX HB, at 2 months of age. The physician did not know if the patient received the first dose at birth. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL 9 lot number L043214 and expiration date of 30-AUG-2017 for prophylaxis (dose and route of administration, were not reported). No adverse symptoms were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, lot # reported as N042851 with expiration date on 18-JAN-2020 (route of administration was not reported). There was no adverse effect reported. The administered dose of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 45 minutes. Data logger was involved in recording of the temperature excursions. There was a previous excursion of 15 to 46 degrees Fahrenheit for 20 minutes reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to 1 or 2 patients of unknown age and gender. There was no information about pertinent medical history reported. The patient's concomitant therapies included sterile diluent. In 2017 after June 2017, the patients were vaccinated with an improperly stored dose of ZOSTAVAX lot number M035147 with expiration date 25-OCT-2017 (dose, route and anatomical location were not reported) for prophylaxis. The ZOSTAVAX temperature was reported as 15 F (Fahrenheit) for 2 hours and 15 minutes. There was no previous temperature excursion and digital data logger was filled. No symptoms were reported. Lot number M035147 has been verified to be a valid lot number for ZOSTAVAX.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-SEP-2017, the patient was vaccinated with a dose of improperly stored dose of PROQUAD (recombinant human albumin (RHA)) lot # N014758 with an expiration date 08-NOV-2018 (dose and route of administration were not reported). The sterile diluent used for reconstitution did not undergo temperature excursion. There was no adverse effect reported. Administered dose of PROQUAD experienced the temperature excursion between -14 and -10 (-12.2) degrees Celsius for 1 hour and 20 minutes. There was previous temperature excursion with temperatures from -9 to -8 degrees Celsius for 6 hours and 26 minutes. Data logger was involved.
Sex: U
Vaccine: HPV9
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. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 12-SEP-2017, the patient was inadvertently vaccinated with expired dose of GARDASIL 9 lot # L028083 with expiration date: 03-SEP-2017 (dose and route of administration were not reported). No adverse effect was reported. Product quality complaint was not involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker and refers to multiple unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # M043424 and expiration date of 06-JUN-2018, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (lot # unknown) which were stored in the range of 9.8  Celsius degrees for 1 hour. Previous temperature excursion was reported: 10.5 Celsius degrees for 2 hours and 14.7 Celsius degrees for 3 hours. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA006745.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified patient an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-AUG-2017, the patient might have been vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # reported as M046303 and expiration date on 04-NOV-2018 (strength, dose, route of administration or anatomical location were not provided), for prophylaxis. The storage temperature was 17.8 degrees Fahrenheit (F) for a time frame of 2 hours. There was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. Lot number M046303 is an invalid lot number for Hepatitis B Vaccine (Recombinant).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient. The patient's age, medical history and concurrent conditions were not provided. On or about 29-JUL-2016 the patient was vaccinated with ZOSTAVAX,(route unknown) at a Health Center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-APR-2016, the patient was treated by a Physician Assistant for a vesicular outbreak that was diagnosed as severe shingles. The patient was treated again on 02-JUN-2016 by a physician for ongoing and worsening symptoms of shingles, and at that encounter was diagnosed with post herpetic neuralgia, a chronic condition involving residual nerve pain and damage secondary to shingles. The patient was prescribed gabapentin and acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the  patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II albumin status unknown, lot # M045390, expiration date of 14-NOV-2018; lot# M011667, expiration date of 08-MAR-2018 and lot# M004899, expiration date of 27-JAN-2018 (doses and route of administration were not reported). Administered doses of M-M-R II underwent a temperature excursion between 32 degrees Fahrenheit and 35 degrees Fahrenheit for 11 hours, which was detected by a digital data logger. There was the previous temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 45 minutes reported. No adverse symptoms were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA004651.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to 4 patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 08-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # M042857, expiration date 21-OCT-2018, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported. The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA008578: US-009507513-1708USA007019: US-009507513-1709USA007602: US-009507513-1709USA007603: US-009507513-1709USA007604: US-009507513-1709USA007605.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 09-AUG-2017, the patient was vaccinated with improperly stored doses of VARIVAX (Lot # M042857, expiration date 21-OCT-2018, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported. The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA008578: US-009507513-1709USA007601: US-009507513-1709USA007603: US-009507513-1709USA007604: US-009507513-1709USA007605: US-009507513-1708USA007019.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 09-AUG-2017, the patient was vaccinated with improperly stored doses of VARIVAX (Lot # N001530, expiration date 13-JAN-2019, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported. The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA008578: US-009507513-1709USA007601: US-009507513-1709USA007602: US-009507513-1709USA007604: US-009507513-1709USA007605: US-009507513-1708USA007019.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 10-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # N001530, expiration date 13-JAN-2019, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported.   The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved.    This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1708USA008578: US-009507513-1709USA007601: US-009507513-1709USA007602: US-009507513-1709USA007603: US-009507513-1709USA007605: US-009507513-1708USA007019:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 14-AUG-2017, the patient was vaccinated with improperly stored doses of VARIVAX (Lot # N001530, expiration date 13-JAN-2019, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported. The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA008578: US-009507513-1709USA007601: US-009507513-1709USA007602: US-009507513-1709USA007603: US-009507513-1709USA007604: US-009507513-1708USA007019:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified amount of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients was vaccinated with doses of improperly stored VARIVAX (dose, frequency, route and indication not reported, lot # M046924 with expiration date 28-NOV-2018) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature that the vaccines exposed to was 6 F to 14 F with time frame 1 hour. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. ; Sender's Comments: US-009507513-1708USA012061:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-AUG-2017, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, frequency, route and indication not reported, lot # M037015 with expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # M035268 with expiration date 19-APR-2019). Temperature that the vaccine exposed to was 40.2 F, the time frame was unknown. There was a previous temperature excursion of 15 F to 46 F for 18 hours and 34 minutes. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1708USA012218: US-009507513-1709USA007623.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-AUG-2017, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, frequency, route and indication not reported, lot # M037015 with expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # M035268 with expiration date 19-APR-2019). Temperature that the vaccine exposed to was 40.2 F, the time frame was unknown. There was a previous temperature excursion of 15 F to 46 F for 18 hours and 34 minutes.  No adverse effects were reported. This is one of three reports received from the same reporter. ; Sender's Comments: US-009507513-1709USA007622: US-009507513-1709USA007623:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # N002922, expiration date 30-SEP-2018 and lot # L042846, expiration date 15-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47.5 degrees Fahrenheit for 1 hour 30 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007678: US-009507513-1709USA007679: US-009507513-1709USA004665.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (RHA) M-M-R II lot # N008366, expiration date 13-MAR-2019 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47.5 degrees Fahrenheit for 1 hour 30 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007677: US-009507513-1709USA007679: US-009507513-1709USA004665.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # N009964, expiration date 22-NOV-2018 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47.5 degrees Fahrenheit for 1 hour 30 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007677: US-009507513-1709USA007678: US-009507513-1709USA004665.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified numbers of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored LIQUID PEDVAXHIB (dose, frequency, route, indication, lot # and expiration not reported, also reported as PEDVAX). Temperature that the vaccines exposed to was 13.1 C with time frame of 22 minutes. There was a previous temperature excursion of 14C for 22 minutes.  No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA013099:
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Glassy eyes, Hyporesponsive to stimuli, Loss of consciousness
Clinical narrative: Notes: Child received vaccines and then underwent her blood draw for cholesterol. After the blood draw, she became light headed and had a syncopal episode with LOC. Code blue called. After syncope, patient was posturing without rhythmic movements. I was called to the room and arrived approx 30 seconds after the syncopal episode. When I entered the room, patient was not posturing, but had glassed over eyes and was minimally responsive to verbal commands. This was at 1030 AM. At that time, we placed a BP cuff and an O2 monitor which showed BP of 80/30, Pulse of 41 and O2 of 100. Teen was able to answer where she was but still appeared sleepy. At 1033, glucose was obtained and was 93. Repeat BP was 67/40 with HR of 48 and O2 of 100. At 1036, she was more alert and we transferred her from her chair to the exam table to lie down. Her BP was 97/63, HR: 69, O2: 97% on RA. At this time she was alert, able to communicate, oriented to date, place, time. At 1038, BP was 102/70, HR: 81, O2: 97% on RA. She was able to sit up and drink some juice at this time and was speaking with her mother. At 1042, BP was 110/75, HR: 86, O2: 99% on RA. She then rested until 1153. Her dad arrived to be with her as well. She did take in 2 small pieces of candy. Color improved, as did activity and alertness. She was released from clinic at 11 AM. BP at discharge after sitting x 10 minutes was 102/73, HR was 90 and O2 was 100% on RA. Discussed with parents re: syncope with vaccines. Tell providers in the future that this has happened so teen can lie down x 15 minutes after vaccines or with blood draws.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Posturing, Syncope
Clinical narrative: Notes: Child received vaccines and then underwent her blood draw for cholesterol. After the blood draw, she became light headed and had a syncopal episode with LOC. Code blue called. After syncope, patient was posturing without rhythmic movements. I was called to the room and arrived approx 30 seconds after the syncopal episode. When I entered the room, patient was not posturing, but had glassed over eyes and was minimally responsive to verbal commands. This was at 1030 AM. At that time, we placed a BP cuff and an O2 monitor which showed BP of 80/30, Pulse of 41 and O2 of 100. Teen was able to answer where she was but still appeared sleepy. At 1033, glucose was obtained and was 93. Repeat BP was 67/40 with HR of 48 and O2 of 100. At 1036, she was more alert and we transferred her from her chair to the exam table to lie down. Her BP was 97/63, HR: 69, O2: 97% on RA. At this time she was alert, able to communicate, oriented to date, place, time. At 1038, BP was 102/70, HR: 81, O2: 97% on RA. She was able to sit up and drink some juice at this time and was speaking with her mother. At 1042, BP was 110/75, HR: 86, O2: 99% on RA. She then rested until 1153. Her dad arrived to be with her as well. She did take in 2 small pieces of candy. Color improved, as did activity and alertness. She was released from clinic at 11 AM. BP at discharge after sitting x 10 minutes was 102/73, HR was 90 and O2 was 100% on RA. Discussed with parents re: syncope with vaccines. Tell providers in the future that this has happened so teen can lie down x 15 minutes after vaccines or with blood draws.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Pruritus
Clinical narrative: Patient reports itching in arm and bruising below injection site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Myalgia
Clinical narrative: Cellulitis, Myalgias- went to Immediate care- treated with Keflex 500mg Q 8 hours x10days.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Influenza, Pain, Pyrexia
Clinical narrative: For 36 hours after the injection, I had severe fatigue, fever, chills, and body aches -- very similar to flu symptoms. This was the first time I have ever had a reaction to a flu shot, except for a temporary sore shoulder.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pyrexia
Clinical narrative: Headache and fever. As per caregiver acetaminophen given and symptoms resolved within 2 days. Caregiver did not go to Emergency room as advised. Instead follow up at doctor office after 5 days.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Crying
Clinical narrative: Parents reported baby cried for 3 days.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: PT CAN IN AND SHOWED ARM WITH WAS HOT TO THE TOUCH, SWOLLEN, RED, ITCHY, SHE SAID IT HAD BEEN SINCE TUESDAY AM WHICH SHE HAS BEEN ICING IT. RECOMMENDED ASHE TAKE ORAL BENADRYL AND SHE MD IF NOT BEWTTER BY A DAY OR 2.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with VARIVAX lot# N012619 with expiration date 21-APR-2019, lot# N012487 with expiration date 20-APR-2019, lot# N014368 with expiration date 09-MAY-2019 and lot# N009766 with expiration date 24-MAR-2019. The vaccine was reconstituted with properly stored sterile diluent. The vaccines underwent a temperature excursion between 15 and 46 degrees Fahrenheit for 2 hours and 13 minutes. Digital data logger was used to record the excursion. No previous temperature excursion was noted. No adverse event was reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1709USA001955.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot# M049122 with expiration date 13-JUN-2018 (therapy type: RHA), lot# N010866 with expiration date 01-OCT-2018 (therapy type: RHA) and lot# N014759 with expiration date 08-NOV-2018 (therapy type: RHA). The vaccine was reconstituted with properly stored sterile diluent. The vaccines underwent a temperature excursion between 15 and 46 degrees Fahrenheit for 2 hours and 13 minutes. Digital data logger was used to record the excursion. No previous temperature excursion was noted. No adverse event was reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1709USA000887.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a 8 week old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-AUG-2017, at 6 weeks of age, the patient was vaccinated with ROTATEQ dose 1, orally (dose, concentration, lot# and expiration date were not reported). On 12-SEP-2017, two weeks after the first vaccination, the patient was vaccinated with second dose of ROTATEQ. The outcome of inappropriate schedule of drug administration was unknown. No Product Quality Complaint (PQC) was reported.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse, referring to a 19 year old patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 13-SEP-2017, the patient was vaccinated with a pediatric dose of VAQTA lot # N017094 with expiration date on 31-AUG-2018 (strength and dose were not mentioned) for prophylaxis. At the reporting time no adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered improperly stored PNEUMOVAX 23, lot # M042324 with expiration date on 10-JUN-2018 (doses and routes of administration were not reported). Administered doses of vaccines underwent a temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit (56.3 degrees Fahrenheit), which lasted for 3 hours and 51 minutes. There was no previous temperature excursion reported. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007887: US-009507513-1709USA005504.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered improperly stored ROTATEQ, lot # M044724 with expiration date on 13-JUN-2018 (doses were not reported). Administered doses of vaccines underwent a temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit (56.3 degrees Fahrenheit), which lasted for 3 hours and 51 minutes. There was no previous temperature excursion reported. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005504: US-009507513-1709USA007886:
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (manufacturer report number: 2017279885) on 05-SEP-2017. This case involves a 79-year-old male patient who was vaccinated with a dose of TETANUS TOXOID (batch number, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medication were not reported. On an unknown date, following vaccination, it was reported that patient developed allergy to tetanus toxoid. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: DTP
Symptoms: Malaise, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 5-month-old male patient who received DTP (A or W not known). On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, less than a year after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be possibly related to DTP vaccine. Additional details were reported as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient became very ill and was hospitalized. The reporter stated that, It was a long and scary three months and the vaccines are garbage and do more harm than good. This case was considered as suspected vaccination failure since time to onset for the event was unknown. The reporter did not consent to follow up. This case was linked to case US2017GSK141271, reported by the same reporter.
Sex: U
Vaccine: DTP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received DTP (A or W not known). On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be possibly related to DTP vaccine. Additional details were reported as follows: The children experienced whooping cough when they were older in spite of being vaccinated against DTP. The reporter stated that, vaccines are garbage and do more harm than good. This case was considered as suspected vaccination failure since time to onset for the event was unknown. The reporter did not consent to follow up. This case was linked to case US2017GSK139593, reported by the same reporter.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Drug administered at inappropriate site, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Immunizations were given at the incorrect injection site. They were given too high and to far to the outer thigh, almost over the greater trochanter. Patient developed fever of 101.3F same day, crying inconsolably, and unable to bear weight on left leg. Injection site swollen and red. MOTRIN was given. Patient seen in ER same day.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Weight bearing difficulty, X-ray of pelvis and hip normal
Clinical narrative: Immunizations were given at the incorrect injection site. They were given too high and to far to the outer thigh, almost over the greater trochanter. Patient developed fever of 101.3F same day, crying inconsolably, and unable to bear weight on left leg. Injection site swollen and red. MOTRIN was given. Patient seen in ER same day.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Mobility decreased, Pain
Clinical narrative: Reported temps of 101-102 for 24 hours. Severe body aches to the point where she can barely move.  Made an appointment to be seen by the PA.
Age: 40.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Arthralgia-cephalexin, prednisone.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: High fever (up to 104 degrees F) for 3 days, gave constant fever reducers (ibuprofen, acetaminophen), resolved on 4th day.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Pain in right arm radiating at times to elbow no redness swelling at site- patient concerned about nerve irritation.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Oedema peripheral, Pain
Clinical narrative: Patient presented with edema from the shoulder extending below the elbow and mild pain 2 days after receiving influenza vaccine, no other associated symptoms. It was recommended to elevate the extremity, put ice and take Ibuprofen for pain control. Patient will have close follow up.
Age: 1.92
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Redness size of palm observed around injection site day after receiving vaccine, subjective temperature the evening of vaccine injection.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site pain, Injection site rash, Tenderness, Ultrasound Doppler
Clinical narrative: Patient given PCV13 in our office on right arm and then present to emergency department on 09/13/2017 with rash and upper arm soft tissue pain. Prescribed cellulitis. In primary care office on 09/15/2017 with improved rash after Keflex but still tender to palpation. Patient's rash on the inner arm and not at site of injection.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema
Clinical narrative: Patient report having a swollen eye lid after receiving the vaccine. It happened soon after she received the vaccine and she still has it as of today (9/15/17). She has no trouble with her vision and did not see a medical professional for treatment. She is to apply cold compresses to it.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Influenza, Influenza like illness, Nausea, Vaccination failure
Clinical narrative: Patient states that he had to go to the hospital the same night as the immunization with flu-like symptoms (nausea, tired, etc.). Hospital kept patient and claims treated him for influenza.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration
Clinical narrative: Redness spread down side of arm and hardness under arm pit.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Pain in extremity, Skin tightness, Skin warm
Clinical narrative: Pt came back to pharmacy on 9/15 complaining of tightness and pain in his right arm. Also was concerned with the "heat" in his arm. He said he only slept about 1.5 hours the night he had the injection.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Macule, Oedema, Tenderness
Clinical narrative: 20X14 cm pink firm macule on left arm, redness with edema and tender.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Barium swallow, Condition aggravated, Diarrhoea, Escherichia sepsis, Feeding disorder
Clinical narrative: This spontaneous report was received from a physician and refers to a 3 month old female patient. The patient's pertinent medical history included feeding intolerance and reflux. The physician reported that the infant had feeding difficulties, reflux and diarrhea since birth. The patient had an allergy for bethanechol which caused bradycardia (onset date was not reported) and also the overdose for "bathanicole" was reported. The patient was diagnosed with E. coli sepsis at birth and kept in intensive care for 7 days. On 26-JUL-2017 (reported as 6 weeks ago and also therapy start date was reported as birth), the patient was vaccinated with a single dose of ROTATEQ, orally (lot # and expiration date were not reported). Concomitant therapy included omeprazole. On an unknown date in 2017, the infant's symptoms of ecoli sepsis, reflux, diarrhea and feeding problems progressed and on 06-SEP-2017 (reported as now), the patient was hospitalized. The physician stated that ROTATEQ was present in infant's stool from an unknown date in 2017. The patient had performed a barium swallow test (date unspecified in 2017) but the result was not reported. The patient's status at the time of the report was reported as recovering. The physician did not think that ROTATEQ had added to infant's medical difficulties. The physician assessed the infant status as life threatening. Upon internal review, the event of E. coli Sepsis was considered to be medically significant.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: This spontaneous report was received from a physician and refers to a 3 month old female patient. The patient's pertinent medical history included feeding intolerance and reflux. The physician reported that the infant had feeding difficulties, reflux and diarrhea since birth. The patient had an allergy for bethanechol which caused bradycardia (onset date was not reported) and also the overdose for "bathanicole" was reported. The patient was diagnosed with E. coli sepsis at birth and kept in intensive care for 7 days. On 26-JUL-2017 (reported as 6 weeks ago and also therapy start date was reported as birth), the patient was vaccinated with a single dose of ROTATEQ, orally (lot # and expiration date were not reported). Concomitant therapy included omeprazole. On an unknown date in 2017, the infant's symptoms of ecoli sepsis, reflux, diarrhea and feeding problems progressed and on 06-SEP-2017 (reported as now), the patient was hospitalized. The physician stated that ROTATEQ was present in infant's stool from an unknown date in 2017. The patient had performed a barium swallow test (date unspecified in 2017) but the result was not reported. The patient's status at the time of the report was reported as recovering. The physician did not think that ROTATEQ had added to infant's medical difficulties. The physician assessed the infant status as life threatening. Upon internal review, the event of E. coli Sepsis was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # M042857 with expiration date on 21-OCT-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of the vaccine experienced temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 9 hours. There were previous temperature excursions: -14 degrees Celsius to -10 degrees Celsius for 12 hours and -9 degrees Celsius to 8 degrees Celsius for 1 hour 30 minutes. Digital data logger was involved in recording the excursions. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA007864.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to 11 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or pertinent medical histories provided. On multiple unspecified dates, 11 unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # N004628, expiration date 08-FEB-2017 (dose, concentration and route of administration were not reported). Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. Digital data logger was involved. Doses of vaccines administered to 2 unspecified patients experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 15 to 46 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Doses of vaccines administered to 7 unspecified patients experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 30 minutes and 15 to 46 degrees Fahrenheit for 2 hours and 30 minutes. There was previous temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 15 to 46 degrees Fahrenheit for 1 hour. Doses of vaccines administered to 2 unspecified patients experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 1 hour and 40 minutes and 15 to 46 degrees Fahrenheit for 45 minutes. There was previous temperature excursion of 6 to 14 degrees Fahrenheit for 2 hours and 30 minutes and 15 to 46 degrees Fahrenheit for 3 hours and 30 minutes. The outcome of incorrect product storage was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered improperly stored M-M-R II, lot # M028130 with expiration date on 03-JUN-2018 and lot # M042846 with expiration date on 21-OCT-2018 (doses and routes of administration were not reported). Sterile diluent (lot # and expiration date were unknown) was properly stored. Administered doses of vaccines underwent a temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit (56.3 degrees Fahrenheit), which lasted for 3 hours and 51 minutes. There was no previous temperature excursion reported. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007887: US-009507513-1709USA007886.