chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Discomfort, Joint range of motion decreased, Middle insomnia, Musculoskeletal stiffness
Clinical narrative: My doctor administered the shot and that evening I begun with severe arm pain, soreness and discomfort. Included in this was the inability to have full range of movement in my shoulder. The pain woke me up at night. The soreness and lack of movement kept me from being able to workout. The constant pain lasted up until December. Thought I do not have constant pain anymore, I still do not have full range of motion in my shoulder and when I do try to move it fully, I feel pain, soreness and stiffness. This has definitely been a burden as I can not resume normal workout activities.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: My doctor administered the shot and that evening I begun with severe arm pain, soreness and discomfort. Included in this was the inability to have full range of movement in my shoulder. The pain woke me up at night. The soreness and lack of movement kept me from being able to workout. The constant pain lasted up until December. Thought I do not have constant pain anymore, I still do not have full range of motion in my shoulder and when I do try to move it fully, I feel pain, soreness and stiffness. This has definitely been a burden as I can not resume normal workout activities.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Hypoaesthesia, Laboratory test, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Progressive tingling/numbness in lower extremities after receiving 2016 Influenza Vaccine. Occasional tingling in hands as well. Still continues.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 15-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 months infant of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 03-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 months old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2016 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 30-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 03-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Sex: F
Vaccine: HPVX
Symptoms: Ill-defined disorder
Clinical narrative: Information was identified on a social media page, from a female patient of unknown age. On an unknown date, the patient was vaccinated with an unspecified human papillomavirus vaccine (manufacturer, lot number, number of doses, dosage, and route of administration not provided). The text of post was as follows: "This vaccine ruined my life. Stay far, far away!"  No further adverse event was reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Seroconversion test negative
Clinical narrative: Information was received on 12-JAN-2017 from a medical assistant regarding a 68 year old female. Medical history/concurrent conditions included penicillin allergy. Concomitant medications were not reported. On an unspecified date the patient received VARIVAX (unknown lot number and expiration date). On an unspecified date after administration of VARIVAX the patient reported "negative seroconversion after titers were drawn." On an unspecified date after the "titers were drawn", the patient received ZOSTAVAX (unknown lot number and expiration date). The outcome of  "negative seroconversion after titers were drawn"  was not provided.  The reporter did not rate the causal relationship. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 20 patients of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with an improperly stored ROTATEQ, oral (dose, strength, and frequency were not provided), lot # reported as M025571 and expiration date 19-JAN-2018 for prophylaxis. The reporter stated that the temperature range  of the vaccine  was 0 Celsius (C) and 2 Celsius (C), the time frame was 15 hours and 42 minutes, also stated that there was no previous temperature excursion, 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-009507513-1701USA013142: US-009507513-1701USA013143:
Age: 53.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt recieved Zostavax in the right arm and 4-5 days later developed a red rash below her right breast, pt states the rash is only painful while wearing a bra, but it had not cleared up 2 weeks later. Counseled pt to seek medical attention as it may be a shingles outbreak.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Headache, Nausea, Poor quality sleep, Pyrexia
Clinical narrative: Thursday: I felt very tired especially in the afternoon. Headache started in the evening. Bad sleeping due to headache and nauseas. No fever. Tylenol extra strength and Paracetamol 1000mg to decrease the pain and nausea from Thursday night.  Friday: Strong headache and nauseas all day long. Low fever in the morning 37.5  Saturday: Headache decrease during the day as well as nauseas. Good sleeping. No fever.
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Chills, Feeling cold, Headache
Clinical narrative: Patient stated chills, feels very cold, back pain and head chills.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Swelling of injection site, pruritus extending down the arm - patient returned after a week, was given diphendyramine (take two when she got home) and event cleared within 36 hours.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Eye swelling, Fatigue
Clinical narrative: Sudden onset of a cough, fatigue and eyes swelling and difficulty breathing approx. 4 hrs. after vaccine administered.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Autoimmune disorder, Blood test, Depression, Postural orthostatic tachycardia syndrome
Clinical narrative: AUTO IMMUNE DISEASE, POTS SYNDROME, ANXIETY/DEPRESSION.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Began with fever and rash that resembled chicken pox rash.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 09-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number L040415, expiration date 13-APR-2017 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 23 month old White male patient with no illness at the time of vaccination. No information about the patient's medical history or concurrent conditions. The patient was not taking any concomitant medications. On 04-NOV-2016 at 04:45 pm, the patient was vaccinated with the first dose of M-M-R II injection, (lot # M010426), intramuscularly in the right thigh, for prophylaxis (strength, expiration date and frequency were not provided). The patient had none relevant diagnostic tests and laboratory data performed. This is one of two reports from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 24-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis. The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot number M031568, expiration date 24-DEC-2017 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 19-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 19-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 23-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013091: US-009507513-1701USA013090: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 24-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013082.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On 26-JAN-2017, the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # L024129 with expiration date: 21-JAN-2017 (route, strength and dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. There was no previous temperature excursions reported or product quality complaint (PQC) involved. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Vomiting 5 times at 8:30PM, 9:30PM; 10:30PM, 10:45PM and 11:15PM. No further symptoms after woke at 7AM the next morning.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Aphasia, Computerised tomogram head, Confusional state, Drooling, Electroencephalogram
Clinical narrative: BILATERAL FACIAL SWELLING, NON VERBAL, DROOLING, CONFUSED, HOLDING HER HEAD, ALTERED MENTAL STATUS; HOSPITALIZATION TWICE OVERNIGHT ONCE ON 01/26/2017 AND AGAIN ON 1/28/2017.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Head discomfort, Mental status changes, Nuclear magnetic resonance imaging, Swelling face
Clinical narrative: BILATERAL FACIAL SWELLING, NON VERBAL, DROOLING, CONFUSED, HOLDING HER HEAD, ALTERED MENTAL STATUS; HOSPITALIZATION TWICE OVERNIGHT ONCE ON 01/26/2017 AND AGAIN ON 1/28/2017.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Chief complaint of redness, swelling, and itching.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Rash pruritic
Clinical narrative: The day following the injections, 01/24/2017 client noticed pain, redness and some swelling around injection sites (bilateral deltoids). Mother provided Ibuprofen for comfort.  The following day, 01/25/2017 approx. mid day, client began to develop rash from just below shoulder, down to approx. 2 inches above elbow bilaterally.  Rash has been itchy.  mom has treated with OTC anti-itch cream (unknown brand)with minimal improvement.  Rash still remains 8 days after vaccination.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injection site abscess, Injection site pain, Injection site rash, Injection site swelling, Rash pruritic
Clinical narrative: The day following the injections, 01/24/2017 client noticed pain, redness and some swelling around injection sites (bilateral deltoids). Mother provided Ibuprofen for comfort.  The following day, 01/25/2017 approx. mid day, client began to develop rash from just below shoulder, down to approx. 2 inches above elbow bilaterally.  Rash has been itchy.  mom has treated with OTC anti-itch cream (unknown brand)with minimal improvement.  Rash still remains 8 days after vaccination.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Redness and bruising at injection site. Extreme pain and inability to put pressure on the leg that was injected.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Body temperature increased, Oropharyngeal pain, Rash generalised
Clinical narrative: Mother states child developed generalized rash, temp ~100 f, sore throat and states this is related to Dtap and Hep A vaccination 1/24/17.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RVX
Symptoms: Dry skin, Eczema, Melanocytic naevus
Clinical narrative: Dry and rough skin patches developed on legs and arms; mole developed on arm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Eczema, Injection site dryness, Injection site reaction, Rash erythematous
Clinical narrative: Erythematous raised dry red patches to interior thighs on day 2, continued to spread to posterior thighs over next few days, peak severity and distribution of rash on 1/31/17. No fevers, no other symptoms. The appearance of the rash, the timeline and family history favors eczema but given timing of outbreak, wanted to report. No treatment other than topical hydrocortisone was prescribed. Will monitor for improvement.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site, tenderness, red.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Bowel movement irregularity, Constipation, Crying, Decreased appetite
Clinical narrative: Baby slept mostly from the time the vaccine was administered until about 6:00 PM the next day. At 6:00 PM she started crying and wouldn't stop for hours on end. She didn't poop until 12/28/2016, then again on 01/02/2017. Since then she goes two or three days between each bowel movement. Since 12/24/2016 she has been in extreme pain when she passes gas, she goes through hours of uncomfortable crying. The first few days she wasn't eating as much and it was hard to get her to sleep, and hard to wake her up from sleep to try and feed her. On 01/22/2017 she pooped and had been pooping 1-3 times a day until 01/28/2016, passing gas is no longer as painful for her as it was following the vaccine. She seems to be as happy as she was before the vaccine. For treatment I rubbed her belly a lot, gave her probiotic gripe water once or twice a day through a bottle for two weeks.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Discomfort, Flatulence, Insomnia, Somnolence
Clinical narrative: Baby slept mostly from the time the vaccine was administered until about 6:00 PM the next day. At 6:00 PM she started crying and wouldn't stop for hours on end. She didn't poop until 12/28/2016, then again on 01/02/2017. Since then she goes two or three days between each bowel movement. Since 12/24/2016 she has been in extreme pain when she passes gas, she goes through hours of uncomfortable crying. The first few days she wasn't eating as much and it was hard to get her to sleep, and hard to wake her up from sleep to try and feed her. On 01/22/2017 she pooped and had been pooping 1-3 times a day until 01/28/2016, passing gas is no longer as painful for her as it was following the vaccine. She seems to be as happy as she was before the vaccine. For treatment I rubbed her belly a lot, gave her probiotic gripe water once or twice a day through a bottle for two weeks.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: Mother called 1/30/17 and stated that patient had complaints of tiredness and achy legs. She stated that she had "no energy."
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Body temperature increased, Malaise, Nausea, Septic shock
Clinical narrative: Had the injection early AM, by 2:00 pm feeling ill BP dropped increased temp nausea called 911 and was transported to hospital.
Age: 57.0
Sex: U
Vaccine: FLU4
Symptoms: Mass, Neuritis, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Had my flu vaccine Oct. 7, 2016, and had TB shot the same day the next day my left arm swollen, had lumps, pain, tingling and nerve on my left arm was inflamed. I was prescribed Methylprednisolone 4 mg on 11/15. On 11/30/16 ER. Prescribed Prednisone 20mg and Tramadol 50mg for pain. On 11/28/16 prescribed 3 times a day.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL, DTAP, HEPA, VARCEL
Symptoms: Rash
Clinical narrative: Patient presented skin rash after about twenty minutes. Prior Hep A, Varicella, DAPTACEL.
Age: 35.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain
Clinical narrative: Flu shot given in left arm. Pain ever since, cannot use arm in full range of motion without pain.
Age: 35.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Flu shot given in left arm. Pain ever since, cannot use arm in full range of motion without pain.
Age: 2.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Administered the Tdap instead of the DTaP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site warmth
Clinical narrative: Red, warm, round place on arm where vaccine was administered. Patient stated that this area itches.
Age: 56.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Swelling
Clinical narrative: Swelling, chills, exhausted left arm pneumonia vacc.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Patient states received flu vaccine 9-26-2016 states still having pain in area that goes down arm when she reaches out.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient's husband came to the pharmacy today and reports that after administration of ZOSTAVAX on 1/28/17. She is now experiencing pain and a red rash at the injection site and it is warm to the touch.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Dr. wrote a prescription for PREVNAR 13. I administered vaccine on 10/21/16. Patient came back on 11/18/16 for PNEUMOVAX and stated she has sore arm from the 1st vaccination. I advised her about potential side effect with the vaccination. Patient came back on 1/28/17 and states she is still having a sore arm. Her Dr. told her to take Ibuprofen but no improvement.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL, HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt given VARICELLA vaccine 1/30/2017 and developed an oblong shaped (3cm x 5cm) indurated area of redness at site of injection within 24 hours of injection. No treatment necessary.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: 3 days after PREVNAR injection patient developed red swelling a few inches from the injection site - red, swollen, warm to touch. Pt. saw MD today 1-31-2017 and determined infection likely due to vaccine. Treated with cephalexin. Vaccine given at Pharmacy - pt. followed up with PCP regarding arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Arthralgia
Clinical narrative: Joint pain, gave Ibuprofen.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fall, Mouth injury, Suture insertion
Clinical narrative: After the HPV was administered pt fell forward from the exam table causing her to injury her mouth. Stitches were applied by physician and than pt was sent to her family dentist for further evaluation.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of MEACTRA given to patient - no adverse reaction.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: (R) arm edema and erythema 4 cm diameter-local rxn. 103.6 fever.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Laboratory test, Nausea, Vomiting
Clinical narrative: Patient got immunization about 9:49 A. 1/30/17. Had lunch and dinner. About 45 min. after dinner, was at funeral and sudden onset nausea and then vomited. Vomited numerous times during eve and night. Next AM felt nauseous, weak. Mother called to inform us.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Inconsolable crying for 5 days.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Vaccines given appropriate for age and catch up schedule. Patient suffered febrile seizure early morning ambulance transfer to Emergency Department.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Reaction to preservatives
Clinical narrative: Initial unsolicited report received from a Pharmacist on 23 January 2017. This case involves a patient who (onset age and gender was not reported) was vaccinated with dose of FLUZONE (batch number: U2493AA, expiry date: 30-JUN-2008, dose and dose in series were not reported) in an unknown site on an unknown date of 2007. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination were reported as unknown by reporter. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date of 2007, following the vaccination, the patient had developed reaction as the FLUZONE had preservatives. The patient required emergency room (ER)/ doctor visit was not reported. Laboratory investigations were not reported. Corrective treatment was reported as unknown. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLUX, HEP, TDAP
Symptoms: Local swelling, Myalgia, Neck mass, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2015US162554, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 572746) website on 24 Nov 2015. This report refers to a 50 years old female patient. Past medical history was not reported. Concomitant medications included as levothyroxine (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm on 24 Dec 2014. The patient also vaccinated with first dose of ENGERIX-B (manufacturer and batch number: not reported) into left arm, intramuscularly on 24 Dec 2014 at 13:00 pm along with received Tdap (manufacturer and batch number: not reported) into left arm, intramuscularly on 24 Dec 2014. On the same day after vaccination, the patient experienced local swelling, neck pain and pain in arm, muscles became sore, felt a ball at the back of her neck (or top of spine) and it was also sore. It was stated that, felt like all the medicine from the ENGERIX-B went straight to her neck. The patient told the office about being sore and they told her that was normal. The outcome of pain in arm was reported as complete recovery on an unknown date in Jan 2015 and events, local swelling, neck pain and muscles became sore was reported as condition unchanged. The seriousness of the events was reported as non-serious. The causality of pain in arm and local swelling as suspected and events, muscles became sore and neck pain was not reported. See case US2015GSK043727.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased
Clinical narrative: Case number PHHY2015US163584, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 574252) website on 24 Nov 2015. This report refers to a 2-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On an unknown date the patient experienced little temperature. The outcome of the events was reported as unknown and seriousness was reported as non serious and causality was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Case number PHHY2015US162031, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 587177) website on 24 Nov 2015. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. After vaccination, the patient experienced a bad severe reaction to a flu vaccine a few years ago. The outcome of the event was not reported. Seriousness of the event was reported as non serious and causality not reported.
Age: 1.0
Sex: U
Vaccine: FLUX, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Injection site rash
Clinical narrative: Case number PHHY2015US162660, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 587445) website on 24 Nov 2015. This report refers to a 01-year-old patient of an unknown gender. Past medical history and concomitant medication were not reported. The patient who was 01 years old was inadvertently vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), VARIVAX ((manufacturer unknown), batch number: not reported) both into left leg and MMR II ((manufacturer unknown), batch number: not reported) in to right leg all on 08 Oct 2015. On the same day after vaccination, the patient developed a pretty impressive rash where the MMR II injection was given (in the right leg). The outcome of the event was reported as unknown. Seriousness of the event was reported as non serious and causality not reported.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Case number PHHY2015US163393, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 587520) website on 24 Nov 2015. This report refers to a 37-year-old female patient. Past medical history was not reported. Past medications included acetylsalicylic acid (manufacturer unknown), penicillin (manufacturer unknown), ibuprofen (manufacturer unknown), indomethacin (manufacturer unknown) and iodine (manufacturer unknown). Concomitant medication included SYNTHROID. The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date in 2012. After vaccination, the patient experienced unspecified adverse events. Outcome, seriousness and causality of the events were not reported.