chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 06-OCT-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 06-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 12-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 13-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 14-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 15-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 19-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 20-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 5 year old patient. On 25-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 28-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 02-OCT-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 6 year old patient. On 06-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 10-OCT-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N019826, expiration date: 09-JAN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date:07-MAY-2018, lot # N013863, expiration date:31-OCT-2018) for prophylaxis(Incorrect product storage). Administered vaccine experienced the temperature excursion of -14 celsius degree to -10 celsius degree (-14.2 celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint(PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 4 year old patient. On 07-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis(Incorrect product storage). This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 11-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner, referring to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9(strength, dose, anatomical location, administration route, lot number and expiration date were not reported); then, on 18-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) and finally on 22-DEC-2016, the patient was vaccinated with the third dose of GARDASIL 9 (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) all the doses used for prophylaxis (inappropriate schedule of vaccine administered). No adverse effects were reported.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Dyspnoea, Flushing, Lip pruritus, Nasal congestion
Clinical narrative: Initial unsolicited report received from physician assistant on 26-Sep-2017. This case involves 21 year old female patient who was vaccinated with a 0.5 ml once dose of ADACEL (Batch number- U5770AA, expiry date - 15-Sep-2019, dose in series not reported) intramuscularly in right deltoid on 26-Sep-2017. Patient had a medical history allergy to milk, peas and eggs. Concomitant medications were not reported. On an unknown date, 15 minutes following vaccination patient had cough, shortness of breath (SOB), nasal congestion, flushing, mild nausea and itching to mouth and lips. Laboratory investigations were not reported. Corrective treatment included 50mg BENADRYL that was administered to patient. On an unknown date, patient got recovered from all the event as patient was asymptomatic upon discharge. List of documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Oral pruritus
Clinical narrative: Initial unsolicited report received from physician assistant on 26-Sep-2017. This case involves 21 year old female patient who was vaccinated with a 0.5 ml once dose of ADACEL (Batch number- U5770AA, expiry date - 15-Sep-2019, dose in series not reported) intramuscularly in right deltoid on 26-Sep-2017. Patient had a medical history allergy to milk, peas and eggs. Concomitant medications were not reported. On an unknown date, 15 minutes following vaccination patient had cough, shortness of breath (SOB), nasal congestion, flushing, mild nausea and itching to mouth and lips. Laboratory investigations were not reported. Corrective treatment included 50mg BENADRYL that was administered to patient. On an unknown date, patient got recovered from all the event as patient was asymptomatic upon discharge. List of documents held by sender: none.
Age: 21.0
Sex: U
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Erythema, Nausea, Oral pruritus
Clinical narrative: Initial unsolicited report received from a consumer on 26-Sep-2017. This case involves a 21-year-old patient (gender not reported) who was vaccinated with a 0.5 ml single dose of ADACEL (batch number, expiry date was not reported) in right arm via intramuscular route on 26-Sep-2017. The patient's medical history and concomitant medications were not reported. On 26-Sep-2017, same day following the vaccination, the patient experienced chest tight, mouth and throat itchy, difficult to breathe, mucous in chest and nose, hot, red and nauseated. Laboratory data was not reported. The patient received corrective treatment with BENADRYL. At the time of report the patient was recovering from the events. List of documents held by sender: none.
Age: 21.0
Sex: U
Vaccine: TDAP
Symptoms: Respiratory tract congestion, Rhinorrhoea, Skin warm, Throat irritation
Clinical narrative: Initial unsolicited report received from a consumer on 26-Sep-2017. This case involves a 21-year-old patient (gender not reported) who was vaccinated with a 0.5 ml single dose of ADACEL (batch number, expiry date was not reported) in right arm via intramuscular route on 26-Sep-2017. The patient's medical history and concomitant medications were not reported. On 26-Sep-2017, same day following the vaccination, the patient experienced chest tight, mouth and throat itchy, difficult to breathe, mucous in chest and nose, hot, red and nauseated. Laboratory data was not reported. The patient received corrective treatment with BENADRYL. At the time of report the patient was recovering from the events. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited report received from a consumer on 26-Sep-2017. This case involves a female patient (onset age not reported) who was vaccinated with a 0.5ml single dose of FLUZONE QIV (batch number, expiry date was not reported) via intramuscular route on an unknown date. The patient had a medical history of necrosis of 2 inches on her forearm. The patient's concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed large raised red area at the injections site that took time to resolve. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patient recovered from event. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Initial unsolicited report received from an other non-healthcare professional (office staff) on 29-Sep-2017. This case involves a two patients (age and gender not reported) who were vaccinated with FLUZONE HIGH DOSE (batch number, expiry date, route and site of administration were not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the two patients showed extreme swelling, redness, and itching. The patient's laboratory data and corrective treatment were not reported. The events outcome was not reported. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Peripheral swelling, Pruritus, Skin reaction, Skin warm
Clinical narrative: Initial unsolicited report received from a nurse on 29-Sep-2017. This case involves a female patient (age was not reported) who was vaccinated with 0.5 ml single intramuscular dose of INFLUENZA FLUZONE QUADRIVALENT (Batch number: UT5911KA, expiration date, dose in series and site of administration were not reported) on 29-Sep-2017. Patient's medical history and concomitant medications were not reported. On 29-Sep-2017, immediately after the vaccination, the patient's right deltoid became red, hot to touch, swollen and itchy and the reddened area was the size of a tennis ball and in the center she developed a hive about the size of a quarter. The patient was seen in the emergency room (ER). Laboratory investigations were not reported. As corrective treatment, the patient was given ALLEGRA. The outcome of all the events was reported as recovering (reported as symptoms were subsiding). List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a nurse on 29-Sep-2017. This case involves a female patient (age was not reported) who was vaccinated with 0.5 ml single intramuscular dose of INFLUENZA FLUZONE QUADRIVALENT (Batch number: UT5911KA, expiration date, dose in series and site of administration were not reported) on 29-Sep-2017. Patient's medical history and concomitant medications were not reported. On 29-Sep-2017, immediately after the vaccination, the patient's right deltoid became red, hot to touch, swollen and itchy and the reddened area was the size of a tennis ball and in the center she developed a hive about the size of a quarter. The patient was seen in the emergency room (ER). Laboratory investigations were not reported. As corrective treatment, the patient was given ALLEGRA. The outcome of all the events was reported as recovering (reported as symptoms were subsiding). List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye swelling
Clinical narrative: PT received influenza vaccine on 24 Oct 2017 around 1300 and states that she developed symptoms of swelling in her eyes on 25 Oct 2017 in both eyes. PT was treated at ER with Ranitidine 150 mg, Prednisone 50 mg, and Hydroxyzine 25 mg.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Developed left arm and shoulder pain after vaccination. Vaccination site may have been too high.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient experienced a burning sensation during the injection and 1 month later is still experiencing muscle soreness around the injection site. Has difficulty lifting her arm still. Recommended contacting her primary MD as well as OTC NSAIDs and rest. No swelling or redness around the injection site that she notices.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Cold sweat, Dyspnoea
Clinical narrative: Two days after taking the flu I start to have shortness of breath and cold sweat for no apparent reason. These symptoms lasted for a couple of weeks from 11/30/16 until about 12/15/16. Before taking flu shot I had no issues at all. I informed the nurse that I had gotten sick in the past from flu shots (in 1985), now it is time for annual flu shots again and I am very concerned for my safety (11/01/17). I did not visit a doctor at the time of incident.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Syncope
Clinical narrative: Nausea, then syncopal episode approximately 10 minutes after receiving vaccine.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: " arm  hurting, swollen, red".
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Limb mass, Peripheral swelling
Clinical narrative: Red swollen arm with hard lump from shot.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Localized erythematous, pruritic skin eruption; recommended OTC ibuprofen; fully resolved: 72 hours.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced swelling, redness, and pain in the arm that the Pneumovax vaccine was given.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising
Clinical narrative: BRUISE At SITE OF INJECTION - BRUISING STARTED IMMEDIATELY AT TIME OF INJECTION. BRUISE WAS 3INCH BY 2 INCH. NO ABNORMAL PAIN--BUT CONSISTENT WITH TYPICAL BRUISING.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Periarthritis
Clinical narrative: After experiencing excruciating pain, especially every single night, patient went to doctors and learned she have Adhesive Capsulitis or Frozen Shoulder. Patient feels there is a possible connection between the Tdap vaccination (received on 8/25 in right shoulder area). Physical Therapy has been recommended and ordered.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: "having pain, swelling, redness in arm". Treatment included: antibiotics and steroids.
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site urticaria, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a medical assistant, regarding an 18 year old female patient. The patient did not have historical conditions or medications, drug reactions, allergies or concomitant medication. On 18-SEP-2017, the patient received the first dose of GARDASIL 9 injection for Human Papilloma Virus vaccination, via intramuscular, lot # N019923 and expiration date 28-APR-2019. The dose and anatomical location of the injection were not provided. On 27-SEP-2017 the patient called to the physician's office to inform that from an unknown day in September 2017 she had pain and swelling at the injection site. An unspecified Health Care Professional informed the patient to take acetaminophen (TYLENOL) or ibuprofen (ADVIL) and use warm compresses to treat the events and to return to the office if there was no improvement. On 02-OCT-2017, the patient returned to the physician's office unable to lift the left arm, with urticaria at the injection site (reported as small welt, 4mm, at injection site) and swollen lymph nodes on the left side of the neck. No lab diagnostics or studies were performed and the patient was not recovered at the time of the reporting. The reporter did not mention if there is an association between the adverse events and the use of GARDASIL 9.
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injected limb mobility decreased, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a medical assistant, regarding an 18 year old female patient. The patient did not have historical conditions or medications, drug reactions, allergies or concomitant medication. On 18-SEP-2017, the patient received the first dose of GARDASIL 9 injection for Human Papilloma Virus vaccination, via intramuscular, lot # N019923 and expiration date 28-APR-2019. The dose and anatomical location of the injection were not provided. On 27-SEP-2017 the patient called to the physician's office to inform that from an unknown day in September 2017 she had pain and swelling at the injection site. An unspecified Health Care Professional informed the patient to take acetaminophen (TYLENOL) or ibuprofen (ADVIL) and use warm compresses to treat the events and to return to the office if there was no improvement. On 02-OCT-2017, the patient returned to the physician's office unable to lift the left arm, with urticaria at the injection site (reported as small welt, 4mm, at injection site) and swollen lymph nodes on the left side of the neck. No lab diagnostics or studies were performed and the patient was not recovered at the time of the reporting. The reporter did not mention if there is an association between the adverse events and the use of GARDASIL 9.
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site urticaria, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a physician, referring to an 18 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On approximately 18-SEP-2017 (reported as "two weeks ago"), the patient was vaccinated with GARDASIL 9 intramuscularly, vaccine dose (frequency, anatomical location, lot #, and expiration date were unknown) to prevent human papillomavirus (HPV). On 02-OCT-2017, it was reported that the patient could not lift the arm that received the GARDASIL 9 vaccine and that her lymph nodes were swollen. The patient sought for medical attention but no treatment was given for the adverse events. There was no product quality complaint. At the time of the report, the outcome of injected limb mobility decreased and lymphadenopathy was reported as not recovered. The reporter's causality assessment between the events of injected limb mobility decreased and lymphadenopathy with GARDASIL 9 was not provided.
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injected limb mobility decreased, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a physician, referring to an 18 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On approximately 18-SEP-2017 (reported as "two weeks ago"), the patient was vaccinated with GARDASIL 9 intramuscularly, vaccine dose (frequency, anatomical location, lot #, and expiration date were unknown) to prevent human papillomavirus (HPV). On 02-OCT-2017, it was reported that the patient could not lift the arm that received the GARDASIL 9 vaccine and that her lymph nodes were swollen. The patient sought for medical attention but no treatment was given for the adverse events. There was no product quality complaint. At the time of the report, the outcome of injected limb mobility decreased and lymphadenopathy was reported as not recovered. The reporter's causality assessment between the events of injected limb mobility decreased and lymphadenopathy with GARDASIL 9 was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The patient was vaccinated with GARDASIL first dose on 07-SEP-2010, second dose on 05-NOV-2010 and third dose on 16-MAR-2011 (concentration, route of administration lot# and expiration date were not reported). On 06-OCT-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M017983, expiration date 30-MAY-2018 (concentration and route of administration were not reported). No adverse effects were reported. The outcome of interchange of vaccine products and extra dose administered was unknown.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to a currently 18 year old female patient. The patient had no pertinent medical history, concurrent conditions or known allergies. Information regarding the patient's concomitant medications was not provided. On an unknown date (reported as "shortly after the patient was born"), the patient was vaccinated with RECOMBIVAX HB dose (anatomical route of vaccination, lot # and expiration date were not provided) for prophylaxis. The patient stated that, on an unknown date (reported as "recently"), she had hepatitis B titers drawn and the titers were negative. The patient then called the reporting pharmacist, to query about the recommendations for revaccination, but otherwise she did not seek for any medical attention. At the time of the report, the outcome of hepatitis b surface antibody negative was reported as not recovered. Additionally, the reporter did not provide for causality between the adverse event and vaccination with RECOMBIVAX HB.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist on 30-Sep-2017. This case involves a 70-year-old female patient who was vaccinated with a 0.5ml single dose of FLUZONE HD (batch number and expiry date was not reported) via intramuscular route on 30-Sep-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed red raised swollen area 6 cm by 6 cm at injection site which was hot and swollen. The patient's laboratory data and corrective treatment were not reported. On the date of report the patient was not recovered from event. List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Initial unsolicited report received from other non-health care professional on 10-Oct-2017. This case involves a 66-year-old male patient who was vaccinated with 0.5 ml second dose of FLUZONE HIGH-DOSE (frequency once, batch number: UI824AA, expiration date and site of administration was not reported) via intramuscular route on 10 Oct 2017 in morning. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was not allergic to eggs or other ingredients known to be in vaccine. On an unspecified date (also reported as this afternoon), following the vaccination, the patient experienced difficulty breathing and he could not take a deep breath. Lab data was not reported. The patient received corrective treatment with 2ml of DEXAMETHASONE (Decadron) and 0.5ml EPINEPHRINE (epinephrine) and had him sit in a treatment room for 30 minutes until they were sure his symptoms resolved. On an unspecified date, the patient recovered from events. Upon internal review, the company decided to consider the event serious because of important medical event difficulty breathing. List of documents held by sender: none.; Sender's Comments: Difficulty breathing was reported following FLUZONE HIGH-DOSE. Time to onset is compatible with the role of vaccine. Patient treated with 2ml of Decadron and 5ml epinephrine. More information regarding patient's medical history, previous history of similar episode, confirmation regarding diagnosis and investigation reports is needed for complete assessment. Based on the available information role of vaccine cannot be excluded.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Chest discomfort, Computerised tomogram, Hot flush, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from pharmacist on 13-Oct-2017. This case involves a 40 year old female patient who was vaccinated with 0.5 ml dose once of FLUBLOK QUADRIVALENT (Batch number: UI829AA, expiration date: 30 Jun 2018, dose, route was not reported) in left deltoid on 10 Mar 2017. The patient's medical history was not reported. It was reported that, the patient had no known drug allergies. Concomitant medications was not reported. It was also reported that no other vaccines given was given today. On 10 Mar 2017, 10 minutes following the vaccination, the patient experienced anaphylactic reaction, which consist of hot flash, nausea and left facial numbness. On an unspecified date, post vaccination, the patient experienced left arm heaviness, chest heaviness, and a burning sensation in her tongue. On an unspecified date, post vaccination, the patient experienced that right side of her lip was numb. The patient was sent to the emergency department for evaluation. Lab data included blood pressure was 142/93 and a CT scan was performed. Corrective treatment was not reported. The patient had not recovered from event symptoms Left facial numbness, left arm heaviness and Right side of her lip is numb. Outcome of other symptoms was not reported. Upon internal review, the company decided to consider the event serious due to important medical event anaphylactic reaction. List of documents held by sender: none.; Sender's Comments: Patient experienced anaphylaxis within ten mins of vaccination. Reported symptoms of hot flash, numbness in face and lips, heaviness in limbs and chest and burning sensation in tongue are consistent with anaphylaxis. Time to onset is compatible with the role of vaccine. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Limb discomfort, Nausea, Tongue discomfort
Clinical narrative: Initial unsolicited report received from pharmacist on 13-Oct-2017. This case involves a 40 year old female patient who was vaccinated with 0.5 ml dose once of FLUBLOK QUADRIVALENT (Batch number: UI829AA, expiration date: 30 Jun 2018, dose, route was not reported) in left deltoid on 10 Mar 2017. The patient's medical history was not reported. It was reported that, the patient had no known drug allergies. Concomitant medications was not reported. It was also reported that no other vaccines given was given today. On 10 Mar 2017, 10 minutes following the vaccination, the patient experienced anaphylactic reaction, which consist of hot flash, nausea and left facial numbness. On an unspecified date, post vaccination, the patient experienced left arm heaviness, chest heaviness, and a burning sensation in her tongue. On an unspecified date, post vaccination, the patient experienced that right side of her lip was numb. The patient was sent to the emergency department for evaluation. Lab data included blood pressure was 142/93 and a CT scan was performed. Corrective treatment was not reported. The patient had not recovered from event symptoms Left facial numbness, left arm heaviness and Right side of her lip is numb. Outcome of other symptoms was not reported. Upon internal review, the company decided to consider the event serious due to important medical event anaphylactic reaction. List of documents held by sender: none.; Sender's Comments: Patient experienced anaphylaxis within ten mins of vaccination. Reported symptoms of hot flash, numbness in face and lips, heaviness in limbs and chest and burning sensation in tongue are consistent with anaphylaxis. Time to onset is compatible with the role of vaccine. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Injection site pain, Muscular weakness, Pain in extremity, Walking aid user
Clinical narrative: Initial unsolicited report received from other healthcare professional on 18-Oct-2017. This case involves a 71-year-old female patient, who was vaccinated once with 0.5 ml FLUZONE HIGH-DOSE via intramuscular route (batch number, expiry date not reported) on 11-Oct-2017 in right deltoid. Patient had no previous adverse reactions to a flu vaccine. Patient handled the initial administration well. Patient's medical history and concomitant medications were not reported. On an unknown date, two days following the vaccination, the patient's both of her legs became very weak and painful. On an unknown date, few days after the vaccination, patient could barely stand without the use of her walker; patient was confined to her bed for almost an entire day. Patient also reported soreness in her right shoulder. Lab test and corrective treatment not reported. On an unknown date, patient's symptoms resolved post 5 days after initial symptoms started. Case was reported as serous due to permanent or significant disability/incapacity events. Documents held by sender: none. Sender's Comments: The patient experienced pain and weakness in legs, pain in right shoulder, difficulty in standing and was confined to her bed almost entire day post vaccination with FLUZONE HD. Time to onset was compatible. The patient had tolerated previous influenza vaccination without events. No other information regarding medical history and coexisting medical conditions was reported. Additional information regarding patient's medical history and medical condition at the time of vaccination would be required to assess the case. There is a possibility of an underlying etiology unrelated to vaccination that might have caused the events. Based upon reported information the role of the vaccine cannot be assessed.