chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 25 July 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). The subject's last menstrual period was on 06 January 2014 and estimated date of delivery was on 13 October 2014. The type of conception was normal. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 10 October 2014 from nurse: The VAERS details and some of the patient's details were provided. Follow-up information received on 30 October 2014 from nurse: No new infor provided.
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from Pfizer Inc via a pharmacist refers to a 60 year old patient of unknown gender. It was reported a patient took PNEUMOVAX 23 a year ago. The patient was supposed to receive PREVNAR 13 a year later but instead the patient received a second PNEUMOVAX 23 injection. It was reported a physician (relationship to patient unspecified) was aware that this has occurred. "The caller wanted to know what is the interval when PREVNAR 13 should be given? The caller was informed that we have ACIP guidelines for the interval to give PNEUMOVAX 23 but we don't have guidelines following receipt of two doses of PNEUMOVAX 23. The caller was informed that we would forward this inquiry to our product team as an urgent request and that they would follow up by phone." Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 39 year old male patient. Patient medical history and current condition was not reported. On an unspecified date in November-2013 the patient was vaccinated with the first dose of RECOMBIVAX HB (strength, dose and frequency not reported), the second dose on an unspecified date in November-2014 and the third dose in approximately 2014 (reported as a few days ago). No adverse effects were reported. The outcome of the event was unknown. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 50 year old female patient with no pertinent medical history or drug reactions/allergies. On 20-NOV-2014 the patient was vaccinated with ZOSTAVAX lot # K007986, expiration date 03-SEP-2015 (dose, frequency and route of administration were not reported). Concomitant medication included COUMADIN. On 21-NOV-2014, the patient experienced red, swollen and sore localized reaction at the injection site. There was no treatment given for the adverse event. No lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of red, swollen and sore localized reaction at the injection site was reported as recovering. The relatedness between red, swollen and sore localized reaction at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Erythema, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Sensation of fever, chills, sore arm, redness, fatigue, flu-like symptoms, local tenderness and erythema.
Age: 35.0
Sex: M
Vaccine: TYP
Symptoms: Pyrexia, Tenderness
Clinical narrative: Sensation of fever, chills, sore arm, redness, fatigue, flu-like symptoms, local tenderness and erythema.
Sex: U
Vaccine: PPV
Symptoms: Circumstance or information capable of leading to medication error, Drug ineffective
Clinical narrative: This spontaneous report as received from a pharmacist via Market Research refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX 23 (lot#, expiration date, dose, route and site of administration were not reported). The reporter stated, that data was lacking for efficacy in preventing infections. It was reported that PNEUMOVAX 23 was removed from hospital core measures. The patients were getting multiple vaccinations (dates unspecified) due to poor medication histories. The outcome of adverse events was unknown. The relatedness between adverse events and PNEUMOVAX 23 was not reported. Additional information is not expected as the reporter was not willing for the Pharmaceutical company's safety team to contact them to discuss further.
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information was received from a pharmacist reporting on his father (age unknown) via another pharmaceutical company (manufacturer report #2014309969). The pharmacist reported that on an unknown date, his father was incorrectly "dispensed PNEUMVOAX23" rather than the PREVNAR 13 and the pharmacy did not know how to remedy the situation. Pharmacist believed there was a protocol that calls for dispensing PREVNAR 13 first. Additional information is not expected.
Age: 0.53
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager via company representative refers to a 6 month old patient. On 04-DEC-2014 the 6 month old patient was inadvertently vaccinated with PNEUMOVAX 23 (dose and lot number was unknown). No adverse effects were reported. No product quality complaint was involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant concerning multiple unspecified patients, who on unknown dates, were vaccinated with PEDVAXHIB that were exposed to temperatures outside of recommended condition. No adverse events were reported. No further information was provided. This is one of four reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Erythema, Nausea, Rash pruritic, Vomiting
Clinical narrative: Symptoms in this area: red, dotted, close together, itchy rash. Across shoulders that spread down arms and trunk. Nausea and vomiting. Painful joints. Fever 101-102. Went to urgent care. Given course of prednisone. Took BENADRYL and TYLENOL.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The physician reported that the patient received first dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) at age 17 (exact date unspecified), the second dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) (exact date unspecified, reported as 8 years later) and was in the office by that time, on 18-DEC-2014 to receive the third dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported). No adverse reaction reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue
Clinical narrative: Information was received from a pharmacist concerning a patient of unknown age and gender. On 28-NOV-2014, the patient was vaccinated with ZOSTAVAX, subcutaneously. On 28-NOV-2014, while administering the vaccine, the pharmacist noticed that the syringe leaked, resulting in an unknown dosage amount. No adverse experience reported. No further information provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 15 September 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route and injection site). Her last menstrual period was on 11 February 2014 and estimated date of delivery was on 10 November 2014. The subject was exposed to the vaccines during the last trimester when she was 32 weeks pregnant. The conception was a normal one (no in-vitro fertilization used). No adverse events were reported. At the time of reporting the pregnancy was ongoing. Follow-up information received on 06 October 2014 from nurse: The VAERS details and some of the patient's details were provided.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 15 July 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 17 November 2013 and estimated date of delivery was on 10 September 2014. The subject was exposed to the vaccines during the last trimester. The conception was a normal one (no in-vitro fertilization used). No adverse event were reported. At the time of reporting the pregnancy was ongoing.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 26-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 19 May 2014 the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular). The subject's last menstrual period date was on 28 October 2013 and her estimated date of delivery was on 12 August 2014. The subject was exposed to the vaccine during her third trimester of pregnancy. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 06 October 2014 from nurse: The VAERS details were provided. This was a normal conception. Some of the patient's details were provided. On 10 August 2014, 83 days after the vaccination with BOOSTRIX, the subject gave birth to a male live infant, by normal vaginal delivery. This was a full-term pregnancy. The infant had an Apgar score of [8-9], a weight of 8 1.3lb, a height of 21 inches, a cranial circumference of 14 inches.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 11 July 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 16 December 2013 and estimated date of delivery was on 22 September 2014. The subject was exposed to the vaccines during the last trimester. The conception was a normal one (no in-vitro fertilization used). No adverse events were reported. At the time of reporting the pregnancy was ongoing. Follow-up information received on 06 October 2014 from nurse: Some of the patient's details were updated. On 09 September 2014, after 38/7 weeks gestation, the patient gave birth to a live infant, by normal vaginal delivery. The infant had an Apgar score of [9-9], a weight of 8 14.0 lb, a height of 20 inches, a cranial circumference of 13 3/4 inches.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 22-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 10 September 2014, the subject received a dose of BOOSTRIX (intramuscular, administration site unknown). Her last menstrual period was on 12 February 2014 and estimated date of delivery on 19 November 2014. The subject was exposed to the vaccine during the third trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 06 October 2014 from nurse: The VAERS details were provided. This was a normal conception. Some of the patient's details were provided.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mass, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient had vaccine on 12/17/14. Reports on 12/18/14 her arm felt sore, slight swelling. Normal side effects. On 12/19/14 reports hard lump redness and warmth not at site of injection but about 3 inches below site all the way around arm.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Mouth swelling, Pain in extremity, Paraesthesia, Rash generalised
Clinical narrative: Reports that after shot was administered her arm was aching; she then developed rash on arm and body. Subsequent mouth swelling - all which are ongoing. On 12/6 reported (L) arm tingling - PCP and cardio says she is OK.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The reporter stated that on 19-NOV-2014 the patient was vaccinated with both (Merck) VARIVAX, 0.5 ml, subcutaneously, (strength, anatomical location, lot number and expiration date were not reported), and (Merck) PROQUAD 0.5 ml, subcutaneously, (strength, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood creatine phosphokinase increased, C-reactive protein increased, Electrocardiogram normal, Injection site swelling, Muscular weakness
Clinical narrative: Information has been received from a pharmacist concerning a 75 year old male patient with lung cancer who on an unspecified date was vaccinated with pneumococcal vaccine (MSD) injection subcutaneously, (lot number, vaccinated date, dose not reported). Other concomitant therapies included Influenza virus vaccine (manufacture unknown). On an unspecified date, in Hospital, the patient was vaccinated with PNEUMOVAX NP, subcutaneous and influenza vaccine at the same time. On an unspecified date, the patient went to the Hospital at first and he was hospitalized for only one day there. At that time, as creatinine phosphokinase (CPK) increased to around 20000 (the patient developed CPK increased), the patient was transferred to the reporter's hospital where the lung cancer was treated. On an unspecified date (about 3 days after vaccination), injection site swelling was found. When the blood test was performed, the patient was found that CPK decreased to 15830, C-reactive protein (CRP) was 17.6 (the patient developed CRP increased), white blood cell was 17700 (the patient developed white blood cell increased), procalcitonin and troponin T were positive, and pyrexia of 40 degree centigrade, so he was hospitalized. On unspecified date, the patient obtained an electrocardiogram for inquiring heart diseases such as cardiac infarction etc., but no special cardiogenic lesion was found. On an unspecified date, the patient developed weakness of the extremities. There was no strength of the whole body's muscle. When he lay down, he was unable to get up. About the injection site, compared with the site of influenza vaccine, the site of pneumococcal vaccine was more considerably swollen. On an unspecified date, the patient was on the way to recovering gradually (the patient was recovering from the injection site swelling, CPK increased, CRP increased, white blood cell increased, procalcitonin positive, troponin T positive, pyrexia and weakness of the extremities). The reporter's comment: the adverse effects which were occurred seriously may be caused by simultaneous inculcation, but the level of CPK value was considerably high. The reporting pharmacist considered that the CPK increased, CRP increased, while blood cell increased, procalcitonin positive, troponin T positive and pyrexia were serious due to hospitalization. The reporting pharmacist did not assess the seriousness of the injection site swelling and weakness of the extremities. The reporting pharmacist did not assess the relationship of injection site swelling, CPK increased, CRP increased, white blood cell increased, procalcitonin positive, troponin T positive, pyrexia and weakness of the extremities to pneumococcal vaccine. Additional information was not expected as the reporter did not wish to be contacted.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Procalcitonin increased, Pyrexia, Troponin T increased, White blood cell count increased
Clinical narrative: Information has been received from a pharmacist concerning a 75 year old male patient with lung cancer who on an unspecified date was vaccinated with pneumococcal vaccine (MSD) injection subcutaneously, (lot number, vaccinated date, dose not reported). Other concomitant therapies included Influenza virus vaccine (manufacture unknown). On an unspecified date, in Hospital, the patient was vaccinated with PNEUMOVAX NP, subcutaneous and influenza vaccine at the same time. On an unspecified date, the patient went to the Hospital at first and he was hospitalized for only one day there. At that time, as creatinine phosphokinase (CPK) increased to around 20000 (the patient developed CPK increased), the patient was transferred to the reporter's hospital where the lung cancer was treated. On an unspecified date (about 3 days after vaccination), injection site swelling was found. When the blood test was performed, the patient was found that CPK decreased to 15830, C-reactive protein (CRP) was 17.6 (the patient developed CRP increased), white blood cell was 17700 (the patient developed white blood cell increased), procalcitonin and troponin T were positive, and pyrexia of 40 degree centigrade, so he was hospitalized. On unspecified date, the patient obtained an electrocardiogram for inquiring heart diseases such as cardiac infarction etc., but no special cardiogenic lesion was found. On an unspecified date, the patient developed weakness of the extremities. There was no strength of the whole body's muscle. When he lay down, he was unable to get up. About the injection site, compared with the site of influenza vaccine, the site of pneumococcal vaccine was more considerably swollen. On an unspecified date, the patient was on the way to recovering gradually (the patient was recovering from the injection site swelling, CPK increased, CRP increased, white blood cell increased, procalcitonin positive, troponin T positive, pyrexia and weakness of the extremities). The reporter's comment: the adverse effects which were occurred seriously may be caused by simultaneous inculcation, but the level of CPK value was considerably high. The reporting pharmacist considered that the CPK increased, CRP increased, while blood cell increased, procalcitonin positive, troponin T positive and pyrexia were serious due to hospitalization. The reporting pharmacist did not assess the seriousness of the injection site swelling and weakness of the extremities. The reporting pharmacist did not assess the relationship of injection site swelling, CPK increased, CRP increased, white blood cell increased, procalcitonin positive, troponin T positive, pyrexia and weakness of the extremities to pneumococcal vaccine. Additional information was not expected as the reporter did not wish to be contacted.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Deafness unilateral, Ear irrigation
Clinical narrative: Left ear slight hearing loss. Tried irrigating ear and put sweet oil and chewed gum.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ear congestion
Clinical narrative: Left ear slight hearing loss. Tried irrigating ear and put sweet oil and chewed gum.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: PER PATIENT, THE PATIENT HAD A LOCALIZED REACTION TO THE SUBQ IMMUNIZATION OF ZOSTAVAX. PAINFUL AND SWOLLEN. THE PATIENT WENT TO THE DOCTOR AND RECEIVED A MEDROL DOSE PACK.
Age: 31.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Rash inside both palms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Pt developed cellulitis at site of injection.  Md diagnosed and prescribed cephalexin.
Age: 0.77
Sex: F
Vaccine: FLUX, HEP
Symptoms: Cough, Decreased appetite, Dyspnoea, Irritability, Lethargy
Clinical narrative: Fever, runny nose, coughing, congestion, wheezing, gasping for air when coughing, no appetite, lethargic, fussy. We notified the office on 12/19/2014 @ 1:41PM and we were told to keep her hydrated and comfortable by the nurse on call. The nurse also told us not to bring her in and to call the doctor on call on 12/21/2014 to update the office on her status.
Age: 0.77
Sex: F
Vaccine: FLUX, HEP
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, Wheezing
Clinical narrative: Fever, runny nose, coughing, congestion, wheezing, gasping for air when coughing, no appetite, lethargic, fussy. We notified the office on 12/19/2014 @ 1:41PM and we were told to keep her hydrated and comfortable by the nurse on call. The nurse also told us not to bring her in and to call the doctor on call on 12/21/2014 to update the office on her status.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Injection site pain, Pyrexia
Clinical narrative: Chills and low fever with intense aching of injection area of the left arm. Symptoms worsened through the next 12 hours with temperature climbing to 101.3 degrees and resistant to Tylenol treatment. Other symptoms developed over first night to include severe headache and dizziness. Temperature subsided within 12 hours, but other symptoms persisted for another 24 hours. Total adverse event lasted a little over 48 hours.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus, Rash
Clinical narrative: Burning, itching, rash, blisters.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Injection site pain, Pain, Swelling
Clinical narrative: Burning during vaccination.  Almost immediate swelling and hot.   Used ice pack only. Still red circle and sore 12/20/2014.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Red rash 2 and 1/2 inches in diameter around the injection area.  The rash was swollen and warm/hot to the touch.   It lasted for a few days but did start to go down once I took Advil and put cortisone cream on it.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Influenza like illness, Myalgia, Pain, Pain in extremity
Clinical narrative: Patient states initially muscle soreness and mild flu-like symptons and slightly red and hot on evening after administered.  Within next few weeks and currently the arm is sore and achy and hurts with certain movements.  Has had previous hand and forearm nerve issue in same arm but did not feel this way "higher up" until received vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Patient states initially muscle soreness and mild flu-like symptons and slightly red and hot on evening after administered.  Within next few weeks and currently the arm is sore and achy and hurts with certain movements.  Has had previous hand and forearm nerve issue in same arm but did not feel this way "higher up" until received vaccine.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Accelerated hypertension, Condition aggravated, Epistaxis, Vision blurred
Clinical narrative: Accelerated HTN, nosebleed, blurry vision x 5 days.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Lump, redness, and pain at site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Very itchy rash developed first on left hand and then on right hand. Washed 3-4 times per day and applied topical hydrocortisone, lasted 3-4 days.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed swollen area around injection site along with red streaks and was painful. Was prescribed antibiotic which cured infection.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Demyelination, Laboratory test abnormal, Neuropathy peripheral
Clinical narrative: Within 30 day neuropathy admitted to shock trauma.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis. Cephalexin 125mg/5ml - 5ml every 8 hrs x 10 days.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Lethargy, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 6-month-old female subject who was vaccinated with PEDIARIX, (GlaxoSmithKline) and DAPTACEL (non-GSK). On an unspecified date, the subject received an unspecified dose of PEDIARIX (unknown route and injection site, batch number not provided). On the same day, the subject also received an unspecified dose of DAPTACEL (unknown route and injection site) instead of Hib vaccine which led to an overdose for DTPa antigens. At an unspecified time after vaccination with DAPTACEL and PEDIARIX, the subject experienced fever and lethargy. After 48 hours, the events were resolved. The physician considered the events were possibly related to vaccination with PEDIARIX and DAPTACEL.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Diet refusal, Pyrexia, Screaming
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of high fever in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On 29 July 2014, the subject received 1st dose of PEDIARIX (.5 ml, unknown route, injection site and batch number). On an unspecified date in 2014, less than one week after vaccination with PEDIARIX, the subject experienced high fever (102 F), was screaming and did not want to eat. On 04 August 2014, the child started to eat. At the time of reporting, the outcome of the other events was unspecified. No more information was available.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site abscess sterile
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sterile abscess at injection site in a male subject of unspecified age who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included DTAP, hepatitis B recombinant and IPV (GlaxoSmithKline) unspecified dose give at 2 months of age. On an unspecified date, at 4 months of age, the subject received unspecified dose of PEDIARIX (unknown route, unknown lot number). At an unspecified time after vaccination with PEDIARIX, the subject experienced sterile abscess at injection site. After the next vaccination with PEDIARIX the events recurred. On an unspecified date, at 6 months of age, the subject received unspecified dose of PEDIARIX (unknown route, unknown lot number). At an unspecified time after vaccination with PEDIARIX, the subject experienced sterile abscess at injection site. At the time of reporting the events were resolved. The subject received DAPTACEL (Non-GSK) for the following dose. This was of 4 cases reported by the same nurse.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 101 on and off for 5 days. Rash on stomach and face.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Erythema, Headache, Injection site erythema, Injection site pain
Clinical narrative: Injection site red swollen painful. Hurt to have my arm touching the surface if the bed. By Thursday AM 12/18/2014 woke with very bad headache. Arm painful more swollen and red. Soreness and swelling spreading further down my arm. Nausea body aches  chills. Took 600 MG Motrin and went back to bed around 12:30 pm. Friday felt better but rash/redness still getting larger. Started to itch. Today Saturday 12/20/14 soreness, redness, swelling, itching continues to spread down into the for arm. Can't really scratch because it hurts to touch just rub it. It alternates between pain, tingling, and itching. Sight and the red swollen area is her dish to touch.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Injection site red swollen painful. Hurt to have my arm touching the surface if the bed. By Thursday AM 12/18/2014 woke with very bad headache. Arm painful more swollen and red. Soreness and swelling spreading further down my arm. Nausea body aches  chills. Took 600 MG Motrin and went back to bed around 12:30 pm. Friday felt better but rash/redness still getting larger. Started to itch. Today Saturday 12/20/14 soreness, redness, swelling, itching continues to spread down into the for arm. Can't really scratch because it hurts to touch just rub it. It alternates between pain, tingling, and itching. Sight and the red swollen area is her dish to touch.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Peripheral swelling, Pruritus, Rash, Tenderness
Clinical narrative: Injection site red swollen painful. Hurt to have my arm touching the surface if the bed. By Thursday AM 12/18/2014 woke with very bad headache. Arm painful more swollen and red. Soreness and swelling spreading further down my arm. Nausea body aches  chills. Took 600 MG Motrin and went back to bed around 12:30 pm. Friday felt better but rash/redness still getting larger. Started to itch. Today Saturday 12/20/14 soreness, redness, swelling, itching continues to spread down into the for arm. Can't really scratch because it hurts to touch just rub it. It alternates between pain, tingling, and itching. Sight and the red swollen area is her dish to touch.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Discomfort, Joint stiffness, Muscular weakness
Clinical narrative: Began feeling systemic body aches, stiffness in legs and hips, weakness in arms. Nausea and fever, chills by 6:30pm. Nausea, fever, chills subsided within 10 hours. Joint stiffness and aching in legs and hips continued for six weeks, however it was worsened by a severe, almost crippling pain through the left knee and what felt like the left calf and bone being crushed in a vice.  Doctor ordered x-rays of left leg and knee; came back inconclusive. My legs felt as though they were heavy boards and my feet were bricks. The discomfort was intense, and pain moving (especially coming down a set of stairs) was unbelievable. The discomfort seemed to run in waves ... it appeared to be improving a little after ten days or so for a day or two, then flared up for another 10 days or so. After about 5 weeks, the discomfort seems to have subsided in earnest, and has all but disappeared.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Began feeling systemic body aches, stiffness in legs and hips, weakness in arms. Nausea and fever, chills by 6:30pm. Nausea, fever, chills subsided within 10 hours. Joint stiffness and aching in legs and hips continued for six weeks, however it was worsened by a severe, almost crippling pain through the left knee and what felt like the left calf and bone being crushed in a vice.  Doctor ordered x-rays of left leg and knee; came back inconclusive. My legs felt as though they were heavy boards and my feet were bricks. The discomfort was intense, and pain moving (especially coming down a set of stairs) was unbelievable. The discomfort seemed to run in waves ... it appeared to be improving a little after ten days or so for a day or two, then flared up for another 10 days or so. After about 5 weeks, the discomfort seems to have subsided in earnest, and has all but disappeared.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Sensation of heaviness, X-ray limb
Clinical narrative: Began feeling systemic body aches, stiffness in legs and hips, weakness in arms. Nausea and fever, chills by 6:30pm. Nausea, fever, chills subsided within 10 hours. Joint stiffness and aching in legs and hips continued for six weeks, however it was worsened by a severe, almost crippling pain through the left knee and what felt like the left calf and bone being crushed in a vice.  Doctor ordered x-rays of left leg and knee; came back inconclusive. My legs felt as though they were heavy boards and my feet were bricks. The discomfort was intense, and pain moving (especially coming down a set of stairs) was unbelievable. The discomfort seemed to run in waves ... it appeared to be improving a little after ten days or so for a day or two, then flared up for another 10 days or so. After about 5 weeks, the discomfort seems to have subsided in earnest, and has all but disappeared.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Site of vaccine injection continues to be sore and painful.
Age: 63.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, pain, itching entire upper arm of injection site.  Treatment (self medicated) Tylenol 1000mg 4 times a day, Claritin antihistamine once a day, cold compresses. Still present today, 6 days after immunization.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Ear pain, Headache, Pruritus
Clinical narrative: Stabbing feeling in the ear, headache, shivers, arm bruised, itching legs.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever-102.  Sore throat, body aches-all over, harsh cough/congestion, severe headache. No current long term outcomes identified at this time.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: Fever-102.  Sore throat, body aches-all over, harsh cough/congestion, severe headache. No current long term outcomes identified at this time.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dysphonia, Malaise, Myalgia, Pain
Clinical narrative: Muscle aches in entire left arm from this date thru Sunday 3:45 PM, chills all day Sunday, Saturday morning hoarseness and wheezing. All day Sunday chills, body aches and basically feeling like crap.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Muscle aches in entire left arm from this date thru Sunday 3:45 PM, chills all day Sunday, Saturday morning hoarseness and wheezing. All day Sunday chills, body aches and basically feeling like crap.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Pruritus, Rash generalised, Tachycardia
Clinical narrative: Full body rash, itching, redness, tachycardia, shortness of breath. Cleared up within one hour after treatment with otc Benadryl.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Depression, Joint crepitation, Muscular weakness, Nervous system disorder
Clinical narrative: Muscle weakness, and nerve issues.  Lost all use of muscles holding in joints. Joints started to pop. Depression started.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Five to six minutes after receiving injection, a half dollar sized area appeared. It was swollen (no knot) and the area was red and itching. After an additional 10 minutes, redness had subsided and area did not itch.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pharyngeal oedema, Rash generalised, Urticaria
Clinical narrative: Severe allergic reaction - welts/hives/rash over entire body, ears and ear canals swelling - swelling of throat. Required EPIPEN shot and steroid shot and 12 days oral steroid Rx.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Seizure like phenomena
Clinical narrative: This case was reported by a consumer (mother of the subject) and described the occurrence of possible seizure in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk), PREVNAR 13 (non-gsk) and ROTATEQ (non-gsk). A physician or other health care professional has not verified this report. Concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given in December 2013. On 19 February 2014 at around 09:00 the subject received 2nd dose of PEDIARIX (.5 ml, unknown route, left thigh). On 19 February 2014, at an unknown time, the subject also received 2nd dose of ACTHIB (unknown details), 2nd dose of PREVNAR 13 (unknown details), 2nd dose of ROTATEQ (unknown details). On 19 February 2014, within hours of vaccination with ACTHIB, PREVNAR 13 and ROTATEQ, 9 hours after vaccination with PEDIARIX, the subject experienced possible seizure. The mother reported that "the doctors think her son had a seizure but they cannot verify it because he did not have any additional seizures at the hospital." The mother stated that the subject had a "possible reaction to PEDIARIX." The mother reported that the immunization series was not discontinued and it was unknown if the series was delayed. The subject was hospitalised. Relevant test results included: The mother reported that "the outcome as, the MRI (nuclear magnetic resonance imaging) and the EEG (electroencephalogram), showed the [subject] is fine." The physicians have planned a follow up EEG per the mother. The MRI and EEG tests were administered in February 2014 and a specific date was not reported. At the time of reporting the outcome of the event was unspecified.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by a consumer (mother of the subject) and described the occurrence of possible seizure in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk), PREVNAR 13 (non-gsk) and ROTATEQ (non-gsk). A physician or other health care professional has not verified this report. Concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given in December 2013. On 19 February 2014 at around 09:00 the subject received 2nd dose of PEDIARIX (.5 ml, unknown route, left thigh). On 19 February 2014, at an unknown time, the subject also received 2nd dose of ACTHIB (unknown details), 2nd dose of PREVNAR 13 (unknown details), 2nd dose of ROTATEQ (unknown details). On 19 February 2014, within hours of vaccination with ACTHIB, PREVNAR 13 and ROTATEQ, 9 hours after vaccination with PEDIARIX, the subject experienced possible seizure. The mother reported that "the doctors think her son had a seizure but they cannot verify it because he did not have any additional seizures at the hospital." The mother stated that the subject had a "possible reaction to PEDIARIX." The mother reported that the immunization series was not discontinued and it was unknown if the series was delayed. The subject was hospitalised. Relevant test results included: The mother reported that "the outcome as, the MRI (nuclear magnetic resonance imaging) and the EEG (electroencephalogram), showed the [subject] is fine." The physicians have planned a follow up EEG per the mother. The MRI and EEG tests were administered in February 2014 and a specific date was not reported. At the time of reporting the outcome of the event was unspecified.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Decreased appetite, Lethargy, Productive cough, Pyrexia
Clinical narrative: Child began spiking a temp, first noted to be 101.4. This has continued until current date of 12/22/2014. Tylenol will not bring fever down, ibuprofen at dose for weight of 22lbs will bring fever down to 99. Also began sneezing, thick phlegm and wheezing with cough. Child has croup like cough since admin of Nasal flu vaccine. Child not wanting to eat, drink. Slightly lethargic, when fever controlled child is more active and will take PO pedia-lyte or Popsicles. Will be seeing medical treatment on 12/22/2014 related to symptoms.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Sneezing, Wheezing
Clinical narrative: Child began spiking a temp, first noted to be 101.4. This has continued until current date of 12/22/2014. Tylenol will not bring fever down, ibuprofen at dose for weight of 22lbs will bring fever down to 99. Also began sneezing, thick phlegm and wheezing with cough. Child has croup like cough since admin of Nasal flu vaccine. Child not wanting to eat, drink. Slightly lethargic, when fever controlled child is more active and will take PO pedia-lyte or Popsicles. Will be seeing medical treatment on 12/22/2014 related to symptoms.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: When shot was administered it felt different from other flu shots I previous had. Felt the vaccine enter the arm and it was sore immediately following shot. Over the course of several days the soreness increased until I was unable to raise or lower my arm without severe pain. Went to see my doctor on 11-3-14. He prescribed prednisone. There was relief within 48 hours but after the final dose on the 5th day the pain returned daily increasing over the course of about two weeks to just about the same level. I called my doctor again and he prescribed another round of prednisone which I started on 12-4-14. Again within 48 hours there was some relief but the pain is now returning again but not yet to the same level as the week after the shot.
Age: 15.0
Sex: M
Vaccine: HEP, MMR, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Patient had likely syncope v. seizure post vaccines. Sent to ER where determined to be syncopal event.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Patient c/o of arm numbness after receiving vaccine. Numbness lasted for 1 week per patient.  Patient had second dose on 8/22/14 and pt reports he had numbness in entire arm x 1 week again.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chest discomfort, Dyspnoea, Full blood count, Infection
Clinical narrative: Went to ER evening of 12/13/14. Massive swelling, inflammation. Diagnosed with Cellulitus. Given oral antibiotics in ER. Sent home with prescriptions for pain, nausea and antibiotics which did not work. By 12/14/2014, rash and swelling continued to spread. On morning of 12/15/2014, rushed to ER with chest discomfort, shortness of breath. Admitted and transported by medical transport ambulance and admitted to hospital. From 12/15/2014 until discharge on 12/17, administered continuous IV antibiotics. At discharge last afternoon 12/17/14 was given prescriptions for Keflex and Bactrim. As of 12/22/2014 infection and swelling reduced 95%. Small knot still is at injection site.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site nodule, Rash, Swelling, Ultrasound scan
Clinical narrative: Went to ER evening of 12/13/14. Massive swelling, inflammation. Diagnosed with Cellulitus. Given oral antibiotics in ER. Sent home with prescriptions for pain, nausea and antibiotics which did not work. By 12/14/2014, rash and swelling continued to spread. On morning of 12/15/2014, rushed to ER with chest discomfort, shortness of breath. Admitted and transported by medical transport ambulance and admitted to hospital. From 12/15/2014 until discharge on 12/17, administered continuous IV antibiotics. At discharge last afternoon 12/17/14 was given prescriptions for Keflex and Bactrim. As of 12/22/2014 infection and swelling reduced 95%. Small knot still is at injection site.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Local swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 45-year-old male patient who received FLUARIX QUADRIVALENT (batch number MM773, expiry date 30th June 2015). On 28th October 2014, the patient received FLUARIX QUADRIVALENT (intramuscular). On an unknown date, the dose was an unknown dose. On 28th October 2014, 4 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced swelling arm (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the swelling arm was not recovered/not resolved. It was unknown if the reporter considered the swelling arm to be related to FLUARIX QUADRIVALENT. Additional information received: The pharmacist reports that a patient was given the flu vaccine on Tuesday, 28 October 2014. He received the vaccine on his left arm/left deltoid muscle. The patient started experiencing swelling on his right arm near the antecubital area about 4 hours after receiving the vaccine. The patient has not recovered from this event and is going to see the doctor today (31 October 2014).
Age: 26.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Agitation, Anxiety, Arthralgia, Arthritis, Blood cholesterol increased
Clinical narrative: Burning sensation, ache joints and bones, acid reflux, Agitation, Anxiety, arthritis, blood pressure high, high cholesterol, concentration, eyes, memory failure, difficulty, trouble remembering recent information, masturbation loss, migraine, insomnia, suicide attempt.
Age: 26.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Bone pain, Burning sensation, Disturbance in attention, Erectile dysfunction, Eye disorder
Clinical narrative: Burning sensation, ache joints and bones, acid reflux, Agitation, Anxiety, arthritis, blood pressure high, high cholesterol, concentration, eyes, memory failure, difficulty, trouble remembering recent information, masturbation loss, migraine, insomnia, suicide attempt.
Age: 26.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Gastrooesophageal reflux disease, Hypertension, Insomnia, Memory impairment, Migraine
Clinical narrative: Burning sensation, ache joints and bones, acid reflux, Agitation, Anxiety, arthritis, blood pressure high, high cholesterol, concentration, eyes, memory failure, difficulty, trouble remembering recent information, masturbation loss, migraine, insomnia, suicide attempt.
Age: 26.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Suicide attempt
Clinical narrative: Burning sensation, ache joints and bones, acid reflux, Agitation, Anxiety, arthritis, blood pressure high, high cholesterol, concentration, eyes, memory failure, difficulty, trouble remembering recent information, masturbation loss, migraine, insomnia, suicide attempt.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Blood immunoglobulin G increased, Central nervous system inflammation, Convulsion, Electroencephalogram
Clinical narrative: Oct 4 2012 received 3rd GARDASIL and one month later developed headaches, visual changes and seizures along with optic neuritis. MRI showed inflammation in Rt frontoparietal region with elevated IgG levels. Eval by neuro and immunology felt to be autoimmune inflammatory process.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Laboratory test, Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Visual impairment
Clinical narrative: Oct 4 2012 received 3rd GARDASIL and one month later developed headaches, visual changes and seizures along with optic neuritis. MRI showed inflammation in Rt frontoparietal region with elevated IgG levels. Eval by neuro and immunology felt to be autoimmune inflammatory process.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Joint range of motion decreased, Muscular weakness, Pain, X-ray normal
Clinical narrative: Sharp pain, "achiness", with discomfort that has not gone away. Muscle weakness with loss of range of motion. Physical therapy with massage.