chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient reported a skin rash about 2 - 3 inch diameter; feverish; she said it lasted one week. Took a few doses of Benadryl oral.
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling over both arms where she recieved vaccines. Treated with ice pack and Benadryl by weight.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Chest pain, Dyspnoea, Lip swelling, Swollen tongue, Tachycardia
Clinical narrative: SHORTNESS OF BREATH, CHEST PAIN, SWELLING TO LIPS AND TONGUE, TACHY HEART RATE, TRANSPORTED VIA 911 TO HOSPITAL.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Skin burning sensation
Clinical narrative: Arm started burning and area around injection site a bit raised and red.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Pain in arm immediate.   Continued pain in arm on a daily basis.  Tylenol and exercise.  No resolution as of current date.... 8-8-2015.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Slight redness and itching at injection site after recieving a Zostavax injection.  Upon follow up an hour later redness had mostly resolved and itching had subsided.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Antibody test positive, Antinuclear antibody positive, Antiphospholipid antibodies positive, Aspartate aminotransferase increased
Clinical narrative: Malaise, low grade fever, nausea, vomiting, body aches, difficulty voiding, sore thorat, morning stiffness/swelling of knees.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Biopsy kidney abnormal, Blood creatine phosphokinase increased, Blood creatinine increased, Blood urea increased, Disseminated intravascular coagulation
Clinical narrative: Malaise, low grade fever, nausea, vomiting, body aches, difficulty voiding, sore thorat, morning stiffness/swelling of knees.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Double stranded DNA antibody positive, Dysuria, Hepatic function abnormal, Joint swelling, Lupus nephritis
Clinical narrative: Malaise, low grade fever, nausea, vomiting, body aches, difficulty voiding, sore thorat, morning stiffness/swelling of knees.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Malaise, Musculoskeletal stiffness, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Malaise, low grade fever, nausea, vomiting, body aches, difficulty voiding, sore thorat, morning stiffness/swelling of knees.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia, Renal disorder, Renal injury, Rhabdomyolysis, Sepsis
Clinical narrative: Malaise, low grade fever, nausea, vomiting, body aches, difficulty voiding, sore thorat, morning stiffness/swelling of knees.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Serositis, Staphylococcal bacteraemia, Systemic lupus erythematosus, Vomiting
Clinical narrative: Malaise, low grade fever, nausea, vomiting, body aches, difficulty voiding, sore thorat, morning stiffness/swelling of knees.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Full blood count normal, Malaise, Mononucleosis heterophile test negative, Myalgia, Pyrexia
Clinical narrative: Fever, Malaise, Myalgia's.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: White blood cell count increased
Clinical narrative: Fever, Malaise, Myalgia's.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: Injection site red/hot and hard in the center. Left side of glands on neck swollen. Fever night before.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Within 48 hours, patient developed a rash around neck and upper chest.  No shortness of breath or tongue selling.  Resolved after 1 week.  Used Benadryl to help with itch during the week.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: Patient reports that 24-48 hours after injection she developed redness, a 4x5 inch area of swelling and heat.  She went to MD and was diagnosed with cellulitis.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Feeling weak, fever 101.8, chills, dizzy, aches.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site irritation
Clinical narrative: Reaction was first noticed the day after administration, starting as an approximately 3" diameter area of red, inflamed tissue around the site of administration on the right deltoid. Pt thought this was a normal reaction until the inflammation spread, and came in 2 days after administration at which time the irritated area was an approximately 5" by 6.5" area of cellulitis. Diagnosis was cellulitis. Treated by 20 capsules of 500mg Cephalexin BID x 10 days paired with 24 tablets of 325mg acetaminophin Q4H PRN.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching for 2 days. Rx BENADRYL and antibiotic.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Patient developed hives to right forearm approximately 60 minutes after immunization.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching and tenderness at the site of injection in left left posterior upper arm. In a linear fashion extending inferiority approximately 10 cm.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates since May 2015, the patients were administered improperly stored dose of PEDVAXHIB (lot # K008877, exp. 24-FEB-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates, the patients were administered improperly stored dose of PNEUMOVAX 23 (lot # K020795, exp. 19-MAR-2015, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates, the patients were administered improperly stored dose of VAQTA (lot # K009506, exp. 22-SEP-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patients' medical history or concurrent condition was not provided. On unknown date 3 doses of improperly stored PROQUAD (lot # L003221, expiration date of 30-JUL-2016) (dose, strength and route unknown) were administered to the patients. No concomitant therapy was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent condition were not provided. On unknown dates 8 doses of improperly stored (Oka/Merck) VARIVAX (lot # L006385 with expiration date of 25-FEB-2017, dose and route unknown) were administered to the patients. No concomitant therapy was reported. No adverse effects were reported. This is one of several cases that received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician assistant via company representative referring to a male patient in his "sixties". The patient's medical history and drug reaction/allergies were not reported. ON an unknown date of several years ago the patient was vaccinated with a dose of ZOSTAVAX (dose, strength and route unknown). Concomitant medication was not reported. Several years after the patient came down with a mild case of the shingles. The outcome of the event was recovered. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates since May 2015, the patients were administered improperly stored dose of ROTATEQ (lot # K016279, exp. 24-APR-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown date since May 2015, the patients were administered improperly stored dose of GARDASIL (lot # K006124, exp. 01-FEB-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates since May 2015, the patients were administered improperly stored dose of RECOMBIVAX HB (lot # K022265, exp. 22-OCT-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates since May 2015, the patients were administered improperly stored dose of RECOMBIVAX HB (lot # K010238, exp. 14-APR-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates, the patients were administered improperly stored dose of PNEUMOVAX 23 (lot # K020215, exp. 15-MAY-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates the patients were administered improperly stored dose of COMVAX (lot # J013884, exp. 19-AUG-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting throughout day.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Fatigue, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Arm red, hard and sore at injection site.  Muscles aches from neck to back both sides, but more so on injection side of body. Fatigue, feel crummy all over as if getting the flu, mild temp.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Arm red, hard and sore at injection site.  Muscles aches from neck to back both sides, but more so on injection side of body. Fatigue, feel crummy all over as if getting the flu, mild temp.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Headache, Diarrhea, Pain/redness/swelling at injection site (left arm) - increased every day, currently 3.5" x 3.5" area (VACCINE FOR SHINGLES).
Age: 33.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: The patient was to receive a PPD TB skin test sub-dermal in the left forearm. The technician used Typhiod (lot#J1631.1) instead on accident. After the patient left the immunizations clinic, it was discovered that she gave injected the wrong vaccine. I immediately went downstairs in brought him into an exam room. I notifiedour medical director. He came in to evaluate the patient at 0820. He exposed his arm and there was redness and swelling around injection site. The patient c/o a burning sensation. We got his vital signs, which were normal. As he was being evaluated, the redness and swelling increased. Dr. instructed him to go to the Emergency room to be evaluated for possible chemical reaction. The patient has received the Typhiod vaccine (IM) 6 times in the past without any reaction, so it was our belief he was not having an allergic reaction. The patient left at 0941 and went to ER.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Extreme pain not alleviated with pain medication or warm compress.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: Patient developed febrile response to vaccine, complained of feeling cold on a 104 degree day. Also was experiencing rigors x 20 minutes. Patient was given one ibuprofen 200 mg and symptoms resolved within 1 hour.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling abnormal, Injection site pain, Pain, Pain in extremity
Clinical narrative: Per patient, "On June 9, 2015 I went to your clinic for a Tdap vaccine and now I'm having to forgo physical therapy for this arm. I wanted to inform a Manager that this happened. Maybe the shot was given too high in the arm. It felt funny. Not only the normal pain associated with the vaccine but it felt weird. It hurt if I lay on that side, it hurt when driving. The whole left arm and shoulder area, any movement with that arm causes pain."
Age: 0.22
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Cyanosis, Decreased eye contact, Irritability, Lethargy
Clinical narrative: Initial severe cry (not normal), lethargic -not interacting normally, sleepy, fussy, continuation of severe persistent crying, high fever then fluctuation of fever with Tylenol 98-100.6 (with tylenol given), cyanosis of lips and around nose once before and once after an episode of projectile vomiting, skin rash appearing the following day after vaccination.
Age: 0.22
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia, Rash, Somnolence, Vomiting projectile
Clinical narrative: Initial severe cry (not normal), lethargic -not interacting normally, sleepy, fussy, continuation of severe persistent crying, high fever then fluctuation of fever with Tylenol 98-100.6 (with tylenol given), cyanosis of lips and around nose once before and once after an episode of projectile vomiting, skin rash appearing the following day after vaccination.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Anger, Computerised tomogram, Depression, Electroencephalogram, Fatigue
Clinical narrative: My daughter started feeling tired, depressed, angry, withdrawn and started having seizure like episodes where she would lose control of her body.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Nuclear magnetic resonance imaging, Seizure like phenomena, Social avoidant behaviour
Clinical narrative: My daughter started feeling tired, depressed, angry, withdrawn and started having seizure like episodes where she would lose control of her body.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Increase redness, swelling, warm to the area (L deltoid).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Cx came on Mon 8/3/15 claimed that after walked the dog to the park, he got itchy and start crashed his feet (L); he didn't know that from the shingle vaccine he got on Sat. 8/1/15 or not. Red dots rash.
Age: 23.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a consumer with sulfamethoxazole, MICROBID allergy and without pertinent medical history referring to her 23 year old sone. On 01-JUL-2015, the consumer was vaccinated with a dose of ZOSTAVAX (dose, lot number and route not provided). The consumer's concomitant therapy included LASIX, hydrochlorothiazide, baby aspirin and AMBIEN. The consumer suspected that she might have transmitted the vaccine virus to her son because the patient developed shingles-like rash on 10-JUL-2015 (secondary transmission). He sought medical case on an unspecified date at an urgent care facility and was diagnosed with shingles by physician who also reported as he did not see a primary care physician. The consumer reported no adverse experience on herself as the patient after receiving ZOSTAVAX. No treatment was given for adverse event and no lab diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 30-JUL-2015 the patient was vaccinated with PROQUAD (dose, dosage #, strength and route were not reported, lot # L007229, expiry date: 03-SEP-2018). The second suspect therapy included KINRIX (administration date: 30-JUL-2015). The patient came back to the office as the patient had developed a rash all over the body on 31-JUL-2015. The outcome of the event was not reported. The reporter also requested a lot check and that lot check request was time sensitive and the reporter wanted a response quickly. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Initial report received from a Consumer who is also the patient on 21 October 2012. A patient, whose age, gender, medical history and concomitant medication were not reported, received a dose of ADACEL vaccine (lot number: C4136BA, route and site of vaccination was not reported), on 22 June 2012. It was reported that, the patient had severe after vaccination. The corrective treatments and laboratory investigations were not reported. At the time of report the outcome was not reported. Documents held by sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: Initial report was received from a non-healthcare professional on 10 January 2013, who received the report from a consumer (the patient's guardian). A male patient (a minor), had received ADACEL, Sanofi Pasteur Inc. lot number U3979CA (corresponding Sanofi Pasteur Ltd. lot number C3915) on 09 August 2012 and an unspecified amount of time later, he experienced an adverse event (not specified). Outcome was not reported, and no additional information was provided at the time of the report. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Paraesthesia, Vaccination site discolouration, Vaccination site haemorrhage
Clinical narrative: Initial report received from a non-healthcare professional who is also a patient on 12 December 2012. A 68-year-old female patient, who had no known allergies and had history of "CA" and concomitant medications were not reported, had received first intramuscular dose of ADACEL (batch number-C4313AA) in left deltoid on 09 November 2012. Patient had no other illness at the time of vaccination. On 09 November 2012, on the night of the vaccination the patient developed knot on left deltoid followed by bleeding and redness at the vaccination site. The area around redness was black and blue. On 10 November 2012 (the next day), the patient had tingling of the left arm. The tingling was persisting till the date of this report. The patient was treated with unspecified antibiotics, muscle relaxants and anti-inflammatory medications by the doctor. Laboratory investigations/details were not reported. On unspecified date, the patient had recovered from the events. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 18 April 2013. A patient whose age, gender, date of birth, medical history and concomitant medication were not reported, had received dose of MENACTRA vaccine (lot number, route and site of administration were not reported) on an unspecified date. On an unspecified date, it was reported that patient presented 10cm swelling and erythema at injection site. The corrective treatments and laboratory investigations were not reported. As of 18 April 2013, the outcome of the event was not reported. Follow-up information received from a healthcare professional on 05 June 2013: A 12-year-old female patient received an intramuscular dose 1 of MENACTRA vaccine; lot number U4575BA in left deltoid on 16 April 2013. The patient had experienced localized inflammation at the age of 6 years after receiving dose 2 of varicella. On 18 April 2013, the patient presented 10 cm swelling and erythema at injection site. At the time of report, the outcome of events was unknown. List of documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Areflexia, Asthenia, Dysphagia, Full blood count, Gait disturbance
Clinical narrative: Initial unsolicited report received from a healthcare professional on 29 July 2015. A 52-year-old male patient had received a dose of FLUZONE QIV (batch number: UI205AD, expiry date: 30 June 2015, dose, dose in series and site of administration were not reported) in left deltoid on 06 October 2014. Any other vaccination within four weeks of vaccination, illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as none. Medical history included disability for a shoulder injury and had rotator cuff surgery in June. Previous medications included eight doses of FLUZONE QIV. Concomitant medications were not reported. On 01 January 2015, 87 days after vaccination, the patient had developed numbness in his feet that gradually progressed up his legs within 24 hours which continued to progress up his body, difficulty breathing (never placed on a ventilator) and swallowing. The patient was diagnosed with Guillain Barre Syndrome. The patient was hospitalized on an unknown date for 26 days and had life-threatening illness. Relevant diagnostic tests/laboratory data reported as unsure for testing performed at the hospital. Corrective treatments were not reported. At the time of this report, the patient had recovered from all the events on an unspecified date. Documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Hypoaesthesia, Hypopnoea, Immunoglobulin therapy, Lumbar puncture, Lumbar puncture abnormal
Clinical narrative: Initial unsolicited report received from a healthcare professional on 29 July 2015. A 52-year-old male patient had received a dose of FLUZONE QIV (batch number: UI205AD, expiry date: 30 June 2015, dose, dose in series and site of administration were not reported) in left deltoid on 06 October 2014. Any other vaccination within four weeks of vaccination, illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as none. Medical history included disability for a shoulder injury and had rotator cuff surgery in June. Previous medications included eight doses of FLUZONE QIV. Concomitant medications were not reported. On 01 January 2015, 87 days after vaccination, the patient had developed numbness in his feet that gradually progressed up his legs within 24 hours which continued to progress up his body, difficulty breathing (never placed on a ventilator) and swallowing. The patient was diagnosed with Guillain Barre Syndrome. The patient was hospitalized on an unknown date for 26 days and had life-threatening illness. Relevant diagnostic tests/laboratory data reported as unsure for testing performed at the hospital. Corrective treatments were not reported. At the time of this report, the patient had recovered from all the events on an unspecified date. Documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Plasmapheresis
Clinical narrative: Initial unsolicited report received from a healthcare professional on 29 July 2015. A 52-year-old male patient had received a dose of FLUZONE QIV (batch number: UI205AD, expiry date: 30 June 2015, dose, dose in series and site of administration were not reported) in left deltoid on 06 October 2014. Any other vaccination within four weeks of vaccination, illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as none. Medical history included disability for a shoulder injury and had rotator cuff surgery in June. Previous medications included eight doses of FLUZONE QIV. Concomitant medications were not reported. On 01 January 2015, 87 days after vaccination, the patient had developed numbness in his feet that gradually progressed up his legs within 24 hours which continued to progress up his body, difficulty breathing (never placed on a ventilator) and swallowing. The patient was diagnosed with Guillain Barre Syndrome. The patient was hospitalized on an unknown date for 26 days and had life-threatening illness. Relevant diagnostic tests/laboratory data reported as unsure for testing performed at the hospital. Corrective treatments were not reported. At the time of this report, the patient had recovered from all the events on an unspecified date. Documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Dysphagia, Dyspnoea, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 29 July 2015. A 52-year-old male patient had received a dose of FLUZONE QIV (batch number: UI205AD, expiry date: 30 June 2015, dose, dose in series and site of administration were not reported) in left deltoid on 06 October 2014. Any other vaccination within four weeks of vaccination, illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as none. Medical history included disability for a shoulder injury and had rotator cuff surgery in June. Previous medications included eight doses of FLUZONE QIV. Concomitant medications were not reported. On 01 January 2015, 87 days after vaccination, the patient had developed numbness in his feet that gradually progressed up his legs within 24 hours which continued to progress up his body, difficulty breathing (never placed on a ventilator) and swallowing. The patient was diagnosed with Guillain Barre Syndrome. The patient was hospitalized on an unknown date for 26 days and had life-threatening illness. Relevant diagnostic tests/laboratory data reported as unsure for testing performed at the hospital. Corrective treatments were not reported. At the time of this report, the patient had recovered from all the events on an unspecified date. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Blood culture, Culture urine, Electrocardiogram, Electroencephalogram, Headache
Clinical narrative: Case number PHEH2015US014813, is an initial spontaneous report from patient's mother (also physician) received on 28 Jul 2015. This report refers to a 17 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with BEXSERO (batch number: 146101, expiry date: 20 Apr 2016) at a dose of 0.5 ml intramuscularly into left arm on 27 Jul 2015 at 01:30 PM. On the same day, after vaccination, the patient went to golf where she passed out around 04:45 PM. The reporter picked her up around 05:15 PM and the patient was still out of it. The patient was then taken to the hospital at around 06:00 PM. Her vitals were taken and started on IV. Around 07:30 PM, the patient started to respond but for the next several hours, she was in and out of sleep. The patient remained at the hospital. The patient became dizzy and nauseous when trying to stand. At times, the patient was unresponsive to sound but responds to touch. Outcome of the events was reported as not recovered. Case was assessed as serious (hospitalization and medically significant). Causality of the events was reported as probable.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Loss of consciousness
Clinical narrative: Case number PHEH2015US014813, is an initial spontaneous report from patient's mother (also physician) received on 28 Jul 2015. This report refers to a 17 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with BEXSERO (batch number: 146101, expiry date: 20 Apr 2016) at a dose of 0.5 ml intramuscularly into left arm on 27 Jul 2015 at 01:30 PM. On the same day, after vaccination, the patient went to golf where she passed out around 04:45 PM. The reporter picked her up around 05:15 PM and the patient was still out of it. The patient was then taken to the hospital at around 06:00 PM. Her vitals were taken and started on IV. Around 07:30 PM, the patient started to respond but for the next several hours, she was in and out of sleep. The patient remained at the hospital. The patient became dizzy and nauseous when trying to stand. At times, the patient was unresponsive to sound but responds to touch. Outcome of the events was reported as not recovered. Case was assessed as serious (hospitalization and medically significant). Causality of the events was reported as probable.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Blood test, Chills, Computerised tomogram head, Electrocardiogram, Electroencephalogram
Clinical narrative: Case number PHEH2015US014813, is an initial spontaneous report from patient's mother (also physician) received on 28 Jul 2015. This report refers to a 17 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with BEXSERO (batch number: 146101, expiry date: 20 Apr 2016) at a dose of 0.5 ml intramuscularly into left arm on 27 Jul 2015 at 01:30 PM. On the same day, after vaccination, the patient went to golf where she passed out around 04:45 PM. The reporter picked her up around 05:15 PM and the patient was still out of it. The patient was then taken to the hospital at around 06:00 PM. Her vitals were taken and started on IV. Around 07:30 PM, the patient started to respond but for the next several hours, she was in and out of sleep. The patient remained at the hospital. The patient became dizzy and nauseous when trying to stand. At times, the patient was unresponsive to sound but responds to touch. Outcome of the events was reported as not recovered. Case was assessed as serious (hospitalization and medically significant). Causality of the events was reported as probable.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Headache, Pyrexia, Syncope
Clinical narrative: Case number PHEH2015US014813, is an initial spontaneous report from patient's mother (also physician) received on 28 Jul 2015. This report refers to a 17 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with BEXSERO (batch number: 146101, expiry date: 20 Apr 2016) at a dose of 0.5 ml intramuscularly into left arm on 27 Jul 2015 at 01:30 PM. On the same day, after vaccination, the patient went to golf where she passed out around 04:45 PM. The reporter picked her up around 05:15 PM and the patient was still out of it. The patient was then taken to the hospital at around 06:00 PM. Her vitals were taken and started on IV. Around 07:30 PM, the patient started to respond but for the next several hours, she was in and out of sleep. The patient remained at the hospital. The patient became dizzy and nauseous when trying to stand. At times, the patient was unresponsive to sound but responds to touch. Outcome of the events was reported as not recovered. Case was assessed as serious (hospitalization and medically significant). Causality of the events was reported as probable.
Age: 17.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Dizziness postural, Loss of consciousness, Nausea, Unresponsive to stimuli
Clinical narrative: Case number PHEH2015US014813, is an initial spontaneous report from patient's mother (also physician) received on 28 Jul 2015. This report refers to a 17 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with BEXSERO (batch number: 146101, expiry date: 20 Apr 2016) at a dose of 0.5 ml intramuscularly into left arm on 27 Jul 2015 at 01:30 PM. On the same day, after vaccination, the patient went to golf where she passed out around 04:45 PM. The reporter picked her up around 05:15 PM and the patient was still out of it. The patient was then taken to the hospital at around 06:00 PM. Her vitals were taken and started on IV. Around 07:30 PM, the patient started to respond but for the next several hours, she was in and out of sleep. The patient remained at the hospital. The patient became dizzy and nauseous when trying to stand. At times, the patient was unresponsive to sound but responds to touch. Outcome of the events was reported as not recovered. Case was assessed as serious (hospitalization and medically significant). Causality of the events was reported as probable.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blood test, Computerised tomogram, Joint contracture, Malaise, Posture abnormal
Clinical narrative: Case number PHEH2015US014804 is an initial spontaneous report received from a nurse via sales representative on 29 Jul 2015. This report refers to a 17 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 23 Jul 2015. After vaccination, on her way home, she experienced seizure. The seizure lasted for few minutes. The patient was reportedly also experiencing some brain fog since the seizure. She visited emergency room and was evaluated and released (not admitted). Seizure recovered on 23 Jul 2015. She was referred to a neurologist who saw her on 28 Jul 2015. The outcome of brain fog was reported as condition unchanged. The seriousness of the events was not reported, but the event seizure was upgraded as medically significant based on NVS-IME list and brain fog was upgraded as medically significant based on the information available in the source documents. The nurse did not report the causality of the events. According to the patient's mother, the neurologist felt that the events might be from the MENVEO, but they were in the process of ruling out other causes. No further information was provided.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Tremor
Clinical narrative: Case number PHEH2015US014804 is an initial spontaneous report received from a nurse via sales representative on 29 Jul 2015. This report refers to a 17 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 23 Jul 2015. After vaccination, on her way home, she experienced seizure. The seizure lasted for few minutes. The patient was reportedly also experiencing some brain fog since the seizure. She visited emergency room and was evaluated and released (not admitted). Seizure recovered on 23 Jul 2015. She was referred to a neurologist who saw her on 28 Jul 2015. The outcome of brain fog was reported as condition unchanged. The seriousness of the events was not reported, but the event seizure was upgraded as medically significant based on NVS-IME list and brain fog was upgraded as medically significant based on the information available in the source documents. The nurse did not report the causality of the events. According to the patient's mother, the neurologist felt that the events might be from the MENVEO, but they were in the process of ruling out other causes. No further information was provided.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Feeling abnormal, Seizure
Clinical narrative: Case number PHEH2015US014804 is an initial spontaneous report received from a nurse via sales representative on 29 Jul 2015. This report refers to a 17 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 23 Jul 2015. After vaccination, on her way home, she experienced seizure. The seizure lasted for few minutes. The patient was reportedly also experiencing some brain fog since the seizure. She visited emergency room and was evaluated and released (not admitted). Seizure recovered on 23 Jul 2015. She was referred to a neurologist who saw her on 28 Jul 2015. The outcome of brain fog was reported as condition unchanged. The seriousness of the events was not reported, but the event seizure was upgraded as medically significant based on NVS-IME list and brain fog was upgraded as medically significant based on the information available in the source documents. The nurse did not report the causality of the events. According to the patient's mother, the neurologist felt that the events might be from the MENVEO, but they were in the process of ruling out other causes. No further information was provided.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Erythema, Myalgia, Nausea
Clinical narrative: Fever, chills, rash, arm swollen & red, loss of appetite, sick at stomach, muscle aches.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Fever, chills, rash, arm swollen & red, loss of appetite, sick at stomach, muscle aches.
Sex: M
Vaccine: DTAP, DTPHIB, FLUX, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Brain scan abnormal, Pyrexia
Clinical narrative: After patient would receive set of immunizations couple months apart would get very high fever.  I would call physician back and was told is normal to give Tylenol or Motrin for fever and pain.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain, Injection site warmth, Musculoskeletal disorder
Clinical narrative: Severe pain and heat at injection site and sore muscle of arm and shoulder, numbness of fingers and poor grip, unable to use right arm.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Myalgia
Clinical narrative: Severe pain and heat at injection site and sore muscle of arm and shoulder, numbness of fingers and poor grip, unable to use right arm.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Seizure, Syncope
Clinical narrative: Pt received his second dose of MCV4, after administration pt fainted and had a seizure. Pt was not responding to this nurse verbally. Dr was called and assesed the pt. Pt was then alert and oriented X3. Dr ordered some tests and blood work. BP was checked 127/72 P 72 RR 20, BP 116/67, P 70 RR20. Pt left the clinic on stable conditions with dad.
Age: 0.92
Sex: M
Vaccine: FLU3
Symptoms: Decreased eye contact, Ear infection, Ear tube insertion, Eczema, Hearing impaired
Clinical narrative: Patient stopped making eye contact, stopped saying "momma" and "dada", puffy face, major eczema, water eyes, ear infections, beef allergy, now has: speech delayed and auditory and vestibular disorder. Ear tubes, EPI-PEN, speech and OT therapy, beef allergy diagnosed 3-27-14 "am hours" and pediatrician office gave flu shot on 3-27-14 "pm hours". (Confirmed gelatin in flu vaccine after given. + dr. office informed of beef allergy prior to administering flu shot to patient. Various on going medical conditions after receiving this flu shot.
Age: 0.92
Sex: M
Vaccine: FLU3
Symptoms: Lacrimation increased, Speech disorder developmental, Swelling face
Clinical narrative: Patient stopped making eye contact, stopped saying "momma" and "dada", puffy face, major eczema, water eyes, ear infections, beef allergy, now has: speech delayed and auditory and vestibular disorder. Ear tubes, EPI-PEN, speech and OT therapy, beef allergy diagnosed 3-27-14 "am hours" and pediatrician office gave flu shot on 3-27-14 "pm hours". (Confirmed gelatin in flu vaccine after given. + dr. office informed of beef allergy prior to administering flu shot to patient. Various on going medical conditions after receiving this flu shot.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Diarrhoea
Clinical narrative: Patient complained of diarrhea and weakness starting the day after receiving vaccine. Patient is currently experiencing side effect, has not resolved yet. (08/10/2015 AM) Patient's husband also received same vaccine and is not complaining of any issues.
Age: 39.0
Sex: M
Vaccine: HEPAB, MMR, TDAP
Symptoms: Lip swelling, Urticaria
Clinical narrative: Swelling of top and bottom lip and hives on back. There was no airway obstruction or wheezing. Patient arrived at the clinic, was seen by a provider and given Benadryl.  He was also given methylprednisolone 4mg for 7 days.  Follow up was provied by provider and nursing staff following the treatment.  Patient recovered with no other issues.
Age: 44.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site nodule, Injection site pain, Injection site swelling, Pain
Clinical narrative: The reaction started with a large painful bulge at the injection site. Some six hours later a low grade fever of 100.2 set in. The following day the fever got much worse. It reached it's highest point at 102.7 on that following Saturday and remained so for about a 24 hour period. There were terrible body aches and profuse sweating. On Sunday 08/09/2015, at midday the fever finally broke. There is still a good sized knot at the injection site but it is no longer hurting.
Age: 44.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The reaction started with a large painful bulge at the injection site. Some six hours later a low grade fever of 100.2 set in. The following day the fever got much worse. It reached it's highest point at 102.7 on that following Saturday and remained so for about a 24 hour period. There were terrible body aches and profuse sweating. On Sunday 08/09/2015, at midday the fever finally broke. There is still a good sized knot at the injection site but it is no longer hurting.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site and was seen for a follow up on 8/3/2015 and had improved.
Age: 83.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Alopecia
Clinical narrative: Initial report received from a healthcare professional on 21 November 2012. An 83-years-old female patient, whose medical history was hypothyroid, osteoporosis and was taking Iodipine. Illness at the time of vaccination was not reported. Patient had no known allergies. Received a dose of Tetanus Toxoid Ads (Lot number: U3919BA, dose number and site of vaccination not reported) intramuscularly on 01 November 2012. The patient also received Flu Vaccine (Lot number, dose number, route and site of vaccination were not reported) on an 23 October 2012. It was reported on 08 November 2012 is one week after vaccination, the patient noticed hair loss. Relevant diagnostic test and laboratory data was unknown. Corrective medications were not reported. The outcome of the event was unknown on an unspecified date. Documents held by sender: none. Follow-up information received from a healthcare professional on 13 March 2013. The patient's outcome was recovered on an unspecified date.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: I took shingles shot at pharmacy in am. My 35 year old son developed shingles by pm. Rash on face, blisters, watering eye. Went to urgent care today. Prescribed acylovir. Have ophthalmologist appointment this afternoon.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Fever of 100.6 F on 08/06/2015, fever of 101.2 on 08/07/2015, left upper arm very red, swollen and painful - approx. 6 x 5 in. Fatigue, aching knee joints, light-headedness, flu- like symptoms, chills.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever of 100.6 F on 08/06/2015, fever of 101.2 on 08/07/2015, left upper arm very red, swollen and painful - approx. 6 x 5 in. Fatigue, aching knee joints, light-headedness, flu- like symptoms, chills.