chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MENB
Symptoms: Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. This Pharmacist reported for 8 patients (students). Only 4 experienced an adverse event. This case refers to patient 5. A male patient of unknown age received TRUMENBA on unknown date at 3 PM, single dose. On unknown date the patient experienced fever and chills at 8 PM at the same day. No follow up attempts possible. No further information expected.
Sex: M
Vaccine: MENB, MENB
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported for 8 patients (students). Only 4 experienced an adverse event. This case refers to patient 4. A male patient of an unspecified age received TRUMENBA at single dose and BEXSERO, both via an unspecified route of administration on unknown date. The patient medical history and concomitant medications were not reported. The patient experienced severe myalgia so that he can't move his arm on an unspecified date with outcome of unknown. No follow-up attempt possible. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Rash macular
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported for 8 patients (students). Only 4 experienced an adverse event. This case refers to patient 3. A patient of unspecified age, gender and ethnicity received TRUMENBA on an unknown date, singe dose. Relevant medical history and concomitant medications were unknown. On unknown date, after vaccination, the patient experienced redness two inches below injection site in blotches. Clinical outcome of the events was unknown at time of this report. No follow up attempt possible. No further information expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 19-year-old female patient received the first single dose of TRUMENBA intramuscular in the left arm on 02MAR2014 at 3;30 PM as a meningococcal B outbreak was reported in the campus that the patient attended. No relevant history was reported, concomitant medication included an intrauterine contraceptive device for contraception. The patient did not receive any other vaccine in the previous eight weeks. On 02MAR2015 her arm initially hurt. On 03MAR2015 the patient experienced fatigue, severe spinal pain radiating through her body, achy joints, she was nauseous and she was feeling abnormal (really funky). No investigation, emergency room visit or physician visit were performed. Outcome of arm hurt and feeling really funky was unknown, the patient did not recover from the other reported events. Follow-up (03MAR2015): New information reported from the same contactable consumer includes: reaction data (new event she was feeling abnormal (really funky) was added, new details on event spinal pain were provided). Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Spinal pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 19-year-old female patient received the first single dose of TRUMENBA intramuscular in the left arm on 02MAR2014 at 3;30 PM as a meningococcal B outbreak was reported in the campus that the patient attended. No relevant history was reported, concomitant medication included an intrauterine contraceptive device for contraception. The patient did not receive any other vaccine in the previous eight weeks. On 02MAR2015 her arm initially hurt. On 03MAR2015 the patient experienced fatigue, severe spinal pain radiating through her body, achy joints, she was nauseous and she was feeling abnormal (really funky). No investigation, emergency room visit or physician visit were performed. Outcome of arm hurt and feeling really funky was unknown, the patient did not recover from the other reported events. Follow-up (03MAR2015): New information reported from the same contactable consumer includes: reaction data (new event she was feeling abnormal (really funky) was added, new details on event spinal pain were provided). Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous
Clinical narrative: This initial case was missing the following minimum criteria: no specified suspect product was present. Upon receipt of follow-up information on 05MAR2015, this case now contains all required information to be considered valid. Follow-up (05MAR2015): This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on 02MAR2015. The patient medical history and concomitant medications were not reported. The patient got red bumps near the injection site on 04MAR2015. Outcome of event was unknown. The consumer asked if other reports of red bumps near the injection site were received. Follow-up (10APR2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Hypersensitivity, Incorrect product storage, Oral pruritus
Clinical narrative: This is a spontaneous report from a contactable physician (who reported for her daughter) via a sales representative. A child female patient of unspecified age received TRUMENBA on unknown date in FEB2015 (mentioned as the week before the report), at single dose. Medical history and concomitant medications were not reported. On unknown date in FEB2015, while transporting the vaccine on her own, the physician mentioned that it froze. In FEB2015, the patient experienced allergy in palate with outcome of recovered. The patient also experienced allergic reaction with itching in her mouth that improved with BENADRYL. Follow-up (17FEB2015): new information received from a contactable physician via sales representative includes: new events. Follow-up (27MAR2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This patient of an unspecified age, and gender receive the first single dose of TRUMENBA via an unspecified route of administration on 27Apr2015 at approximately 1:30 PM. The patient medical history and concomitant medications were not reported. While the injection site did not hurt at first, within a few hours (at approximately 4 PM) sharp pain at the injection site and in the surrounding muscle had developed, as well as a moderate headache. The patient took ALEVE for the pain at approximately 5:45 PM. By 9 PM the pain had reduced, and the headache was gone. In the morning of 28Apr2015 she only had a moderate soreness in the arm that received the injection, headache was not present. Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Hypoaesthesia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his daughter. The reporter was reporting for his two daughters. A 16-year-old female patient started to receive TRUMENBA, via an unspecified route of administration at single dose on 24Apr2015. The patient medical history and concomitant medications were not reported. In Apr 2015, the patient experienced chills with outcome of not recovered, fever with outcome of not recovered, numbness of leg with outcome of unknown. Therapeutic measures were taken as a result of chills and fever.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Hypoaesthesia, Pyrexia
Clinical narrative: .This is a spontaneous report from a contactable consumer who reported for his daughter. The reporter was reporting for his two daughters. A 14-year-old female patient received TRUMENBA, via an unspecified route of administration, at single dose, on 24Apr2015. The patient medical history and concomitant medications were not reported. In Apr2015, the patient experienced chills, fever and numbness of leg. The patient received ADVIL as therapeutic measures, taken for chills and fever. The patient did not recover from chills and fever; while clinical outcome of the event, numbness of leg, was unknown
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Pyrexia, Vision blurred
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a sales representative. This pharmacist (mother) reported same event for two patients. This is the second of two reports. A 15-year old male patient received, on 17APR2015, TRUMENBA intramuscularly in deltoid, at 0.5 ml, single dose. Vaccines given on the same date along with TRUMENBA were none. Vaccines given within four weeks of administration of TRUMENBA were none. Relevant medical history and concomitant medications were unknown. On 18APR2015 at 1:30 AM, the patient experienced fever, chills. In the afternoon of the same day, on 18APR2015, the dizziness and blurred vision began. Clinical outcome of the events was unknown at time of this report.
Sex: F
Vaccine: MENB
Symptoms: Glossodynia, Injection site swelling
Clinical narrative: This is a spontaneous report from a non clinical study program for a contactable consumer who reported for her daughter. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 03MAR2015 at single dose. The patient medical history and concomitant medications were not reported. In MAR2015, 1-2 weeks after vaccination, the patient experienced had a lot of pain in her tongue. On an unspecified date the patient developed a pea sized swelling at the injection site. The outcome of the events was unknown. Follow up (06APR2015): New information from a contactable consumer included: new event, vaccination date.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Muscle tightness, Neck pain
Clinical narrative: This is a spontaneous report from a non-clinical study program. A 19-year-old male patient received TRUMENBA vaccine because there was a meningitis outbreak at his school on 13MAR2015 at 4:00 PM or 5:00 PM on left arm. The following day the vaccination the patient received prednisone table for him headaches. The patient had a history of concussion, and really bad headaches two or three weeks after  concussion. On unknown date after vaccination the patient experienced neck sore and tense and back soreness and tense. He did not sure if they were related to TRUMENBA or prednisone. The outcome of the events back tense and soreness was reported as recovered while the outcome of the events neck sore and tense was not recovered.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Malaise, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician through a sales representative. A female patient (a college student) of unknown age received on unknown date TRUMENBA 0.5 ml single dose, intramuscular. The patient experienced redness and swelling of the arm and general malaise that went away after one day. The outcome of the other two events was unknown. Follow-up (07MAY2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable physician. A female patient of an unspecified age received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced gradually spreading diffuse pruritic rash over several days again starting about 24 hours post the vaccination, on an unspecified date. The outcome of the reported event was unknown at the time of this report. Follow-up (06MAY2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Chest X-ray normal, Full blood count normal, Pyrexia, Wheezing
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unknown age and gender received TRUMENBA single dose on unknown date. The patient experienced wheezing 24  hours post vaccination. No history of asthma or ever having wheezing. The patient also experienced a slight fever on unknown date. The patient received albuterol and QVAR as treatment for the event wheezing. Chest X-ray was clear and full blood count was unremarkable. The outcome of the events was unknown. Follow-up (08MAY2015): Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Back pain, Chills, Fatigue, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 22-year-old female patient received the first single dose of TRUMENBA intramuscular in the right arm on 05MAR2015 at 02:30 PM against diphtheria meningitis which was going around the campus that she was attending. The patient had not any other relevant conditions and hse had not received any concomitant medications. No other vaccine was administered in the previous eight weeks. On 05MAR2015 she had soreness at the injection site, on an unspecified date in MAR2015 (unknown if on 05MAR2015 or 06MAR2015) she experienced tiredness, on 06MAR2015 at 11 AM chills appeared, at 12 she had soreness stomach, a bad stomach ache and at an unknown time she experienced soreness on lower back, thighs and other arm. Due to the reported events, the patient did not visit medical doctor or emergency room. No relevant tests were performed. The patient did not recover from the reported events at the time of this report. Follow-up (15APR2015): Follow-up attempts completed.  No further information expected.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 22-year-old female patient received the first single dose of TRUMENBA intramuscular in the right arm on 05MAR2015 at 02:30 PM against diphtheria meningitis which was going around the campus that she was attending. The patient had not any other relevant conditions and hse had not received any concomitant medications. No other vaccine was administered in the previous eight weeks. On 05MAR2015 she had soreness at the injection site, on an unspecified date in MAR2015 (unknown if on 05MAR2015 or 06MAR2015) she experienced tiredness, on 06MAR2015 at 11 AM chills appeared, at 12 she had soreness stomach, a bad stomach ache and at an unknown time she experienced soreness on lower back, thighs and other arm. Due to the reported events, the patient did not visit medical doctor or emergency room. No relevant tests were performed. The patient did not recover from the reported events at the time of this report. Follow-up (15APR2015): Follow-up attempts completed.  No further information expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Eye irritation, Fatigue, Feeling hot, Headache
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 19 year-old female patient received on 03MAR2015, TRUMENBA intramuscular on left arm, single dose. No other vaccines were received. Relevant medical history was unknown. Concomitant medications included oral MICROGESTIN, 1/20 tables) once a daily, for birth control and fluticasone (nasal spray) as needed used to relieve stuffy (caused by an allergy). On 05MAR2015, the patient experienced lightheadedness, fatigue, dizziness, feeling of warmth, sweating, nausea, irritation of eyes, and headache. On an unspecified date, the patient was feeling like she was going to faint. No hospitalization was required. The patient was recovering from the event, nausea. Clinical outcome of the event "felt faint" was unknown; while clinical outcome of the other events was reported as not recovered.  Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. A 19 year-old female patient received on 03MAR2015, TRUMENBA intramuscular on left arm, single dose. No other vaccines were received. Relevant medical history was unknown. Concomitant medications included oral MICROGESTIN, 1/20 tables) once a daily, for birth control and fluticasone (nasal spray) as needed used to relieve stuffy (caused by an allergy). On 05MAR2015, the patient experienced lightheadedness, fatigue, dizziness, feeling of warmth, sweating, nausea, irritation of eyes, and headache. On an unspecified date, the patient was feeling like she was going to faint. No hospitalization was required. The patient was recovering from the event, nausea. Clinical outcome of the event "felt faint" was unknown; while clinical outcome of the other events was reported as not recovered.  Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 19-year-old female patient of unknown ethnicity received at school first single dose of TRUMENBA on 03MAR2015 16:30 intramuscular injection in left upper arm. Once of the students at the school previously died from meningitis, so the school offered vaccines to the other students. Concomitant medications were none, no other vaccines were given on the same date or within four weeks. The patient never had adverse events with prior vaccinations, nor her siblings  had adverse events with prior vaccinations. The patient had not a relevant medical history. No relevant testing. The patient was not ill at time of vaccination. On 04MAR2015 the patient experienced left arm a little swollen, 2 red non-raised blotches in left arm (described as one blotch about 3 inches below the injection site, and the second blotch about nickel size, to the right of the first one), soreness in left arm at level 4 on 1-10 scale and left arm warm to touch. The patient went to the school health clinic where she was instructed to draw a circle around the red areas and if the areas got bigger than to go back to health clinic. The event 2 red non-raised blotches in left arm was noticed on 04MAR2015 at about 17:30. The red blotches were bigger on the following morning on 05MAR2015. As of 05MAR2015, outcome of the events left arm a little swollen and 2 red non-raised blotches in left arm was not recovered, while outcome of soreness in left arm at level 4 on 1-10 scale and left arm warm to the touch was unknown. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old female patient received TRUMENBA (lot # J29203, Exp date JUN2016 NDC# 100000008535) via an unspecified route of administration in left deltoid, on 01JUL2015 at 11:00 AM. The patient had no significant medical history. Concomitant medications included ORTHO TRI-CYCLEN, oral at 35 ug daily. The patient experienced fever of 100.1, vomiting and significant redness at injection site on 02JUL2015. Fever of 100.1 and vomiting recovered on 03JUL2015, outcome of significant redness at injection site was unknown.
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a non-contactable nurse. A female patient of unspecified age received the first single dose of TRUMENBA on unknown date. Medical history and concomitant medications were not provided. One day after vaccination the patient developed rash on her face, neck and her leg. Event outcome was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable Reporter who reported for a consumer. A female patient of an unspecified age and ethnicity started to receive TRUMENBA via an unspecified route of administration at unknown dose from an unspecified ate to an unspecified date for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced hives on her face and on her legs on an unspecified date with outcome of unknown. Follow-up (22JUL2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for his son. A male patient of unknown age and ethnicity received TRUMENBA, single dose on unknown date. After vaccination the arm was got all red which was about 10 inches long and painful. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient mother) via a non-clinical study program. This consumer reported similar events for 2 patients. This is the 2nd of 2 reports. A 19 years old male patient of an unspecified age and ethnicity received the first dose of TRUMENBA Lot number and Expiration Date: J28923, JUN2016, in the arm at 0.5 ml single on 20JUN2015. The patient was not taking any other medications and was not having any other medical conditions. On 21JUN2015, the patient experienced swelling and tenderness of lymph node  under arm where vaccine was given. The events were described as tenderness at the injection site, glands at the injection site swelling under the arm. The events had resolved. The patient's brother reported the same events after administration of the same vaccine (first dose). The patient did not undergo any lab work. No doctor was consulted. The reported stated that she decided to give ADVIL because of the tenderness at the injection site. Follow-up (22JUN2015): New information from a contactable consumer via a non-clinical study program, includes: patient age, ethnicity, height, weight, vaccination date, events details, onset date, outcome, treatment received. Follow-up (16JUL2015): New from a contactable consumer: This Consumer reported in response to the Non HCP letter sent which includes: Lot Number and Expiration Date, onset date and outcome. Follow-up (16JUL2015): This follow up report contains no new safety information.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Eye swelling, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient mother) via a non-clinical study program. This consumer reported similar events for 2 patients. This is the 2nd of 2 reports. A 19 years old male patient of an unspecified age and ethnicity received the first dose of TRUMENBA Lot number and Expiration Date: J28923, JUN2016, in the arm at 0.5 ml single on 20JUN2015. The patient was not taking any other medications and was not having any other medical conditions. On 21JUN2015, the patient experienced swelling and tenderness of lymph node  under arm where vaccine was given. The events were described as tenderness at the injection site, glands at the injection site swelling under the arm. The events had resolved. The patient's brother reported the same events after administration of the same vaccine (first dose). The patient did not undergo any lab work. No doctor was consulted. The reported stated that she decided to give ADVIL because of the tenderness at the injection site. Follow-up (22JUN2015): New information from a contactable consumer via a non-clinical study program, includes: patient age, ethnicity, height, weight, vaccination date, events details, onset date, outcome, treatment received. Follow-up (16JUL2015): New from a contactable consumer: This Consumer reported in response to the Non HCP letter sent which includes: Lot Number and Expiration Date, onset date and outcome. Follow-up (16JUL2015): This follow up report contains no new safety information.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a non-clinical study program, by a contactable consumer (the mother) who reported similar events for two patients (her two sons). This is the first of two reports. A 21-year-old male patient received TRUMENBA, Lot Number and Expiration Date: J28923 JUN2016 via an unspecified route of administration at 0.5 ml, single on 20JUN2015. The patient was not having any other medical conditions and as not taking any other  medications. On 21JUN2015, the patient experienced swelling and tenderness of lymph node under arm/tenderness at the injection site/glands at the injection site are swelling under the arms. Therapeutic measures taken as a result of the events included administration of ADVIL. The patient did not undergo any lab work. The outcome of the events was recovered. The patient's brother reported the same events after administration of the same vaccine (first dose). Follow-up (22JUN2015): New information from a non-clinical study program, by a contactable consumer (mother) includes: report type from spontaneous, patient's age, date of administration, details of the events, onset and outcome, treatment. Follow-up (16JUL2015) and 6JUL2015): New information from a non-clinical study program, by a contactable consumer (mother) includes: vaccine details, event onset and outcome.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Fatigue, Grip strength decreased, Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer via a non-clinical study program. A 21-year old female patient (weight was between 166 pounds to 170 pounds) received first dose of TRUMENBA on 04MAR2015 at single dose in arm after an outbreak of meningitis. Medical history included ongoing seasonal allergy. Concomitant medications were not reported. On 04MAR2015, after receiving the vaccine, she felt a little tired and nauseated and her arm started feeling really weak; initially her arm was sore where shot was received (on 04MAR2015), then the soreness spread on unspecified date in MAR2015. She could not sleep on the side she received the vaccine because it was sore and kept her awake. On 05MAR2015 she could not lift her arm very far, she could not lift her wrist, elbow or shoulder for about a week after getting the vaccine. On 06MAR2015 she did not have enough strength in her arm to move it around. She stated she did not remember if her arm felt heavy and if it did, it was not very much. On an unknown date all limbs were weak, she could move fingers but they were weak. She could not clinch her hand to hold stuff.  No hospitalization was required. She was treated with acetaminophen for soreness on the site of vaccination which helped a little bit. No treatment was received for the other events. Fatigue resolved on 07MAR2015, felt nauseated resolved on 05MAR2015. The other reported events resolved on an unspecified date. She did not receive her second dose of TRUMENBA which was scheduled in MAY2015. Follow-up attempts completed. No further information expected. Follow up (30JUN2015). This is a follow up spontaneous report from a contactable consumer. The same contactable consumer reported in response to the telephone follow-up activities that included: events outcomes and details. Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Muscular weakness, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer via a non-clinical study program. A 21-year old female patient (weight was between 166 pounds to 170 pounds) received first dose of TRUMENBA on 04MAR2015 at single dose in arm after an outbreak of meningitis. Medical history included ongoing seasonal allergy. Concomitant medications were not reported. On 04MAR2015, after receiving the vaccine, she felt a little tired and nauseated and her arm started feeling really weak; initially her arm was sore where shot was received (on 04MAR2015), then the soreness spread on unspecified date in MAR2015. She could not sleep on the side she received the vaccine because it was sore and kept her awake. On 05MAR2015 she could not lift her arm very far, she could not lift her wrist, elbow or shoulder for about a week after getting the vaccine. On 06MAR2015 she did not have enough strength in her arm to move it around. She stated she did not remember if her arm felt heavy and if it did, it was not very much. On an unknown date all limbs were weak, she could move fingers but they were weak. She could not clinch her hand to hold stuff.  No hospitalization was required. She was treated with acetaminophen for soreness on the site of vaccination which helped a little bit. No treatment was received for the other events. Fatigue resolved on 07MAR2015, felt nauseated resolved on 05MAR2015. The other reported events resolved on an unspecified date. She did not receive her second dose of TRUMENBA which was scheduled in MAY2015. Follow-up attempts completed. No further information expected. Follow up (30JUN2015). This is a follow up spontaneous report from a contactable consumer. The same contactable consumer reported in response to the telephone follow-up activities that included: events outcomes and details. Follow-up attempts completed. No further information expected.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (father). A 12-year-old male patient of unknown ethnicity received the first dose of TRUMENBA, lot number J296203 at 0.5 ml single dose on 16JUN2015. Medical history and concomitant medications were not reported. Approximately 12 hours from receiving the injection, on 16JUN2015, the patient developed a temperature of 37.6, fatigue, nausea. The patient also got sick overnight (16JUN2015). Temperature returned to normal with ibuprofen, then on 17JUN2015, the patient vomited and temperature reached highest point of 38.7C. Outcome was unknown. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported for her daughter, and then from a contactable physician. A 18-year-old female patient received first dose of TRUMENBA (lot # J29203x6116), intramuscular in left deltoid, on 11Jun2015 at 03:30 pm, at 0.5 ml single. Relevant medical history included appendectomy in 2009, urticarial on 30May2013 and allergy to AMOXIL. Concomitant medication included ALEVE as needed when she had her cycle. On 11Jun2015 injection site was hurting and it swelled up very bad, it was very painful, the patient had chills and temperature rising (it had not hit 100, she did not measure at that time, she had broken out in rash and had also elevation of white blood count. Nausea and really bad headache developed on 12Jun2015 at 02:00 am. The patient was taken to the Emergency Room at the hospital because headache was so bad and the temperature did not go down. The patient had unspecified laboratory work in the emergency room on 12Jun2015 that revealed she did not had any infection. Full blood count on 12Jun2015 revealed elevation of white blood count. The patient was then discharged. On an unknown date the patient also experienced urticarial. The patient too ADVIL on 12Jun2015 at 07:00 am but it did not help for headache and put little bit of liquid in. The patient was given also BENADRYL, and TYLENOL. Rash went away and swelling went down and she was pretty sure that she was reacting to vaccine. The doctor put her on prednisone when she was returning to normal. Pharmacist mentioned that eh patient was recovering. The pharmacist mentioned that all the side effects (tenderness, swelling, nausea, headache, chills and temperature rising) that the patient had were all because of vaccine. The patient was brought to the pediatrician on `3Jun2015 and he also agreed that the meningitis vaccine did it. The physician considered that meningococcal group b rlp2-086 had a causal effect to the adverse events and that there were no adverse reactions related to ibuprofen. Follow-up (29Jun2015): New information from a contactable physician included: reporter's assessment. Follow up (06Jul2015): new information received from a contactable physician includes: TRUMENBA lot# updated, treatment updated, medical history updated, causal relationship updated. Follow-up attempts. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Rash, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported for her daughter, and then from a contactable physician. A 18-year-old female patient received first dose of TRUMENBA (lot # J29203x6116), intramuscular in left deltoid, on 11Jun2015 at 03:30 pm, at 0.5 ml single. Relevant medical history included appendectomy in 2009, urticarial on 30May2013 and allergy to AMOXIL. Concomitant medication included ALEVE as needed when she had her cycle. On 11Jun2015 injection site was hurting and it swelled up very bad, it was very painful, the patient had chills and temperature rising (it had not hit 100, she did not measure at that time, she had broken out in rash and had also elevation of white blood count. Nausea and really bad headache developed on 12Jun2015 at 02:00 am. The patient was taken to the Emergency Room at the hospital because headache was so bad and the temperature did not go down. The patient had unspecified laboratory work in the emergency room on 12Jun2015 that revealed she did not had any infection. Full blood count on 12Jun2015 revealed elevation of white blood count. The patient was then discharged. On an unknown date the patient also experienced urticarial. The patient too ADVIL on 12Jun2015 at 07:00 am but it did not help for headache and put little bit of liquid in. The patient was given also BENADRYL, and TYLENOL. Rash went away and swelling went down and she was pretty sure that she was reacting to vaccine. The doctor put her on prednisone when she was returning to normal. Pharmacist mentioned that eh patient was recovering. The pharmacist mentioned that all the side effects (tenderness, swelling, nausea, headache, chills and temperature rising) that the patient had were all because of vaccine. The patient was brought to the pediatrician on `3Jun2015 and he also agreed that the meningitis vaccine did it. The physician considered that meningococcal group b rlp2-086 had a causal effect to the adverse events and that there were no adverse reactions related to ibuprofen. Follow-up (29Jun2015): New information from a contactable physician included: reporter's assessment. Follow up (06Jul2015): new information received from a contactable physician includes: TRUMENBA lot# updated, treatment updated, medical history updated, causal relationship updated. Follow-up attempts. No further information expected.
Age: 14.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Fatigue, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable other HCP via Pfizer sales representative. This reporter reported for 2 patients. This is 2nd of 2 reports. A 14-year-old male patient of an unspecified ethnicity received TRUMENDA (lot J29203, exp. date Jun2016, NDC number: 300050100102) intramuscular in left deltoid 15:03 at 0.5 ml single dose, and GARDASIL (lot L001312, exp. date 24Feb2017, NDC number: 0006412102) intramuscular on right deltoid at 0.5 ml single dose, both on 10Jun2015 3:30 pm (flu like symptoms). The patient medical history was not reported. Concomitant medication were not reported. The patient experienced fatigue on 11Jun2015 and flu like symptom on an unspecified date. The AEs did not require an emergency room or physician visit. The patient did not recover from the event fatigue but the outcome of the event flu like symptom was unknown. The final action taken with the products was to continue to monitor the child. This patient had a sister that received the same vaccine on 10Jun2015 and experienced the same adverse events. The reporter was provided with the information regarding the adverse events by the patient. The reporter considered the Pfizer product had a causal effect to the adverse event. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (23Jul2015): New information received from a contactable other-HCP on behalf of physician includes: HPV-9 set as suspect; TRUMENDA and HPV-9 indication and vaccination date; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable other HCP via Pfizer sales representative. This reporter reported for two patients. This is first of two reports. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA (lot J29203, exp. date 30Jun2016, NDC number: 300050100102), intramuscular in left deltoid on 10Jun2015 at 15:03 at 0.5 ml single dose. The patient medical history was not reported. Concomitant medication included MENVEO (lot A14091, exp. date 30Nov2015, NDC number: 46028020801), intramuscular in right deltoid at 0.5ml single doss on unknown date in 2010. The patient experienced fatigue on 11Jun2015 and flu like symptoms on an unspecified date. The outcome of the event fatigue was not recovered, while the outcome of the event flu like symptom was reported as unknown. This patient had a brother that received the same vaccine on 10Jun2015 and experienced the same adverse events. Follow-up (23Jul2015): New information received from a contactable other-HCP includes: Vaccines Lot # and expiration date updated. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a sale representative. A patient of an unspecified age, gender and ethnicity received, on an unknown date, TRUMENBA, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced rash on the arm which was larger n size (its got 4 inches big) than usual size. Clinical outcome was unknown at time of this report. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-year-old patient of unspecified gender and ethnicity received first dose of TRUMENBA, intramuscular in the arm, on an unspecified date, at 0.5 ml single, for MENACTRA, intramuscular in the arm, on an unspecified date, at 1DF single. Relevant medical history and concomitant medications were not reported. On an unspecified date the vaccines were administered intramuscularly in the same arm during the same visit. On an unspecified date the patient allegedly developed a rash. Outcome of the reported events was unknown at the time of this report. Follow-up (01AUG2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a non-contactable consumer via a non-clinical study program. A patient of unspecified age and gender received TRUMENBA at single dose, on unknown date. Medical history and concomitant medications were not provided. The patient got a rash on an unknown date after vaccine injection. Event outcome was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA, via an unspecified route of administration in the arm, on an unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced rash on the arm and burning on the site on an unspecified date. Outcome of the reported events was unknown at the time of this report. Follow-up (24JUL2015): Follow-up attempts completed. No further information expected.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Myalgia, Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on behalf of her son. A 15 years old male patient received first dose of TRUMENBA on 15May2015 at 4:45 P.M. at 0.5 ml single to prevent meningitis. Medical history included Asperger's disorder diagnosed several years ago, maybe in 2012 (before that they thought it was ADHD). Concomitant medications included ZOLOFT at 250 mg, VYNASE at 60 mg and calcium carbonate, CALTRATE SELECT gummies daily and gummy laxative do not know brand. On 18May2015 the patient experienced muscle ache in neck, headache, low fever, hives on both arms. The mother was sick for the last 4 days; she thought he had received a cold from her. The patient was recovering from hives. Outcome of the other reported events was not resolved. Follow-up (15JUL2015): Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: MEN
Symptoms: Back pain, Headache, Injection site pain, Nausea, Swelling
Clinical narrative: This is a spontaneous case from a contactable consumer who reported for herself. This 23-year-old female patient received on 17MAy2015 the first single dose of meningococcal group b rip2086 (manufacturer unknown) (lot number and expiration date not available). Concomitant medications and medical history were not reported. On 18MAY2015, the patient experienced extreme  nausea, lower back pain swelling, injection location very sore and extreme headache. On the same date the patient had the shakes a little bit. The consumer was instruction by the pharmacist to call manufacturer. Outcome was not recovered.  Follow-up (17JUL2015): Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: MEN
Symptoms: Tremor
Clinical narrative: This is a spontaneous case from a contactable consumer who reported for herself. This 23-year-old female patient received on 17MAy2015 the first single dose of meningococcal group b rip2086 (manufacturer unknown) (lot number and expiration date not available). Concomitant medications and medical history were not reported. On 18MAY2015, the patient experienced extreme  nausea, lower back pain swelling, injection location very sore and extreme headache. On the same date the patient had the shakes a little bit. The consumer was instruction by the pharmacist to call manufacturer. Outcome was not recovered.  Follow-up (17JUL2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Lymphadenopathy, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician via representative and from a contactable pharmacist. A 18 year old female patient received first single dose  TRUMENBA (lot J29203, expiry date JUN2016) on 05MAY2015. Medical history and concomitant medications were not provided. The patient experienced vomiting, limited arm movement, body weakness, swelling of arm, pain and swollen lymph under arms on unknown date. THe events did not require an emergency room or physician visit or hospitalization. No specific tests and/or treatment were required. The physician wanted to know information about the immune response after the first dose because the patient did not want to receive the succeeding shots because of these reactions. Events outcome was not provided. Causality assessment was unknown. Follow-up (19JUN2015): New information from a contactable pharmacist includes: vaccine dose number, lot number, expiry date,, vaccination date, additional event.
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via representative and from a contactable pharmacist. A 18 year old female patient received first single dose  TRUMENBA (lot J29203, expiry date JUN2016) on 05MAY2015. Medical history and concomitant medications were not provided. The patient experienced vomiting, limited arm movement, body weakness, swelling of arm, pain and swollen lymph under arms on unknown date. THe events did not require an emergency room or physician visit or hospitalization. No specific tests and/or treatment were required. The physician wanted to know information about the immune response after the first dose because the patient did not want to receive the succeeding shots because of these reactions. Events outcome was not provided. Causality assessment was unknown. Follow-up (19JUN2015): New information from a contactable pharmacist includes: vaccine dose number, lot number, expiry date,, vaccination date, additional event.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer. This 22-year-old female patient received the second dose of TRUMENBA via an unspecified route of administration on 15MAY2015. The patient medical history was not reported. Concomitant medication included APRI tablet as oral contraceptive. The patient had previously received the first dose of TRUMENBA in MAR2015. On 15MAY 2015 the patient had a lot of swelling in her arm, it was really red and really warm, it was sore like/was very painful. None investigation was reported. The outcome of the reported events was unknown. Follow-up (15JUL2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Pain, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. This male patient of an unspecified age and ethnicity received the second single dose of TRUMENBA via an unspecified route of administration on 14MAY2015. The patient medical history and concomitant medications were not reported. On 14MAY2015 the patient felt achy, really shaky and as he was going to faint and to pass out, dizzy, lightheaded and weak. His head hurt a little bit. The patient was not recovered at the time of this report. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable reporter (patient's brother). The reporter has reported similar events for one other patient. This is the 2nd of 2 reports. A female patient of an unspecified age received TRUMENBA, NDC, lot number, or expiration date unknown) via an unspecified route of administration at an unspecified dose on an unspecified date. The medical history was not reported. The concomitant medications were not reported. On unknown date the patient experienced sick symptoms after the vaccine was administered. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at unspecified dose. Relevant medical history and concomitant medications were not reported. After a couple of hours from vaccination the patient was not looking too good and was super nauseous. Outcome of the events was unknown at the time of this report. Follow-up (10JUL2015): Follow-up attempts completed. No further information expected.