chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Muscle disorder, Myalgia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for himself. This 82-year-old male patient received PREVNAR 13 at 0.5 ml single dose on 30Aug2016 for immunisation on the right deltoid. Relevant medical history included ongoing high blood pressure, several back operations, he had an electronic nerve stimulator on his back, ongoing diabetes. Concomitant ongoing medications included metformin for diabetes, amlodipine besilate at 10 mg and lisinopril both for high blood pressure and meloxicam at 15 mg. On an unspecified day in Sep2016 the patient experienced severe reaction in his muscle/ had reaction in all the muscles, on his fore arm and around his neck, severe swelling/swelling in right shoulder and severe muscle pain. The patient was hospitalized on an unspecified date in 2016 due to severe swelling/swelling in right shoulder.  The patient took TYLENOL/ACETAMINOPHEN or morphine as treatment for the events and also THERA-GESIC cream for severe muscle pain. The patient was not recovered from the events. Follow-up (15Nov2016): New information reported from the same contactable consumer includes: reaction data (the patient was hospitalized for swelling in right shoulder, updated events onset and outcome), meloxicam as additional concomitant medication. Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dyspnoea, Rash generalised
Clinical narrative: This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A 12-year-old female patient otherwise healthy of an unspecified ethnicity received TRUMENBA at single dose in one arm and HPV9 in the other arm, both via an unspecified route of administration on an unspecified date at an unspecified dose for immunisation. The patient medical history and concomitant medications were not reported. The next day she presents body rash and difficulty breathing managed at office until ambulance arrived-upon arrival at ER situation resolved. No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. This physician reported similar events for 3 patients. This is the first of three reports. A patient of unknown age, unknown gender and unknown raced received PREVNAR 13 at single dose for immunization. Relevant medical history and concomitant medication were unknown. On an unknown date the patient experienced sick. The outcome of the event was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016542415 same reporter/different patient, same product, similar events;US-PFIZER INC-2016542418 same reporter/different patient, same product, similar events.
Sex: U
Vaccine: PNC13
Symptoms: Malaise, Vomiting
Clinical narrative: This is a report from a contactable physician reported through a Pfizer sales representative. This physician reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient got really sick and started vomiting about 3 hours after vaccination. Vomiting was better within 24 hours. Outcome of the reported events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016542398 Same reporter/product, different patient;US-PFIZER INC-2016542418 Same reporter/product, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Malaise, Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. This physician reported similar events for 3 patients. This is the third of three reports. A patient of unknown age, gender and race received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medication were unknown. On an unknown date the patient was sick and started vomiting about 3 hours after vaccination. The patient was better within 24 hours and was recovering from the events at the time of report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016542398 same reporter/different patient, same product, similar events;US-PFIZER INC-2016542415 same reporter/different patient, same product, similar events.
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Impaired driving ability, Impaired work ability, Mental status changes
Clinical narrative: Initial unsolicited report received from a nurse on 10 Nov 2016. This case involves a male patient (age-unspecified) who was vaccinated with an injection of FLUZONE QUADRIVALENT  (Batch number-UI684AA; expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient developed change in mental status and confusion which lasted approximately 4 hours and patient had to be driven home from work. Laboratory investigations and corrective treatments were not reported. The patient recovered from all the events. List of documents held by sender: none
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine, Hypothermia, Swelling
Clinical narrative: Initial unsolicited report received from other non healthcare professional via other company (Pfizer) on 16 November 2016. (Manufacturer report number: 2015409683) This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (dose, batch number, expiration date site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had hypothermia, swelling and allergy to vaccine. Lab data and corrective treatment were not reported. Outcome of events was not reported. Upon internal review the case was considered as serious because of important medical event: hypothermia. List of documents held by sender: none. Sender's Comments: Hypothermia and swelling reported post TETANUS TOXOID. Patient had allergy to multi drugs and had history of multiple disease. Patient was on Breast Cancer Therapy. More details regarding allergic test to identify the culprit antigen and patient's history of reactions after previous vaccinations and TETANUS TOXOID vaccine manufacturer is needed to completely assess the case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 56.0
Sex: U
Vaccine: FLU4
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Initial unsolicited report received from a other non-health professional (office staff) on 15 November 2016. This case involves a patient (age and gender not reported) who was vaccinated with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number: UI678AB; dose, dose in series, expiry date of the product, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date and duration following the vaccination, the patient suffered from Inflammatory demyelinating polyneuropathy. Relevant laboratory data and corrective treatment were not reported. The outcome of the event was not reported. The reporter assessed the causal relationship with Flu vaccine as possible. List of documents held by sender: none. Sender's Comments: This poorly documented case concerns of unknown age patient to be suspected Inflammatory Demyelinating Polyneuropathy after vaccination with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Hence Details regarding date of vaccination, onset of event, relevant medical history, prior history of vaccination and its tolerance are needed to further assess the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Injection site erythema, Vomiting
Clinical narrative: Abdominal pain, vomiting, erythema distal to injection site. Vital signs WNL. Benadryl 25 mg given. Monitored x 20 minutes. Symptoms resolved.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling, found to have Guillain Barre Syndrome.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Vertigo
Clinical narrative: Fever, sore throat, Congestion, Vertigo.
Age: 17.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Pt turned pale and became unresponsive after injection given-vasovagal syncope, pt left clinic 15 minutes later and was feeling fine.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: Lump under skin and warm to touch at injection site of Left Deltoid since administration date 20 days ago. Per patient's mother lump seems to be getting bigger.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Electrocardiogram, Electromyogram, Gastric disorder
Clinical narrative: Thighs became numb, then stomach then weakness began 11/11/16 also with shortness of breath on 11/9/16.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Thighs became numb, then stomach then weakness began 11/11/16 also with shortness of breath on 11/9/16.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Joint swelling, Ligament sprain, Pain in extremity, Peripheral swelling
Clinical narrative: Her right knee felt swollen and painful and like it had been twisted. This started the evening the vaccine was given(11/21)(given in the AM). The next night (11/22) after the vaccine her right hand became visibly swollen and too painful to move. Both issues are improving and she states they are resolving without medical care.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain radiating from shoulder to wrist.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Dizziness, Eye movement disorder, Fall, Headache
Clinical narrative: PATIENT LOSS CONSCIOUSNESS FOR LESS THAN 10 SECONDS WITH SIGNS AND SYMPTOMS OF SEIZURE (MUSCLE RIGIDITY/SPASMS, EYES ROLLED BACKED). PRIOR TO LOSING CONSCIOUSNESS, PATIENT WAS PALE AND SWEATY AND CLAIMED TO FEEL LIGHTHEADED. PATIENT REGAINED CONSCIOUSNESS AND GIVEN WATER AND CRACKERS. ASKED TO LIE DOWN FOR ABOUT 5-10 MIN.  EXPRESSED A TINGLING SENSATION AFTER REGAINED CONSCIOUSNESS AND A CONTUSION FROM WHERE HE FELL.  GIVEN IBUPROFEN 200 MG TO HELP WITH THE HEADACHE. ALSO APPLIED COLD WET TOWEL TO PATIENT HEAD. COUNSELED PATIENT TO REMAIN IN PHARMACY FOR ABOUT 20-25 MIN UNTIL HE WAS WELL ENOUGH TO LEAVE.  PATIENT EXPRESSED THAT HE FELT FINE TO LEAVE AFTER RESTING, REPORTED NO MORE TINGLING SENSATION, AND ABLE TO SPEAK CLEARLY AND WAS ABLE WALK AROUND. PATIENT DOES NOT HAVE PRIMARY CARE PROVIDER FOR REPORTING. PATIENT REFUSED EMERGENCY RESPONSE/AMBULANCE. WILL FOLLOW UP IN ABOUT 2 HOURS.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Loss of consciousness, Muscle rigidity, Muscle spasms, Pallor
Clinical narrative: PATIENT LOSS CONSCIOUSNESS FOR LESS THAN 10 SECONDS WITH SIGNS AND SYMPTOMS OF SEIZURE (MUSCLE RIGIDITY/SPASMS, EYES ROLLED BACKED). PRIOR TO LOSING CONSCIOUSNESS, PATIENT WAS PALE AND SWEATY AND CLAIMED TO FEEL LIGHTHEADED. PATIENT REGAINED CONSCIOUSNESS AND GIVEN WATER AND CRACKERS. ASKED TO LIE DOWN FOR ABOUT 5-10 MIN.  EXPRESSED A TINGLING SENSATION AFTER REGAINED CONSCIOUSNESS AND A CONTUSION FROM WHERE HE FELL.  GIVEN IBUPROFEN 200 MG TO HELP WITH THE HEADACHE. ALSO APPLIED COLD WET TOWEL TO PATIENT HEAD. COUNSELED PATIENT TO REMAIN IN PHARMACY FOR ABOUT 20-25 MIN UNTIL HE WAS WELL ENOUGH TO LEAVE.  PATIENT EXPRESSED THAT HE FELT FINE TO LEAVE AFTER RESTING, REPORTED NO MORE TINGLING SENSATION, AND ABLE TO SPEAK CLEARLY AND WAS ABLE WALK AROUND. PATIENT DOES NOT HAVE PRIMARY CARE PROVIDER FOR REPORTING. PATIENT REFUSED EMERGENCY RESPONSE/AMBULANCE. WILL FOLLOW UP IN ABOUT 2 HOURS.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Seizure
Clinical narrative: PATIENT LOSS CONSCIOUSNESS FOR LESS THAN 10 SECONDS WITH SIGNS AND SYMPTOMS OF SEIZURE (MUSCLE RIGIDITY/SPASMS, EYES ROLLED BACKED). PRIOR TO LOSING CONSCIOUSNESS, PATIENT WAS PALE AND SWEATY AND CLAIMED TO FEEL LIGHTHEADED. PATIENT REGAINED CONSCIOUSNESS AND GIVEN WATER AND CRACKERS. ASKED TO LIE DOWN FOR ABOUT 5-10 MIN.  EXPRESSED A TINGLING SENSATION AFTER REGAINED CONSCIOUSNESS AND A CONTUSION FROM WHERE HE FELL.  GIVEN IBUPROFEN 200 MG TO HELP WITH THE HEADACHE. ALSO APPLIED COLD WET TOWEL TO PATIENT HEAD. COUNSELED PATIENT TO REMAIN IN PHARMACY FOR ABOUT 20-25 MIN UNTIL HE WAS WELL ENOUGH TO LEAVE.  PATIENT EXPRESSED THAT HE FELT FINE TO LEAVE AFTER RESTING, REPORTED NO MORE TINGLING SENSATION, AND ABLE TO SPEAK CLEARLY AND WAS ABLE WALK AROUND. PATIENT DOES NOT HAVE PRIMARY CARE PROVIDER FOR REPORTING. PATIENT REFUSED EMERGENCY RESPONSE/AMBULANCE. WILL FOLLOW UP IN ABOUT 2 HOURS.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Started to get nausea and headache around 1 and then began vomiting.  Treamtent with fluid and rest so far.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Induration, Swelling
Clinical narrative: 11/15 (day after imz) some redness beginning 11/16 pt reported swelling continues and becomes firm to touch and seeks medical attention. MD rx antibiotics and steroids for cellulitis-type reaction.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient received Pneumovax 23 on 11/18/2016.  Patient had site reaction on 11/19/2016, it progressed to swelling and warmth to the touch of the upper left arm.  On 11/21/16 the doctors office stated patient possibly developed cellulitis and started the patient on oral antibiotics.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Vaccination site pain
Clinical narrative: After receiving the vaccination the patient had a lot of pain where she got vaccinated. She also developed a very large bruise that turned very dark.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, itching and swelling of most of her upper arm.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: More redness, less swollen on the side of injection site on left thigh. More swollen, hardness, less redness around injection site on the right thigh Ibuprofen is prescribed for fever as needed.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm redness and swelling.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site mass, Skin warm, Tenderness
Clinical narrative: She has a large area of redness, that is very painful to the touch and hot.  There is a lump but it is a few inches away from the sight of injection.  She is going to try Acetaminophen and cold compresses and then followup with her primary care physician if not better in a day or two.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Left Deltoid swollen and reddened, applied Ice and Cortisone cream to the Inj site. By Monday 11/14, swelling better and redness gone. On Wed 11/16, Mom noted "hives" on chest "from neck to pant line "blister type". Denies any new meds, change in detergent or any other exposure to anything new. Mom states he had a similar reaction when he got his "one Yr Shots". Mom concerned regarding whether or not to complete the HPV series as this was Dose #1.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, raised spot around site of injection.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Acupuncture, Flank pain, Musculoskeletal pain
Clinical narrative: Pain in shoulder, radiating down her side, extreme pain, needed to take muscle relaxers, pain medication, and acupuncture with little to no relief.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: PATIENT REPORTED BEING LIGHTHEADED THEN PASSED OUT AFTER THE VACCINATION.
Age: 10.0
Sex: F
Vaccine: PNC13
Symptoms: Gaze palsy, Headache, Postictal state, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Likely Seizure Activity: inappropriate laughter with unidirectional gaze and unresponsiveness for about 3-5 mins per mom with post-ictal state for about 1-2 mins followed by headache.
Age: 0.58
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Agitation, Decreased eye contact, Hypotonia, Infantile vomiting, Lethargy
Clinical narrative: Baby awoke from a nap agitated, within 5 minutes began throwing up. Proceeded to throw up 7/8 times and then immediately became pale, limp, lethargic and would not make eye contact. Called 911, and an ambulance brought us to hospital 15 minutes into ride she came to and has been fine. Stayed for 24 hr observation.
Age: 0.58
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Pallor
Clinical narrative: Baby awoke from a nap agitated, within 5 minutes began throwing up. Proceeded to throw up 7/8 times and then immediately became pale, limp, lethargic and would not make eye contact. Called 911, and an ambulance brought us to hospital 15 minutes into ride she came to and has been fine. Stayed for 24 hr observation.
Age: 0.58
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Hypotonia, Lethargy, Pallor, Vomiting
Clinical narrative: Baby awoke from a nap agitated, within 5 minutes began throwing up. Proceeded to throw up 7/8 times and then immediately became pale, limp, lethargic and would not make eye contact. Called 911, and an ambulance brought us to hospital 15 minutes into ride she came to and has been fine. Stayed for 24 hr observation.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Burning sensation, Diplegia, Pain, Polymyalgia rheumatica
Clinical narrative: On evening of 10-14-16, patient experienced a burning sensation in his thighs. It progressed to a partial paralysis of his legs. His torso from knees to shoulders were involved. He had severe pain and saw MDs three times now. He said they ruled out Guillain-Barre Syndrome but definitely thought it was due to the flu shot. Diagnosed with polymyalgia rheumatica.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: Patient stated injection site was red, swollen, hot to the touch, pain radiated to neck, shoulders, back for a couple days - she used heat and ice to subside pain no symptoms as of 11/3/16.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Patient stated injection site was red, swollen, hot to the touch, pain radiated to neck, shoulders, back for a couple days - she used heat and ice to subside pain no symptoms as of 11/3/16.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Dyspnoea, Electrocardiogram PR interval
Clinical narrative: Nov 13 ER visit for <24hr duration acute most pleuritic pain with SOB. No hypoxia, afebrile. Dx: Pericardial Inflammation. Tx: Torodal IM- home with anti-inflammatory meds.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram abnormal, Electrocardiogram repolarisation abnormality, Pericarditis, Pleuritic pain, Red blood cell sedimentation rate increased
Clinical narrative: Nov 13 ER visit for <24hr duration acute most pleuritic pain with SOB. No hypoxia, afebrile. Dx: Pericardial Inflammation. Tx: Torodal IM- home with anti-inflammatory meds.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Troponin normal, White blood cell count increased
Clinical narrative: Nov 13 ER visit for <24hr duration acute most pleuritic pain with SOB. No hypoxia, afebrile. Dx: Pericardial Inflammation. Tx: Torodal IM- home with anti-inflammatory meds.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: This is a spontaneous report from a contactable consumer calling on behalf of her son. This consumer reported different events with the same suspect vaccine (different dose) for the same patient. This is the second of two reports. This 17 year-old male patient received the first single dose of TRUMENBA via an unspecified route of administration on 14Mar2016. The patient medical history and concomitant medications were not reported. After a few days on an unspecified date in Mar 2016 the patient experienced a localized reaction on his arm, that was red and hot to touch around the injection site and that hurt just like the injection site. The pediatrician said it was normal and to not worry. Outcome was unknown. Follow-up (07OCT2016): Follow-up attempt are completed. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Chills, Lethargy, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable medical office staff member reporting on behalf of a Physician communicated to a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml, single on 12May2016. The patient medical history included that her brother had been exposed to meningitis in the past. Concomitant medications were not reported. The patient previously received MENACTRA when she was 13 or 14 years old. In May2016 (within 12 hours of receiving the vaccine), the patient experienced pain in her leg, spine and neck, chills, fever, lethargic, it was as if she could not even walk on her own. The patient underwent lab tests and procedures on 13May2016 which included temperature 99 degrees Fahrenheit, blood pressure normal and a Negative Rapid Strep Test. The outcome of the events was unknown. Follow-up (27Sep2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Spinal pain, Streptococcus test negative
Clinical narrative: This is a spontaneous report from a contactable medical office staff member reporting on behalf of a Physician communicated to a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml, single on 12May2016. The patient medical history included that her brother had been exposed to meningitis in the past. Concomitant medications were not reported. The patient previously received MENACTRA when she was 13 or 14 years old. In May2016 (within 12 hours of receiving the vaccine), the patient experienced pain in her leg, spine and neck, chills, fever, lethargic, it was as if she could not even walk on her own. The patient underwent lab tests and procedures on 13May2016 which included temperature 99 degrees Fahrenheit, blood pressure normal and a Negative Rapid Strep Test. The outcome of the events was unknown. Follow-up (27Sep2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA intramuscular in the arm on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced redness (the reaction was around the back of the arm and not right at the site of injection). The outcome was unknown. Follow-up (14OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Hypotonia, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist reported for his son. A male patient of unknown age and ethnicity received, on an unspecified date, TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced high fever and his arm went limp. Clinical outcome was unknown at this time of this report.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner. A 17-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA Lot# M77282 Expiry Date Jun2017, intramuscular in the left arm on 16Aug2016 at 09:00 am at single dose. The patient medical history and concomitant medications were not reported. The patient turned pale, had chills, severe headache, abdominal pain, nausea, vomiting and stomach ache on 16Aug2016 at 10 am, within an hour after vaccination. The nurse advised the patient to take fluids and take Ibuprofen. No emergency room or physician visit was needed. All the symptoms improved in 8 hours and resolved within 24 hours. The reporter considered the events as associated to the vaccine administration and she would likely not get the 2nd and the 3rd dose of vaccine due to severity of reaction. Follow-up (07Sep2016): New information reported from the same contactable nurse includes: suspect vaccine details (route, anatomical location and time of administration, dose number), reaction data (new events nausea, vomiting, stomach ache were added, time of events onset, updated outcome), no visit, causality assessment. Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pallor, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner. A 17-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA Lot# M77282 Expiry Date Jun2017, intramuscular in the left arm on 16Aug2016 at 09:00 am at single dose. The patient medical history and concomitant medications were not reported. The patient turned pale, had chills, severe headache, abdominal pain, nausea, vomiting and stomach ache on 16Aug2016 at 10 am, within an hour after vaccination. The nurse advised the patient to take fluids and take Ibuprofen. No emergency room or physician visit was needed. All the symptoms improved in 8 hours and resolved within 24 hours. The reporter considered the events as associated to the vaccine administration and she would likely not get the 2nd and the 3rd dose of vaccine due to severity of reaction. Follow-up (07Sep2016): New information reported from the same contactable nurse includes: suspect vaccine details (route, anatomical location and time of administration, dose number), reaction data (new events nausea, vomiting, stomach ache were added, time of events onset, updated outcome), no visit, causality assessment. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Dyspnoea, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: This is a spontaneous report from a non contactable consumer via Pfizer sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA via an unspecified route of administration at single dose on an unspecified date on a Monday afternoon. The patient medical history and concomitant medications were not reported. On an unspecified date, about 12 hours after injection, the patient experienced patient had sweats. On an unspecified date he also experienced fatigue, headache, muscle pain. Patient reported shortness of breath and possible swelling of tongue about 36 hours after injection. The outcome of the events was unknown. Patient was still having symptoms of headache, fatigue, muscle pain on Friday. The outcome of the other events was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Laboratory test, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician assistant. A 20-years-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 22Jul2016 at single dose. The patient medical history and concomitant medications were not reported. The patient experienced fever (102, unit unknown), achy, and fatigue on 22Jul2016 at night with outcome of recovered. On 23Jul2016 experienced arm was a little warm and sore with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: 102 (unit unknown) on 22Jul2016. The caller declined to complete a report at this time. No additional information was obtained. Follow-up (14OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician assistant. A 20-years-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 22Jul2016 at single dose. The patient medical history and concomitant medications were not reported. The patient experienced fever (102, unit unknown), achy, and fatigue on 22Jul2016 at night with outcome of recovered. On 23Jul2016 experienced arm was a little warm and sore with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: 102 (unit unknown) on 22Jul2016. The caller declined to complete a report at this time. No additional information was obtained. Follow-up (14OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: This is a spontaneous report from contactable Other HCP via a Pfizer sales representative. A 17-year-old male patient of unspecified ethnicity received first dose of TRUMENBA via an unspecified route, at single dose on 15Aug2016. No medical history or concomitant medications were reported. After administration of vaccine the patient experienced headache, chills, nausea, fever 100.9 Fahrenheit, sore throat and congestion. The outcome of the events was unknown. Follow-up (14OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Respiratory tract congestion
Clinical narrative: This is a spontaneous report from contactable Other HCP via a Pfizer sales representative. A 17-year-old male patient of unspecified ethnicity received first dose of TRUMENBA via an unspecified route, at single dose on 15Aug2016. No medical history or concomitant medications were reported. After administration of vaccine the patient experienced headache, chills, nausea, fever 100.9 Fahrenheit, sore throat and congestion. The outcome of the events was unknown. Follow-up (14OCT2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: MENB, VARCEL
Symptoms: Anxiety, Fatigue, Headache, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable female consumer reported for her son. An 18-year-old male patient received TRUMENBA, via an unspecified route of administration in arm on Jul2016 at 0.5 ml, single. The patient medical history was not reported. Concomitant medication included varicella zoster vaccine. The patient experienced swollen arm, his arm hot to the touch, tiredness, headache once or twice. Also had anxiety on an unspecified date with outcome of not recovered. Follow-up (15-OCT-2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Headache, Malaise
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A male patient of an unspecified age and ethnicity started to receive 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 and general feeling of not being well day on an unspecified date with outcome of recovered by 2nd day post dose. No follow up attempts possible. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Bone pain, Chills, Mobility decreased, Muscular weakness, Pain
Clinical narrative: This is a spontaneous report obtained from a contactable physician (patient's mother) reported for her son. A 18-year-old male patient received the second dose of TRUMENBA, (Lot. M37315, Expiration date: 30Apr2017) on 06Apr2016 14:03 at 0.5 ml single dose, intramuscular in the left arm. The patient was vaccinated at private doctor's office and was purchased with private funds. Medical history included asthma (from 2000 and ongoing) and attention deficit/hyperactivity disorder (ongoing). Concomitant medication included oral VIVACE, 60 mg, daily (ongoing, started about 5 years before this report). The patient previously received the first dose of TRUMENBA on 16Dec2015 14:03 at 0.5 ml single dose, via intramuscular route on left arm. On 16Dec2015 the patient experienced chills, fever, very bad body aches, couldn't move arm extending to clavicle, felt weakness in both arms, worse in the arm where the injections was given. After the second dose, on 06Apr2016, the patient experienced clavicular pain, chills, body aches and fever. Clavicular pain started the same night, but not immediately. An emergency room or doctor visit were not required. The patient recovered from the event, clavicular pain, on 10Apr2016; while recovered from the other events on 08Apr2016. The events were considered related to TRUMENBA. Follow-up (07OCT2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable physician (patient's mother) reported for her son. A 18-year-old male patient received the second dose of TRUMENBA, (Lot. M37315, Expiration date: 30Apr2017) on 06Apr2016 14:03 at 0.5 ml single dose, intramuscular in the left arm. The patient was vaccinated at private doctor's office and was purchased with private funds. Medical history included asthma (from 2000 and ongoing) and attention deficit/hyperactivity disorder (ongoing). Concomitant medication included oral VIVACE, 60 mg, daily (ongoing, started about 5 years before this report). The patient previously received the first dose of TRUMENBA on 16Dec2015 14:03 at 0.5 ml single dose, via intramuscular route on left arm. On 16Dec2015 the patient experienced chills, fever, very bad body aches, couldn't move arm extending to clavicle, felt weakness in both arms, worse in the arm where the injections was given. After the second dose, on 06Apr2016, the patient experienced clavicular pain, chills, body aches and fever. Clavicular pain started the same night, but not immediately. An emergency room or doctor visit were not required. The patient recovered from the event, clavicular pain, on 10Apr2016; while recovered from the other events on 08Apr2016. The events were considered related to TRUMENBA. Follow-up (07OCT2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Chills, Mobility decreased, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician reported for her son. A 18-year-old male patient received the first dose of TRUMENBA on 16Dec2015 14:03 at 0.5ml single dose, via intramuscular route on left arm. Medical history included asthma, ongoing and attention deficit/hyperactivity disorder ongoing. Concomitant medication included VIVACE, 60 mg, daily. On 16Dec2015 the patient experienced chills, fever, very bad body aches, couldn't move arm extending to clavicle, felt weakness in both arms, worse in the arm where the injections were given. The outcome of the event couldn't move arm extending to clavicle/couldn't lift his arms was recovered on 20Dec2015, of the event very bad body aches was recovered on 18Dec2015, of the events fever and chills was recovered on 17Dec2015. The outcome of the other events was unknown. The events were considered as not serious. Follow-up (07OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Malaise, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable medical assistant communicated to a Pfizer sales representative. This medical assistant reported similar events for 3 patients. This is the third of three reports. A 17-18 year-old female patient 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 swelling and pain, malaise and possible fever in Aug2016 a couple of days after vaccination. The outcome of the events was unknown. Follow-up (07OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable female consumer reporting for her son. A male patient of an unspecified age and ethnicity received the 1st dose of TRUMENBA via an unspecified route of administration on an unspecified date at 0.5ml, single. The patient medical history was and concomitant medications were not reported. The patient experienced massive fever and body aches on second day of receiving first dose. The outcome of the events was reported as recovering. The patient then received the second dose of the same vaccine and all was fine. Follow up (25Aug2016): additional information received from the same consumer includes clarification on dose of vaccine administered and body aches added as adverse event. Follow-up (21OCT2016): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Local reaction
Clinical narrative: This is a spontaneous report from a contactable physician. A 19-year-old female patient received the first dose of TRUMENBA (Lot# M77282, Expiry date 30Jun2017, NDC# 0005-0100-01), intramuscular at 0.5 ml, single in the left deltoid on 08Aug2016 10:15 AM. Medical history included mood disorder, asthma on 2013, rhinitis allergic on 2013, anxiety depression on 2013. Concomitant medication included LOESTRIN 1/20 for contraception, SEROQUEL for mood disorder, LAMICTAL for mood disorder, FLOVENT for asthma, all on 2013. The patient experienced patient developed local reactions around the injection site "patches" and a "hive"/three different patches of redness which appeared to be hives on 09Aug2016 with outcome of recovering. Follow-up (29Aug2016): New information obtained from a contactable physician includes: anatomical location and date/time of vaccine administered, additional medical history and concomitant, outcome, onset date of the event updated. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Cough
Clinical narrative: This is a spontaneous report obtained from a non-contactable nurse through a Pfizer sales representative. A patient of an unspecified age, gender and ethnicity received TRUMENBA on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced cough. Clinical outcome was unknown at time of this report. No follow up attempts possible. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Cough, Headache, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A 18-year-old male patient received TRUMENBA (lot M68769) on 28Jul2016 at single dose. The patient medical history was not reported. Ongoing concomitant medication included PAXIL at 50 mg daily. The patient experienced headache on 29Jul2016 with outcome of not recovered, chills on 29Jul2016 with outcome of not recovered, fever on 29Jul2016 with outcome of not recovered, cough on 29Jul2016 with outcome of not recovered, nausea on 29Jul2016 with outcome of not recovered, weight loss due to decreased appetite (current weight: 144 lbs) on an unspecified date in 2016 with outcome of unknown, decreased appetite on 29Jul2016 with outcome of not recovered, pain on 29Jul2016 with outcome of not recovered. No treatment was received in response to the events. The reporting nurse mentioned it was a suspected adverse reaction with the administered vaccine. Follow-up (07OCT2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 18-year-old male patient received TRUMENBA (lot M68769) on 28Jul2016 at single dose. The patient medical history was not reported. Ongoing concomitant medication included PAXIL at 50 mg daily. The patient experienced headache on 29Jul2016 with outcome of not recovered, chills on 29Jul2016 with outcome of not recovered, fever on 29Jul2016 with outcome of not recovered, cough on 29Jul2016 with outcome of not recovered, nausea on 29Jul2016 with outcome of not recovered, weight loss due to decreased appetite (current weight: 144 lbs) on an unspecified date in 2016 with outcome of unknown, decreased appetite on 29Jul2016 with outcome of not recovered, pain on 29Jul2016 with outcome of not recovered. No treatment was received in response to the events. The reporting nurse mentioned it was a suspected adverse reaction with the administered vaccine. Follow-up (07OCT2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Cough
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 18-year-old male patient received, on 08Jun2016, the first dose of TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced persistent cough. Clinical outcome was unknown at time of this report. Follow-up (30OCT2016): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Vesicular rash started that is all over the patient's body. She stated she noticed it in the morning 10/30/16 and that it had already begun to resolve. It was on her entire legs, back, stomach, and arms.
Age: 79.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy, red and swollen in (R) deltoid x 24 hours.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Severe chills/shaking. Wet to bed at 11:00 PM with chills.
Age: 93.0
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Pain
Clinical narrative: L.A. - pain lifting arm. I had this shot on 10 Oct 2016 and I still notice left arm doesn't function like it should.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Mobility decreased, Pain in extremity
Clinical narrative: Sore arm for about 3 days that progressed to very painful arm that patient was unable to lift arm over her head. Went to urgent care - they prescribed antibiotic and prednisone. Prednisone relieved pain. After finished w/ pred -> pt. developed migraine. Went to family MD-prescribed EXCEDRIN Migraine, arm still sore as of 11/7/16.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain when raising arm above shoulder. Pain lasted from Sept 20 to Nov 1, 2016. It started to improve after that. Put ice on shot site after shot and next few days. No improvement. Did less lifting. no improvement.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: 40 hrs after vaccination - patient experienced swelling/redness of arm (left) to elbow. MD consulted and antibiotic given and BENADRYL. MD Consulted - Band-Aid not removed until reaction occurred.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Within the hour of receiving the flu shot I began to ache all over. I went to a meeting and when I got home 4 hrs after I received the shot I had a fever of 101.4 and was severely fatigued.  My only symptoms were fatigue, very bad muscle aches and a fever. This lasted 3 days and then symptoms continued at a lesser degree for a week.
Age: 71.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Flank pain, Herpes zoster
Clinical narrative: Within 5 days patient was having pain on side/back. Went to MD 1 wk after immunization and was diagnosed with shingles.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Activities of daily living impaired, Back pain, Blood test, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: On 9/21/16 I started to feel pain in my lower back. As time went by I started feeling pain in my left leg. It was painful, muscle tightening and stiffness. I couldn't take a shower I had to take a wash up with a bucket. In my room sitting on my bed. It was hard for me to get in and out of the car. I also had a hard time sitting on the toilet and getting off. I went to the ER on 10-7-16 and 10-11-16 and they didn't give me anything to take. I went to doctor on 10-27-16. He gave me some gabapentin 300 mg and diclofenac 75 mg. On 11-15-16 I will seek further treatment. On 10-7-16 I went to the ER and they gave me an X-ray. An on 10-11-16 they took blood. On 10-27-16 doctor took two x-rays.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pain in extremity, X-ray
Clinical narrative: On 9/21/16 I started to feel pain in my lower back. As time went by I started feeling pain in my left leg. It was painful, muscle tightening and stiffness. I couldn't take a shower I had to take a wash up with a bucket. In my room sitting on my bed. It was hard for me to get in and out of the car. I also had a hard time sitting on the toilet and getting off. I went to the ER on 10-7-16 and 10-11-16 and they didn't give me anything to take. I went to doctor on 10-27-16. He gave me some gabapentin 300 mg and diclofenac 75 mg. On 11-15-16 I will seek further treatment. On 10-7-16 I went to the ER and they gave me an X-ray. An on 10-11-16 they took blood. On 10-27-16 doctor took two x-rays.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: 11/8 2hr after injection-hives on arms-given antihistamine. 11/9 Hives increased to whole body-saw PCP-treated with OTC meds. 11/10 Hives and swelling of hands and feet-to ER-treated with IV steroids and oral steroids.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Decreased appetite, Headache, Hyperhidrosis, Malaise
Clinical narrative: Within 5 minutes of injection, tightness in chest and throat lasting a few minutes. As day progressed lost appetite and felt ill. Later severe headache and fever. Body aches, sweating lasted 3 days with less severe symptoms each day.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Throat tightness
Clinical narrative: Within 5 minutes of injection, tightness in chest and throat lasting a few minutes. As day progressed lost appetite and felt ill. Later severe headache and fever. Body aches, sweating lasted 3 days with less severe symptoms each day.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Severe swelling of arm where injection was given. Pt. states size of grapefruit.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Muscular weakness, Myalgia
Clinical narrative: Pt received 11/18/16. pt reported her arm has a bruise then she also had muscle aches and weakness.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain rated 10/10 that evening and presented to urgent care. Difficulty lifting arm. Update on 11-22-16 with no pain, but it aches still. Able to lift arm more, but not full range.