chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were administered with doses of VARIVAX (Merck) (Lot # L001335, expiry date: 13-JAN-2017; lot # L001325, expiry date: 13-JAN-2017, lot # L005298, expiry date: 17-FEB-2017) which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of the six reports received from the same source (MARRS # 1506USA014028, 1506USA011037, 1506USA014024, 1506USA014026 and 1506USA014027). Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/ allergies were not reported. On unspecified dates, the patients were administered with doses of PROQUAD (Merck) (lot # K025760, expiry date: 08-JUN-2016; lot # K020747, expiry date: 30-APR-2016, lot # L002419, expiry date: 23-JUL-2016) which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of the six reports received from the same source (MARRS # 1506USA014028, 1506USA011037, 1506USA014025, 1506USA014026 and 1506USA014027). Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were administered with doses of RECOMBIVAX HB (Lot # L001441, expiry date: 17-AUG-2017) which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of the six reports received from the same source (MARRS # 1506USA011037, 1506USA014024, 1506USA014025, 1506USA014026 and 1506USA014027). Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditinos and drug reactions/allergies were not reported. On unspecified dates, the patients were administered with doses of GARDASIL (Lot # K010574, expiry date: 08-APR-2017; lot # J013326, expiry date: 12-FEB-2016; lot # K001500, expiry date: 06-NOV-2016; lot # K011138, expiry date: 08-APR-2017) which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of the six reports received from the same source (MARRS # 1506USA014028, 1506USA011037, 1506USA014024, 1506USA014025 and 1506USA014027). Additionnal information is not expected as the reporter did not wish further contact.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Autopsy, Death, Dizziness, Nausea, Resuscitation
Clinical narrative: Administered 08/22/2013. 08/24/2013 Nausea and Light Headed. 08/25/2013 Up at 6:30 am. Collapsed at 6:50 am. Found face down on floor holding back of neck with right hand other hand at side. Paramedics called administered chest compressions and two drugs. Pronounced Dead at Hospital at approx 9:00am. No trauma.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Toxicologic test
Clinical narrative: Administered 08/22/2013. 08/24/2013 Nausea and Light Headed. 08/25/2013 Up at 6:30 am. Collapsed at 6:50 am. Found face down on floor holding back of neck with right hand other hand at side. Paramedics called administered chest compressions and two drugs. Pronounced Dead at Hospital at approx 9:00am. No trauma.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Swelling face
Clinical narrative: Patient received shingles shot at pharmacy on 6/27/15 at 1 pm.  Patient was instructed to wait at least 20 minutes before leaving.  After 20 minutes, no problems were reported and patient left. Today 6/28/15 called the pharmacy in the morning around 10:00AM and reported injection site redness and itching as well as itching and swelling on her face (especially on her left side).  Patient decided to come into the pharmacy for evaluation.  Upon inspecting her, I suggested that she take some Benadryl and proceed to an urgent care facility for further evaluation.  She reported no other symptoms other than the ones mentioned above.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Injection site reaction, Mononucleosis heterophile test negative, Pain
Clinical narrative: First day after shot:  Fatigue. Second and third days:  Diarrhea. One week after shot:  Painful and itching hives and rash all over body, with blotchy rash around shot site.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash generalised, Rash macular, Streptococcus test negative, Urticaria
Clinical narrative: First day after shot:  Fatigue. Second and third days:  Diarrhea. One week after shot:  Painful and itching hives and rash all over body, with blotchy rash around shot site.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Large raised red area, approximately the size of a dollar bill, the area is red and hot around the area of the Zostavax vaccination site.
Age: 37.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Hives on inner thighs, underarms, and right hip. Took one Benadryl tablet 06/27/2015 am, another at recurrence on 06/27/2015 11 pm and 06/28/2015 4 pm.
Age: 47.0
Sex: F
Vaccine: OPV
Symptoms: Chills, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: Throughout that afternoon, I felt more tired and achy. By 530pm, I had a fever of 101.3 and bad muscle aches. By 10pm, my fever had risen to 101.4 and I had aches and chills.  I took Advil and went to bed. The next day, my fever started off lower but stayed between 99.5 and 101 all day.  Muscles were extremely painful and I slept a lot.  Everything was the same on 6/27, and I began to feel nauseated. In the evening my bowels became loose.  All day on 6/28, I ran a fever up to 100.3 and had nausea and diarrhea all day (at least 15 times). Soreness and aches continue.  I did not hurt this much when I had pneumonia or when I received my first pneumonia vaccine. The potential benefit of this drug is NOT worth what I have been put through the last 4 days.
Age: 47.0
Sex: F
Vaccine: OPV
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Throughout that afternoon, I felt more tired and achy. By 530pm, I had a fever of 101.3 and bad muscle aches. By 10pm, my fever had risen to 101.4 and I had aches and chills.  I took Advil and went to bed. The next day, my fever started off lower but stayed between 99.5 and 101 all day.  Muscles were extremely painful and I slept a lot.  Everything was the same on 6/27, and I began to feel nauseated. In the evening my bowels became loose.  All day on 6/28, I ran a fever up to 100.3 and had nausea and diarrhea all day (at least 15 times). Soreness and aches continue.  I did not hurt this much when I had pneumonia or when I received my first pneumonia vaccine. The potential benefit of this drug is NOT worth what I have been put through the last 4 days.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood test normal, Computerised tomogram normal, Seizure
Clinical narrative: Information has been received from a physician referring to a 17 years old female patient. The patient had no medical history or drug reactions/allergies. On 10-JUN-2015 the patient was vaccinated with a dose of GARDASIL (lot # K009902, expire date unknown, dose, frequency were not reported) intramuscularly. Concomitant therapy included MENACTRA (manufacturer unspecified) on the same day. On 16-JUN-2015, the patient had a seizure (the type of seizure was unspecified). Then, on that same date, the patient went to the emergency room at Hospital, where "blood tests and a Computerised tomogram (CT) scan" were performed. The results of these tests did not show anything abnormal. It was unspecified if the patient recovered from the seizure before going to the emergency room or after entering the emergency room. However, the patient did recover from the seizure on 16-JUN-2015. No treatment was given for the event. Causality was not reported. Upon internal review, the event of seizure was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 19-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was snot reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 29-JAN-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-JAN-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient's medical history was not reported. On 14-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication war snot reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 06-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant (CMA) concerning unknown number of patients of unknown demographics. There were no medical history or drug reactions/allergies reported. It was reported that since 04-MAY-2015, the patients had been administered improperly stored GARDASIL (dose, frequency, route, lot number and expiration were unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Drug administration error, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 52 year old male patient. The patient's concurrent and historical conditions were not reported. On an unknown date in November 2104 the patient was vaccinated with first dose of GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for benign neoplasm of the larynx (inappropriate schedule of drug administration and drug administration error). Concomitant therapies were not reported. Patient had not received any further doses. No symptoms were reported. Additional information has been requested. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue(PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. No information about medical history, concurrent conditions was reported for the patient. The reporter stated that the patient completed series of hepatitis B vaccine (manufacturer unknown) (dose strength, frequency unspecified) intramuscularly on an unknown date in 1996. On 12-JUN-2015 the patient was vaccinated with an additional dose of hepatitis B vaccine (manufacturer unknown) (dose strength unspecified) intramuscularly for nursing school although she did not have any titers drawn. No adverse effects reported. The outcome of the events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 12-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 19-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medications was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-JAN-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 29-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 22-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 03-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US057917 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 561893) website on 12 May 2015 and with a follow-up information received from the Quality Assurance Department (reference number: 371083) on 18 May 2015 with a follow up information received from the quality assurance department on 15 Jun 2015. This report refers to an 11 year old female patient. Historical conditions and current illness were none. Concomitant medications were none. On 19 Jan 2015, she was vaccinated with MENVEO (batch number: M14041, expiry date: Aug 2015) intramuscularly into the right arm, along with ADACEL (other manufacturer, batch number U5030AA) intramuscularly into the left arm. On 21 Jan 2015, the patient experienced localized cellulitis in the right upper arm with significant redness, swelling, warmth, and tenderness. Final outcome of the events was unknown. The events were reported as non-serious; but the event cellulitis was upgraded as medically significant based on NVS-IME list. The causality of the events was not reported. Based on the documents review performed, it was concluded that the MENVEO batch M14041 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 371083) on 18 May 2015: Updated QA reference number only. Follow up information received from the quality assurance department on 15 Jun 2015: Batch summary and expiry date updated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Localised infection
Clinical narrative: Case number PHHY2015US061407, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 563089) website on 12 May 2015 with a follow up information received from the quality assurance department (QA reference number: 373617) on 02 Jun 2015 with a follow up information received from the quality assurance department on 16 Jun 2015. This report refers to an 11-year-old male patient. Historical conditions and current illnesses were none. Concomitant medications were none. The patient was vaccinated with MENVEO (batch number: M14056, expiry date: Aug 2015) along with BOOSTRIX (other manufacturer, batch number: N4L77); both vaccines administered intramuscularly into the right arm on 23 Jan 2015. On 25 Jan 2015, the patient experienced redness and swelling in the right upper arm between injection sites and elbow. The patient's mom took the patient to urgent care on 25 Jan 2015. The patient was seen by the physician and was placed on cephalexin stating that the arm was infected. The final outcome of the events was complete recovery. The events were reported as non-serious, but the event, arm was infected was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the event was not reported. Based on the documents review performed, it was concluded that the MENVEO batch M14056 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up information received from the quality assurance department on 02 Jun 2015: QA reference number updated. Follow up information received from the quality assurance department on 16 Jun 2015: Batch summary and expiry date updated.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Erythema, Headache, Heart rate increased
Clinical narrative: Arm redness and swelling, fever (over 102 degrees F), body aches, nausea, headache, dizziness, trouble staying awake, resting heart rate over 100, weakness. Symptoms lasted 36 hours. Doctor advised to take Tylenol for fever and Benadryl for other side effects. Called doctor's office 06/24/2015 at 09:17 AM.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Peripheral swelling, Pyrexia, Somnolence
Clinical narrative: Arm redness and swelling, fever (over 102 degrees F), body aches, nausea, headache, dizziness, trouble staying awake, resting heart rate over 100, weakness. Symptoms lasted 36 hours. Doctor advised to take Tylenol for fever and Benadryl for other side effects. Called doctor's office 06/24/2015 at 09:17 AM.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: Nurse inadvertently administered Zostavax rather than Varivax on 6/25/15. On 6/26/15 Mother noted skin lesions on torso and right leg similar to insect bites. Child has redness and swelling at injection site. Later in day complained of pruritis and would not bear weight on left leg. Redness and warmth left kinee, redness, warmth, and swelling left ankle.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS, VARZOS
Symptoms: Joint warmth, Pruritus, Skin lesion, Weight bearing difficulty, Wrong drug administered
Clinical narrative: Nurse inadvertently administered Zostavax rather than Varivax on 6/25/15. On 6/26/15 Mother noted skin lesions on torso and right leg similar to insect bites. Child has redness and swelling at injection site. Later in day complained of pruritis and would not bear weight on left leg. Redness and warmth left kinee, redness, warmth, and swelling left ankle.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Nurse inadvertently administered Zostavax rather than Varivax on 6/25/15. On 6/26/15 Mother noted skin lesions on torso and right leg similar to insect bites. Child has redness and swelling at injection site. Later in day complained of pruritis and would not bear weight on left leg. Redness and warmth left kinee, redness, warmth, and swelling left ankle.
Age: 91.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Swelling face
Clinical narrative: Facial swelling.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 35 year old male patient (who is also a pharmacist). The patient's concurrent conditions included asthma, rhinitis allergic and allergy to penicillin (reported as 'penicillin gave him a rash'). On 22-MAY-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K019561, expiration date: 20-APR-2016) dose unspecified, intramuscularly in the left deltoid. Concomitant therapies included albuterol sulfate (manufacturer unknown) as needed. On 22-MAY-2015, the patient developed soreness at the injection site. The next day, he experienced pain and local swelling in his left arm, which then progressed to encompass most of his upper left arm. The following day, these symptoms became severe and he presented to the emergency room, was diagnosed with cellulitis, and was treated with antibiotics (unspecified). His white blood cell count was elevated with a left shift. The pain and swelling did not improve and he was admitted to the hospital on an unspecified date in 2015. His symptoms then spread down to his left elbow. While hospitalized, the patient also experienced headache, chills, a flat red rash along with the pain and swelling. He was treated with intravenous steroids and vancomycin. The patient was discharged from the hospital on an unspecified date in 2015. The patient was seen in the office on 24-JUN-2015 (reported as "today") and his symptoms had completely resolved (on an unknown date in 2015). The relatedness between the events and PNEUMOVAX 23 was not provided. Upon internal review, the events were considered to be medically significant, as they were treated with intravenous steroids. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash erythematous, Shift to the left, White blood cell count increased
Clinical narrative: This spontaneous report as received from a physician refers to a 35 year old male patient (who is also a pharmacist). The patient's concurrent conditions included asthma, rhinitis allergic and allergy to penicillin (reported as 'penicillin gave him a rash'). On 22-MAY-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K019561, expiration date: 20-APR-2016) dose unspecified, intramuscularly in the left deltoid. Concomitant therapies included albuterol sulfate (manufacturer unknown) as needed. On 22-MAY-2015, the patient developed soreness at the injection site. The next day, he experienced pain and local swelling in his left arm, which then progressed to encompass most of his upper left arm. The following day, these symptoms became severe and he presented to the emergency room, was diagnosed with cellulitis, and was treated with antibiotics (unspecified). His white blood cell count was elevated with a left shift. The pain and swelling did not improve and he was admitted to the hospital on an unspecified date in 2015. His symptoms then spread down to his left elbow. While hospitalized, the patient also experienced headache, chills, a flat red rash along with the pain and swelling. He was treated with intravenous steroids and vancomycin. The patient was discharged from the hospital on an unspecified date in 2015. The patient was seen in the office on 24-JUN-2015 (reported as "today") and his symptoms had completely resolved (on an unknown date in 2015). The relatedness between the events and PNEUMOVAX 23 was not provided. Upon internal review, the events were considered to be medically significant, as they were treated with intravenous steroids. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Tingling in hands, face, and feet. Total muscle strength loss in legs.
Sex: U
Vaccine: UNK
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date, route of administration and dose were not reported). Other suspect therapies included FLUMIST (dose, route and lot # were not reported). The vaccines were administered two weeks apart on unknown dates. The physician stated he did not remember which vaccine was administered first. He received a letter from the health department stating these doses were administered too close together and were therefore invalid. No adverse effect was reported. Additional information is not expected, because the reporter declined any further contact.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed herpes zoster within 72 hrs of immunization.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX (lot number J009731 and expiration date 07-AUG-2015; lot number J012816 and expiration date 10-OCT-2015; lot number K005425 and expiration date 15-APR-2016; lot number K006139 and expiration date 29-APR-2016; lot number K016132 and expiration date 24-SEP-2016; lot number L002870 and expiration date 27-JAN-2017) dose, frequency, route of administration not provided, which were post defrost cycling. No adverse effects were noted. This is one of several reports received 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 as received from a nurse refers to two unspecified patients of unknown age and gender. On 01-JUN-2015, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot number and expiration date not reported) dose, frequency, route of administration not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot number K012924 and expiration date 29-NOV-2015; lot number L006382 and expiration date 25-MAY-2016) dose, frequency, route of administration not provided,  which were post defrost cycling. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with PROQUAD (Merck) (lot number K020750 and expiration date 30-APR-2016; lot number L002419 and expiration date 23-JUL-2016) dose, frequency, route of administration not provided, which were post defrost cycling. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from an approximately 46 year old male patient concerning himself. Pertinent medical history included: high blood pressure, kidney transplant. Drug reactions/allergies includes shellfish. On 14-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 0.5ml/one dose, intramuscular (lot # K008409; 04-MAR-2016). Concomitant therapies included unspecified HIP B vaccine and unspecified blood pressure medication. On 15-JUN-2015, the patient experienced his arm swelling up, stated that it felt like a loose bag of water, and was warm to the touch after receiving PNEUMOVAX 23. Lab diagnostics studies included unspecified blood work (details unknown). No treatment given for the events. The outcome of skin warm and swelling arm was reported as not resolved. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a health care professional refers to six unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, frequency, lot # unspecified). Concomitant therapy was not reported. On an unknown date the patients were administered improperly stored PNEUMOVAX23. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. No product quality complaint involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year adult female patient. The patient's pertinent medical history included bronchopneumonia. The pharmacist stated that patient had unspecified reaction to unspecified Non-steroidal anti-inflammatory  drugs on unspecified date. On 09-JUN-2015 the patient was vaccinated with PNEUMOVAX23 lot # K009874, expiration date 19-MAR-2016, 0.5 ml once, intramuscularly. Concomitant therapies included clonazepam, fluconazole, acetaminophen, PERCOCET, prednisone, FLOMAX, ZOFRAN, ZOLOFT, gabapentin, SOMA, budesonide, SYMBICORT and LEVAQUIN. On 10-JUN-2015, the patient experienced nausea, vomiting, diarrhea, fever and injection site soreness. The pharmacist reported that the patient took TYLENOL for the fever and KAOPECTATE for diarrhea. The outcome of the events reported was not recovered/not resolved. The patient sought medical attention by calling pharmacy. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Low grade fever within 24 hours after administration; mild rash at injection site (24-48 hours post-injection) manifesting to moderate rash after 48 hours (>4 inches in diameter).
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Pt felt her arm become itchy and warm and redness spread into a circle. Currently just itches this morning.
Age: 83.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain, Abdominal pain upper, Chest pain, Dyspnoea, Palpitations
Clinical narrative: Heart pounding, shortness of breath.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: 24 hours after Tdap vaccine was adminstered the patient had a significant reaction with entire upper right arm was inflamed and erythematous and warm to the touch. Patient was placed on Bactrim and doxycycline for cellulitis.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Visual impairment
Clinical narrative: Patient stated that she could not see clearly and became very pale. She was placed on the table and given crackers and juice and her BP was monitored.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Lymphadenitis, Pyrexia, Rash, Scab, Varicella post vaccine
Clinical narrative: Vaccines given 5/22/15. Pt developed fever/rash initially thought to be enterovirus. Rash came in crops and crusted. All sx resolved until 6/23/15. Pt brought in for lymphadenopathy. Dx with  vaccine type varicella and secondary lymphadenitis.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain, X-ray limb
Clinical narrative: Pain during administration of vaccine that occurred on 06/12/15 that went down into elbow then resolved and noted pain again in proximal right arm near shoulder worse with abduction, extension, and certain range of motion including her using right arm to pull up pants. Persisting pain 4-3/10 intensity. Worse with ROM. No radiation-pain persisting at least 10 days after vaccination. No skin color changes.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Heat, redness, swelling, induration at injection site covered 1/3 of upper arm on 6/26/15. Redness went down to elbow on 6/29. On 6/28 Lt parotid area swollen and tender to touch. Unable to bite down on Lt side from afternoon->late night. 6/29 area tender but able to chew.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Immediate pain, decreased range of motion. Attended physical therapy for approx 6 weeks w/little improvement. Cortisone injection x 2.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Injection site swelling, Mass
Clinical narrative: Pain, swelling of upper rt arm lower than injection area. Redness plus a large area of a mass under my skin, moon shape 4" x 8" approx. (more than a week to dissipate).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Neck pain, Pain
Clinical narrative: Shot Fri 12th sx eve of Sun 14th neck ache on right traveled to entire neck. Very painful. Then to top of chest couldn't breathe c/o pain. Then under arm then left hip. Still there, then ankle pain still here after 10 days. Pt exhausted.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Depressed level of consciousness, Diarrhoea, Eye movement disorder, Fatigue, Musculoskeletal stiffness
Clinical narrative: Several hours after the vaccines, mother had difficulty arousing her and her eyes rolled back, she felt stiff and war,. Taken to ED where she was febrile and tired. After antipyretics and ZOFRAN, she was alert with normal neuro exam. They felt she had afebrile seizure. She has had running nose and diarrhea since.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Neurological examination normal, Rhinorrhoea, Seizure
Clinical narrative: Several hours after the vaccines, mother had difficulty arousing her and her eyes rolled back, she felt stiff and war,. Taken to ED where she was febrile and tired. After antipyretics and ZOFRAN, she was alert with normal neuro exam. They felt she had afebrile seizure. She has had running nose and diarrhea since.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, Pertussis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pertussis in a 4-year-old male patient who received PEDIARIX (batch number AC21B408BA, expiry date 23rd January 2015). Co-suspect products included PEDIARIX. On 1st August 2013, the patient received the 1st dose of PEDIARIX. On an unknown date, the patient received the 2nd dose of PEDIARIX. In June 2015, 2 years after receiving PEDIARIX and not applicable after receiving PEDIARIX, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the pertussis was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the pertussis to be related to PEDIARIX. It was unknown if the reporter considered the drug dose administration interval too long to be related to PEDIARIX. Additional information was provided Physician reported that a 4 year old patient had received only one dose of PEDIARIX on 01 August 2013. In June 2015, he had not received any subsequent dose, which led to a maladministration. At the time of reporting, the patient was in the clinic with pertussis. This was one of 2 cases reported by the same reporter.
Age: 1.56
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, Pertussis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pertussis in a 2 year-old male patient who received PEDIARIX (batch number 9EA47, expiry date 17th April 2016). Co-suspect products included PEDIARIX. Previously administered products included PEDIARIX (1st dose given on 1 August 2013 (AC21B408BA exp 23Jan2015)). On 11th July 2014, the patient received the 2nd dose of PEDIARIX. On an unknown date, the patient received the 3rd dose of PEDIARIX. In June 2015, 335 days after receiving PEDIARIX and not applicable after receiving PEDIARIX, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the pertussis was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the pertussis and drug dose administration interval too long to be related to PEDIARIX. It was unknown if the reporter considered the drug dose administration interval too long to be related to PEDIARIX. Additional information was provided: Physician reported that a 2 year old patient had received only two doses of PEDIARIX on 01 August 2013 and 11 July 2014. The second dose was late, and he is late on any subsequent doses which led to a maladministration. At the time of reporting, the patient was in the clinic with pertussis. This was one of 2 cases reported by the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to multiple unspecified patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On multiple unknown dates (ranging from December 2014, January 2015, and February 2015), the patients were vaccinated with doses of improperly stored (MMR II (lot# K003823, expiration date 14-MAR-2016, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to multiple unspecified patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On multiple unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot# K005958, expiration date 09-FEB-2017, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Redness, warmth, itchy, swollen. TX: topical triamcinolone, TYLENOL, cool compress. Added to PT allergy list.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swelling, redness, warmth. Cold compress placed by patient. OTC pain medication taken by patient.