chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. Since 14-OCT-2016, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of M030380 and an expiration date of 02-JAN-2019; however, dosage number and route of administration were not reported). Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 8 hours: 35 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. Since 14-OCT-2016, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, (which had a lot #of M019690 and an expiration date of 02-NOV-2017; however, dosage number and route of administration were not reported). Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 8 hours: 35 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: This spontaneous report was received from a pharmacist refers to a currently 43-year-old male patient. The patient's concurrent conditions included asthma. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # M022086, expiration date: 09-OCT-2017) (dose, route of administration and injection site were not provided). On an unknown date, three to five days after the vaccination, the patient began to feel heaviness in his chest and experienced difficulty breathing. No treatment was given for the adverse events. There were no lab diagnostic studies performed. The outcome of the events was reported as recovered, on an unknown date. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On 14-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 lot# 1040181, expiration date 18-AUG2017, (strength dosage were not provided). Concomitant therapies were not provided. The pharmacist reported that on 15-NOV-2016, the patient experienced pain in her arm and hard time being able to move her arm. The patient sought medical attention calling the pharmacy. There were not treatment given for the adverse events. Product quality complain was not filled. The outcome of pain in extremity and movement disorder was reported as not recovered at the time of this report. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX (DTaP/IV) administered to 4 month old.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored GARDASIL 9 with lot number M023169 and expiration date of 13-JUN-2018 (strength, route of administration, anatomical location and dose were unknown), which was stored at 23.4 Fahrenheit degrees for 8 hours and 44 minutes (1 cycle). There was no previous temperature excursion. The temperature excursions were not detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ with lot number M016238 and expiration date of 07-DEC-2017, orally (strength and dose were unknown), which was stored at 23.4 Fahrenheit degrees for 8 hours and 44 minutes (1 cycle). There was no previous temperature excursion. The temperature excursions were not detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Redness, swelling, cellulitis.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # M037669, expiry date 09-MAY-2016 (dose, route and site of administration were not reported). On an unknown date, 1 day after receiving the vaccine, the patient experienced redness, swelling and warmth at the injection site. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not provided. The reporter requested lot check due to another patient having the same adverse reactions after receiving PNEUMOVAX 23 with same lot #. This is one of two cases received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 70 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 09-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M037669, expiry date 09-MAY-2016 (dose, route and site of administration were not reported). On 10-NOV-2016, the patient called the physician's office to informed that they experienced redness, swelling and warmth at the injection site and to seek medical attention. The patient received unspecified treatment for the events. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not provided. The reporter requested lot check due to another patient having the same adverse reactions after receiving PNEUMOVAX 23 with the same lot #. This is one of two cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced a cold sore outbreak appeared on their upper lip. The patient notified the pharmacist about her event. There was no treatment given for the adverse event. The outcome of the event was not reported. The relatedness between vaccination with ZOSTAVAX and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (patient's father) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was vaccinated with GARDASIL intramuscularly, first improperly stored dose on 15-DEC-2015, second improperly stored dose on an unknown date in February 2016 and third improperly stored dose on an unknown date in June 2016. The vaccine was exposed to temperature of "below 35 Fahrenheit" several times. It was unknown if there was any previous temperature excursion. The reported nurse received a letter from a physician that revaccination series of GARDASIL need to be repeated however the reporter did not receive the complete temperature excursion details. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, Tooth disorder
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 08-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (lot # 669308/0636AA, expiry date 11-AUG-2013), dose and route were not reported. On 25-JUL-2016, the patient was vaccinated with the second dose in series with GARDASIL 9 (lot# L019297), intramuscularly. The nurse reported that the patient was in the office "2 days ago" to receive the 3rd dose of GARDASIL 9 in the series and did not receive it due to "surgery for teeth removal scheduled the next day" on an unspecified date. The nurse reported that the "the teeth removal is due to an unknown cause and was unsure of diagnosis". The relatedness between "the teeth removal is due to an unknown cause and was unsure of diagnosis" with vaccination was not reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Patient had a pink face for a few seconds. The pinkness resolved when the patient sat down.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Pain, numbness and tingling throughout arms and legs. Muscle weakness in both arms and legs.
Age: 1.67
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient woke up with a fever of 101 and a rash covering his back. Rash is small pink raised bumps.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Excessive bleeding with swelling at injection site. Recommended for pt to go to ER on the advice of urgent care. We even called ER to let them know she was on her way. Pt called later and said she did not go to ER but went to her sister who is a RN and put ice then heat. She was much better and the swelling had gone down and bleeding had stopped.
Age: 36.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Generalised erythema, Pruritus generalised
Clinical narrative: Itching/redness generalized.  Severe at the time, but has since much improved.  Still c/o itching but much improved.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Dizziness, nausea, vertigo.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: A lot of Hair loss. Possiblessings telogen effluvium from GARDASIL 9 vaccine.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Hyperhidrosis, Pyrexia, Syncope
Clinical narrative: Patient got up to go to the bathroom and fainted. wife got up and realized he was sweating profusely from his back to the point that the sheets were drenched. He spent the rest of the day with a fever of 102. Wife alternated between Tylenol and Advil to bring down the fever. 11/27/206 was a repeat of the profuse sweating during the night but no fevers.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Pain in extremity, Skin warm
Clinical narrative: Patient states arm was sore and got red, now 6 days later is still warm to the touch and red from injection site to 2 inches above elbow.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Herpes zoster, Pain, Pruritus
Clinical narrative: Patient woke up with a shingles-like rxn. It was just on her face. Reaction was red, painful, and itchy. Only half of her face was affected (symmetrical).
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: PATIENT SAID SHE EXPERIENCED TINGLING SENSATION ON HER FINGERS ON THE LEFT ARM WHERE SHE RECEIVED THE INJECTION AND LASTED FOR 2 DAYS. NO TREATMENT WAS GIVEN.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Patient was admitted in Hospital on 11/14/2016 and released on 11/16/2016 with a diagnosis Guillain-Barre syndrome resulting in weakness of both legs.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Aphasia, Autism spectrum disorder, Deafness, Pyrexia
Clinical narrative: Fever of 105 degrees, lost hearing, lost speech, later diagnosed with ASD.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse and refers to a 68-year-old male patient. The patient's pertinent medical history included history of torn of left rotator. No information regarding the patent's drug or allergies and concomitant medications was reported. On 01-NOV-2016, the patient was vaccinated with a one dose of PNEUMOVAX 23 intramuscularly in the left deltoid (lot #, expiration date and dose number were not reported) for routine vaccination. On 02-NOV-2016 (reported as the day after administration), the patient experienced excessive warmth and redness at the injection site. The patient sought medical attention by calling his physician. The physician told the patient to take TYLENOL and to apply warm compress to the left arm. No lab diagnostics studies were performed. The outcome of injection excessive warmth and redness at the injection site was reported as recovering/resolving at the time of this report. The relatedness between PNEUMOVAX 23 and the events was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse and refers to a 68-year-old male patient. The patient's pertinent medical history included history of torn of left rotator. No information regarding the patent's drug or allergies and concomitant medications was reported. On 01-NOV-2016, the patient was vaccinated with a one dose of PNEUMOVAX 23 intramuscularly in the left deltoid (lot #, expiration date and dose number were not reported) for routine vaccination. On 02-NOV-2016 (reported as the day after administration), the patient experienced excessive warmth and redness at the injection site. The patient sought medical attention by calling his physician. The physician told the patient to take TYLENOL and to apply warm compress to the left arm. No lab diagnostics studies were performed. The outcome of injection excessive warmth and redness at the injection site was reported as recovering/resolving at the time of this report. The relatedness between PNEUMOVAX 23 and the events was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a nurse 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 therapies was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (exact dose and lot number were not provided) and had an unknown reaction to the vaccine. Unspecified treatment was provided to the patient. The outcome of the event was not reported. The event was considered to be related to PNEUMOVAX 23. Additional information is not expected as there is no consent to the contact the reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The patients' concurrent condition, concomitant medication and medical history were not provided. On unknown dates, the patients were administered improperly stored doses of RECOMBIVAX HB (lot # L039660, expiration date 04-FEB-2018; lot # M022077, expiration date 10-MAR-2019) (strength, dose and route were not reported). It was reported that the vaccines were exposed to a temperature excursion of 14.3 Celsius degree for 10 hours 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On 07-NOV-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # K021581 with expiration date 24-OCT-2016; dose and route were unknown. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medial assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M007764 with expiration date 30-JAN-2018, lot # M011117 with expiration date 07-DEC-2017) (dose and route unknown). The vaccine was exposed to temperature excursion of 32.7Fahrenheit degree (F), 34.2F, 35.0F, 35.4F for 123 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # L048456, expiration date 25-MAY-2017) (lot # M001815, expiration date 20-SEP-2017) (lot # M009377, expiration date 17-JUN-2017) (lot # M011116, expiration date 17-JUN-2017) (lot # M017982, expiration date 13-SEP-2017) (dose and route unknown). The vaccine was exposed to temperature excursion od 32.7Fahrenheit degree (F), 34.2F, 35.0F, 35.4F for 123 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received fro the same report source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # M000997, expiration date 07-JAN-2018 (lot # M006733, expiration date 09-FEB-2018) (lot # M009766, expiration date 23-FEB-2018) (lot # M020900, expiration date 27-APR-2018) (dose and route unknown). The vaccine was exposed to temperature excursion of 7.9 Fahrenheit degree (F) for 15 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same report source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 15 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies were reported. The patient had a twin sister. In an approximately November 2015 (reported as about 1 year ago), the patient was vaccinated with a dose of GARDASIL (exact dose, route of administration, lot number and expiration date were not reported). On 09-NOV-2016, the patient came to receive a second, late dose of GARDASIL 9 (exact dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. The relatedness between the event of interchange of vaccine products and suspect vaccines was unknown. This is one of two reports received from the same reporter and considered the patient's twin sister. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates, the patients were administered improperly stored doses of VAQTA (lot# K012457, expiration date 04-JUN-2017; lot# K024697, expiration date 28-APR-2017; lot# M018767, expiration date 01-FEB-2018) (dose and route were not reported). It was reported that the vaccines were exposed to a temperature excursion of 14.3 Celsius degree for 10 hours 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a consumer referring to her son of unknown age. Information about concurrent condition, medical history and concomitant medication was not provided. On an unspecified date in "the week of 09-OCT-2016" the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot# unknown). The patient received the second dose of GARDASIL series on 08-NOV-2016 which was given outside of the recommended dosing schedule. No other adverse event information was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-NOV-2016, the patient was administered an expired dose of RECOMBIVAX HB (lot # K011957, expiration date 24-OCT-2016; dose and route were unknown). No adverse effects were reported. Additional information is not expected as there is no consent for follow up/
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Pyrexia
Clinical narrative: Information has been received from the patient's mother referring to a 2.5 year old of female patient. The patient's concurrent condition included sickle beta thalassemia. There was no concomitant medication and drug reactions/allergies. On 27-OCT-2016, the patient was vaccinated with a dose of (wistar ra 27-3) M-M-R II (dose, lot number and expiration date were unknown) subcutaneously. On approximately 03-NOV-2016, 1 week after receiving (wistar ra 27-3) M-M-R II, the patient developed a fever. The patient was taken to an unspecified emergency room and was given unspecified medication to treat fever. Unspecified blood work was performed (results were not reported). The outcome of the event was reported as not recovered. The causal relationship between the event and (wistar ra 27-3) M-M-R II was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not informed. On 16-NOV-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU, (lot #, dosage and therapy route were not provided), expiration date 06-OCT-2016. Concomitant therapies were not informed. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant referring to a 65 year old female patient with hypertension. The patient's concomitant medication and drug reactions/allergies were unknown. On 11-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L035686 with expiration date 16-FEB-2017; dose and route were unknown). On an unknown date in November 2015, the patient had localized swelling and soreness at the injection site. On 13-NOV-2015, the patient contacted an unspecified physician and was prescribed an unspecified dose of ibuprofen (manufacture unknown). No lab diagnostics studies were performed. The events were resolved on an unknown date. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no information about concurrent condition, concomitant medication and medical history. On 16-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L025000, expiration date 06-OCT-2016) (dose and unit unknown) subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 22-NOV-2016 the patient was vaccinated with expired dose of PNEUMVOAX 23 (dosing details were not reported) (lot # L012042, expiry date: 18-NOV-2016) intramuscularly. The dose had not been exposed to any temperatures outside of the recommended range. The patient had not experienced any adverse effects. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 11/25/16 - Patient experienced redness and swelling down from injection site towards elbow. No pain. Pt. applied ice pack. Reported 11/25/16 PM - swelling going down . 11/27/16 Patient came by Pharmacy - redness/swelling got worse 11/26/16 PM. Pt went to ED.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 15 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies were reported. The patient had a twin sister. In an approximately November 2015 (reported as about 1 year ago), the patient was vaccinated with a dose of GARDASIL (exact dose, route of administration, lot number and expiration date were not reported). On 09-NOV-2016, the patient came to receive a second, late dose of GARDASIL 9 (exact dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. The relatedness between the event of interchange of vaccine products and suspect vaccines was unknown. This is one of two reports received from the same reporter and considered the patient's twin sister. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old male patient. No concurrent conditions, historical conditions or concomitant medications were reported. On 10-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # M033086, expiration date unknown) via unspecified route in the right arm. It was the second dose of the PNEUMOVAX 23. It was not reported when the first dose was administered. On 11-OCT-2016, the patient experienced mild topical reaction: top back of his arm down to elbow became red and warm. The patient was advised to take BENADRYL as directed. The outcome of the adverse event was reported as recovered/resolved on an unknown date in approximately 2016. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old male patient. No concurrent conditions, historical conditions or concomitant medications were reported. On 10-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # M033086, expiration date unknown) via unspecified route in the right arm. It was the second dose of the PNEUMOVAX 23. It was not reported when the first dose was administered. On 11-OCT-2016, the patient experienced mild topical reaction: top back of his arm down to elbow became red and warm. The patient was advised to take BENADRYL as directed. The outcome of the adverse event was reported as recovered/resolved on an unknown date in approximately 2016. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness unilateral, Skin warm
Clinical narrative: Had flu shot 10/24/16. Woke up 10/25 w/ no hearing in left ear. Lost complete hearing, ended up in hospital due to loss of balance, dizziness, vomiting. Hearing loss is severe and permanent.
Age: 34.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Acoustic stimulation tests, Angiogram, Balance disorder, Computerised tomogram, Deafness unilateral
Clinical narrative: Had flu shot 10/24/16. Woke up 10/25 w/ no hearing in left ear. Lost complete hearing, ended up in hospital due to loss of balance, dizziness, vomiting. Hearing loss is severe and permanent.
Age: 34.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Nuclear magnetic resonance imaging, Vomiting
Clinical narrative: Had flu shot 10/24/16. Woke up 10/25 w/ no hearing in left ear. Lost complete hearing, ended up in hospital due to loss of balance, dizziness, vomiting. Hearing loss is severe and permanent.
Age: 36.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Generalised erythema, Pruritus generalised
Clinical narrative: Patient reported that he started with itchy and red skin all over, predominantly on his upper body, the evening after his vaccination. This itchiness is improved but is still persisting.
Age: 72.0
Sex: M
Vaccine: PNC13, TD
Symptoms: Movement disorder, Musculoskeletal discomfort
Clinical narrative: Severe neck problem. Unable to move my head.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure increased, Computerised tomogram head normal, Electrocardiogram normal, Fatigue, Hypoaesthesia
Clinical narrative: Body aches and fatigue followed by numbness in left arm, nausea, elevated blood pressure and pulse leading to ER visit. Labs, Head CT, and EKG all normal. Persisting fatigue, and body aches with left arm numbness coming and going.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Pain
Clinical narrative: Body aches and fatigue followed by numbness in left arm, nausea, elevated blood pressure and pulse leading to ER visit. Labs, Head CT, and EKG all normal. Persisting fatigue, and body aches with left arm numbness coming and going.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Sore shoulder muscle, limited arm movement, hard to raise left arm over head. Possible rotator cuff injury or bursitis.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Influenza like illness, Rash
Clinical narrative: Patient developed flu like symptoms then a rash on chest and torso 3 days later.  Completely resolved by 11/15/16.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pruritus, Vaccination site rash
Clinical narrative: Developed "itchy bumps" at vaccination site, then 2" x 2" firm red hardened area.  Physician prescribed antibiotic per patient.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac flutter, Dizziness, Eyelid oedema, Fatigue, Nausea
Clinical narrative: Nausea & dizziness; next morning woke up with "crusty eyes", face slightly swollen, eyelids swollen, large puffy bags under eyes, "top of head from eyes up felt heavy", heart fluttering on & off for 2 weeks, tired & dizzy, slept 13 - 14 hours/day. Lasted about 3 weeks, broke out in fever blister 3 weeks later. Advised she see MD to culture the blister.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Oral herpes, Swelling face
Clinical narrative: Nausea & dizziness; next morning woke up with "crusty eyes", face slightly swollen, eyelids swollen, large puffy bags under eyes, "top of head from eyes up felt heavy", heart fluttering on & off for 2 weeks, tired & dizzy, slept 13 - 14 hours/day. Lasted about 3 weeks, broke out in fever blister 3 weeks later. Advised she see MD to culture the blister.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face, Urticaria
Clinical narrative: PT WITH URTICARIA AND FACIAL SWELLING AFTER FLU VACCINE ADMINISTRATION. PT GIVEN BENADRYL 5ML, AND PREDNISONE 10ML IN OFFICE. SYMPTOMS DECREASED UPON DISCHARGE.
Age: 17.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Zostavax was inadvertently given instead of Varivax.  No adverse effects noted.
Age: 11.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Skin induration
Clinical narrative: Mother calls reporting that where patient got her PCV-23 vaccination is very red and hard. She denies fever, or drainage at this time. Redness is not spreading. She denies extreme pain. As long as no fever or drainage, ok to continue to monitor. Use a warm compress and she can take ibuprofen or TYLENOL to help with the pain.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: INTUSSUSCEPTION.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received yellow fever vaccine and approximately 5 days post vaccine patient complained of redness, swelling and slight warmth at sight of injection.  Ice pack and OTC Pain reliever with effect.
Age: 8.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Injection site pain, Pyrexia, Skin warm
Clinical narrative: Mom states right leg is warm to the touch, but not red. Pt does complain of soreness to both injection sites. ER physician note: Vaccination reaction, initial encounter: new and requires workup. Impression: Inflammatory changes around vaccination site and right anterior thigh consistent with normal reaction in my opinion. I do not think that this is a silent process at this time. Edges marked with surgical pen, given diabetic status recommend close observation, recommended 2 day follow-up, and to return to the ED if significant extension of erythema beyond marked borders or fever/chills. -- d/c home with clear RTED instructions.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt received vaccine morning of 10/31/16. She went to work that night and returned to clinic the next morning after her shift. Her arm had become painful, swollen, warm, and red. Pt reported headache as well.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Abnormal behaviour, Amnesia, Frustration tolerance decreased, Urticaria
Clinical narrative: Body broke out in hives arms, chest and back.  Child displayed chronic memory loss, bizarre behavior and frustration.  Highly unusual behavior for patient. Dr.was notified about this.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pruritus
Clinical narrative: 3:50PM Administered Influenza 0.5 ml IM LD and lot # UT5575BA Exp-6/30/17-Vis data 8/7/15 C/O itching immediately after injection at site.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Paralysis
Clinical narrative: Onset of symptoms started Nov. 14, 2015 w/tingling and numbness in hands and feet, followed by full paralysis within 2 days. Treatment still continuing as of Aug. 21, 2016.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, warmth, swelling tenderness in left upper arm. No treatment.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for himself/herself, via a sales representative. This patient of unspecified age, race, ethnicity and gender received a single dose of PREVNAR 13 via an unspecified route of administration in the arm on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, a week after the vaccination, the patient experienced redness on arm around injection site. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer.   A 66-year-old male patient of an unspecified race received  PREVNAR 13, at single dose in Nov2016 for immunisation. Medical history included oral surgery to have a tooth removed and to prepare for a tooth implant. The patient's concomitant medications were not reported. In Nov2016, the patient experienced pain in his arm, chills and body aches with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age and ethnicity received  PREVNAR 13 lot# R45377, NDC number 00005197102, Expiry Date Dec2017, via an unspecified route of administration in Nov2016  at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient developed rash of about 2-3 inches across in that circular area and it was very itchy in Nov2016 with outcome of unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable physician. A 17 year-old male patient received TRUMENBA, (lot R45078, expiry date Sep2017, NDC 0005-0100-10) at 0.5 ml single intramuscular in the left deltoid on 08Nov2016 for immunisation.  The patient medical history and concomitant medications were not reported. On 08Nov2016 at 7 pm the patient experienced swelling and pain at site of injection (left deltoid). Due to pain and swelling at the site of injection the patient was given MOTRIN and the mother applied heating pad to the area. On 09Nov2016 at 8 am the patient also experienced headaches, inability to move left arm fully, and had persistent pain and swelling at left deltoid. These side effects continued for 3 days and the patient recovered after that on 12Nov2016.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Swelling face
Clinical narrative: This is a spontaneous report from a contactable Physician. An 18-year-old female patient received TRUMENBA, via an unspecified route of administration on 08Nov2016 14:00 to at single dose in right deltoid for immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced swelling and pain at the site of injection right deltoid on 08Nov2016 19:00, swelling of right side of face on 09Nov2016 06:00 with outcome of unknown, pain at right side of thigh on 09Nov2016 06:00. All symptoms lasting for 3-4 days but final outcome was reported as unknown.  Physician gave MOTRIN 600mg and mother applied heating pad.
Sex: M
Vaccine: PNC13
Symptoms: Adverse reaction, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient had bad reaction and was very sick for a week, right after vaccination on an unspecified date with outcome of unknown.
Sex: U
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer of unspecified age, race and gender received a single dose of PREVNAR 13 and unspecified pneumococcal vaccinations (several times) on unspecified dates, for immunisation. Medical history and concomitant medications were not reported. The consumer experienced lack of effect and pneumonia on an unspecified date with unknown outcome.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Flushing, Injection site induration
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient of an unspecified ethnicity  received PREVNAR 13 , via an unspecified route of administration at the beginning of the 2016  at single dose for immunization.  The patient medical history was not reported. There were no concomitant medications. She never had any reactions with the vaccines. The patient stated that after half an hour or hour later of the vaccination, her face became completely flushed, her face was completely red and injection site become hard on an unspecified date with outcome of unknown. In Jan2017 was planned another pneumonia vaccine.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test, Malaise, Skin reaction
Clinical narrative: This is a spontaneous report from a contactable nurse, reporting for herself. This 50 year-old female patient receive a single dose of  PREVNAR 13 via an unspecified route of administration on 17Nov2016 for immunization. Medical history was reported as none.  The patient's concomitant medications were not reported.  On 17Nov2016 the patient experienced a local skin reaction and she was sick.  The patient underwent unspecified laboratory tests on an unspecified day in Nov2016.  In response to the events the patient took diphenhydramine hydrochloride (BENADRYL) over the weekend. The patient was not recovered at the time of this report. The events were considered as related to the vaccination.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 76-year-old female patient received PREVNAR 13 Lot N47827, NDC number 00005197102, Expiry Date Nov2017, via an unspecified route of administration in left arm, on 14Nov2016 13:00 at 0.5 ml, single for immunisation.  Medical history included ongoing blood cholesterol.  Concomitant medication included pitavastatin calcium (LIVALO), and escitalopram (at least since 2015).  The patient experienced 1 inch in diameter knot at injection site, red and warm at injection site on 20Nov2016 with outcome of not recovered.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist  through a Pfizer sales representative. A patient of an unspecified age, ethnicity and gender received PREVNAR 13 on an unknown date, at 0.5 ml, single dose, for immunization. It was the only vaccine administered. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced redness and swelling at injection site. Clinical outcome of the events was unknown at time of this report. The events were considered related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Pneumonia, Tremor, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for himself. This 65 year-old male patient received PREVNAR 13 on 08Nov2016 at 15:12 at 0.5 ml single intramuscular in the left arm for immunization.  Medical history included ongoing disability (the patient was disabled, he was retired and he did not work).  There were no concomitant medications. No other vaccines were given on the same day or within four weeks prior. On 09Nov2016 the patient started to experience uncontrollable chills and shaking, due to these symptoms he went to the emergency room on 10Nov2016. There he underwent laboratory tests which included white count at 27000, he was diagnosed with pneumonia and hospitalized from 10Nov2016 to 12Nov2016. The patient was not recovered from the reported events at the time of this report.