chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Headache, Influenza, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A 40-year-old female (non-pregnant) patient received a single dose of TRUMENBA on 17Jul2015. Relevant medical history included menstrual-associated migraines. Concomitant medications were unknown. The patient previously took meningococcal quadrivalent conjugate vaccine (MCV 4). She was in her usual state of good health until on 17Jul2015 (Friday) when she received TRUMENBA since she was recommended to receive it because of her occupational exposure (she was a microbiology technician). On an unspecified date, the patient experienced a very large local reaction. Within 2 hours of vaccine receipt, on 17Jul2015, the patient complained of arm pain. Then later in the evening, she experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day, 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day, 19Jul2015, she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. Over the next 5-7 day period, her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sandpaper. In the area surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She did not take acetaminophen or any NSAIDs. The outcome of the events arm pain and vaccination site erythema was recovering. The outcome of all other events was not reported. Follow up (19Oct2015): New information received from a contactable physician includes: patient's age; administration date; medical history; clinical course; 'arm pain', 'chills', 'her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered', 'enlarged, raised, erythematous area at the injection site', 'generalized body aches/body aches', 'mild subjective fever', 'severe headache, different from her usual migraine headaches/headache', 'malaise', 'fatigue', 'feeling as if she had a bad flu with sore' and 'pruritus' added as events.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Local reaction, Malaise, Pain, Pain in extremity, Pruritus
Clinical narrative: This is a spontaneous report from a contactable physician. A 40-year-old female (non-pregnant) patient received a single dose of TRUMENBA on 17Jul2015. Relevant medical history included menstrual-associated migraines. Concomitant medications were unknown. The patient previously took meningococcal quadrivalent conjugate vaccine (MCV 4). She was in her usual state of good health until on 17Jul2015 (Friday) when she received TRUMENBA since she was recommended to receive it because of her occupational exposure (she was a microbiology technician). On an unspecified date, the patient experienced a very large local reaction. Within 2 hours of vaccine receipt, on 17Jul2015, the patient complained of arm pain. Then later in the evening, she experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day, 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day, 19Jul2015, she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. Over the next 5-7 day period, her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sandpaper. In the area surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She did not take acetaminophen or any NSAIDs. The outcome of the events arm pain and vaccination site erythema was recovering. The outcome of all other events was not reported. Follow up (19Oct2015): New information received from a contactable physician includes: patient's age; administration date; medical history; clinical course; 'arm pain', 'chills', 'her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered', 'enlarged, raised, erythematous area at the injection site', 'generalized body aches/body aches', 'mild subjective fever', 'severe headache, different from her usual migraine headaches/headache', 'malaise', 'fatigue', 'feeling as if she had a bad flu with sore' and 'pruritus' added as events.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pyrexia, Skin texture abnormal, Skin warm, Vaccination site erythema, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable physician. A 40-year-old female (non-pregnant) patient received a single dose of TRUMENBA on 17Jul2015. Relevant medical history included menstrual-associated migraines. Concomitant medications were unknown. The patient previously took meningococcal quadrivalent conjugate vaccine (MCV 4). She was in her usual state of good health until on 17Jul2015 (Friday) when she received TRUMENBA since she was recommended to receive it because of her occupational exposure (she was a microbiology technician). On an unspecified date, the patient experienced a very large local reaction. Within 2 hours of vaccine receipt, on 17Jul2015, the patient complained of arm pain. Then later in the evening, she experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day, 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day, 19Jul2015, she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. Over the next 5-7 day period, her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sandpaper. In the area surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She did not take acetaminophen or any NSAIDs. The outcome of the events arm pain and vaccination site erythema was recovering. The outcome of all other events was not reported. Follow up (19Oct2015): New information received from a contactable physician includes: patient's age; administration date; medical history; clinical course; 'arm pain', 'chills', 'her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered', 'enlarged, raised, erythematous area at the injection site', 'generalized body aches/body aches', 'mild subjective fever', 'severe headache, different from her usual migraine headaches/headache', 'malaise', 'fatigue', 'feeling as if she had a bad flu with sore' and 'pruritus' added as events.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable physician. A 40-year-old female (non-pregnant) patient received a single dose of TRUMENBA on 17Jul2015. Relevant medical history included menstrual-associated migraines. Concomitant medications were unknown. The patient previously took meningococcal quadrivalent conjugate vaccine (MCV 4). She was in her usual state of good health until on 17Jul2015 (Friday) when she received TRUMENBA since she was recommended to receive it because of her occupational exposure (she was a microbiology technician). On an unspecified date, the patient experienced a very large local reaction. Within 2 hours of vaccine receipt, on 17Jul2015, the patient complained of arm pain. Then later in the evening, she experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day, 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day, 19Jul2015, she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. Over the next 5-7 day period, her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sandpaper. In the area surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She did not take acetaminophen or any NSAIDs. The outcome of the events arm pain and vaccination site erythema was recovering. The outcome of all other events was not reported. Follow up (19Oct2015): New information received from a contactable physician includes: patient's age; administration date; medical history; clinical course; 'arm pain', 'chills', 'her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered', 'enlarged, raised, erythematous area at the injection site', 'generalized body aches/body aches', 'mild subjective fever', 'severe headache, different from her usual migraine headaches/headache', 'malaise', 'fatigue', 'feeling as if she had a bad flu with sore' and 'pruritus' added as events.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Dry skin, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A 40-year-old female (non-pregnant) patient received a single dose of TRUMENBA on 17Jul2015. Relevant medical history included menstrual-associated migraines. Concomitant medications were unknown. The patient previously took meningococcal quadrivalent conjugate vaccine (MCV 4). She was in her usual state of good health until on 17Jul2015 (Friday) when she received TRUMENBA since she was recommended to receive it because of her occupational exposure (she was a microbiology technician). On an unspecified date, the patient experienced a very large local reaction. Within 2 hours of vaccine receipt, on 17Jul2015, the patient complained of arm pain. Then later in the evening, she experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day, 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day, 19Jul2015, she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. Over the next 5-7 day period, her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sandpaper. In the area surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She did not take acetaminophen or any NSAIDs. The outcome of the events arm pain and vaccination site erythema was recovering. The outcome of all other events was not reported. Follow up (19Oct2015): New information received from a contactable physician includes: patient's age; administration date; medical history; clinical course; 'arm pain', 'chills', 'her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered', 'enlarged, raised, erythematous area at the injection site', 'generalized body aches/body aches', 'mild subjective fever', 'severe headache, different from her usual migraine headaches/headache', 'malaise', 'fatigue', 'feeling as if she had a bad flu with sore' and 'pruritus' added as events.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician. A 40-year-old female (non-pregnant) patient received a single dose of TRUMENBA on 17Jul2015. Relevant medical history included menstrual-associated migraines. Concomitant medications were unknown. The patient previously took meningococcal quadrivalent conjugate vaccine (MCV 4). She was in her usual state of good health until on 17Jul2015 (Friday) when she received TRUMENBA since she was recommended to receive it because of her occupational exposure (she was a microbiology technician). On an unspecified date, the patient experienced a very large local reaction. Within 2 hours of vaccine receipt, on 17Jul2015, the patient complained of arm pain. Then later in the evening, she experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day, 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day, 19Jul2015, she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. Over the next 5-7 day period, her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sandpaper. In the area surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She did not take acetaminophen or any NSAIDs. The outcome of the events arm pain and vaccination site erythema was recovering. The outcome of all other events was not reported. Follow up (19Oct2015): New information received from a contactable physician includes: patient's age; administration date; medical history; clinical course; 'arm pain', 'chills', 'her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered', 'enlarged, raised, erythematous area at the injection site', 'generalized body aches/body aches', 'mild subjective fever', 'severe headache, different from her usual migraine headaches/headache', 'malaise', 'fatigue', 'feeling as if she had a bad flu with sore' and 'pruritus' added as events.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Headache, Influenza, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A 40 year old female microbiologist received TRUMENBA since she was recommended to receive the meningococcal B vaccine on 17Jul2015 because of her occupation exposure risk. She had no chronic medical conditions, only menstrual-associated migraines, and was in her usual state of good health until on 17Jul2015 at the time of vaccination. Within 2 hours of vaccine receipt she complained of arm pain. Then later in the evening, experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day 19Jul2015 she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. The patient has no underlying health conditions, and never had a previous adverse events following immunization. Over the next 5-7 day period her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sand paper. In the areas surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She had not taken acetaminophen or any NSAIDS and was not pregnant. Patient has no underlying health conditions, and never had a previous adverse events following immunizations.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Local reaction, Malaise, Pain, Pain in extremity, Pruritus
Clinical narrative: This is a spontaneous report from a contactable physician. A 40 year old female microbiologist received TRUMENBA since she was recommended to receive the meningococcal B vaccine on 17Jul2015 because of her occupation exposure risk. She had no chronic medical conditions, only menstrual-associated migraines, and was in her usual state of good health until on 17Jul2015 at the time of vaccination. Within 2 hours of vaccine receipt she complained of arm pain. Then later in the evening, experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day 19Jul2015 she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. The patient has no underlying health conditions, and never had a previous adverse events following immunization. Over the next 5-7 day period her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sand paper. In the areas surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She had not taken acetaminophen or any NSAIDS and was not pregnant. Patient has no underlying health conditions, and never had a previous adverse events following immunizations.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pyrexia, Skin texture abnormal, Skin warm, Vaccination site erythema, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable physician. A 40 year old female microbiologist received TRUMENBA since she was recommended to receive the meningococcal B vaccine on 17Jul2015 because of her occupation exposure risk. She had no chronic medical conditions, only menstrual-associated migraines, and was in her usual state of good health until on 17Jul2015 at the time of vaccination. Within 2 hours of vaccine receipt she complained of arm pain. Then later in the evening, experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day 19Jul2015 she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. The patient has no underlying health conditions, and never had a previous adverse events following immunization. Over the next 5-7 day period her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sand paper. In the areas surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She had not taken acetaminophen or any NSAIDS and was not pregnant. Patient has no underlying health conditions, and never had a previous adverse events following immunizations.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable physician. A 40 year old female microbiologist received TRUMENBA since she was recommended to receive the meningococcal B vaccine on 17Jul2015 because of her occupation exposure risk. She had no chronic medical conditions, only menstrual-associated migraines, and was in her usual state of good health until on 17Jul2015 at the time of vaccination. Within 2 hours of vaccine receipt she complained of arm pain. Then later in the evening, experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day 19Jul2015 she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. The patient has no underlying health conditions, and never had a previous adverse events following immunization. Over the next 5-7 day period her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sand paper. In the areas surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She had not taken acetaminophen or any NSAIDS and was not pregnant. Patient has no underlying health conditions, and never had a previous adverse events following immunizations.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Dry skin, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A 40 year old female microbiologist received TRUMENBA since she was recommended to receive the meningococcal B vaccine on 17Jul2015 because of her occupation exposure risk. She had no chronic medical conditions, only menstrual-associated migraines, and was in her usual state of good health until on 17Jul2015 at the time of vaccination. Within 2 hours of vaccine receipt she complained of arm pain. Then later in the evening, experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day 19Jul2015 she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. The patient has no underlying health conditions, and never had a previous adverse events following immunization. Over the next 5-7 day period her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sand paper. In the areas surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She had not taken acetaminophen or any NSAIDS and was not pregnant. Patient has no underlying health conditions, and never had a previous adverse events following immunizations.
Age: 40.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician. A 40 year old female microbiologist received TRUMENBA since she was recommended to receive the meningococcal B vaccine on 17Jul2015 because of her occupation exposure risk. She had no chronic medical conditions, only menstrual-associated migraines, and was in her usual state of good health until on 17Jul2015 at the time of vaccination. Within 2 hours of vaccine receipt she complained of arm pain. Then later in the evening, experienced chills and her upper arm became more painful, warm, and erythematous in the area surrounding where the vaccine was administered. On the next day 18Jul2015, she noted an enlarged, raised, erythematous area at the injection site. She also had generalized body aches, and mild, subjective fever, but no GI or URI symptoms. Then on the next day 19Jul2015 she developed a severe headache, different from her usual migraine headaches. The patient spent the weekend on the couch, feeling as if she had a 'bad flu' with sore, hot arm, body aches, malaise/fatigue, and headache. She never went to ER and was not hospitalized. The patient has no underlying health conditions, and never had a previous adverse events following immunization. Over the next 5-7 day period her arm improved and as the redness and swelling subsided, the involved skin on the upper arm felt 'coarse', like sand paper. In the areas surrounding the injection there were no pustules, no discrete lesions, and no vesicles. There was no pruritus initially, but some developed over time. She had not taken acetaminophen or any NSAIDS and was not pregnant. Patient has no underlying health conditions, and never had a previous adverse events following immunizations.
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal, Headache, Malaise, Myalgia, Pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A male consumer of unspecified age received TRUMENBA on unknown date, at single dose. Medical history and concomitant medications were not provided. After the consumer got the vaccine, he was having lot of muscle pain in his lower back and neck, kind of shooting muscle pain, it had been very achy, he was feeling not very good like he was getting sick. The events started in the morning on 24Sep2015 and towards the end of the day the consumer started getting worst slight headache. Events outcome was unknown. No follow up attempts possible. No further information expected.
Age: 67.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for himself via a Pfizer sales representative. A 67-year-old male patient of unspecified ethnicity started to received TRUMENBA (Lot Number J28923, Expiration Date Jun2016) via intramuscular route of administration into the right deltoid muscle on 25Sep2015 at 11:00 hours at 0.5ml, single, for asplenia (initially reported as for immunization). Medical history included asplenia from an unknown date and unknown if ongoing (in his 20's (1980)) and inflammatory bowel disease. The patient experienced mild erythema little bit lower than the injection site/erythema right bicep/deltoid on 25Sep2015 with outcome of recovered and "indication: asplenia" on an unspecified date with outcome of unknown. The events were reported as nonserious. According to the reporting nurse, the vaccine was to be administered again in 2 months, then in 4 months. The action taken for meningococcal group b rip2086 was not applicable. The nurse reported that there was a reasonable possibility that the event was related to meningococcal group b rip2086. Follow up (09Oct2015): New information from a contactable nurse includes: reporter details. Follow-up (09Nov2015): New information reported from the same contactable nurse includes: drug data (lot number, expiration date, start and stop date and time), medical history, concomitant medication, reaction data (added event: drug use for unapproved indication and reaction details), seriousness (nonserious), and causality (related). Follow up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 17-year-old female patient received TRUMENBA (Lot# L13514, Exp. date 21Feb2016, NDC 0005010010, UPC 300050100102) intramuscularly in the left deltoid muscle, on 06Oct2015 at 02:30 pm, at 0.5 ml single, for immunization to protect her from meningococcal b. Relevant medical history was not reported. Concomitant medications included flu vaccine (unspecified trade name) (Lot # U5304AB, Exp. date 30Jun2016, NDC 4928141510, UPC 4928141510) on 06Oct2015 at 12:00 pm, in the right deltoid, for immunization; LOESTRIN for birth control and cetirizine (unspecified trade name) tablet at 10 mg once a day for environmental allergies. The patient was fine after the vaccine but that night, on 06Oct2015, the injection site was very sore and she was so sore she couldn't lift her left arm, her mom had to wash her hair. The following morning, on 07Oct2015, the patient's whole left side was in a lot of pain. There had been no rash or swelling or redness, just the pain on the left side of her body. Therapeutic measures were taken as a result of pain and pain in extremity and included treatment with ADVIL 200 mg, at 2 dosage forms (400 mg) on 07Oct2015 at 6:30 am. The outcome of the event 'injection site was very sore' was not reported. The other events were not recovered at the time of this report and, on the contrary, they worsened. Follow-up (07Oct2015-08Oct2015-09Oct2015): new information received from a contactable nurse via a Pfizer sales representative includes: clinical course, outcomes changed to not recovered.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Dizziness, Erythema, Headache, Induration
Clinical narrative: This is spontaneous report from a contactable medical assistant was reporting on behalf of a physician. The medical assistant reported similar events for three patients. This is the second of three reports. A 14-year-old female patient received TRUMENBA (NDC Number; 0005010010; Lot number L13514, Expiry date: Jul2016) intramuscular in her left deltoid at 0.5 ml single dose, on 07Oct2015 around 1pm. Relevant medical history and concomitant medications were not reported. On 07Oct2015 the patient experienced headache, loss of appetite, vomiting, erythema, induration, dizziness, oedema and where the vaccine was given inability to move the arm. The outcome of the events was unknown. The patient went to doctor's office due to the events. Follow up (08Oct2015): Additional information received from the same contactable medical assistant includes ethnicity, gender and age of the patient, onset date of the events, date of vaccination, lot and exp. date of vaccine, route of administration. Erythema, induration added as adverse events.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Oedema, Vomiting
Clinical narrative: This is spontaneous report from a contactable medical assistant was reporting on behalf of a physician. The medical assistant reported similar events for three patients. This is the second of three reports. A 14-year-old female patient received TRUMENBA (NDC Number; 0005010010; Lot number L13514, Expiry date: Jul2016) intramuscular in her left deltoid at 0.5 ml single dose, on 07Oct2015 around 1pm. Relevant medical history and concomitant medications were not reported. On 07Oct2015 the patient experienced headache, loss of appetite, vomiting, erythema, induration, dizziness, oedema and where the vaccine was given inability to move the arm. The outcome of the events was unknown. The patient went to doctor's office due to the events. Follow up (08Oct2015): Additional information received from the same contactable medical assistant includes ethnicity, gender and age of the patient, onset date of the events, date of vaccination, lot and exp. date of vaccine, route of administration. Erythema, induration added as adverse events.
Age: 10.0
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Dizziness, Erythema, Headache, Mobility decreased
Clinical narrative: This is spontaneous report from a contactable other healthcare professional who reported similar events for three patients and from a physician. This is the third of three reports. A 10-year-old female patient received TRUMENBA, (lot number L13514, expiration date Jul2016, NDC number 0005010010) on 07Oct2015 around 4:15 PM at 0.5 ml single dose intramuscular in the left deltoid. Relevant medical history and concomitant medications were not reported. No illness at time of vaccination. On 07Oct2015, the patient experienced localized erythema. The patient experienced in Oct2015 headache, loss of appetite, vomiting, inability to move the arm, edema and dizziness. The patient was not hospitalized. The outcome of the events was unknown. Follow up (08Oct2015): New information received from the same contactable Healthcare professional includes: patient and product details, additional event (localized erythema), onset date.
Age: 10.0
Sex: F
Vaccine: MENB
Symptoms: Oedema, Vomiting
Clinical narrative: This is spontaneous report from a contactable other healthcare professional who reported similar events for three patients and from a physician. This is the third of three reports. A 10-year-old female patient received TRUMENBA, (lot number L13514, expiration date Jul2016, NDC number 0005010010) on 07Oct2015 around 4:15 PM at 0.5 ml single dose intramuscular in the left deltoid. Relevant medical history and concomitant medications were not reported. No illness at time of vaccination. On 07Oct2015, the patient experienced localized erythema. The patient experienced in Oct2015 headache, loss of appetite, vomiting, inability to move the arm, edema and dizziness. The patient was not hospitalized. The outcome of the events was unknown. Follow up (08Oct2015): New information received from the same contactable Healthcare professional includes: patient and product details, additional event (localized erythema), onset date.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a Non-contactable physician. The physician reported for a 12-year-old male patient (son). A 12-years-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced fatigue on an unknown date, rested on the couch for 4 hours. He later felt better and was back to his previous self the next day without other sequelae.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Headache, Induration, Mobility decreased
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 14-year-old female patient of an unknown ethnicity received on 07Oct02015 TRUMENBA at single dose. Concomitant medications and medical history were not reported. The patient came back on 08Oct2015 with headache, erythema, induration and limited arm movement. It was not clear if onset date was 07Oct02015or 08Oct2015. Outcome was not reported.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Decreased appetite, Headache, Induration, Mobility decreased, Vomiting
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 11-year-old male patient of an unknown ethnicity received on 07Oct2015 TRUMENBA at single dose. Concomitant medications and medical history were not reported. On an unspecified date, the patient experienced headache, vomiting, limited are movement, induration and loss of appetite. Clinical outcome was unknown at time of this report.
Sex: U
Vaccine: MENB
Symptoms: Activities of daily living impaired, Dizziness, Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report form a contactable physician, who reported similar events for 3 patients. This is first of three reports. A patient of unspecified age and gender received a single dose of TRUMENBA on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced arm so sore that he/she could not move it. Also, the patient had dizziness and could not go to school for a day or 2 on an unspecified date. The outcome of the events was unknown.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Injection site pain, Lethargy, Rhinorrhoea, Urinary hesitation
Clinical narrative: Patient began with injection site pain, lethargy, stomach pain, runny nose worsening, urinary hesitancy.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Musculoskeletal effects  muscle pain in injection arm. Patient received prednisone from doctor visit.
Age: 33.0
Sex: F
Vaccine: FLU3, MMR, TDAP
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: 10/30/15 I was notified by client's interpreter that client was pregnant.  Pregnancy tests on 09.25.15 and 10.09.15 were negative.  Pregnancy test 10.30.15 is positive.
Sex: U
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician, who reported similar events for 3 patients. This is second of three reports. A patient of unspecified age and gender received a single dose of TRUMENBA on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced arm so sore that he/she could no move it on an unspecified date. The outcome of the event was unknown.
Sex: U
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician, who reported similar events for 3 patients. This is third of three reports. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced arm so sore that he/she could not move it on an unspecified date. The outcome of the event was unknown.
Sex: U
Vaccine: MENB
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced joint pain (severe) on an unspecified date. Outcome was recovered in 2 days.
Sex: U
Vaccine: MENB
Symptoms: Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced nausea and vomiting on an unspecified date with outcome of unknown.
Sex: M
Vaccine: MENB
Symptoms: Flushing, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician who reported for his son. A male patient of unspecified age received TRUMENBA on unspecified date, at single dose. Medical history and concomitant medications were not provided. The patient experienced redness and pain at the injection site and flushing feelings on an unknown date after vaccination. Events outcome was unknown.
Age: 16.0
Sex: F
Vaccine: HPVX, MENB, MNQ
Symptoms: Haematuria, Laboratory test normal, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable Pfizer Sales Representative who reported on behalf of a Physician for a patient. A 16-years-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date in 2015 at single dose, on the same day the patient also received human papilloma vaccine, via an unspecified route of administration, and MENACTRA, via an unspecified route of administration. The patient medical history and concomitant medications were unknown. The patient went to the emergency room on an unknown date with nausea, body pain and neon red bloody urine which they diagnosed as hematuria which went away on its own within a day or two. The reporter did not believe that the patient has not taken any treatment for that, and at the emergency room they just monitored her for what the doctor said and then it just went away on its own. The patient underwent lab tests and procedures which included laboratory test with normal results. The outcome of the events nausea and body pain were unknown.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report from a Pfizer sales representative who reported on behalf of a contactable physician for a patient. A patient of an unspecified age, ethnicity and gender started to receive TRUMENBA. The start date, dose and frequency were not provided. Medical history, concomitant drugs and laboratory test were not provided. Pfizer sales representative reported on behalf of the doctor the adverse event severe pain at the injection site and arm pain for TRUMENMA. Pfizer sales representative mentioned that she did not have ant details of the patient, she only knew that there was pain at the injection site for 3 days and then the patient took Naproxen. Pfizer sales representative mentioned that the patient was not suffering from the pain as of 29Jul2015 after taking Naproxen, and it was only for 3 days; patient had it no more and the patient was fine. The action taken was not provided. The events outcome was recovered. Causality was not provided. Follow-up (06SEP2015): Follow-up attempts complete. No further information expected.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his 2 daughters. These patients experienced the same events after first and second dose of vaccine. This is the first of 2 reports for patient 1. A 20-year-old female patient received, on 05Jun2015, the first single dose of TRUMENBA. The patient had ongoing asthma chronic and allergy for entire life. Concomitant medications included birth control pills and inhaler as needed for asthma. On 05Jun2015, the patient experienced minimal pain at the injection site. No treatment was provided. Laboratory tests were not performed. The patient recovered on 05Jun2015. The same reaction occurred to her sister after first vaccination with MenB performed on 05Jun2015. Follow up (07Aug2015): New information received from the same contactable consumer includes: details of patient. Follow-up (13-SEPT-2015): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his 2 daughters. These patients experienced the same events after first and second dose of vaccine. This is first of 2 reports for patient 2. A 20-year-old female patient received, on 05Jun2015, the first single dose of TRUMENBA. Relevant medical history included pink eye form 2015 (ongoing). Had no allergies. Concomitant medications included birth control pills and antibiotic for Pink eye. On 05Jun2015, the patient experienced minimal pain at the injection site. No treatment was provided. Laboratory tests were not performed. The patient recovered from the adverse event on 05Jun2015. The same reactions occurred to her sister after first and second vaccination with TRUMENBA performed respectively on 05Jun2015 and 04Aug2015.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 16-year-old female patient received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The day following after her first injection of TRUMENBA, the patient had a red rash on her arm and it was bumpy and there was some minimal swelling on an unspecified date. The outcome was unknown. Causality was not available. Follow-up (17SEP2015): Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site urticaria, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable registered nurse via a company representative. A 18-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA on 19Aug2015 at 0.5 ml, single for prevention of meningitis. The patient medical history and concomitant medications. On an unknown date in Aug2015 the patient developed hives around injection site and pain at injection site. Patient was treated with BENADRYL. Event was "a reaction from vaccine, may be a slight allergy to sensitivity". The patient recovered on an unknown date in Aug2015. Follow-up (02OCT2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported different events for two patients (brother and sister). This is the first of two reports. A male patient of an unspecified age (but older than 5-year-old) and ethnicity received TRUMENBA, intramuscular on an unspecified date at 0.5 ml single. Medical history and concomitant medications were not reported. The patient experienced aches and pains and nausea on an unspecified date with outcome of unknown. The reporter assessed aches and pains as related to TRUMENBA. Follow-up (08OCT2015): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A female patient of unspecified age received first dose of 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 injection site very sore, on an unspecified date, with outcome of unknown. Follow-up (15OCT2015): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Sales Representative, who reported for her daughter. A 19-year-old female patient received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date in Sep2015. The patient medical history and concomitant medications were not reported. On Sep2015 she had headache, which caused her to stay in bed for two days. She was treated for headache with TYLENOL or ADVIL, that didn't help her. The final outcome of the event was unknown. Follow-up (30OCT2015): Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 10-year-old female patient received on 07Oct2015 TRUMENBA at single dose. Concomitant medications and medical history were not reported. On an unspecified date, in Oct2015, the patient experienced pain at the injection site. Clinical outcome was unknown at time of this report.