chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 29-NOV-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004148 US-009507513-1701USA007912:Original Case : 1701USA004148 US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist (also reported as a nurse) referring to unspecified patients of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On 30-DEC-2016, the patients were vaccinated with an improperly stored ROTATEQ, with lot # M005732, expiration date 19-OCT-2017, lot # M031807 and expiration date 02-APR-2018 and with a lot number reported as # M011632, expiration date 25-JAN-2018, orally, (dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine was 1.4 Celsius (C) and the time frame was 46 minutes, also she stated that the previous temperature excursion was 9.4 Celsius (C) during 1 hour and 35 minutes, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007903: US-009507513-1701USA000848: US-009507513-1701USA007902.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown dates, the patients were administered improperly stored doses of RECOMBIVAX HB lot # L048849, expiration date 04-FEB-2018, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of RECOMBIVAX HB were exposed to a temperature below of 32F and lowest of 31.74F and were out of range for 2 hours and 50 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.; Sender's Comments: US-009507513-1701USA003089:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse an refers to 6 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # reported as M034187, expiration date: 17-MAY-2019 (exact dose and route of administration were not reported). There was no adverse effect reported. The administered doses experienced the temperature excursion between 46 degrees Fahrenheit (F) and 77 F for 6 hours. A data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009338: US-009507513-1701USA009339: US-009507513-1701USA007030.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse an refers to 6 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of vAQTA lot # M033611, expiration date: 03-MAR-2018 (exact dose and route of administration were not reported). There was no adverse effect reported. The administered doses experienced the temperature excursion between 46 degrees Fahrenheit (F) and 77 F for 6 hours. A data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007030: US-009507513-1701USA009339: US-009507513-1701USA009337:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse an refers to 6 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M018625, expiration date: 11-AUG-2018 (exact dose and route of administration were not reported). There was no adverse effect reported. The administered doses experienced the temperature excursion between 46 degrees Fahrenheit (F)  and 77 F for 6 hours. A data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA009338: US-009507513-1701USA007030: US-009507513-1701USA009337:
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for three patients. This is the third of three reports. A 76-year-old female patient received on 05Jan2017 17:05 PREVNAR 13 (NDC number 0005197101, lot number R19477, expiry date 01Jan2018) at 0.5 ml single dose in the left deltoid for routine vaccination. Medical history included blood pressure, allergy, acid reflux, high cholesterol, arthralgia of knee and wrist, all ongoing. The patient received influenza vaccine in Sep2016 for immunization. Concomitant medications included amlodipine for blood pressure, metoprolol for blood pressure, hydrochlorothiazide for blood pressure, valsartan for blood pressure, meloxicam, fluticasone propionate (FLUNASE) for allergy and omeprazole (PRILOSEC) for acid reflux, all ongoing. In Jan2017, the patient experienced redness, itching and tenderness at the injection site of pneumococcal 13-val conj vac (dipht crm197 protein).  She came back to the office on 11Jan2017 for a holter monitor and reported to the doctor that she had been experiencing redness, itching and tenderness at the injection site.  Over the past few days the side effects were worsening and the redness was increasing in size.  The doctor advised the patient to monitor the side effects and take Benadryl. Outcome was unknown.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site rash, Injection site swelling, Malaise
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for three patients. This is the second of three reports. A 75-year-old female patient received on 27Oct2016 10:35 PREVNAR 13 (NDC number 0005197101, lot number R45377, expiry date 01Dec2017) at 0.5 ml single dose in the right deltoid for routine vaccination. Medical history included thyroid, asthma, blood pressure, sleep apnea, all ongoing. The patient received influenza vaccine (manufacturer unknown), lot number A3AD2) on 20Oct2016 for immunization in her right deltoid. Additional concomitant medications included thyroid for thyroid, albuterol for asthma, SPIRIVA for asthma and propranolol for blood pressure, all ongoing. On 28Oct2016, the patient experienced redness, swelling and red spots on her right arm at the site of the injection, felt tired and sick. When the patient came back to the office for a sick visit unrelated to the vaccination on 10Jan2017, she reported that the day after she received PREVNAR 13, she developed redness, swelling and red spots on her right arm at the site of the injection. She felt so tired and sick that she stayed in bed and after about 2 days all of the side effects resolved on their own. Outcome was recovered on an unspecified date in Oct2016.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Asthma, Complex regional pain syndrome, Guillain-Barre syndrome, Neuropathy peripheral, Pneumonia
Clinical narrative: Severe pulmonary hypertension; pneumonia; Guillain-Barre syndrome; CRPS; Severe neuropathy; asthma.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Pulmonary hypertension
Clinical narrative: Severe pulmonary hypertension; pneumonia; Guillain-Barre syndrome; CRPS; Severe neuropathy; asthma.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Knot at injection site, painful to touch, warm to touch, patient has tried warm compresses to help with discomfort. Some itching at site of reaction, but tolerable (patient not scratching or using hydrocortisone at location).
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm pain so severe he was unable to lift arm.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Blood lactic acid, Differential white blood cell count, Flushing, Full blood count, Lipase
Clinical narrative: Symptoms of rash and flushing and aches and vomiting. Pt went to emergency departmnet.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Pain, Rash, Troponin, Ultrasound abdomen
Clinical narrative: Symptoms of rash and flushing and aches and vomiting. Pt went to emergency departmnet.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis, Vomiting
Clinical narrative: Symptoms of rash and flushing and aches and vomiting. Pt went to emergency departmnet.
Age: 22.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Burning sensation, Computerised tomogram head normal, Pain in extremity, Scan with contrast
Clinical narrative: Pain and burning sensation bilateral hands and feet X 3 days.
Age: 22.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Abasia, Activities of daily living impaired, Blood test, Burning sensation, Computerised tomogram head
Clinical narrative: Pain and burning sensation bilateral hands and feet X 3 days.
Age: 22.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Pain in extremity, Peripheral swelling, Vaccination complication, Wheelchair user
Clinical narrative: Pain and burning sensation bilateral hands and feet X 3 days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered..vaccine expired 1/06/17.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Red, warm, area increasing in size from 1/18 to 1/19.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a 25 year old female patient. On 06-OCT-2016, the patient was vaccinated with a dose of GARDASIL injection, 0,5 ml, intramuscularly, lot# M026306, expiration date 30-APR-2018 for prophylaxis. The patient became pregnant with last menstrual period (LMP) date of 05-OCT-2016 (calculated by sub tracking 11 weeks from 21-DEC-2016). On 11-NOV-2016, the patient got a positive result of an urine pregnancy test. On 21-DEC-2016, the patient was 11 weeks pregnant. Due date was estimated on 12-JUL-2017. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to unknown number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On an unknown date, the patients were inadvertently administered VAQTA lot # M027879, expiration date 24-JAN-2018 (formulation, dose, route of administration were not reported) and VAQTA lot # M033611, expiration date 02-MAR-2018 (formulation, dose, route of administration were not reported) that had been improperly stored. No adverse effects were reported. The vaccines experienced a temperature excursion of 47 Fahrenheit degrees (F) for 5 minutes, which was detected by a digital data logger. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1612USA012239: US-009507513-1701USA002061: US-009507513-1701USA002059.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 week old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 06-DEC-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally with lot number M029252 and expiration date of 14-MAR-2018 (strength and dose were not reported) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004152; US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
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. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were orally administered the improperly stored doses of ROTATEQ (lot # reported as M031804 with expiration date on 02-APR-2018; lot # M011832 with expiration date on 25-JAN-2018; lot # M007301 with expiration date on 19-NOV-2017 and lot # reported as M033337 with expiration date on 13-APR-2018; dose was not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA009359: US-009507513-1701USA009357: US-009507513-1701USA009358:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from an office manager refers to a 72 year old female patient. None medical history, concurrent conditions, known drug reactions/allergies and concomitant therapies were reported. On 16-JAN-2017, over the age of 65 years, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M036728, expiration date 20-MAY-2018, intramuscularly; dose was not reported) for prophylaxis. On 17-JAN-2017, the patient experienced a fever and redness and tenderness at the injection site. The patient sought medical attention via calling the physician's office and the physician prescribed ADVIL and ice. None lab diagnostics studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX 23 was not provided. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments:  US-009507513-1701USA007767.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 07-DEC-2016,  the patient was vaccinated with a dose of improperly stored ROTATEQ orally with lot number M029252 and expiration date of 14-MAR-2018 (strength and dose were not reported) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 05-JAN-2017, the patient was vaccinated with a dose of improperly stored ROTATEQ orally with lot number M029252 and expiration date of 14-MAR-2018 (strength and dose were not reported) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007849.
Age: 0.25
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 05-JAN-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally with lot number M029252 and expiration date of 14-MAR-2018 (strength and dose were not reported) for prophylaxis. Also, on the same date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration, anatomical location were unknown) for the same indication. Both vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848.
Age: 0.83
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 06-DEC-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003138: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 1.83
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 22 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 07-DEC-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 0.75
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 06-DEC-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported.  On 23-NOV-2016, the patient was vaccinated with a dose of improperly stored MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA004150; US-009507513-1701USA007912:Original Case : 1701USA007906; US-009507513-1701USA007881:Original Case : 1701USA007910; US-009507513-1701USA007913:Original Case : 1701USA007910; US-009507513-1701USA007882:Original Case : 1701USA007910; US-009507513-1701USA004150:Original Case : 1701USA007916; US-009507513-1701USA007958:Original Case : 1701USA007916; US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Age: 1.33
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 30-NOV-2016, the patient was vaccinated with a dose of improperly stored MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150 US-009507513-1701USA007912: Original Case : 1701USA007906 US-009507513-1701USA007922: Original Case : 1701USA007910 US-009507513-1701USA007881: Original Case : 1701USA007910 US-009507513-1701USA007913: Original Case : 1701USA007910 US-009507513-1701USA007882: Original Case : 1701USA007916 US-009507513-1701USA004150: Original Case : 1701USA007916 US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Seizure
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient with SULFA allergy. On 09-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9, lot # reported as M034780, expiration date 15-APR-2019, intramuscular (dose and site of administration were not reported) for prophylaxis. There were no concomitant medications. On 18-JAN-2017, the patient experienced violent seizure. The patient was taken to the emergency room. A computerized tomogram scan was performed at the hospital and the result was normal. The outcome of seizure was reported as fully recovered in approximately January 2017. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of seizures was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEPA
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. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M027879 with expiration date on 24-JAN-2018; lot # M022924 with expiration date on 24-JAN-2018; lot # M018644 with expiration date on 20-SEP-2017; lot # M033611 with expiration date on 02-MAR-2018 and lot # reported as M036458 with expiration date on 02-MAR-2018; dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009358: US-009507513-1701USA009359: US-009507513-1701USA005323.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Pain soreness right arm after injection, moved to left shoulder later in day, joint pain, stiffness, and muscles aches followed, pain wakes her up at night.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder, Ultrasound scan
Clinical narrative: Pain soreness right arm after injection, moved to left shoulder later in day, joint pain, stiffness, and muscles aches followed, pain wakes her up at night.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Flatulence, Irritability, Seizure
Clinical narrative: Crying-fussy, gassy, severe seizure. Hospitalized.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Activities of daily living impaired, Asthenia, Discomfort, Hypoaesthesia, Injection site discomfort
Clinical narrative: 2015 Shot Effects: Left arm and shoulder pain going on 15 months (Nov 2015 to now). Limited rotation and range of motion, weakened strength, some partial numbness left fingers and hand, difficulty sleeping, physical activities limited or given up such as golf and arm machines at gym. From the time of shot 11/2015 to current date 1/7/17. Treatment for left arm pain 11/2015 to 11/2016: Over counter medication for pain and inflammation. Call to pharmacy to report prolonged discomfort. They said no other reports coming in. Visit to PC physician office, then referred to Ortho. 3 visits to Ortho Doctors: x-rays and 3 cortisone shots over 8-month period. Tendonitis, bursa damage, rotator cuff all explored. Physical therapy Sept and Oct 2016. Discomfort continued, Ortho Arm Dr recommended MRI of neck 11/2016. Then referred to Ortho Spine surgeon and Neurosurgeon and Neurologist for left arm nerve testing. Currently exploring if arm problem could relate to any neck issues. 2016 Shot: Based on possibility pain could be neck related, my PC Dr. and I agreed I should consider a reduced dose flu shot for 2016/2017 season. Shot administered PC office on 12/13/16 in right arm. Has been more than 3 weeks since shot and my right arm is experiencing same issues I had with the prior year's flu shot in left arm. Although not as painful as 2015 there is constant discomfort in upper arm and shoulder, limited range of motion and waking multiple times at night due to pain. Treatment: Back on over counter anti-inflammatory and expecting will need continued Medical attention to both my left and now my right arm. Assumption is now that this is not neck related but direct result of flu shot in 2015 and 2016. Personal observation: I have been taking flu shots for a minimum of 15 years without any issue until the 2015 and 2016 shots. Going forward I will forgo any further flu shots as this has changed my activity level and quality of life substantially. Constant discomfort causing me to reduce the physical activities I used to enjoy. Has aged me prematurely both mentally and physically. I hope this information is helpful in future development of flu treatment and their delivery process.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Insomnia, Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: 2015 Shot Effects: Left arm and shoulder pain going on 15 months (Nov 2015 to now). Limited rotation and range of motion, weakened strength, some partial numbness left fingers and hand, difficulty sleeping, physical activities limited or given up such as golf and arm machines at gym. From the time of shot 11/2015 to current date 1/7/17. Treatment for left arm pain 11/2015 to 11/2016: Over counter medication for pain and inflammation. Call to pharmacy to report prolonged discomfort. They said no other reports coming in. Visit to PC physician office, then referred to Ortho. 3 visits to Ortho Doctors: x-rays and 3 cortisone shots over 8-month period. Tendonitis, bursa damage, rotator cuff all explored. Physical therapy Sept and Oct 2016. Discomfort continued, Ortho Arm Dr recommended MRI of neck 11/2016. Then referred to Ortho Spine surgeon and Neurosurgeon and Neurologist for left arm nerve testing. Currently exploring if arm problem could relate to any neck issues. 2016 Shot: Based on possibility pain could be neck related, my PC Dr. and I agreed I should consider a reduced dose flu shot for 2016/2017 season. Shot administered PC office on 12/13/16 in right arm. Has been more than 3 weeks since shot and my right arm is experiencing same issues I had with the prior year's flu shot in left arm. Although not as painful as 2015 there is constant discomfort in upper arm and shoulder, limited range of motion and waking multiple times at night due to pain. Treatment: Back on over counter anti-inflammatory and expecting will need continued Medical attention to both my left and now my right arm. Assumption is now that this is not neck related but direct result of flu shot in 2015 and 2016. Personal observation: I have been taking flu shots for a minimum of 15 years without any issue until the 2015 and 2016 shots. Going forward I will forgo any further flu shots as this has changed my activity level and quality of life substantially. Constant discomfort causing me to reduce the physical activities I used to enjoy. Has aged me prematurely both mentally and physically. I hope this information is helpful in future development of flu treatment and their delivery process.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Quality of life decreased, Sleep disorder, X-ray
Clinical narrative: 2015 Shot Effects: Left arm and shoulder pain going on 15 months (Nov 2015 to now). Limited rotation and range of motion, weakened strength, some partial numbness left fingers and hand, difficulty sleeping, physical activities limited or given up such as golf and arm machines at gym. From the time of shot 11/2015 to current date 1/7/17. Treatment for left arm pain 11/2015 to 11/2016: Over counter medication for pain and inflammation. Call to pharmacy to report prolonged discomfort. They said no other reports coming in. Visit to PC physician office, then referred to Ortho. 3 visits to Ortho Doctors: x-rays and 3 cortisone shots over 8-month period. Tendonitis, bursa damage, rotator cuff all explored. Physical therapy Sept and Oct 2016. Discomfort continued, Ortho Arm Dr recommended MRI of neck 11/2016. Then referred to Ortho Spine surgeon and Neurosurgeon and Neurologist for left arm nerve testing. Currently exploring if arm problem could relate to any neck issues. 2016 Shot: Based on possibility pain could be neck related, my PC Dr. and I agreed I should consider a reduced dose flu shot for 2016/2017 season. Shot administered PC office on 12/13/16 in right arm. Has been more than 3 weeks since shot and my right arm is experiencing same issues I had with the prior year's flu shot in left arm. Although not as painful as 2015 there is constant discomfort in upper arm and shoulder, limited range of motion and waking multiple times at night due to pain. Treatment: Back on over counter anti-inflammatory and expecting will need continued Medical attention to both my left and now my right arm. Assumption is now that this is not neck related but direct result of flu shot in 2015 and 2016. Personal observation: I have been taking flu shots for a minimum of 15 years without any issue until the 2015 and 2016 shots. Going forward I will forgo any further flu shots as this has changed my activity level and quality of life substantially. Constant discomfort causing me to reduce the physical activities I used to enjoy. Has aged me prematurely both mentally and physically. I hope this information is helpful in future development of flu treatment and their delivery process.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ, FLU4, HPV9, MENB, MNQ
Symptoms: Blood test, Body temperature increased, Headache, Hyperventilation, Panic reaction
Clinical narrative: Admitted to ED, with headache, hyperventilation, panic state, adm temp 97.3F, repeat tem 100.3; awaiting blood work results.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Haematochezia, Intussusception, Irritability
Clinical narrative: Dx intussusception (preceded by fussiness, blood in diaper, crying).
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Chills, Decreased appetite, Dizziness, Dysphagia
Clinical narrative: The evening of the 12th, employee started to experience fever, chills, sweatiness, lightheaded, nausea and abdominal cramping (Tylenol was taken that night). Next morning felt lightheaded, aches and pains, nausea (employee did not eat either that morning or night before) Ibuprofen was taken and felt better on her stomach without food. Sore throat for one week. Unable to swallow food or water. Employee not very hydrated. Redness and soreness to injection site first three days. Employee mentioned continued fevers, sore throat, body chills and aches and slight tenderness to touch over injection site.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Nausea, Oropharyngeal pain
Clinical narrative: The evening of the 12th, employee started to experience fever, chills, sweatiness, lightheaded, nausea and abdominal cramping (Tylenol was taken that night). Next morning felt lightheaded, aches and pains, nausea (employee did not eat either that morning or night before) Ibuprofen was taken and felt better on her stomach without food. Sore throat for one week. Unable to swallow food or water. Employee not very hydrated. Redness and soreness to injection site first three days. Employee mentioned continued fevers, sore throat, body chills and aches and slight tenderness to touch over injection site.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pyrexia
Clinical narrative: The evening of the 12th, employee started to experience fever, chills, sweatiness, lightheaded, nausea and abdominal cramping (Tylenol was taken that night). Next morning felt lightheaded, aches and pains, nausea (employee did not eat either that morning or night before) Ibuprofen was taken and felt better on her stomach without food. Sore throat for one week. Unable to swallow food or water. Employee not very hydrated. Redness and soreness to injection site first three days. Employee mentioned continued fevers, sore throat, body chills and aches and slight tenderness to touch over injection site.