chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient fainted (loss of consciousness) after the shot. Regained consciousness after administering  ammonia inhalant and complained of dizziness thereafter.
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 demographics. 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 PROQUAD lot # M039913 with expiration date on 26-SEP-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 (also reprted 34) degrees Fahrenheit for 300 hours and 47 to 77 (also reported 52) degrees Fahrenheit for 250 hours. Data logger was not involved in recording of the temperature excursions. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA005964:
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 a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX lot # M031969 or lot # M038857. The VARIVAX was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The digital data logger was involved in recording the excursion. This is one of six reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005170: US-009507513-1708USA005168: US-009507513-1708USA001493: US-009507513-1708USA005166: US-009507513-1708USA005167:
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to 5 patients of unknown age. From 05-JUN-2017 to 11-JUL-2017, the patients were vaccinated with improperly stored doses of ROTATEQ for prophylaxis, as follow: lot M040270, expiration date on 29-APR-2018: 1 dose on 05-JUN-2017, 1 dose on 07-JUL-2017, and 1 dose on 11-JUL-2017; lot M002254, expiration date on 15-NOV-2017: 1 dose on 05-JUL-2017, and 1 dose on 07-JUL-2017. No adverse effect reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1707USA010591:
Sex: U
Vaccine: HIBV
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 age and gender. No information about the patients' medical history and concurrent conditions was reported. On an unknown dates in 2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot # M034188 with expiry date 20-MAY-2019 and lot # N000235 with expiry date 26-OCT-2019 for prophylaxis. The administered doses of PEDVAXHIB underwent temperature excursion under 47-77 Fahrenheit degrees for 48 hours. There was no previous temperature excursion. Data Logger was not involved. No adverse effects were reported. The nurse reported the medical office was directed by the state officials that all of the patients, who were vaccinated with the improperly stored PEDVAXHIB, would require a revaccination. The nurse stated that she would forward all data regarding the involved patients when available. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005698: US-009507513-1707USA002480: US-009507513-1708USA005699: US-009507513-1708USA005696.
Age: 25.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. On 01-AUG-2017, the patient was inadvertently administered an expired dose of dose of VARIVAX injection (lot # L028278 with expiration date at 28-JUL-2017, for prophylaxis; exact dose, route of administration and anatomical location were not reported) reconstituted with sterile diluent (lot # reported as N014021 with expiration date at 04-AUG-2019; strength and dose were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N003703 with expiration date of 29-OCT-2019 (doses and route of administration were not reported). On 04-AUG-2017, the administered doses of vaccine underwent a temperature excursion of 48.79 degrees Fahrenheit for 38 minutes which was detected by a digital data logger. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005778: US-009507513-1708USA005890: US-009507513-1708USA005891.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005837: US-009507513-1708USA005841: US-009507513-1708USA005839: US-009507513-1708USA005840: US-009507513-1708USA003358: US-009507513-1708USA005838.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003358: US-009507513-1708USA005841: US-009507513-1708USA005839: US-009507513-1708USA005840: US-009507513-1708USA005836: US-009507513-1708USA005838.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005837: US-009507513-1708USA005841: US-009507513-1708USA005839: US-009507513-1708USA005840: US-009507513-1708USA005836: US-009507513-1708USA003358.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005837: US-009507513-1708USA005841: US-009507513-1708USA003358: US-009507513-1708USA005840: US-009507513-1708USA005836: US-009507513-1708USA005838.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005837: US-009507513-1708USA005841: US-009507513-1708USA005839: US-009507513-1708USA003358: US-009507513-1708USA005836: US-009507513-1708USA005838.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005837: US-009507513-1708USA003358: US-009507513-1708USA005839: US-009507513-1708USA005840: US-009507513-1708USA005836: US-009507513-1708USA005838.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M044399 with expiration date of 25-JUN-2018 (doses were not reported). On 04-AUG-2017, the administered doses of vaccine underwent a temperature excursion of 48.79 degrees Fahrenheit for 38 minutes which was detected by a digital data logger. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005778: US-009507513-1708USA005827: US-009507513-1708USA005891.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # N003536 with expiration date of 02-NOV-2019 (doses and route of administration were not reported). On 04-AUG-2017, the administered doses of vaccine underwent a temperature excursion of 48.79 degrees Fahrenheit for 38 minutes which was detected by a digital data logger. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005778: US-009507513-1708USA005890: US-009507513-1708USA005827.
Sex: U
Vaccine: HPV9
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 demographics. 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 GARDASIL 9 lot # M040412 with expiration date on 30-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 (also reported 34) degrees Fahrenheit for 300 hours and 47 to 77 (also reported 52) degrees Fahrenheit for 250 hours. Data logger was not involved in recording of the temperature excursions. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA002131.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Headache, Vomiting
Clinical narrative: Patient had dose #1 of BEXSERO one year ago but insurance didn't cover so TRUMENBA vaccine was given. An hour after leaving practice he developed a headache and vomited once.
Age: 18.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope.
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Crying, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Evening of vaccines developed fever 102.5. Went on for several days. No seizures. Was having bouts of crying for up to one hour. Highest fever 104 degrees F. Seen on 8/07/2017. Was afebrile for several hours when seen. No focal signs of infection. Had mild generalized red macular rash. Did not look like chicken pox.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: RIGHT UPPER THIGH RED AND WARM TO TOUCH. RED AREA MEASURING 4X4. MEDICATION GIVEN TODAY ON 8/14/17 KEFLEX 250MG/5CC 1TSAP PO BID X 10DAYS, HYDROXYZINE 10MG/5CC 2CC PO Q12 HOURS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Localized erythema and edema of approx. 6 cm in diameter on L upper arm. The problem is moderate. The lesion of concern is described as red color and growing. Additional information: had shingles vaccine L deltoid 8/11/17, woke up on 8/12/17 with redness, swelling, pain at injection site.  No F/C, difficulty breathing or swallowing, no facial swelling.  No past H/O vaccine reaction.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On unknown dates, those patients were vaccinated with improperly stored M-M-R II lot # N008365 for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1708USA005938: US-009507513-1708USA005937: US-009507513-1708USA005935: US-009507513-1708USA005936.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PEDVAXHIB lot # N001348 for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates, unspecified number of patients were vaccinated with improperly stored PROQUAD lot # M035143, expiration 30-JAN-2018 (route and dosage not reported) for prophylaxis, reconstituted with sterile water diluent. Temperature excursion/ time frame: PROQUAD at -9 degrees Celsius to 8 degree Celsius for 5 hours 36 minutes, which was called by a data logger. No adverse effects were reported. This is one of two cases from the same patient. All telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1707USA004372.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB lot # M014927, oral for prophylaxis. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1708USA005938: US-009507513-1708USA005937: US-009507513-1708USA004523: US-009507513-1708USA005936.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On unknown dates, those patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N000508 for prophylaxis. No adverse effect were reported. Additional information has been requested. Sender's Comments: US-009507513-1708USA005938: US-009507513-1708USA005937: US-009507513-1708USA005935: US-009507513-1708USA004523.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On unknown dates, those patients were vaccinated with improperly stored VARIVAX lot # M041079 for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1708USA005938: US-009507513-1708USA004523: US-009507513-1708USA005935: US-009507513-1708USA005936.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple patients of unknown age and gender. On unknown dates, those patients were vaccinated with improperly stored ZOSTAVAX lot # N014942 for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004523: US-009507513-1708USA005937: US-009507513-1708USA005935: US-009507513-1708USA005936.
Sex: M
Vaccine: MENB
Symptoms: Back pain, Injection site pain, Malaise, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent), via Medical Information Team. A male patient of an unspecified ethnicity received TRUMENBA, first dose at age 16 (unit unknown) on an unspecified date and the second dose at age 17 (unit: unknown) on 07Aug2017 (reported as yesterday), both via an unspecified route of administration at a single dose for immunization, (the time between the two doses was not specified). The patient's medical history and concomitant medications were not reported. On an unspecified date, after the patient's first dose he had some pain at the injection site, but now after the second one he was not feeling well in general, he had a lot of pain in his arm, back pain, and fever. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Influenza like illness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a 65-year-old female patient received PREVNAR 13 via unspecified route of administration on 01Aug2017 at single dose on deltoid left, given to people 65 years and above for immunization. Patient medical history included hypertension. Concomitant medication included lisinopril from unspecified date and ongoing (taken for a long time and not allergic to this medication) for hypertension. The patient had an allergic reaction to the product on unspecified date. She is experiencing redness on her arm at the injection site and would like to know how long before that goes away. Patient stated it is warm at the site. The redness is going almost around her arm and down toward her elbow. She also had flu like symptoms. The site was warm, redness around her arm and down toward her elbow, and flu-like symptoms all started 01Aug2017 in the afternoon or evening. The patient explains that her arm hurt up to her shoulder joint on 02Aug2017. She says that it is a reaction to the product. The patient took ADVIL for the pain. She also reported that it was itchy at the injection site on 05Aug2017. Outcome of the event allergic reaction was unknown. Event itchy at the injection site was not recovered; while patient was recovering from the rest of the events. The patient considered events (site was warm, redness is going almost around her arm and down toward her elbow, arm hurt up to her shoulder joint, and itchy at the injection site) to be related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a 65-year-old female patient received PREVNAR 13 via unspecified route of administration on 01Aug2017 at single dose on deltoid left, given to people 65 years and above for immunization. Patient medical history included hypertension. Concomitant medication included lisinopril from unspecified date and ongoing (taken for a long time and not allergic to this medication) for hypertension. The patient had an allergic reaction to the product on unspecified date. She is experiencing redness on her arm at the injection site and would like to know how long before that goes away. Patient stated it is warm at the site. The redness is going almost around her arm and down toward her elbow. She also had flu like symptoms. The site was warm, redness around her arm and down toward her elbow, and flu-like symptoms all started 01Aug2017 in the afternoon or evening. The patient explains that her arm hurt up to her shoulder joint on 02Aug2017. She says that it is a reaction to the product. The patient took ADVIL for the pain. She also reported that it was itchy at the injection site on 05Aug2017. Outcome of the event allergic reaction was unknown. Event itchy at the injection site was not recovered; while patient was recovering from the rest of the events. The patient considered events (site was warm, redness is going almost around her arm and down toward her elbow, arm hurt up to her shoulder joint, and itchy at the injection site) to be related to pneumococcal 13-val conj vac (dipht crm197 protein).
Sex: U
Vaccine: HPVX, MENB, MNQ
Symptoms: Syncope
Clinical narrative: This is spontaneous report from a contactable physician (Pediatrician) via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA at 0.5ml, single, HPV VACCINE at 1 DF, single for immunisation, MENACTRA from an at 1 DF, single, all via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncopal episode/fainted on an unspecified date with outcome of unknown. Course of events: the reporter stated that was having breakfast this morning with doctor. She made the comment about TRUMENBA that he/she administered TRUMENBA concomitantly with HPV and MENACTRA. The patient along with his mother proceeded out to the parking lot where the patient fainted. There was no injury and no hospitalization was necessary.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 73-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at left arm on 2015 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the use of product, the patient experienced severe swelling in left arm. The outcome of the event was unknown.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported for an 18-year-old male patient of an unspecified ethnicity received the second dosage of TRUMENBA (strength 0.5ml), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation, MENACTRA, via an unspecified route of administration on an unspecified date at unknown dose for immunisation. The medical history and concomitant medications were not reported. The patient previously took 1st dose of meningococcal group b rlp2086 for immunisation. The patient experienced chills, fever, and body aches on an unspecified date with outcome of unknown. No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age ethnicity and gender received PREVNAR 13 (expiration date: Oct2018), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The reporter said not to take prescription due to history of folks we know who took it and had permanent muscle soreness. The outcome of the event was unknown.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Chills, Fatigue, Headache, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported for an 18-years-old male patient receive the second dose of TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5ml single for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient complained of headache, fatigue, chills, weakness, vomiting and went to ER. He was sent home from ER to follow up with office. It was reported that he was fine. No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, Fatigue, Feeling hot, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse (patient's mother) via a Company representative. An 18 year-old female patient of an unspecified ethnicity received the fourth dose of TRUMENBA (lot M95612, expiry date 31Jul2017, NDC 00005-0100-01) at 0.5 ml single intramuscular in the right gluteus on 03Jul2017 at 09:23 am for vaccination. Medical history included anxiety depression since childhood (started at around 7 years of age) and unknown if ongoing, bundle branch block right and orthostatic hypotension, both started at 15 years of age and unknown if ongoing. Family medical history was none. There were no concomitant medications. No other vaccines were administered the same day or within four weeks.  The patient had previously received intramuscular for immunization in the right deltoid meningococcal group b rlp2086, the first single dose (lot M95612, expiry Date: 31ul2017) on 06Jul2016, the second single dose (lot M68769, Expiry Date: 30Apr2017) on 09Sep2016 and the third single dose (lot M68769, Expiry Date: 30Apr2017) on 15Oct2016, without adverse event.  The patient experienced fever (at 101 degrees F), pain injection site, fatigue, body aches, cold hands and feet on 03Jul2017.  Her hands and feet were cold but she was burning up. The patient took paracetamol (TYLENOL) for fever. No physician or emergency room visits were needed for the events. The events were considered as serious as medically significant and related to the vaccine. The patient recovered from fever on 03Jul2017, from body aches, pain injection site, fatigue, cold hands and feet on an unspecified date in 2017. The patient received a totally of 4 doses of the vaccine instead of the recommended 3 doses.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient's mother) via a Company representative. An 18 year-old female patient of an unspecified ethnicity received the fourth dose of TRUMENBA (lot M95612, expiry date 31Jul2017, NDC 00005-0100-01) at 0.5 ml single intramuscular in the right gluteus on 03Jul2017 at 09:23 am for vaccination. Medical history included anxiety depression since childhood (started at around 7 years of age) and unknown if ongoing, bundle branch block right and orthostatic hypotension, both started at 15 years of age and unknown if ongoing. Family medical history was none. There were no concomitant medications. No other vaccines were administered the same day or within four weeks.  The patient had previously received intramuscular for immunization in the right deltoid meningococcal group b rlp2086, the first single dose (lot M95612, expiry Date: 31ul2017) on 06Jul2016, the second single dose (lot M68769, Expiry Date: 30Apr2017) on 09Sep2016 and the third single dose (lot M68769, Expiry Date: 30Apr2017) on 15Oct2016, without adverse event.  The patient experienced fever (at 101 degrees F), pain injection site, fatigue, body aches, cold hands and feet on 03Jul2017.  Her hands and feet were cold but she was burning up. The patient took paracetamol (TYLENOL) for fever. No physician or emergency room visits were needed for the events. The events were considered as serious as medically significant and related to the vaccine. The patient recovered from fever on 03Jul2017, from body aches, pain injection site, fatigue, cold hands and feet on an unspecified date in 2017. The patient received a totally of 4 doses of the vaccine instead of the recommended 3 doses.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: HPVX, MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable nurse received from Pfizer-sponsored program. A non-contactable nurse reported for a female patient of an unspecified age and ethnicity (reporter's daughter) that she received first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever of 102.4 on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Lip swelling, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Pt called to cancel Rabies vaccine #3 today stating that 14 days after we gave him rabies vaccine #2 and 1 day after typhoid oral #1 (not prescribed by us) he developed swelling of his fingers, toes, hands, feet and lips, hives to his body and low grade fever. He went to a walk in clinic and was given prednisone Rx. He never took this Rx, instead took alternating doses of BENADRYL and ZYRTEC plus ZANTAC. His sx waxed and waned for 72 hours. His is almost 100% better now. He declines continuing rabies vaccine and oral typhoid and is aware of risks while traveling.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope, Underdose
Clinical narrative: Patient fainted just as medication was beginning to be administered. Full dosing was not achieved.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Cellulitis, Full blood count, Ultrasound abdomen
Clinical narrative: Cellulitis R arm. Evaluated at ER and treated with KEFLEX with resolution.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Pallor, Syncope
Clinical narrative: *FIRST* I am not sure of the  brand of the vaccines. When I looked online in her chart to double check the ones given (HepA, meningococcal conjugate and Tdap) it just said the type but no other info. Patient has received countless numbers of shots, IVs, blood draws, etc and never had an issue. The MA administered the Tdap in the right arm then the other two in the left. She said "OK all done" and I handed my daughter her shirt to get dressed when she just fell over and fainted on the exam table. She was totally pale, having no color in her face/lips and it took a good 30 seconds plus to get her to come to. When she came around and regained consciousness, she seemed almost startled. She had no recollection of the immunizations (saying "what what are the shots done??!!). After sitting for a while and having something to drink, she was feeling better so we were able to go home. She had eaten breakfast and had a snack of peanut butter and crackers in the car on the way to the appointment so she wasn't hungry at the time. I don't know if this would be considered a "reaction" or not but wanted to report it just in case.
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient phoned this AM reporting that she had developed hives at 1:30 AM on 8-12-17. She received Td in our clinic on 8-11-17 at approximately 2:30 PM. States she woke up feeling itchy and noted hives on arms, in mouth and her head felt "itchy." Said she has had hives in past from medications, but has not had them since January 2017. Her immunization screening form listed allergies to PCN, prednisone, CELEBREX, and NEOSPORIN which are not contraindications for Td. States she took 2 BENADRYL tablets at 1:30am, and then Q6hrs x 2 after that on 8/12/17. Hives then dissipated and she did not take any more BENADRYL. Has not had any further hives since that time.
Age: 76.0
Sex: F
Vaccine: DTAP, TTOX
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Pain in multiple joints without synovitis, stiffness and pain in following joints: hands, wrists, shoulders, hips, knees.
Age: 76.0
Sex: F
Vaccine: DTAP, TTOX
Symptoms: No adverse event
Clinical narrative: Pain in multiple joints without synovitis, stiffness and pain in following joints: hands, wrists, shoulders, hips, knees.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Blood glucose normal, Loss of consciousness
Clinical narrative: PASSED OUT AFTER THE SHOTS FOR FEW SECONDS IN THE WAITING ROOM. GAVE HIM WATER AND JUICE. WATCH AND EXAMINED BY DR. GLUCOSE, PULSE OX AND TEMPERATURE WAS COMPLETED AND AT NORMAL LEVELS WAS ALLOWED TO LEAVE PER DR WHEN CHILD FELT GOOD.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Called on 8/10/17 to say that area/arm was sore and swollen in neck.
Age: 0.83
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Patient was seen and given a physical prior to the HIB vaccine on Friday August 11,2017 and was in perfect Health. He got a high fever 103.6 on Saturday evening. He was given MOTRIN, fever came down. His fever came back again 103.8. Kept treating with MOTRIN. Called pediatrician's office Sunday morning was told to keep giving either TYLENOL or MOTRIN. On Monday took him to pediatric quick care. He still was having high fevers. Quick care said his ears were clear, throat was fine. He didn't think it was from the vaccine. Patient is NOT in daycare, has not been around anyone with a cold or illness. No runny or stuffy nose, no vomiting or diarrhea. Everything ruled out BUT the vaccine. No other explanation as to why he was having high fevers. Again was told to treat with TYLENOL or MOTRIN, and if still having fevers in 2 days to return.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 11-AUG-2017 the patient was vaccinated with PROQUAD lot # M006107, .5 ml, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent. On 11-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to PROQUAD and sterile diluent.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Guillain-Barre syndrome
Clinical narrative: Diagnosed with Guillain-Barre syndrome.
Age: 28.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Vaccine given to patient outside of recommended age of 25. Patient experienced no adverse events.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Pruritus
Clinical narrative: After injection of MMR/Varicella the site had an immediate red rash around it. Patient began itching below the injection site right after the injection as well. After 10 minutes rash had decreased in size and patient no longer was itching.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Pruritic macular rash on all extremities and torso. Started 8/12/2017.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Employee broke out in hives. She plans to take BENADRYL, and if that does not alleviate symptoms, she has been advised to seek medical treatment.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Right upper ext. with swelling, redness, and warm to touch. Tenderness noted to touch. States that RUE is pruritic.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Lethargy, Peripheral swelling, Pyrexia, Scab
Clinical narrative: Patient reported that after receiving PNEUMOVAX 23 vaccine, her entire left upper arm and part of lower arm became red and swollen, with 2 scabs on the arm. She said that she also had a fever and felt lethargic. She went to her primary care physician, who advised her that she may be having an allergic reaction, possible to the PNEUMOVAX since she has had flu vaccine several times with no problems. He advised her not to receive the pneumococcal vaccine again in the future. The patient reported this to our pharmacy on 8/14/17.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented 3 days after vaccines were given and the right lateral thigh was noted to have a 90 mm round, red, raised area of erythema. Mother stated that it looked better than the previous day.
Age: 34.0
Sex: M
Vaccine: FLU4, HEP, MMR, TDAP, VARCEL
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient started to feel dizzied and fainted after receiving vaccines. He turn yellowish/green and started to sweat. He was unconscious for 5 seconds approximately. We checked blood sugar levels (89). We called 911 and they did an EKG and repeat blood sugar test. All result were within normal range.
Age: 34.0
Sex: M
Vaccine: FLU4, HEP, MMR, TDAP, VARCEL
Symptoms: Syncope, Yellow skin
Clinical narrative: Patient started to feel dizzied and fainted after receiving vaccines. He turn yellowish/green and started to sweat. He was unconscious for 5 seconds approximately. We checked blood sugar levels (89). We called 911 and they did an EKG and repeat blood sugar test. All result were within normal range.
Age: 7.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reactions reported.
Age: 44.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient received both vaccines in the same arm due to pt. request. He said that the next day he went to the E.R because his arm starting to turn red and swell up. He left the hospital today (08/14/17) and was prescribed prednisone, BENADRYL, and PEPCID.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Patient reported large area of swelling and redness and a small bruise site around injection area upon arriving at home at approximately 6:40 pm just after receiving injection. Reported this to her allergy doctor at a visit thereafter, reported to the pharmacy on 8/14/17. Was told by allergy doctor that this reaction seemed more pronounced than usual and to contact pharmacy where injection was given.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Acne, Amnesia, Anxiety, Blood urine absent, Borrelia test negative
Clinical narrative: Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Computerised tomogram head normal, Confusional state, Drug level therapeutic, Electroencephalogram abnormal, Eosinophil count increased
Clinical narrative: Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Epilepsy, Fatigue, Feeling cold, Gene mutation, Generalised tonic-clonic seizure
Clinical narrative: Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.