chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.54
Sex: M
Vaccine: HEPA
Symptoms: Cellulitis, Swelling, Weight bearing difficulty
Clinical narrative: Within a few hrs of vaccine, leg became non-wt. bearing swollen from hip to toe. Not red ever acc. to mom until 2 d later. Went to hospital, dx with cellulitis, given IV ROCEPHIN, sent home on clinda.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Cyanosis, Electroencephalogram normal, Laboratory test normal, Partial seizures
Clinical narrative: Received immunizations in mid-morning. That afternoon developed 102.3 temp; also had focal seizure x2 - looked blue. Admitted to medical center - initially thought febrile seizure but then considered vaccines; EEG normal - septic w/u neg. Fine since - neuro follow up scheduled 6-1-16.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Bronchitis, Bronchospasm, Laboratory test, Pyrexia, X-ray
Clinical narrative: Yearly check up. Dr suggested the PREVNAR 13 vaccine. Four days later fever onset, bronchial tubes closing. Two more visits, 2 courses of antibiotics, and bronchitis tests. I am a non smoker and never had bronchitis in my life. Now I'm diagnosed with it.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased interest, Poor feeding infant, Selective eating disorder
Clinical narrative: Poor feeding, disorganized latch and suck, less interest.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site mass, Injection site rash, Rash erythematous
Clinical narrative: I noticed when I picked my son up he had a rash on his leg at the sight of the injection and the rash was running down into his inner thigh. He has a lump at the sight of the injection as well. He has had normal BMs and is potty trained but he has a very bad rash on his butt crack and like big red bumps on his butt cheeks that are on the right side (same sight as the injection).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Feeding disorder, Hypoaesthesia, Hypoaesthesia oral, Impaired driving ability
Clinical narrative: This spontaneous report as received from a physician refers to a 72 year old female patient. The patient had none pertinent medical history and none drug reactions or allergies. Concomitant therapies included CRESTOR, NORVASC, vitamin D (unspecified) and vitamins (unspecified). On 23-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L040181, expiration date 18-AUG-2017) 0.5 ml (route not reported). On the same day, about an hour and a half after receiving the vaccine the patient complained of arm swelling (unspecified arm), redness and itching around injection site. The patient had hives on both arms, on face and numbness and tingling of hands, feet and tongue, since an unspecified date in May 2016. The reporter stated that the patient could not eat, was very uncomfortable and was not able to drive. The patient was seen in the office. No labs were performed. The patient was treated with hydroxyzine 50 mg and MEDROL pack. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Paraesthesia, Paraesthesia oral, Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 72 year old female patient. The patient had none pertinent medical history and none drug reactions or allergies. Concomitant therapies included CRESTOR, NORVASC, vitamin D (unspecified) and vitamins (unspecified). On 23-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L040181, expiration date 18-AUG-2017) 0.5 ml (route not reported). On the same day, about an hour and a half after receiving the vaccine the patient complained of arm swelling (unspecified arm), redness and itching around injection site. The patient had hives on both arms, on face and numbness and tingling of hands, feet and tongue, since an unspecified date in May 2016. The reporter stated that the patient could not eat, was very uncomfortable and was not able to drive. The patient was seen in the office. No labs were performed. The patient was treated with hydroxyzine 50 mg and MEDROL pack. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 72 year old female patient. The patient had none pertinent medical history and none drug reactions or allergies. Concomitant therapies included CRESTOR, NORVASC, vitamin D (unspecified) and vitamins (unspecified). On 23-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L040181, expiration date 18-AUG-2017) 0.5 ml (route not reported). On the same day, about an hour and a half after receiving the vaccine the patient complained of arm swelling (unspecified arm), redness and itching around injection site. The patient had hives on both arms, on face and numbness and tingling of hands, feet and tongue, since an unspecified date in May 2016. The reporter stated that the patient could not eat, was very uncomfortable and was not able to drive. The patient was seen in the office. No labs were performed. The patient was treated with hydroxyzine 50 mg and MEDROL pack. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest discomfort, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Dizziness, chest tightness, shortness of breath, feeling faint and diarrhea. Still going on 2 days later.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Blood immunoglobulin E, Chest discomfort, Dyspnoea, Echocardiogram
Clinical narrative: Dizziness, chest tightness, shortness of breath, feeling faint and diarrhea. Still going on 2 days later.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Heart rate increased, Pharyngeal oedema
Clinical narrative: Dizziness, chest tightness, shortness of breath, feeling faint and diarrhea. Still going on 2 days later.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anxiety, Blood immunoglobulin E, Chest discomfort, Dyspnoea, Echocardiogram
Clinical narrative: Dizziness, chest tightness, shortness of breath, feeling faint and diarrhea. Still going on 2 days later.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Gastrooesophageal reflux disease, Heart rate increased, Pharyngeal oedema
Clinical narrative: Dizziness, chest tightness, shortness of breath, feeling faint and diarrhea. Still going on 2 days later.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Elevated blood pressure. Elevated heart rate.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt Developed redness and warmth to the injection site.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: There was no symptoms or signs.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Besides the usual and expected soreness at the site of the injection, the lymph nodes in my armpit have swelled up considerably, adding to the pain in my shoulder.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Peripheral swelling, Pruritus
Clinical narrative: Lots of pain, can't lift arm, swollen, rash, itching very red all around the arm. Very hot to the touch and feels hot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Lots of pain, can't lift arm, swollen, rash, itching very red all around the arm. Very hot to the touch and feels hot.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Mom states patient complains of itching at injection site. Red rash noted at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, dry cough, body aches, chills, headache. Was ill for ten days. Dry cough also turned into full congested bronchial cough, sir throat no ear pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: Redness and swelling at injection site, dry cough, body aches, chills, headache. Was ill for ten days. Dry cough also turned into full congested bronchial cough, sir throat no ear pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine on 5/24/16 approx. around 5 pm. Mom called clinic on 5/26/16 around 3:45pm Stated that pts left deltoid was red, hot and swollen. Mom did not give any Tylenol or ibuprofen, no treatment given. Child was to be brought into clinic to have ppd read, so at this time we were able to see the childs left deltoid. And it was in fact red, warm to touch, and was swollen.  Offered an apt at urgent care for 5/26/16 but parents declined. They were to give pt Tylenol or ibuprofen and apply warm compresses to the left deltoid throughout the evening and was advised to call in the am so we could discuss if child needed to be seen that day (5/27/16). I called child's mom, she stated that the child's left arm was better. She followed instructions and she doesn't feel child needs to be seen at this time. Redness and swelling dereased.  Mom states she will call if condition changes for this child.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Alopecia, Asthenia, Bronchitis, Chest X-ray, Chills
Clinical narrative: Itching at injection spot, with hot rash. High fever 102 degrees, chills, weakness, not feeling well, with lost appetite. Also had a cough, lost 9 pounds, visited Dr. and he said I had the flu and xrayed my chest and said I had Bronchitis. He did not prescribe anything. Now my hair is coming out when I comb it.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Decreased appetite, Influenza, Injection site pruritus, Injection site rash
Clinical narrative: Itching at injection spot, with hot rash. High fever 102 degrees, chills, weakness, not feeling well, with lost appetite. Also had a cough, lost 9 pounds, visited Dr. and he said I had the flu and xrayed my chest and said I had Bronchitis. He did not prescribe anything. Now my hair is coming out when I comb it.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Malaise, Pyrexia, Weight decreased
Clinical narrative: Itching at injection spot, with hot rash. High fever 102 degrees, chills, weakness, not feeling well, with lost appetite. Also had a cough, lost 9 pounds, visited Dr. and he said I had the flu and xrayed my chest and said I had Bronchitis. He did not prescribe anything. Now my hair is coming out when I comb it.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. received Menigococcal B. Redness/swelling and soreness at injection site. No streaks and swelling minimal.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local site erythema reaction approx 4 x 4 cm.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Differential white blood cell count
Clinical narrative: FROM FACE TO ANKLES COVERED IN HUNDREDS OF 1/4 CM WHITE PAPULES ONLY 4-5 SCABBED OVER.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Full blood count, Papule, Scab
Clinical narrative: FROM FACE TO ANKLES COVERED IN HUNDREDS OF 1/4 CM WHITE PAPULES ONLY 4-5 SCABBED OVER.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Drug administered at inappropriate site, Headache, Impaired work ability, Malaise, Mobility decreased
Clinical narrative: Injection of Typhoid vaccine given to high on shoulder and not in deltoid. Sparks or electricity and injection. Nerve? Pain in entire arm continued to worsen as night wore on. Sick all night and next day. Went to work and ended up going home because arm was so painful, nausea and major headache. Could hardly move arm. Pain has lessened but continues. Sporadic bursts of electricity, same pain during the days.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Injection of Typhoid vaccine given to high on shoulder and not in deltoid. Sparks or electricity and injection. Nerve? Pain in entire arm continued to worsen as night wore on. Sick all night and next day. Went to work and ended up going home because arm was so painful, nausea and major headache. Could hardly move arm. Pain has lessened but continues. Sporadic bursts of electricity, same pain during the days.
Age: 17.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Syncope
Clinical narrative: Pt had a syncopal episode roughly 5 minutes after receiving vaccines.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Anaemia, Colitis ulcerative, Colonoscopy, Computerised tomogram abdomen, Dyspnoea
Clinical narrative: Pt has develop intolerance to activity, c/o chronic shortness of breath, heart racing, near syncopal, vision disturbance. Pt has also developed ulcerative colitis with anemia.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Echocardiogram, Electrocardiogram ambulatory, Endoscopy gastrointestinal, Exercise tolerance decreased, Laboratory test
Clinical narrative: Pt has develop intolerance to activity, c/o chronic shortness of breath, heart racing, near syncopal, vision disturbance. Pt has also developed ulcerative colitis with anemia.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Palpitations, Presyncope, Visual impairment
Clinical narrative: Pt has develop intolerance to activity, c/o chronic shortness of breath, heart racing, near syncopal, vision disturbance. Pt has also developed ulcerative colitis with anemia.
Age: 59.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Bruise at injection site, especially when received ADACEL shot on left arm. As for right arm, received Pneumovax 23 and had swelling/inflammation along with pain where she could not lift her arm; area is below the injection site. Patient was informed to use TYLENOL (APAP) or NAPROSYN she has at home and seek medical help or contact PCP if needed or if pain still persists and bothersome.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling of arm from armpit to elbow, area of swelling is 10x3 inches.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Injection site pain, Nerve injury, Pain in extremity, Peripheral swelling
Clinical narrative: Pain at the injection site, Wrong injection site....given way below the deltoid, right above the elbow joint, swollen sharp pain running down through my left arm. Treatments: ultra sounds and vascular ultra sounds. Referred to occupational therapy, TYLENOL tablet, NAPROXEN for pain, warm and cold compressions.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound Doppler, Ultrasound scan
Clinical narrative: Pain at the injection site, Wrong injection site....given way below the deltoid, right above the elbow joint, swollen sharp pain running down through my left arm. Treatments: ultra sounds and vascular ultra sounds. Referred to occupational therapy, TYLENOL tablet, NAPROXEN for pain, warm and cold compressions.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Fall, Seizure, Tremor
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative and refers to a female patient, who is currently 15 years old. The patient had a history of epilepsy and it was reported that she has not had seizures or any medications for that in over 5 years. On an unknown date, the patient was vaccinated with GARDASIL 9, Lot number reported as M007728, expiry date 21-MAR-2018, intramuscularly (dose and anatomical site of injection were not reported). Concomitant therapies were not provided. It was reported that the patient was nervous about receiving the vaccine. Also, after the vaccination, the patient walked out of the clinic room and described that she was feeling dizzy. Afterwards, she said she was seeing black spots and then her eyes rolled back and she fell backwards. The patient's step mother also described that the patient experienced some generalized shaking for less than 10 seconds, without incontinence, and all the event last for about one minute. The patient's step mother called for first responders and then the patient was put on a wheelchair and received a pediatric treatment that included "ZAFRA" 4 mg for her nausea and "METRIN", however, it was reported that the patient could not take any pill. In addition, the patient's father stated that his daughter was acting like she used to when her seizures ended. No product quality complain (PQC) was involved. At the time of reporting, the outcome of seizure was reported as recovered. The reporter did not provide a causality assessment between the event and the GARDASIL 9. Upon internal review, the event seizure was considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Visual impairment, Wheelchair user
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative and refers to a female patient, who is currently 15 years old. The patient had a history of epilepsy and it was reported that she has not had seizures or any medications for that in over 5 years. On an unknown date, the patient was vaccinated with GARDASIL 9, Lot number reported as M007728, expiry date 21-MAR-2018, intramuscularly (dose and anatomical site of injection were not reported). Concomitant therapies were not provided. It was reported that the patient was nervous about receiving the vaccine. Also, after the vaccination, the patient walked out of the clinic room and described that she was feeling dizzy. Afterwards, she said she was seeing black spots and then her eyes rolled back and she fell backwards. The patient's step mother also described that the patient experienced some generalized shaking for less than 10 seconds, without incontinence, and all the event last for about one minute. The patient's step mother called for first responders and then the patient was put on a wheelchair and received a pediatric treatment that included "ZAFRA" 4 mg for her nausea and "METRIN", however, it was reported that the patient could not take any pill. In addition, the patient's father stated that his daughter was acting like she used to when her seizures ended. No product quality complain (PQC) was involved. At the time of reporting, the outcome of seizure was reported as recovered. The reporter did not provide a causality assessment between the event and the GARDASIL 9. Upon internal review, the event seizure was considered to be a medically significant event. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Chills, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced body aches and chills on an unspecified date after vaccination, with unknown outcome. Follow-up (08MAY2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer representative for a female patient (patient initial unknown). An adolescent female patient aged between 16 to 18 years, of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient experienced hives reaction on an unspecified date with outcome of unknown.
Sex: U
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported for two patient. This is the first of two reports. A patient of unspecified age, ethnicity and gender started to receive TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced a lot of vomiting on an unspecified date. The outcome of the event was unknown. Follow-up (19-MAY-2016): Follow-up attempts are completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site pruritus, Injection site warmth, Middle insomnia, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for her daughter via a Pfizer sales representative. A 18-year-old female patient received third dose of TRUMENBA (Batch/Lot# M13066 and expiration date 30Sep2016) intramuscular in left arm on 25Feb2016, at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient had received the first dose on unknown date, the second dose, on unknown date, after two months and the third dose after 4 months. The patient experienced swelling on her left arm with the circumference of the size of baseball, she had itching all over her body especially at the injection site, injection site was very warm to touch for several days, there was muscle tenderness, the patient woke during night, very sore arm and redness, all on 25Feb2016, with outcome of recovered. Follow up (17May2016): Additional information from a contactable nurse includes age of the patient, route of administration of the vaccine, anatomical location and date of vaccination, nocturnal awakening, pain in arm and redness added as adverse events.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Peripheral swelling, Pruritus generalised
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for her daughter via a Pfizer sales representative. A 18-year-old female patient received third dose of TRUMENBA (Batch/Lot# M13066 and expiration date 30Sep2016) intramuscular in left arm on 25Feb2016, at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient had received the first dose on unknown date, the second dose, on unknown date, after two months and the third dose after 4 months. The patient experienced swelling on her left arm with the circumference of the size of baseball, she had itching all over her body especially at the injection site, injection site was very warm to touch for several days, there was muscle tenderness, the patient woke during night, very sore arm and redness, all on 25Feb2016, with outcome of recovered. Follow up (17May2016): Additional information from a contactable nurse includes age of the patient, route of administration of the vaccine, anatomical location and date of vaccination, nocturnal awakening, pain in arm and redness added as adverse events.
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 7-year-old male patient of an unspecified ethnicity received a single dose of TRUMENBA, via an unspecified route of administration on 21Apr2016. Medical history and concomitant medications were not reported. The patient experienced fever and nausea on an unspecified date after receiving the vaccination and he was still having the same. Fever and nausea are controlled with the medication taken as a treatment: TYLENOL 15 mg per kilo and ZOFRAN 4 mg as needed. The final outcome of the events was reported as unknown. The pharmacist mentioned that she did not believe that nausea and fever were because of TRUMENBA, but it happened right after the vaccine was given to the patient, so she was calling to get more information whether it was happened actually with the vaccine.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (office manager) received via a sales representative. This office manager reported similar events for two patients. This is the first of two reports. A 14-years-old male patient of an unspecified ethnicity received TRUMENBA (Lot# M13066, exp date 30Sep2016), at 0.5 ml, single on 28Jan2016 and GARDASIL, on an unspecified date at an unspecified dose both via an unspecified route of administration on the left arm. The patient medical history and concomitant medications were not reported. The patient experienced swollen red arm, fever, chills and body aches all on 29Jan2016 with outcome of recovered after 2 days. The patient had not received any treatment. Follow-up (14APR2016): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Rash macular, Vaccination site reaction, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. This nurse reported similar events for 2 patients. This is the first of two reports. A patient of an unspecified age, gender and ethnicity received on an unspecified date TRUMENBA at single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient developed redness and blotchy swelling at the vaccination site. Clinical outcome was unknown. Follow-up (24Mar2016): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported about two patients. This is the second of two reports. A patient of an unspecified age, gender and ethnicity received, on an unspecified date, TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient developed redness and blotchy swelling at the vaccination site. Clinical outcome was unknown. Follow-up (24Mar2016): Follow-up attempts completed. No further information 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 an unspecified age and 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 soreness in her arm when they administered the vaccine in on an unspecified date with outcome of not recovered. Follow-up (01-APR-2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a sales representative. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever and achiness, both on an unspecified date with unknown outcome.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for 3 different patients. This is the 1st of three reports. An adolescent patient of an unspecified ethnicity and gender received TRUMENBA at 0.5 ml single and MENACTRA at 1 DF single, both via an unspecified route of administration in arm on an unspecified date. Medical history and concomitant medications were not reported. The patient had local site reaction described as arm was red and swollen on an unspecified date. The outcome of the events was unknown.
Sex: U
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A female patient of unspecified age and ethnicity received TRUMENBA, on an unspecified date at single dose. On the same day the patient felt like she was going to faint. The nurse asked her to lay down and put her feet up. She recovered after eating a cracker and getting a drink of water. She did not have anything to eat the day of vaccination, which could've contributed to the feeling of faint. The patient medical history and concomitant medications were not reported. No follow up attempts possible. No further information expected.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Local reaction, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative reporting similar events for 3 different patients. This is the 3rd of three reports. A 17 year-old female patient of unspecified ethnicity received the first dose of TRUMENBA (lot number M37315, expiry date 01Apr2017) intramuscularly on 18Apr2016 at 16:00 at 0.5ml single in the left deltoid and the first dose of MENACTRA (Sanofi, lot number 45272AA) intramuscularly on the left arm on 18Apr2016 (time unspecified) at 1DF single. Relevant medical history was not reported. None concomitant medications. The patient experienced a local site reaction described as arm was red and swollen on 18Apr2016. The patient experienced numbness and left arm pain on unknown date. No emergency room, Physician visit, treatment or hospitalization was required for the events. The patient was recovering from redness and swelling arm. The outcome of the event numbness and left arm pain was unknown. The physician stated that the patient provided to him/her information regarding the reported adverse events with the use of the vaccines. The physician considered the Pfizer vaccine had a causal effect to the adverse events. Follow-up (16May2016): New information reported from a contactable Physician includes: patient's age and gender, details of vaccination with TRUMENBA and MENACTRA, concomitant medications none, onset date of the events, new events (numbness and left arm pain), outcome, causality assessment, confirmation that the patient provided to the physician information regarding the reported adverse events with the use of the vaccines.
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unspecified age, ethnicity and gender 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 headache, chills, vomiting, pain at injection site and very flu like all on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Endocrine test normal, Full blood count normal, Headache, Laboratory test, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's mother). The consumer reported similar events for her 3 kids. This is one of the 3 reports. A 22-year-old female patient received first dose of TRUMENBA, via an unspecified route of administration, on 11Dec2015, at 0.5 ml single. Relevant medical history included ovarian cyst on an unspecified date. Concomitant medications were none. A couple of days after vaccination the patient experienced not feeling well, slight fever, headache, nausea, she just had ache. The patient took TRUMENBA because she was a college student and she read to be in age group in high risk situation. The reporter mentioned that they talked to the patient's physician. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL, ALEVE, she took some over the counter pain killer. The patient stayed at home and rested. The patient underwent lab tests and procedures which included: complete blood count (normal), hormone testing (normal). The patient had some test on 24Dec2015 and 30Dec2015 with unknown result. Outcome of the reported events was recovered. Follow-up (19MAY2016): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's mother). The consumer reported similar events for her 3 kids. This is one of the 3 reports. A 22-year-old female patient received first dose of TRUMENBA, via an unspecified route of administration, on 11Dec2015, at 0.5 ml single. Relevant medical history included ovarian cyst on an unspecified date. Concomitant medications were none. A couple of days after vaccination the patient experienced not feeling well, slight fever, headache, nausea, she just had ache. The patient took TRUMENBA because she was a college student and she read to be in age group in high risk situation. The reporter mentioned that they talked to the patient's physician. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL, ALEVE, she took some over the counter pain killer. The patient stayed at home and rested. The patient underwent lab tests and procedures which included: complete blood count (normal), hormone testing (normal). The patient had some test on 24Dec2015 and 30Dec2015 with unknown result. Outcome of the reported events was recovered. Follow-up (19MAY2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Chills, Full blood count normal, Malaise, Pallor
Clinical narrative: This is a spontaneous report from a contactable nurse via a Company sales representative. A 16-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA intramuscular in the upper arm on 13Apr2016 at 0.5 ml single and a single dose of pneumococcal vaccine (unknown trade name) via an unspecified route of administration on an unspecified date, both for immunization. The patient medical history and concomitant medications were not reported. On 13Apr2016 the patient experienced low grade fever, chills, some joint pain, she was very pale and on 14Apr2016 she was not feeling well. The patient underwent laboratory tests and procedures which included full blood count that was negative on 14Apr2016. No treatment was given due to the reported events. Outcome of the reported events was unknown at the time of this report. The reporter believed that there was a causal relationship between the vaccines and the side effects.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Company sales representative. A 16-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA intramuscular in the upper arm on 13Apr2016 at 0.5 ml single and a single dose of pneumococcal vaccine (unknown trade name) via an unspecified route of administration on an unspecified date, both for immunization. The patient medical history and concomitant medications were not reported. On 13Apr2016 the patient experienced low grade fever, chills, some joint pain, she was very pale and on 14Apr2016 she was not feeling well. The patient underwent laboratory tests and procedures which included full blood count that was negative on 14Apr2016. No treatment was given due to the reported events. Outcome of the reported events was unknown at the time of this report. The reporter believed that there was a causal relationship between the vaccines and the side effects.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This is a spontaneous report obtained form a contactable pediatrician via a Pfizer sales representative. This physician reported similar events for 3 patients. This is the 2nd of three reports. A 17-years-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, (Batch/Lot #: M37315, expiration date: 01APR2017) at 0.5 ml single at 16:00 and MENACTRA (Manufacturer: Sanofi, Lot # 45272AA) at 1 DF single, both intramuscular in the right arm on 12Apr2016. Medical history and concomitant medications were not reported. The patient had local site reaction described as arm was red and swollen on 12Apr2016 with outcome of recovered. The outcome of the events was unknown. Follow-up (16May2016): New information from the same contactable Physician included: patient age and gender; administration details (lot/batch number, exp date, route site, date); event start date and outcome. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: This spontaneous report from a contactable other healthcare professional (HCP) and from contactable physician. A 18-year-old male patient of an unspecified ethnicity received the first single dose of TRUMENBA, (lot M13065, expiration date Apr 2017) intramuscular in the right upper arm on 06Jan2016 at 5pm. Medical history included ongoing attention deficit/hyperactivity disorder (ADHD) since 29Dec2011 and ongoing Tourette's disorder since 2010. Concomitant medication included ongoing FOCALIN since 22Feb2014 at 10 mg twice a day (at 9 am and at 9 pm) oral for ADHD. The patient experienced redness and swelling at the vaccination site on an unspecified date in 2016. Due to the reported events the patient did not receive any emergency room or physician visit. No specific date in 2016. Due to the reported events the patient did not receive any emergency room or physician visit. No specific tests and/or treatment was required. The reporter considered there was a causal relationship between TRUMENBA and the reported events. Outcome of events was unknown at the time of this report.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse and physician communicated to a Pfizer sales representative. This nurse and physician reported similar events for two patients. This is the second of two reports. A patient of an unspecified ethnicity and gender received TRUMENBA on an unspecified date at single dose, and MENACTRA. the patient medical history was and concomitant medications were not reported. The patient felt sick for 4 days with  nausea and fatigue, on an unknown date with outcome of unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: This spontaneous report from a contactable clinical coordinator communicated to a Pfizer sales representative. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA on an unspecified date at single dose. The patient medical history was and concomitant medications were not reported. The patient experienced fever, flu like symptoms, and did not feel well on an unspecified date with outcome of unknown.
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient's parent). A male patient of an unspecified age and ethnicity received two doses of TRUMENBA, via unspecified route of administration, on unspecified dates, at unspecified doses. The patient's medical history and concomitant medications were not reported. The patient's parent mentioned that he received these 2 doses on time. As the patient had an illness he could not receive the third dose, he was a month late now. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Nausea
Clinical narrative: This is a spontaneous report from a non-contactable physician via a Pfizer colleague. A 18-uyear-old male patient received 2 doses of TRUMENBA at 0.5 ml single dose on unspecified dates. Concomitant medications and medical history were not reported. The patient reported potential side effects like fatigue and nausea after each of the two doses. Outcome was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Limited range of motion with pain across clavicle, across right shoulder - shoulder blade and down right arm extremity to hand.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Injection site swelling, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable Medical assistant on behalf of a Physician. An 11-year-old male patient of an unspecified ethnicity received TRUMENBA, intramuscular at 1 0.5 ml single on 30MAR2016. The patient medical history was not reported. There were no concomitant medications. The following day, on 31MAR2016, the patient experienced fever, swelling on the injection site, vomiting and outcome of unknown. The reporter assessed the events as related to TRUMENBA. Follow-up (11-MAY-2016): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 19-year-old female patient received TRUMENBA, via an unspecified route of administration on MAR2016 at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. On unknown date in MAR2016 the patient experienced muscle ache, headache and fever. The outcome of the events was reported as recovered. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: A 17-year-old male patient of an unspecified ethnicity received first dose of TRUMENBA, on 09FEB2016 at 0.5 ml, single. The patient medical history was not reported. There were no concomitant medications. On 10FEB2016, 24 hours, after vaccine administration, the patient experienced fever, headache and arm soreness. Patient recovered from the events on 11FEB2016. The patient is expected to receive two  more doses of the vaccine. Follow-up (31-MAR-2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Rash generalised
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A female patient of an unspecified age and ethnicity received, on an unspecified date, the second dose of TRUMENBA single dose, in the arm and flu vaccine (injection) in the arm. The patient previously received, on an unspecified date, the first dose of TRUMENBA. The patient did not have a reaction with the first dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced rash all over the body. The nurse mentioned that it was not on the arm that the vaccine was given but was all over the body. Clinical outcome of the event was unknown at time of this report. Follow-up (11-MAY-2016): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Chills, Dizziness, Fatigue, Malaise, Myalgia
Clinical narrative: A 19-year-old female patient received intramuscular (in the left arm, deltoid) TRUMENBA, NDC number 005-0100-01) first dose on 25NOV2015 at 2:00 PM (lot. J29203) and second dose on 18JAN2016 at 11:00 AM (lot. M13066), both at single dose. On 18JAN2016, the patient received also Tdap, Lot U5243AA) intramuscular in the right arm. The vaccines was administered at the private physician's office/hospital. The reporter did not know of any illness at time of vaccination. Medical history and concomitant medications were not reported. After first dose of TRUMENBA, the patient experienced chills, fatigue, dizziness, myalgia, and generalized malaise on an unspecified date. After the second dose, she felt the same symptoms. She has recovered completely from the symptoms on an unspecified date. Follow-up (07APR2016): Follow-up attempts completed.. No further information expected. Follow-up (03MAY2016): New information received from a contactable physician includes: suspect drug details and reaction data.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer repotting for her daughter. A 18-year-old female patient received the first dose of TRUMENBA, intramuscular in right arm, on 29FEB2015 a 16:00, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On 25FEB2016, about 4 hours after vaccination, the patient experienced pain at injection site to her right shoulder and chills all over. As a result of the events the patient took ibuprofen. Events outcome was unknown. Follow-up (06APR2016): Follow up attempts are completed. No  further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hypersensitivity, Local reaction, Rash, Rash erythematous, Rash macular
Clinical narrative: This is a spontaneous report from a contactable medical assistant and from a health care professional reporting on behalf of a physician  via a Pfizer  sales representative. A 17-year-old female patient of an unspecified ethnicity received 0.5 ml single dose of TRUMENBA, Batch/Lot # M37315, Exp date APR2017, intramuscular in Left Deltoid on 08MAR2016 at 3:51 PM. Medical history included headache, nausea and dizzy on off lately. Concomitant Drug includes: JUNEL for birth control and multivitamins. The patient had a bad local reaction on her arm, skin rash, described as itchy. It has been located on the left arm on 09MAR2016. The patient was visited on 10MAR2016. No fever, chills, sore throat, cough or difficulty breathing. No hoarseness, lump in throat or enlarged lymph nodes. All systems otherwise negative expect as recorded above. The rash was macular, urticarial and erythematous. There was warmth. Clinical diagnosis was Localized allergic reaction with skin rash secondary to intramuscular vaccine. The patient had no history of heart disease, lung disease, hypertension or hyperlipidemia. No history of neurological disease, GI disease or diabetes mellitus. Social history: Never smoker, No alcohol use or drug use. Rash and symptoms improved with BENADRYL 25 mg 2DF orally every 4 hours as needed for itching and recovered on an unknown date. The physician assessed the adverse reaction as related to TRUMENBA and commented as follows: The patient had the headache before the product was given. Follow up 11APR2016: New information from a contactable health care professional included vaccination date, onset date and event description, medical history and concomitant medications. Follow up 19-MAY-2016: Follow-up attempts are completed. No further information is expected.