chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Patient said he did not have a problem until the third day after immunization. He said it was very sore, red, and was swollen at site of injection. He also said that he became very weak and tired and also felt very dizzy. The next day he said he was much better.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Patient said he did not have a problem until the third day after immunization. He said it was very sore, red, and was swollen at site of injection. He also said that he became very weak and tired and also felt very dizzy. The next day he said he was much better.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Patient was given Adult Hep A instead of Pediatric/Adol HepA. No adverse event or reactions noted.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Haematocrit normal, Haemoglobin normal, Petechiae, Platelet count normal, Pruritus
Clinical narrative: Child started with a rash on 7/03/2017. It started on face and spread to body, was on trunk, arms and legs, neck. None in mouth, palms of hands or bottom of feet. No fever, was playing, not fussy but was scratching at times. Mother gave a dose of Ibuprofen on7/4, and made appointment on 7/5. Had numerous bumps -Purpura- Petechial .
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Purpura, Rash, Red blood cell count normal, Streptococcus test negative, White blood cell count decreased
Clinical narrative: Child started with a rash on 7/03/2017. It started on face and spread to body, was on trunk, arms and legs, neck. None in mouth, palms of hands or bottom of feet. No fever, was playing, not fussy but was scratching at times. Mother gave a dose of Ibuprofen on7/4, and made appointment on 7/5. Had numerous bumps -Purpura- Petechial .
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Feeling cold, Local swelling
Clinical narrative: Patient received Tdap on Lt. deltoid. Pt. came back on 07/05/17 and said that he felt very cold, little bit dizzy, tired, and Lt. deltoid swollen, body temperature was 98 F. He felt little dizzy and Lt. armpit swollen today. Dr. saw pt. in the clinic without new order made.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Patient complained of fatigue for 48 hours after vaccine, causing him to sleep most hours of the following two days.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypoaesthesia, Injection site induration, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Patient had a reaction from the Tdap shot, she had swelling and pain at site (site was hard and numb) then pain started to radiate to her whole arm and then to her neck (neck was stiff), she went to urgent care and they gave her pain medication and she was also prescribed prednisone 50 mg daily for 5 days. This all happened over a course of a week. Patient states she is getting better.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient had a reaction from the Tdap shot, she had swelling and pain at site (site was hard and numb) then pain started to radiate to her whole arm and then to her neck (neck was stiff), she went to urgent care and they gave her pain medication and she was also prescribed prednisone 50 mg daily for 5 days. This all happened over a course of a week. Patient states she is getting better.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reports pain in administration arm, progressive worsening, limited range of motion over time. Obtained vaccine on 11/30/2016 and states pain has been going on since time of administration, however wife states pain occurred since January. Pain described as 8 out of 10 on pain scale, throbbing, aching down to fingers on a daily basis. Patient obtained tramadol pain medication and Tylenol of which neither seemed to help per wife.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Neuralgia
Clinical narrative: Patient reported that she has neuropathic pain in the abdominal pain.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Aching and pain in my upper and lower arms, and in both thighs.
Age: 1.58
Sex: M
Vaccine: HEPA, MMR
Symptoms: Decreased appetite, Injection site rash, Lethargy, Pyrexia, Rash
Clinical narrative: Patient began experiencing right posterior shoulder rash, fever of 100.2 F and lethargy at 1700 on 7/4/2017. Patient continued to experience intermittent rash, fever and lethargy from that point on. Fever (up to 100.4 F) was treated with Ibuprofen Q6H as needed. Rash would subside within a few hours following ibuprofen administration. Patient has experienced rashes on right thigh, buttocks, right posterior shoulder, entire anterior abdomen & partial left lateral-posterior abdomen at independent times. Patient has had decreased appetite since 7/4/2017.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: 8 days after administering vaccine, pt. has red welt and warmth in vicinity of injection sight. Tenderness, no other symptom.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Product preparation error
Clinical narrative: On 6/29/17 pt was in to see FNP and received a MENVEO booster. On 6/30/17 she came in for a nursing visit appointment and C/O pain, redness, swelling and warm at the injection site. Medical Assistant informed me she was not given the complete vaccine, she was only given the liquid conjugate component. Pt was given the complete vaccine on 6/30/17 and office manager when in and spoke to the parents.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient given TDaP 6-29-17 pain in RD that day and has continuing pain as of 7-6-17. Advised to alternate hot and cold compress. Move her arm in a circular motion. Rx MEDROL dosepak.
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Fear
Clinical narrative: Fright, dizziness, lightheadedness. Laid flat on floor w/elevated legs until symptoms resolved (approximately 15-20 mins).
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Rash - urticaria - mom states about 1 hour after receiving vaccines. Mom also states allergic to multiple food and insects - no meds. Allergies.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Speech disorder, Throat tightness
Clinical narrative: Pt receiving 1st HPV-GARDASIL imm. orange juice given prior to inj. Pt sitting in chair-imm. given. 2 min later, Pt was pale and saying he was light headed and throat was tightening up/hard to speak. Pt laid down, orange juice/water, sucker given and vitals taken. Vitals WNL. 5 min later, Pt says doing better. Monitored for 25 min. Vitals still WNL, Pt said no longer dizzy and throat ok.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Rash generalised, Rash pruritic
Clinical narrative: 7/6/17 Patient's mother called and stated patient has a below 100 degree temp x 3 days following vaccines given on 6/21/17. After that, for the last 10 days has had body rash, it started itching on 7/5/17.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nausea, Pain, Weight decreased
Clinical narrative: Live Zoster vaccine administered on 7-13-2011. Starting in December 2013 I have had shingles repeatedly. Episodes have been very severe. I have experienced ongoing weight loss and nausea and severe pain.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient received the GARDASIL 9 vaccine as well as MENVEO in the left deltoid muscle on 6/27/2017. The day after the vaccines, the left upper arm became edematous erythematous, mildly tender to touch. She was evaluated in the office for this 6/29/2017
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: "Faint-like feeling after administration." "The day after redness and swelling started and it had progressed in site." Malaise-fatigue-myalgias-itching-rash. Given Loratadine 10mg PO.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pruritus, Rash
Clinical narrative: "Faint-like feeling after administration." "The day after redness and swelling started and it had progressed in site." Malaise-fatigue-myalgias-itching-rash. Given Loratadine 10mg PO.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Osteoarthritis, Pain in extremity, X-ray limb abnormal
Clinical narrative: Patient felt pain in left thumb after injection was received in (L) arm. After evaluation by ortho - thumb xray revealed stage 3 CMC joint degeneration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Malaise, Pyrexia, Rash
Clinical narrative: Pt reported raised circular painful rash approx 4" in diameter around injection site, starting day of injection and continuing several days later. Also had fever and malaise evening of vaccination.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Dermatitis, Erythema, Pruritus
Clinical narrative: Vaccine caused severe erythema, inflammation of skin and itching.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Right arm and neck pain-began immediately after injection, mild itching. Seen 24 hours after IZ; experiencing itching and pain; physical exam normal.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: HPV Vax #1 given IM (L) deltoid with immediate discomfort in shoulder "fluid expanding the shoulder". Pain increasing over past 5 weeks with decreased range of motion and deep burning pain. Pain to palpation over deltoid and posterior rotator cuff muscles. No redness. No swelling. No drainage. No fevers. Orthopedics to evaluate shoulder joint.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema
Clinical narrative: Developed red discoloration of skin about 10 minutes after HPV 9 vaccine. Redness of upper clavicle, upper back, upper arms. Observed 30 min. Lungs - clear, vital signs stable throughout. Sent home. Dad called 2 hr later "fine".
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Day after immunization pt had 6cmx5cmx2cm red raised area on Lt deltoid. Area stayed red and raised for 5 days.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dysphonia, Hypophagia, Irritability, Poor feeding infant
Clinical narrative: Pt experienced irritability and fussiness 5 hours after vaccine; she then developed hoarse voice that persisted for several days. Also decreased PO intake and feeding difficulties for 2 days. No fever, no wheeze, no respiratory distress.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Feeding disorder, Loss of personal independence in daily activities
Clinical narrative: In bed two days, couldn't eat, missed my meds, severe arm and shoulder pain, upset stomach, nausea, dizziness, shortness of breath, unable to do my work-activities, not easy, missed morning exercises, couldn't lay on my side, etc.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Musculoskeletal pain, Nausea, Pain in extremity
Clinical narrative: In bed two days, couldn't eat, missed my meds, severe arm and shoulder pain, upset stomach, nausea, dizziness, shortness of breath, unable to do my work-activities, not easy, missed morning exercises, couldn't lay on my side, etc.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Pruritus generalised, Throat tightness, Urticaria
Clinical narrative: Itching/hives all over body. Anaphylaxis reaction/"throat closing". Administered EPIPEN 0.3 mg.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Left upper arm redness and pain from shoulder to elbow. Raised areas x 2, inner arm welt. 3:54 pm 7/3 - follow up call - feels better after ibuprofen and ice. Looks better per patient.
Age: 98.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Skin warm
Clinical narrative: Patient states discomfort since injection. Redness is located on the anterior portion of right shoulder. Surrounding skin abnormally hot (right lateral shoulder extending to right upper chest) with region of surrounding erythema, TTP and warmth approximately 6 inch x 8 inch. Treated with doxycycline hydrate 100 mg BID for 10 days.
Age: 98.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: Patient states discomfort since injection. Redness is located on the anterior portion of right shoulder. Surrounding skin abnormally hot (right lateral shoulder extending to right upper chest) with region of surrounding erythema, TTP and warmth approximately 6 inch x 8 inch. Treated with doxycycline hydrate 100 mg BID for 10 days.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Dizziness, Nausea, Fainting/Syncope. BP checked 98/60 L Patient advised she did not eat prior to vaccine. Patient was instructed to set on floor. Patient was eventually moved to bed/table and instructed to lay down. Patient was assisted with the above: time/request. Patient left office at 9:40 AM. Per patient she started period today.
Age: 1.08
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall
Clinical narrative: Gave vaccines at 8 AM-Pt. sat in lobby for 20 minutes nurse found pt. "laying on floor" at 820. B/P 110/68, PEERL and A at 0x3. EMS called due to previous head injury this past December. Evaluation completed by EMS, mom declined hospital at this time.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Approximately 9 days after vaccination a 1 cm tender indurated lump in left upper lateral thigh appeared. Had physician appointment on 07-05-17. Dx - cellulitis lower extremity. Rx-cephalexin.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left lower extremity.
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Laboratory test, Pyrexia
Clinical narrative: Child became febrile one week after vaccination. Fever lasted a month and a half and reached as high as 103.4.
Sex: M
Vaccine: MENB
Symptoms: Peripheral swelling, Swelling, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of welts in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced welts and swelling. On an unknown date, the outcome of the welts and swelling were unknown. It was unknown if the reporter considered the welts and swelling to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported to the representative that patient's (HCP's son) arm blew up and there was a welt on his arm. No additional information was provided. The reporter would like a follow up from the safety department.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a adult female patient who received FLULAVAL Quadrivalent (batch number Y7X9Z, expiry date 30th April 2017). In September 2016, the patient received FLULAVAL Quadrivalent. In September 2016, 1 day after receiving FLULAVAL Quadrivalent, the patient experienced injection site warmth, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site swelling were recovered/resolved. The reporter considered the injection site warmth, injection site erythema and injection site swelling to be almost certainly related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced warm, raised and red areas around the injection site. The area was noted to be approximately 2 to 3 inches in diameter. In about 2 days all events were resolved without further medical attention. The health care professional stated that no other vaccines were administered on the same day. No further information was provided. This case was one of the 4 cases, reported by same reporter. The reported lot number (Y7X92) for FLULAVAL Quadrivalent did not exist and was updated to Y7X9Z, according to sales database.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 6-year-old male patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). In September 2016, the patient received FLULAVAL QUADRIVALENT. On an unknown date, 1 day after receiving FLULAVAL QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb, injection site warmth and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were recovered/resolved and the outcome of the injection site erythema was unknown. The reporter considered the extensive swelling of vaccinated limb, injection site warmth and injection site erythema to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient experienced warm, raised, red areas in around the injection site. The injection site reactions extended from shoulder to elbow, which led to extensive swelling of vaccination limb. In about 2 days all events were resolved without further medical attention. The health care professional stated that no other vaccines were administered on the same day. The reported lot number (Y7X92) for FLULAVAL QUADRIVALENT did not exist and was updated to Y7X9Z, according to sales database. No further information was provided. This case was one of the 4 cases, reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a adult female patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). In September 2016, the patient received FLULAVAL QUADRIVALENT. In September 2016, 1 day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site warmth, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced warm, raised and red area around the injection site. The area was noted to be approximately 2 to 3 inches in diameter. In about 2 days all events were resolved without further medical attention. The health care professional stated that no other vaccines were administered on the same day. The reporter lot number (Y7X92) for FLULAVAL QUADRIVALENT season did not exist and was updated to Y7X9Z, according to sales database. No further information was provided. This case was one of the 4 cases, reported by the same reporter.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Staphylococcal infection, Surgery
Clinical narrative: I received a Pneumococcal 13 valent conjugate (PREVNAR 13) shot and two weeks later developed MRSA in my right knee. After the shot, I was hospitalized, I had no open wounds. I had to have three surgeries and I almost died, three weeks in the hospital and five weeks in a nursing home.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Rash
Clinical narrative: Loss of muscle strength in arm, severe pain, unable to lift arm above head or stretch it out. By Sunday 19th I was rushed to a walk-in centre. TORADOL 60 mg, ADVIL, BENADRYL 25 mg. I have been forced to have weekly massage/PT.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: Loss of muscle strength in arm, severe pain, unable to lift arm above head or stretch it out. By Sunday 19th I was rushed to a walk-in centre. TORADOL 60 mg, ADVIL, BENADRYL 25 mg. I have been forced to have weekly massage/PT.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: Information was received from an other health professional via Pfizer, referring to a 19 year old  female patient (also reported as 2 female patients (twin girls with same reaction)). The patient did not have medical history and family medical history relevant to adverse event. The patient did not have prior vaccination within 4 weeks. On 07-JUL-2016, the patient received her first dose of TRUMENBA (in left arm, lot# reported as M95612 with expiration date in July 2017), and the patient experienced swelling, pain and redness at injection site. Information about concomitant medication was not provided. On 15-MAY-2017, the patient was vaccinated with the third dose of GARDASIL (in the left arm, lot# reported as N000326 with expiration date in October 2019, 0.5ml prefilled syringe; route and frequency were unknown) for prophylaxis. Other suspect therapy included her second dose of TRUMENBA (in the left arm, lot# reported as R56659 with expiration date in January 2019; concentration, route and frequency were unknown) for prophylaxis. On an unknown date, the patient passed out, fainted, loss of consciousness for 7-10 seconds. The patient also reported she experienced injection site erythema, injection site pain and injection site swelling on an unknown date. The vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient, and the patient waited 15 minutes and was found to be good. For the swelling, pain and redness at injection site, no treatment was sought for this. The patient did not have relevant tests. At the time of the report, the outcome of the events were recovered. The causality between events and suspect therapies was not provided. Upon internal review, loss of consciousness was determined to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Loss of consciousness, Syncope
Clinical narrative: Information was received from an other health professional via Pfizer, referring to a 19 year old  female patient (also reported as 2 female patients (twin girls with same reaction)). The patient did not have medical history and family medical history relevant to adverse event. The patient did not have prior vaccination within 4 weeks. On 07-JUL-2016, the patient received her first dose of TRUMENBA (in left arm, lot# reported as M95612 with expiration date in July 2017), and the patient experienced swelling, pain and redness at injection site. Information about concomitant medication was not provided. On 15-MAY-2017, the patient was vaccinated with the third dose of GARDASIL (in the left arm, lot# reported as N000326 with expiration date in October 2019, 0.5ml prefilled syringe; route and frequency were unknown) for prophylaxis. Other suspect therapy included her second dose of TRUMENBA (in the left arm, lot# reported as R56659 with expiration date in January 2019; concentration, route and frequency were unknown) for prophylaxis. On an unknown date, the patient passed out, fainted, loss of consciousness for 7-10 seconds. The patient also reported she experienced injection site erythema, injection site pain and injection site swelling on an unknown date. The vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient, and the patient waited 15 minutes and was found to be good. For the swelling, pain and redness at injection site, no treatment was sought for this. The patient did not have relevant tests. At the time of the report, the outcome of the events were recovered. The causality between events and suspect therapies was not provided. Upon internal review, loss of consciousness was determined to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Limb discomfort, Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: Information was received from an other health professional via Pfizer, referring to a 19 year old  female patient (also reported as 2 female patients (twin girls with same reaction)). The patient did not have medical history and family medical history relevant to adverse event. The patient did not have prior vaccination within 4 weeks. On 07-JUL-2016, the patient received her first dose of TRUMENBA (in left arm, lot# reported as M95612 with expiration date in July 2017), and the patient experienced swelling, pain and redness at injection site. Information about concomitant medication was not provided. On 15-MAY-2017, the patient was vaccinated with the third dose of GARDASIL (in the left arm, lot# reported as N000326 with expiration date in October 2019, 0.5ml prefilled syringe; route and frequency were unknown) for prophylaxis. Other suspect therapy included her second dose of TRUMENBA (in the left arm, lot# reported as R56659 with expiration date in January 2019; concentration, route and frequency were unknown) for prophylaxis. On an unknown date, the patient passed out, fainted, loss of consciousness for 7-10 seconds. The patient also reported she experienced injection site erythema, injection site pain and injection site swelling on an unknown date. The vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient, and the patient waited 15 minutes and was found to be good. For the swelling, pain and redness at injection site, no treatment was sought for this. The patient did not have relevant tests. At the time of the report, the outcome of the events were recovered. The causality between events and suspect therapies was not provided. Upon internal review, loss of consciousness was determined to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Information was received from an other health professional via Pfizer, referring to a 19 year old  female patient (also reported as 2 female patients (twin girls with same reaction)). The patient did not have medical history and family medical history relevant to adverse event. The patient did not have prior vaccination within 4 weeks. On 07-JUL-2016, the patient received her first dose of TRUMENBA (in left arm, lot# reported as M95612 with expiration date in July 2017), and the patient experienced swelling, pain and redness at injection site. Information about concomitant medication was not provided. On 15-MAY-2017, the patient was vaccinated with the third dose of GARDASIL (in the left arm, lot# reported as N000326 with expiration date in October 2019, 0.5ml prefilled syringe; route and frequency were unknown) for prophylaxis. Other suspect therapy included her second dose of TRUMENBA (in the left arm, lot# reported as R56659 with expiration date in January 2019; concentration, route and frequency were unknown) for prophylaxis. On an unknown date, the patient passed out, fainted, loss of consciousness for 7-10 seconds. The patient also reported she experienced injection site erythema, injection site pain and injection site swelling on an unknown date. The vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient, and the patient waited 15 minutes and was found to be good. For the swelling, pain and redness at injection site, no treatment was sought for this. The patient did not have relevant tests. At the time of the report, the outcome of the events were recovered. The causality between events and suspect therapies was not provided. Upon internal review, loss of consciousness was determined to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information was received from an other health professional via Pfizer, referring to a 19 year old  female patient (also reported as 2 female patients (twin girls with same reaction)). The patient did not have medical history and family medical history relevant to adverse event. The patient did not have prior vaccination within 4 weeks. On 07-JUL-2016, the patient received her first dose of TRUMENBA (in left arm, lot# reported as M95612 with expiration date in July 2017), and the patient experienced swelling, pain and redness at injection site. Information about concomitant medication was not provided. On 15-MAY-2017, the patient was vaccinated with the third dose of GARDASIL (in the left arm, lot# reported as N000326 with expiration date in October 2019, 0.5ml prefilled syringe; route and frequency were unknown) for prophylaxis. Other suspect therapy included her second dose of TRUMENBA (in the left arm, lot# reported as R56659 with expiration date in January 2019; concentration, route and frequency were unknown) for prophylaxis. On an unknown date, the patient passed out, fainted, loss of consciousness for 7-10 seconds. The patient also reported she experienced injection site erythema, injection site pain and injection site swelling on an unknown date. The vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient, and the patient waited 15 minutes and was found to be good. For the swelling, pain and redness at injection site, no treatment was sought for this. The patient did not have relevant tests. At the time of the report, the outcome of the events were recovered. The causality between events and suspect therapies was not provided. Upon internal review, loss of consciousness was determined to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Syncope
Clinical narrative: Information was received from an other health professional via Pfizer, referring to a 19 year old  female patient (also reported as 2 female patients (twin girls with same reaction)). The patient did not have medical history and family medical history relevant to adverse event. The patient did not have prior vaccination within 4 weeks. On 07-JUL-2016, the patient received her first dose of TRUMENBA (in left arm, lot# reported as M95612 with expiration date in July 2017), and the patient experienced swelling, pain and redness at injection site. Information about concomitant medication was not provided. On 15-MAY-2017, the patient was vaccinated with the third dose of GARDASIL (in the left arm, lot# reported as N000326 with expiration date in October 2019, 0.5ml prefilled syringe; route and frequency were unknown) for prophylaxis. Other suspect therapy included her second dose of TRUMENBA (in the left arm, lot# reported as R56659 with expiration date in January 2019; concentration, route and frequency were unknown) for prophylaxis. On an unknown date, the patient passed out, fainted, loss of consciousness for 7-10 seconds. The patient also reported she experienced injection site erythema, injection site pain and injection site swelling on an unknown date. The vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient, and the patient waited 15 minutes and was found to be good. For the swelling, pain and redness at injection site, no treatment was sought for this. The patient did not have relevant tests. At the time of the report, the outcome of the events were recovered. The causality between events and suspect therapies was not provided. Upon internal review, loss of consciousness was determined to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: Information has been received from the Pfizer (MFR # 2017252009) on 22-JUN-2017. Information has been received from a practice manager referring to a 19 years old female patient. The patient had injection site swollen, painful and red from the first dose of TRUMENBA (given on 07-JUL-2016). The patient's concomitant therapy included VIIBRYD. The patient's concurrent condition was not reported. On 24-MAY-2017, the patient was firstly vaccinated with GARDASIL (lot # N002720, expiation date May 2019, dose 3, 0.5 ml, route not reported) in the left arm for prophylaxis. Then, approximately at 14:00 of 24-MAY-2017, the patient was vaccinated with TRUMENBA (lot # R56659, expiration date January 2019, dose 2, dose and route not reported) in the left arm for prophylaxis. After receiving TRUMENBA (approximately at 14:00), the patient passed out, fainted and lost consciousness for 7-10 seconds. When she came to, vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient. The patient waited 15 minutes and was found to be good. On an unknown date in 2017, the patient also had swelling, pain and redness at injection site. Reports area was very swollen with a hard knot, and couldn't touch it as it was very painful, very sore and throbbing at times. The patient had recovered completely on an unknown date in 2017. The causality between the events and suspect therapies was not provided. Upon internal review, the event "passed out, fainted and lost consciousness" was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA000078:
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Loss of consciousness, Syncope
Clinical narrative: Information has been received from the Pfizer (MFR # 2017252009) on 22-JUN-2017. Information has been received from a practice manager referring to a 19 years old female patient. The patient had injection site swollen, painful and red from the first dose of TRUMENBA (given on 07-JUL-2016). The patient's concomitant therapy included VIIBRYD. The patient's concurrent condition was not reported. On 24-MAY-2017, the patient was firstly vaccinated with GARDASIL (lot # N002720, expiation date May 2019, dose 3, 0.5 ml, route not reported) in the left arm for prophylaxis. Then, approximately at 14:00 of 24-MAY-2017, the patient was vaccinated with TRUMENBA (lot # R56659, expiration date January 2019, dose 2, dose and route not reported) in the left arm for prophylaxis. After receiving TRUMENBA (approximately at 14:00), the patient passed out, fainted and lost consciousness for 7-10 seconds. When she came to, vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient. The patient waited 15 minutes and was found to be good. On an unknown date in 2017, the patient also had swelling, pain and redness at injection site. Reports area was very swollen with a hard knot, and couldn't touch it as it was very painful, very sore and throbbing at times. The patient had recovered completely on an unknown date in 2017. The causality between the events and suspect therapies was not provided. Upon internal review, the event "passed out, fainted and lost consciousness" was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA000078:
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Limb discomfort, Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: Information has been received from the Pfizer (MFR # 2017252009) on 22-JUN-2017. Information has been received from a practice manager referring to a 19 years old female patient. The patient had injection site swollen, painful and red from the first dose of TRUMENBA (given on 07-JUL-2016). The patient's concomitant therapy included VIIBRYD. The patient's concurrent condition was not reported. On 24-MAY-2017, the patient was firstly vaccinated with GARDASIL (lot # N002720, expiation date May 2019, dose 3, 0.5 ml, route not reported) in the left arm for prophylaxis. Then, approximately at 14:00 of 24-MAY-2017, the patient was vaccinated with TRUMENBA (lot # R56659, expiration date January 2019, dose 2, dose and route not reported) in the left arm for prophylaxis. After receiving TRUMENBA (approximately at 14:00), the patient passed out, fainted and lost consciousness for 7-10 seconds. When she came to, vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient. The patient waited 15 minutes and was found to be good. On an unknown date in 2017, the patient also had swelling, pain and redness at injection site. Reports area was very swollen with a hard knot, and couldn't touch it as it was very painful, very sore and throbbing at times. The patient had recovered completely on an unknown date in 2017. The causality between the events and suspect therapies was not provided. Upon internal review, the event "passed out, fainted and lost consciousness" was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA000078:
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from the Pfizer (MFR # 2017252009) on 22-JUN-2017. Information has been received from a practice manager referring to a 19 years old female patient. The patient had injection site swollen, painful and red from the first dose of TRUMENBA (given on 07-JUL-2016). The patient's concomitant therapy included VIIBRYD. The patient's concurrent condition was not reported. On 24-MAY-2017, the patient was firstly vaccinated with GARDASIL (lot # N002720, expiation date May 2019, dose 3, 0.5 ml, route not reported) in the left arm for prophylaxis. Then, approximately at 14:00 of 24-MAY-2017, the patient was vaccinated with TRUMENBA (lot # R56659, expiration date January 2019, dose 2, dose and route not reported) in the left arm for prophylaxis. After receiving TRUMENBA (approximately at 14:00), the patient passed out, fainted and lost consciousness for 7-10 seconds. When she came to, vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient. The patient waited 15 minutes and was found to be good. On an unknown date in 2017, the patient also had swelling, pain and redness at injection site. Reports area was very swollen with a hard knot, and couldn't touch it as it was very painful, very sore and throbbing at times. The patient had recovered completely on an unknown date in 2017. The causality between the events and suspect therapies was not provided. Upon internal review, the event "passed out, fainted and lost consciousness" was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA000078:
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from the Pfizer (MFR # 2017252009) on 22-JUN-2017. Information has been received from a practice manager referring to a 19 years old female patient. The patient had injection site swollen, painful and red from the first dose of TRUMENBA (given on 07-JUL-2016). The patient's concomitant therapy included VIIBRYD. The patient's concurrent condition was not reported. On 24-MAY-2017, the patient was firstly vaccinated with GARDASIL (lot # N002720, expiation date May 2019, dose 3, 0.5 ml, route not reported) in the left arm for prophylaxis. Then, approximately at 14:00 of 24-MAY-2017, the patient was vaccinated with TRUMENBA (lot # R56659, expiration date January 2019, dose 2, dose and route not reported) in the left arm for prophylaxis. After receiving TRUMENBA (approximately at 14:00), the patient passed out, fainted and lost consciousness for 7-10 seconds. When she came to, vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient. The patient waited 15 minutes and was found to be good. On an unknown date in 2017, the patient also had swelling, pain and redness at injection site. Reports area was very swollen with a hard knot, and couldn't touch it as it was very painful, very sore and throbbing at times. The patient had recovered completely on an unknown date in 2017. The causality between the events and suspect therapies was not provided. Upon internal review, the event "passed out, fainted and lost consciousness" was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA000078:
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Syncope
Clinical narrative: Information has been received from the Pfizer (MFR # 2017252009) on 22-JUN-2017. Information has been received from a practice manager referring to a 19 years old female patient. The patient had injection site swollen, painful and red from the first dose of TRUMENBA (given on 07-JUL-2016). The patient's concomitant therapy included VIIBRYD. The patient's concurrent condition was not reported. On 24-MAY-2017, the patient was firstly vaccinated with GARDASIL (lot # N002720, expiation date May 2019, dose 3, 0.5 ml, route not reported) in the left arm for prophylaxis. Then, approximately at 14:00 of 24-MAY-2017, the patient was vaccinated with TRUMENBA (lot # R56659, expiration date January 2019, dose 2, dose and route not reported) in the left arm for prophylaxis. After receiving TRUMENBA (approximately at 14:00), the patient passed out, fainted and lost consciousness for 7-10 seconds. When she came to, vital signs were checked and found to be within normal limits. The patient was given a snack to be sure blood sugar was okay. The physician checked on patient. The patient waited 15 minutes and was found to be good. On an unknown date in 2017, the patient also had swelling, pain and redness at injection site. Reports area was very swollen with a hard knot, and couldn't touch it as it was very painful, very sore and throbbing at times. The patient had recovered completely on an unknown date in 2017. The causality between the events and suspect therapies was not provided. Upon internal review, the event "passed out, fainted and lost consciousness" was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA000078:
Age: 0.08
Sex: F
Vaccine: MENB, MENB
Symptoms: Poor feeding infant, Pyrexia, Somnolence, Wrong drug administered
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 1-month-old patient received a single dose of TRUMENBA (Lot# R47584) on an unknown date as immunization. Patient was seen on 08Jun2017 for 1 month checkup. Infant was supposed to receive hepatitis B vaccine but meningococcal group b rlp2086 was given in error on an unknown date. On an unspecified date the patient became febrile with temperature at 101 F and approximatively 10 hours later, was admitted to hospital. Patient was then transferred to another facility. Full septic work up was done and diagnosis was aseptic meningitis. Patient received antibiotics for 3 days. Also became anemic during hospital stay and received blood transfusion. Patient was discharged from hospital on an unknown date. Outcome of the events was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 0.08
Sex: F
Vaccine: MENB, MENB
Symptoms: Anaemia, Laboratory test abnormal, Meningitis aseptic, Pyrexia, Transfusion
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 1-month-old patient received a single dose of TRUMENBA (Lot# R47584) on an unknown date as immunization. Patient was seen on 08Jun2017 for 1 month checkup. Infant was supposed to receive hepatitis B vaccine but meningococcal group b rlp2086 was given in error on an unknown date. On an unspecified date the patient became febrile with temperature at 101 F and approximatively 10 hours later, was admitted to hospital. Patient was then transferred to another facility. Full septic work up was done and diagnosis was aseptic meningitis. Patient received antibiotics for 3 days. Also became anemic during hospital stay and received blood transfusion. Patient was discharged from hospital on an unknown date. Outcome of the events was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.