chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Herpes zoster, Musculoskeletal disorder
Clinical narrative: This spontaneous report was received from a 74 year old male patient, who is also a pharmacist, who refers to himself and whose concurrent conditions included drug hypersensitivity/drug reaction to MOTRIN and diabetes mellitus. In approximately 2006 (also reported as "about 9 to 11 years ago"), the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date, the patient experienced musculoskeletal disorder. On 24-AUG-2017, the patient experienced shingles outbreak on an unspecified area of the body. The patient sought medical attention regarding the shingles outbreak by calling his primary care physician on the day of the report. No treatment was given. He reported that he had multiple computed tomography (CT) scans performed on unspecified dates due to orthopaedic problems (results were not provided). The outcome of musculoskeletal disorder and shingles outbreak was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of GARDASIL first (dose, lot number and expiration date were not reported). On an unknown date, 6 months later, the patient was vaccinated with the second dose of GARDASIL 9 (dose, lot number and expiration date were not reported), which was the second dose for Human Papilloma Virus (HPV) series. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions werenot reported. The patient's concomitant medications included a sterile diluent (manufacturer unknown). It was reported that, on 21-MAY-2012, the patient was vaccinated with one dose of measles, mumps and rubella (MMR) (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) for prophylaxis. Then, on 01-JUN-2015, the patient was vaccinated with a first dose of PROQUAD (strength, dose, route, lot number and expiration date were not reported) , and later, on 07-SEP-2017, was vaccinated with a second dose of PROQUAD lot number reported as M015479 with expiration date of 23-JUL-2019 (strength and route were not reported ); both for prophylaxis (extra dose administered). No adverse effects were reported. Lot number M015479 is an invalid lot number for PROQUAD.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as 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 in 2017, (also reported as"27-JUL-2017-12-SEP-2017"), the patients were vaccinated with improperly stored doses of PROQUA) recombinant human albumin (rHA) lot # M033209 with expiration date 09-JAN-2018, lot# N009773 with expiration date 20-AUG-2017, lot# N010247 with expiration date 25-AUG-2018, N013268 with expiration date 25-OCT-2018, (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of PROQUAD experienced the temperature excursion from 15 to 46 degrees Fahrenheit for 21.5 hours. Digital data logger was involved. there was no previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007003: US-009507513-1709USA007002:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, refers to 4 year-old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications include sterile diluent. On 18-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018, albumin status: rHa; M044719, exp. date: 07-MAY-2018, albumin status: rHa) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. The outcome of events was unknown. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA001467: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1708USA001338: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820:
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. The patients' medical history, concomitant medications and concurrent conditions were not reported. On unknown dates in 2017 (reported as from 27-JUL-2017 to 13-SEP-2017), the unspecified number of improperly stored doses of VARIVAX lot # N012487 with expiration date 20-APR-2019, or lot# N001530 with expiration date 13-JAN-2019 (dose and route not reported) reconstitute with properly stored sterile diluent (MRK), were administered to the patients. The doses were stored in temperature -3.5 degrees Celsius for 2 hours and 15 minutes. There was a previous temperature excursion reported (-12.5 degrees Celsius for 50 minutes). Digital data logger was involved. No adverse effects have been reported. Product quality complaint was not involved. This is one of two reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number patients of unknown age and gender. There was no information regarding the patients' medical history, concomitant medications, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N010107, expiration date: 18-MAR-20119, for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). The vaccines were stored in temperature from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 26 hours and 15 minutes. There was no previous temperature excursion. The call was because of digital data logger. No product quality complaint was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with an unknown number of improperly stored doses of LIQUID PEDVAXHIB)(dose, frequency and route of administration were not reported) lot# M001814 and expiration date: 15-OCT-2018. No adverse effects were reported. The LIQUID PEDVAXHIB was stored in 48 Fahrenheit degrees (F) for 1 hour 20 minutes and in 47 F for 23 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA011251:
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 multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, therapy type: human serum albumin (HSA) (dose number, exact dose, route of administration were not reported; lot # M044351 with the expiration date of 04-NOV-2018), for prophylaxis. There were no adverse effects reported. The administered doses of M-M-R II experienced a temperature excursion of: - 6 Fahrenheit degrees for 37 hours on 24-JUL-2017; - 9 Fahrenheit degrees for 16 hours on 01-AUG-2017; - 10 Fahrenheit degrees for 16 hours on 10-AUG-2017; - 12 Fahrenheit degrees for 16 hours on 15-AUG-2017; - minus 17 Fahrenheit degrees for 21 hours on 19-AUG-2017; - 21 Fahrenheit degrees for 16 hours on 22-AUG-2017; - 13 Fahrenheit degrees for 37 hours on 28-AUG-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005467: US-009507513-1709USA006071: US-009507513-1709USA009874: US-009507513-1709USA009893: US-009507513-1709USA009750:
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 4 unspecified 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, beginning sometime in May 2017, the patients were vaccinated with improperly stored doses of PROQUAD, lot # M040143 with expiration date on 27-MAR-2018 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines underwent a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 583 hours and an excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 127 hours. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA006071: US-009507513-1709USA005467:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history reported. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M024702 with expiration date 18-MAY-2018, (dose, route and anatomical location were not reported). The vaccine was exposed to temperatures between 6 F to 14 F (Fahrenheit) during 1 hour and 45 minutes. Additionally, previous temperature excursion was reported between 15F to 46F (Fahrenheit) during 6 hours. Digital data logger was filled. No adverse effects were reported. Lot number L007563 has been verified to be a valid lot number for sterile diluent.
Sex: M
Vaccine: HPV9
Symptoms: Seizure like phenomena
Clinical narrative: This spontaneous report has been received from a nurse practitioner via a company representative and refers to a 16 year old male patient. 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 GARDASIL 9 intramuscularly (dose, lot # and expiration date were not reported). On the same day, directly afterwards, the patient had chronic seizure-like symptoms. The outcome of the event was not reported. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of chronic seizure-like symptoms was considered to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients (may be 80) of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M034894, expiration date: 11-NOV-2018 (dose, frequency and route of administration were unspecified) for prophylaxis. Additionally, it was mentioned that there were two separate refrigerators with the same lot# and that only 7 doses were administered to unspecified patients on unspecified dates from the second refrigerator. No adverse effects were reported. The temperature excursion details were as follows: Temperature and time frame: 47.3 Fahrenheit degrees for 30 minutes, 2.2 to 33.7 Fahrenheit degrees for 24 hours, 31.4 Fahrenheit degrees for 18 hours. One refrigerator was exposed to 47 to 77 (47.3) Fahrenheit degrees for 30 minutes and 32 to 35 (32.2) Fahrenheit degrees for 24 hours, and the second refrigerator was exposed to 47 to 77 (47.3) Fahrenheit degrees for 30 minutes and 31 Fahrenheit degrees for or colder (31.4) for 18 hours. There were not previous temperature excursions or product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported. On unspecified dates, between 08-MAR-2017 and 29-JUN-2017, the patients were vaccinated with VARIVAX (lot # L034367, expiration date: 08-SEP-2017; and lot # M002063, expiration date: 12-JAN-2018) for prophylaxis. According to the reporter, VARIVAX was exposed to the following temperature excursions: 58 degrees Fahrenheit (F) for 10 hours (from 08-MAR-2017 to 10-MAR-2017), 20 F for 65 hours (from 16-APR-2017 to 19-APR-2017), 26 F for 420 hours (from 20-APR-2017 to 06-MAY-2017), 19 F for 94 hours (from 08-MAY-2017  to 12-MAY-2017), 25 F for 133 hours (from 17-MAY-2017 to 26-MAY-2017), and 20 F for 339 hours (from 30-MAY-2017 to 29-JUN-2017). No adverse symptoms were reported. A digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA010754: US-009507513-1709USA010755: US-009507513-1709USA010569:
Sex: U
Vaccine: HPV9
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. The patients' medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with GARDASIL 9 (lot # L007560, expiration date: 08-APR-2017; lot # L040164, expiration date: 20-FEB-2018; lot # M004116, expiration date: 12-OCT-2017; and lot # M036059, expiration date: 03-JUN-2019) for prophylaxis. According to the reporter, GARDASIL 9 was exposed to the following temperature excursions: 47 degrees Fahrenheit (F) to 77 F  (71.5 F) for 57 hours, and 32 F to 35 F (33.5 F) for 166 hours. No adverse symptoms were reported. A digital data logger was involved.  This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA010569: US-009507513-1709USA010755: US-009507513-1709USA010753:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, who referred to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 20-MAR-2017 and 20-APR-2017, the patient was vaccinated with GARDASIL 9 dose 1 and dose 2 respectively, lot# M037770 and expiration date: 01-JUN-2019 (route of administration was not reported) for prophylaxis. On 23-AUG-2017, the patient received the third dose of GARDASIL 9 lot# M033583 and expiration date: 14-APR-2019 (route of administration was not reported) for prophylaxis. The medical assistant reported that, on 23-AUG-2017, the patient received dose of GARDASIL 9 outside of the recommended dosing schedule. No adverse effects were reported. No product quality complaint was involved.
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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unspecified dates from 01-AUG-2017 to 14-SEP-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M035828, expiry date 28-MAY-2018 (doses were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 13 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008598:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with an unknown number of improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) lot# M042324 and expiration date: 10-JUN-2018. No adverse effects were reported. The PNEUMOVAX 23 was stored in 48 Fahrenheit degrees (F) for 1 hour 20 minutes and in 47 F for 23 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA009251.
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. The patients' medical history, concomitant medications and concurrent conditions were not reported. On unknown dates in 2017 (reported as from 27-JUL-2017 to 13-SEP-2017), the unspecified number of improperly stored doses of PROQUAD lot # N010115 with expiration date 24-SEP-2019 (dose and route not reported) reconstituted with properly stored sterile diluent (MRK), were administered to the patients. The doses were stored in temperature -3.5 degrees Celsius for 2 hours and 15 minutes. There was a previous temperature excursion reported (-12.5 degrees Celsius for 50 minutes). Digital data logger was involved. No adverse effects have been reported. Product quality complaint was not involved. This is one of two reports received from the same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist via a Pfizer Sales Representative. A patient of unknown age, gender and race/ethnicity received on an unknown date a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient had pain at the injection site. Outcome was recovering. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician. A 16-year-old male adolescent patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration, on an unspecified date, single dose for immunization. Relevant medical history and concomitant medications were not reported. On an unknown date, the patient experienced arm soreness and nausea. It was reported that the patient experienced similar side effects with other non-elated vaccines. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: I started having pain in my arm/shoulder a few hours after the vaccine was given, this had happened before but only lasted for a day or so. The evening of the day I received the vaccine the injection site began to itch. It also felt very hot around the area that the vaccine was given. The itch lasted through the next night and for a couple of days. The area that was hot around the vaccine lasted for a day or so. I then began to experience pain when sleeping on my left side, which is the side the vaccine was given in. I had to at one point in the night move my left arm with my right arm because it was too painful and I was unable to move it when I went to roll over to my right side during the night. I have since found it increasingly difficult to pull my sheets or blanket over myself with that arm and I am not able to sleep on it. I also have difficulty and pain when I raise my shoulder or try certain ranges of motion. I have never had shoulder pain, surgery, or any injuries prior. The pain in my arm/shoulder have not gotten any better over the past 9 days and is seemingly getting a bit worse. I have included the below information about my shot which I found on my patient portal through my doctors office. Influenza 3+ yo IM NDC 49281062778 Influenza 0.5mL 9y-64y Dose: .5 Date administered: 09/13/2017 Administration Site: Left Deltoid.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: I started having pain in my arm/shoulder a few hours after the vaccine was given, this had happened before but only lasted for a day or so. The evening of the day I received the vaccine the injection site began to itch. It also felt very hot around the area that the vaccine was given. The itch lasted through the next night and for a couple of days. The area that was hot around the vaccine lasted for a day or so. I then began to experience pain when sleeping on my left side, which is the side the vaccine was given in. I had to at one point in the night move my left arm with my right arm because it was too painful and I was unable to move it when I went to roll over to my right side during the night. I have since found it increasingly difficult to pull my sheets or blanket over myself with that arm and I am not able to sleep on it. I also have difficulty and pain when I raise my shoulder or try certain ranges of motion. I have never had shoulder pain, surgery, or any injuries prior. The pain in my arm/shoulder have not gotten any better over the past 9 days and is seemingly getting a bit worse. I have included the below information about my shot which I found on my patient portal through my doctors office. Influenza 3+ yo IM NDC 49281062778 Influenza 0.5mL 9y-64y Dose: .5 Date administered: 09/13/2017 Administration Site: Left Deltoid.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt was given PNEUMOVAX at pharmacy on 9/20/17 am and by that evening pt says his arm was swollen and red down to his elbow. Denies fevers. Pt was started on anitibiotic by doctor.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was given PNEUMOVAX 23 IM vaccination in the right arm at approx. 11am on 9/20. Patient began to experience pain, swelling and redness of injection site and surrounding tissues at approx. 9pm on 9/20. Patient reported back to pharmacy the morning of 9/21 at approx. 9am and took ibuprofen and diphenhydramine and by 11:30am was feeling much better - pain had reduced significantly. Patient was also given FLUZONE HD IM vaccination in the left arm at approx. 11am on 9/20 with no adverse effects on that arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Developed a raised rash at injection site, that was about 4x6 inchs in size about 18 hours after injection. pt also reported getting the same reaction the year prior to the same version of flu shot. patient had been applying ice packs and taking Benadryl 25mg to manage symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Insomnia, Myalgia, Pain in extremity
Clinical narrative: Fever, diarrhea, very sore arm, severe muscle aches in arms and legs, headache, could not sleep lasting on and off for 48 hours.  Was not told I received the High dose shot and have taken flu shots for more than 10 years and never before had any reactions.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, diarrhea, very sore arm, severe muscle aches in arms and legs, headache, could not sleep lasting on and off for 48 hours.  Was not told I received the High dose shot and have taken flu shots for more than 10 years and never before had any reactions.
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, 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 adult female patient who received dTpa  vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant and other: serious per reporter). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. It was unknown if the reporter considered the vaccination failure and pertussis to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had pertussis as an adult and was out of work for one month. The reporter was not willing for GlaxoSmithKine safety team to contact them to discuss further. This case was considered as a suspected vaccination failure case since the time to event onset and the laboratory test confirming the event was unknown at the time reporting.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Head injury, Syncope
Clinical narrative: Patient had a syncope episode shortly after receiving the vaccine. Vaccine given at 10:22 approximate time of syncope episode is 10:30. Patient did hit her head.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Liver function test normal, Nausea, Pharyngeal oedema, Pyrexia
Clinical narrative: Patient had flu shot around 1pm and by 5pm she was experiencing swelling in the throat as well as fever and nausea. She went to the ER and was treated and released same day. Her Primary Care doctor requested to her that we fill out an adverse event report. Patient states she is fine now.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Renal function test normal
Clinical narrative: Patient had flu shot around 1pm and by 5pm she was experiencing swelling in the throat as well as fever and nausea. She went to the ER and was treated and released same day. Her Primary Care doctor requested to her that we fill out an adverse event report. Patient states she is fine now.
Age: 31.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema
Clinical narrative: Red circular spots noted on face, torso, back and upper extremities. Denies itching or pain.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Localized redness and swelling in arm.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Hyperhidrosis, Lymphadenopathy, Nausea
Clinical narrative: 24 hrs Nausea, Headache, Photophobia, Fever, Sweating, Arm swelling, redness and axillary L node enlargement.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling, Photophobia, Pyrexia, Tenderness
Clinical narrative: 24 hrs Nausea, Headache, Photophobia, Fever, Sweating, Arm swelling, redness and axillary L node enlargement.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Fever, chills, nausea, Severe muscle aches, headache, dizziness off and on for 48 hours. I was not told I would be getting the High dose shot. I have taken flu shots for many years and never have had a reaction like this. I am a 4 year cancer survivor and felt as bad from this as I did during my chemotherapy. I feel this is very dangerous to older people who's health is already compromised.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, chills, nausea, Severe muscle aches, headache, dizziness off and on for 48 hours. I was not told I would be getting the High dose shot. I have taken flu shots for many years and never have had a reaction like this. I am a 4 year cancer survivor and felt as bad from this as I did during my chemotherapy. I feel this is very dangerous to older people who's health is already compromised.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient/employee 12cm diameter hot red and firm area at the injection site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient complained of redness and heat  on upper arm close in the area of injection site.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Computerised tomogram, Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Pt' s daughter called and report was weak and could not get out of bed. Could not move left leg. Left side felt numb/tingling.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Anger, Erythema, Hypothyroidism, Mood altered, Pain
Clinical narrative: Redness, swelling, soreness and feelings of anger/rage mood changes. Diagnosed with Hypothyroidism in 2004, no family history.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Redness, swelling, soreness and feelings of anger/rage mood changes. Diagnosed with Hypothyroidism in 2004, no family history.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Blood with Stool.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection -  fever, swelling, redness and tenderness to the touch.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: High fever, shakes, muscle soreness, dizziness, weak - day 1. Bad headache - day 2.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Tremor
Clinical narrative: High fever, shakes, muscle soreness, dizziness, weak - day 1. Bad headache - day 2.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site bruising, Vaccination site discolouration
Clinical narrative: Patient came in 24 hours after vaccine was administered to show bruising on her arm that vaccine was given. The bruise began below the vaccine site and was darker the further away from the site.  No treatment was given. Advised patient to contact the pharmacy or health care provider if it becomes worse.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Cyanosis, Lip swelling, Pruritus, Swollen tongue, Urticaria
Clinical narrative: 5 year old cardiac pt (Double inlet (L) ventricle) not ill. Received VZV and KINRIX and within two minutes became itchy and within 5 minutes developed hives, swollen lips and tongue and became slightly cyanotic. EPIPEN Jr administered in office and 911 called and child taken to ER. BENADRYL given. No secondary reaction. No further meds needed. Observed for observation due to severity of reaction and his cardiac history.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: 5 year old cardiac pt (Double inlet (L) ventricle) not ill. Received VZV and KINRIX and within two minutes became itchy and within 5 minutes developed hives, swollen lips and tongue and became slightly cyanotic. EPIPEN Jr administered in office and 911 called and child taken to ER. BENADRYL given. No secondary reaction. No further meds needed. Observed for observation due to severity of reaction and his cardiac history.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse, concerning a 32 year old female patient. The patient's medical history and concurrent condition were not provided. On 07-SEP-2017, the patient was vaccinated with an expired dose of M-M-R II (albumin status rHA) lot # L029266 and expiration date 04-AUG-2017 (strengh, frequency and route of administration were not provided) for prophylaxis which was reconstituted with a sterile diluent(manufacturer unknown). No adverse effects reported.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician, refers to a 16 year old patient of unknown gender. On 20-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018, albumin status: rHa) (strength, dose and route unspecified) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (°C) to -10 °C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. A digital data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA001467: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820: US-009507513-708USA001338.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, refers to 12 months old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications include sterile diluent. On 25-JUL-2017, the patients were vaccinated with improperly stored VARIVAX (lot # M047660, exp. date: 02-DEC-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe of 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001338: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006820: US-009507513-1708USA001467:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist  and refers to a four unspecified patients of unknown ages and genders. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, which had a lot # reported as "N045206", expiration date of 27-JUN-2019, for prophylaxis. Temperature: 47°F to 77°F (64F) Time frame: 8 hours Was it administered (AE): yes Previous temperature excursion: yes, 47°F to 77°F {71F) for 62 hours. No adverse symptoms reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner, and refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were administered an unspecified number of improperly stored doses of M-M-R II, lot number reported as "M046372", expiration date 08-JUL-2019, for prophylaxis (routes of administration were not provided); which were reconstituited with an sterile diluent (manufacturer unknown) (lot and expiration date unknown) that did not undergo a temperature excursion. On unknown dates, the doses of M-M-R II underwent temperature excursions of 47 degrees Fahrenheit (°F) to 77°F for a time frame of 12 hours and 47°F to 77°F for 9 hours, which were detected by the data logger. No adverse effects were reported.  This is one of two reports received from the same reporter. Lot number M046372 is an invalid lot number for M-M-R II.; Sender's Comments: US-009507513-1709USA010588:
Sex: U
Vaccine: HEP
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. The patients' medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot # M037248, expiration date: 21-JUL-2017) for prophylaxis. According to the reporter, RECOMBIVAX HB was exposed to the following temperature excursions: 47 degrees Fahrenheit (F) to 77 F (71.5 F) for 57 hours, and 32 F to 35 F (33.5 F) for 166 hours. No adverse symptoms were reported. A digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA010569: US-009507513-1709USA010754: US-009507513-1709USA010753.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right thigh 3x3 cm pink warm indurated area.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Vomiting, fever, chills, injection site swollen, red, size of a softball, limited movement of arm.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vomiting
Clinical narrative: Vomiting, fever, chills, injection site swollen, red, size of a softball, limited movement of arm.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered
Clinical narrative: Adult patient received pediatric/adolescent dose of Hepatitis A vaccine.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Patient was given both immunizations on 9/16/17. Patient reports her arm became red and warm to the touch the day following the immunizations and continued. She sought treatment 2 days post vaccination on 9/18/17 where she was given a course of antibiotics (Keflex) to treat possible cellulitis. Diagnosis was cellulitis vs. very heightened immune response. Patient reported on 9/22/17 that redness is going down in arm but is still somewhat present and that it is still warm to the touch.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth below the injection site, started 2 days after administration of the vaccine at the pharmacy.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Patient developed pruritis over her arms, trunk and neck within about 5 minutes of immunization. No overt urticarial or other rash, no respiratory or neurologic symptoms. No s/sxs of anaphylaxis. Examined at Clinic, treated with oral diphenhydramine 50mg po and sent home with instructions to RTC or ER if sxs persist or worsen over the weekend.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Eye swelling, Urticaria
Clinical narrative: Received FLUZONE 0.5 ml at 0930 on 9/21/2017. Patient reported on 9/22/2017 that on 9/21/2017 at 1400 she began to experience eye itching. At 1900 on 9/21/2017 she had urticaria on the left side of her neck. She woke up on 9/22/2017 with "swollen eyes". She took 25 mg of BENADRYL at 0900 on 9/22/2017. She was seen by Dr. at clinic. He did not prescribe additional treatments and released with instructions to follow up if condition changes.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site inflammation, Injection site rash, Pain
Clinical narrative: Patient complained of feeling terrible, achy and running a fever the following day. On the second day after immunizations, she reported a rash. The rash is a bit lower than the injection sites. She came to the pharmacy and the area was very red and inflamed. She did say she had applied ASPERCREME the previous day because of the hurting. She was advised to stick with ice packs and to take some acetaminophen if needed. She did say she was feeling much better today (the 2nd day after). We will follow up with her over the next couple days. The symptoms can not be linked to one vaccine rather than the other.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Patient complained of feeling terrible, achy and running a fever the following day. On the second day after immunizations, she reported a rash. The rash is a bit lower than the injection sites. She came to the pharmacy and the area was very red and inflamed. She did say she had applied ASPERCREME the previous day because of the hurting. She was advised to stick with ice packs and to take some acetaminophen if needed. She did say she was feeling much better today (the 2nd day after). We will follow up with her over the next couple days. The symptoms can not be linked to one vaccine rather than the other.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis, Vertigo
Clinical narrative: Per the patient's note to us: "Since I was there, I asked for a flu shot, which I did receive. I woke up at 2:00 am on Tuesday morning with a horrible case of vertigo that lasted for 2 days, and now I have a bad cold. Some say vertigo can be caused by the shot, and others say that is not the case.  Either way, in my mind it has to be associated with the shot, because I was perfectly fine until I got the shot. I have had vertigo before, but it never lasted more that 12 hours. Prior to this flu shot, I never had any after effects from the shot. "
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion, Erythema, Peripheral swelling
Clinical narrative: The vaccination was administered on 9/15/17. The patient's doctor called on 9/22/17 to find out which vaccination she received in her left arm.  I called the patient who said she had redness, swelling and bruising on her left arm. She said the doctor told her to take benadrly and prescribed Doxcycline hyclate 100 mg twice daily for ten days. The patient said the doctor instructed her to follow up 9/24/17 and if the reaction was not resolve she may need an MRI.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Feeling cold, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Around 9:30pm I started feeling nauseas and was having really bad chills to the point of shaking. My fingertips were also becoming numb and tingly. I left work arrived home by 11pm. At this point I had a coat and 3 blankets and was shaking uncontrollably because I still felt so cold. My temperature was 102.5. By 1am most of the shaking subsided but I was experiencing severe muscle aches in my legs and my temperature was now 103.2. Woke up at 5 am and vomited. Checked temperature again and it was coming down. 10am next morning temp was down to 101. Stayed that way almost all day 9/21 accompanied my headache and body aches. Today 9/22 temp is normal but still having painful muscle aches in legs and headaches. Severe chills and shakes Numbness in fingers Muscle aches - legs and back Fever of 103.2 Nausea  Vomiting
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Paraesthesia, Pyrexia, Tremor
Clinical narrative: Around 9:30pm I started feeling nauseas and was having really bad chills to the point of shaking. My fingertips were also becoming numb and tingly. I left work arrived home by 11pm. At this point I had a coat and 3 blankets and was shaking uncontrollably because I still felt so cold. My temperature was 102.5. By 1am most of the shaking subsided but I was experiencing severe muscle aches in my legs and my temperature was now 103.2. Woke up at 5 am and vomited. Checked temperature again and it was coming down. 10am next morning temp was down to 101. Stayed that way almost all day 9/21 accompanied my headache and body aches. Today 9/22 temp is normal but still having painful muscle aches in legs and headaches. Severe chills and shakes Numbness in fingers Muscle aches - legs and back Fever of 103.2 Nausea  Vomiting
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Around 9:30pm I started feeling nauseas and was having really bad chills to the point of shaking. My fingertips were also becoming numb and tingly. I left work arrived home by 11pm. At this point I had a coat and 3 blankets and was shaking uncontrollably because I still felt so cold. My temperature was 102.5. By 1am most of the shaking subsided but I was experiencing severe muscle aches in my legs and my temperature was now 103.2. Woke up at 5 am and vomited. Checked temperature again and it was coming down. 10am next morning temp was down to 101. Stayed that way almost all day 9/21 accompanied my headache and body aches. Today 9/22 temp is normal but still having painful muscle aches in legs and headaches. Severe chills and shakes Numbness in fingers Muscle aches - legs and back Fever of 103.2 Nausea  Vomiting
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Patient reported swelling on his upper arm. The inflammation has spread from the vaccination site to the front and back of the upper part of the arm. His arm did not show any redness, but patient reported pain and tenderness.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Mobility decreased
Clinical narrative: On Friday 9/15/2017 Patient reported being unable to lift her arm more than ten degrees and "no range of motion." She planned to see a physician on Monday 9/18/2017. On Monday 9/18/2017 Patient reported almost complete recovery as of Saturday 9/16/2017, with symptoms 95% resolved. She decided against seeing a physician.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came in on Saturday and showed me her arm, it was red and swollen, from elbow up. It was also hot to the touch. But she said it was looking better then the day before. I advised her to start taking benadryl  50 mg everhy 6 hours and ice pack it every couple hrs .
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Itching at the injection site 10 minutes after injection. Swollen redden area left deltoid area of arm at site of injection noted 9/20 am. The area XXXXinches in diameter warm to touch. Reported it to clinic manager by patient directly who then reported it to the nurse who injected 24 hours after the injection given. It appears to be unusually local reaction advised to speak with Health care provider.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling and redness below injection site.