chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Skin reaction, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two patients. This is the second of two reports. A 21-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration at single dose in the left arm on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced big red bumpy spot at injection site, pain and trouble lifting arm on an unspecified date with outcome of recovered. Follow-up (15Aug2016): This is a follow-up spontaneous report from a contactable Nurse. This nurse reported for the same patient that: Suspect products: TRUMENBA. Adverse events: Skin reaction which was red hot. Patient details. Is the patient also the reporter? No. What happened: Skin reaction which was red hot. Products: Suspect products: TRUMENBA. Is this a Pfizer product? Yes. In your medical opinion, is there a reasonable possibility this event is related to this suspect product? Skin reaction which was red hot: Yes (Related). Additional Context: This is the 2nd case among two cross linked cases. The nurse mentioned that their sales rep had reported the event and she was reporting it again. The nurse mentioned that two of their employees received the first vaccine and had quite a skin reaction and it lasted for several days. She added it was red hot. The nurse mentioned that the patients had come for their second shot, so she wanted to know was that a bad enough reaction not to give it. The nurse further stated that the sales rep did report it but when she came the other day she said she did not what to do about it. The nurse stated that she was not gong to stay on for that long for probing, because this event was already reported to Pfizer by their sales rep (Name). She did not have the reference number of the previous call. The nurse stated that all the information was taken from the two girls by their sales rep, including their names when it was reported earlier and they had spent quite a bit of time in finding out what happened but nobody know whether to give them the second shot or forget it. Causality: The nurse said that in her medical opinion the skin reaction was definitely because of TRUMENBA. The nurse was informed that regarding this concern her call could be transferred to Pfizer Medical Information to which she agreed. QR Comment: The medical inquiry is captured in the parent case.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Malaise, Middle insomnia, Migraine, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse. A 18-year-old female patient received the first dose of TRUMENBA, NDC number: 00005010010, Expiry Date: 30Apr2017, lot M37315, on 23Jun2016 14:15 at 0.5mL intramuscular into left deltoid. Medical history included ongoing hypothyroidism  and weight loss. Concomitant medication included SYNTHROID, ongoing. The patient experienced did not feel well, awoke during the night shaking , migraine-like headache, neck pain radiating down arm, emesis, nauseous, fever greater then 102 degrees Fahrenheit, swelling at the site of injection all on an unspecified date with outcome of unknown. Follow-up (22Aug2016): This is a follow-up spontaneous report from a contactable Nurse and another Nurse. This both Nurse reported in response to HCP letter sent that included: Did the patient provide information to you regarding the reported adverse events with the use of product: Yes, (Mother). If yes above, do you consider the Pfizer product had a causal effect to the adverse event: Yes. Are you willing to be contacted again by Pfizer on the reported adverse events: Yes. Suspect vaccine: Suspect Vaccine name and/or generic name: TRUMENBA. Batch/Lot# and expiration date: M37315. Prescribed dose, units, and frequency: 0.5 ml. Route of administration: IM. Start Date: 23Jun2016. Stop Date: 23Jun2016. Time vaccination was given (hour; minute-24 hour clock): 1:49 PM. Anatomical location of the administration of the vaccine: Left Deltoid. Did any of the AEs require an emergency room or physician visit: No. If the patient was hospitalized, how many days was the hospital stay: -. What was the final action taken with the products: Dose not changed. Adverse Event: Was the patient admitted to hospital: No; Event Onset Date: 23Jun2016, Causal Relationship: Is there a reasonable possibility that the event is related that the event is related to suspect products: Yes. Suspect product name: TRUMENBA. Batch and/or Lot number and Expiration date: M37315, Exp: 30Apr2017. Please circle the Outcome of the Event for each event: Outcome of the Event: Recovered. Adverse event following prior vaccination: In patient: Adverse event: None. As applicable, list all vaccines given on same date along with suspect vaccine: Vaccine name: None. As applicable, list any other vaccination within four weeks prior to date of vaccination: Vaccine name: None. Dechallenge/Rechallenge? Did reactions recur on re-administration: If yes, please specify: N/A. Were specified tests and/or treatment required: No. Is patient deceased: No. Vaccinated at: Private Physician's office/Hospital. Vaccine purchased with: Private funds. Illness at time of vaccination: Weight loss. Patient Medical History: Illness Hypothyroidism; Onset Date: 09Jun. Illness: Hashimoto Thyroiditis; Onset Date: 09Jun. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Pain in extremity, Pyrexia, Tremor, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse. A 18-year-old female patient received the first dose of TRUMENBA, NDC number: 00005010010, Expiry Date: 30Apr2017, lot M37315, on 23Jun2016 14:15 at 0.5mL intramuscular into left deltoid. Medical history included ongoing hypothyroidism  and weight loss. Concomitant medication included SYNTHROID, ongoing. The patient experienced did not feel well, awoke during the night shaking , migraine-like headache, neck pain radiating down arm, emesis, nauseous, fever greater then 102 degrees Fahrenheit, swelling at the site of injection all on an unspecified date with outcome of unknown. Follow-up (22Aug2016): This is a follow-up spontaneous report from a contactable Nurse and another Nurse. This both Nurse reported in response to HCP letter sent that included: Did the patient provide information to you regarding the reported adverse events with the use of product: Yes, (Mother). If yes above, do you consider the Pfizer product had a causal effect to the adverse event: Yes. Are you willing to be contacted again by Pfizer on the reported adverse events: Yes. Suspect vaccine: Suspect Vaccine name and/or generic name: TRUMENBA. Batch/Lot# and expiration date: M37315. Prescribed dose, units, and frequency: 0.5 ml. Route of administration: IM. Start Date: 23Jun2016. Stop Date: 23Jun2016. Time vaccination was given (hour; minute-24 hour clock): 1:49 PM. Anatomical location of the administration of the vaccine: Left Deltoid. Did any of the AEs require an emergency room or physician visit: No. If the patient was hospitalized, how many days was the hospital stay: -. What was the final action taken with the products: Dose not changed. Adverse Event: Was the patient admitted to hospital: No; Event Onset Date: 23Jun2016, Causal Relationship: Is there a reasonable possibility that the event is related that the event is related to suspect products: Yes. Suspect product name: TRUMENBA. Batch and/or Lot number and Expiration date: M37315, Exp: 30Apr2017. Please circle the Outcome of the Event for each event: Outcome of the Event: Recovered. Adverse event following prior vaccination: In patient: Adverse event: None. As applicable, list all vaccines given on same date along with suspect vaccine: Vaccine name: None. As applicable, list any other vaccination within four weeks prior to date of vaccination: Vaccine name: None. Dechallenge/Rechallenge? Did reactions recur on re-administration: If yes, please specify: N/A. Were specified tests and/or treatment required: No. Is patient deceased: No. Vaccinated at: Private Physician's office/Hospital. Vaccine purchased with: Private funds. Illness at time of vaccination: Weight loss. Patient Medical History: Illness Hypothyroidism; Onset Date: 09Jun. Illness: Hashimoto Thyroiditis; Onset Date: 09Jun. Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Influenza like illness, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Sales representative. A 18-year old female patient of unspecified ethnicity received a first single dose of TRUMENBA (lot number L13515, expiry date 28JUL2016) via an unspecified route of administration, on unknown date, for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced severe flu like symptoms, chills, stiff neck and fever on an unknown date after receiving the vaccine. The patient did not want second dose. The outcome of the events was unknown. Follow-up (15Aug2016): This is a follow-up spontaneous report from a contactable nurse. This nurse reported in response to HCP letter sent to physician which included that: Did the patient provide information to you regarding the reported adverse event (s) with the use of the product: Yes. If yes, above, do you consider the product had a causal effect to the adverse event?: No. Are you willing to be contacted again by Pfizer on the reported adverse event (s) ?: Yes. Suspect Vaccine: Please provide below information (if more than one suspect vaccine or other product is involved please add all available information. If more space is needed please use the Additional Comments section at the end of this form). Suspect vaccine name and/or generic name: TRUMENBA. Route of administration: IM. Start date (note dates for any subsequent dosing): 2016 Mar2016 due May. Anatomical location of the administration of the vaccine: Deltoid. Did any of the AEs require an emergency room or physician visit?: No. What was the final action taken with the product (s)? Pleas circle below: Permanently withdrawn. Adverse event: Please provide description of the course of events including body site and severity/seriousness criteria: Was the patient admitted to hospital Y/N: N. Causal relationship: Is there a reasonable possibility that the event is related to suspect product/s: Batch and/or Lot number and expiration date: L13515. Please circle the Outcome of each event: Recovered. As applicable, list all vaccines given on same date along with suspect vaccine: Vaccine Name: None. As applicable, list any other vaccinations within four weeks prior to date of vaccination: Vaccine Name: None. Were specific tests and/or treatment required?: No. Is patient deceased: No. Relationship to patient. Vaccine provider. Vaccinated at: Private physician's office/hospital. Vaccine purchased with: Private Funds. Illness at time of vaccination (Specify): None. Have you reported this adverse event previously?:No. concomitant Medications: Concomitant drug: None. Patient medical history: Provide other relevant medical history including but not limited to these conditions. Diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Illness: None. May we contact you to request additional information if needed. Yes.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Night sweats, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist, who reported events occurred to her daughter and her son (twins) with meningococcal group b rlp2086 vaccine. This is the first of two reports. A 18-year-old female patient received a single dose of TRUMENBA, intramuscular in left arm, deltoid muscle, on 11Jul2016 at 10:00. No other vaccine was given on same day. The patient was vaccinated at the pediatrician's office. Relevant medical history included asthma. Concomitant medication included VENTOLIN as needed, for asthma. On 11Jul2016, the patient experienced body ache, night sweats, sore arm and low grade fever. On 12Jul2016, the patient developed also diarrhea; and on an unspecified date, in Jul2016, there was an aggravation of her pain. No treatment given for the events. She was feeling better except her very sore arm. The events, body ache, sore arm and low grade fever related to meningococcal group b rlp2086.
Sex: F
Vaccine: MENB
Symptoms: Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for two patients. This is second of two reports. An adolescent female patient (age group 15 and 16) of unspecified ethnicity received a single dose of TRUMENBA via an unspecified route of administration, on arm on unknown date. Relevant medical history and concomitant medications were not reported. The patient experienced hot to the touch at the point of injection on unknown date. The outcome of the event was unknown.
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Injection site rash, Nausea
Clinical narrative: This is a spontaneous report form a non-contactable nurse reported for a female patient. A female patient of an unspecified age and ethnicity received TRUMNBA, via an unspecified route of administration on and unspecified date at 0.5ml, single. The patient medical history and the patient's concomitant medications were not reported. The patient experienced rashes around the injection site, nausea and feeling crabby, all on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received from TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced hives that came through three days after the injection. The outcome of the event was  unknown.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 19-year-old female patient received TRUMENBA, intramuscular at single dose in the left arm on 12Jul2016. The patient medical history was none. Concomitant medication included oral doxycycline at 1 DF once daily on ongoing for acne. On 13Jul2016, the patient experienced pain at the injection site, fever, aches and pains, flu-like symptoms and weakness, all with outcome of recovering.
Sex: U
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration at single dose in the arm on an unspecified date. The patient experienced fever and achiness the day after receiving the vaccine on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the events included TYLENOL.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 14 year-old male patient of unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date, at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced induration, redness and low-grade fever, all on an unspecified date with outcome unknown. No follow up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer representative. A 19 year-old male patient of unspecified ethnicity received a single dose of TRUMENBA via an unspecified route of administration, on 12Jul2016 at 11:00. Relevant medical history and concomitant medications were not reported. The patient experienced body ache and nausea on 13Jul2016, approximately at 3:00 pm. The patient was afebrile, and he did not have pain, redness, tenderness or swelling at the injection site. The patient was recovering from the events. The physician believed that the events were related to the vaccine.
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This is a spontaneous report from a contactable pediatrician. A 17 year-old male patient of an unspecified ethnicity received a single dose of TRUMENBA via a unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date for 48 to 72 hours after having received the vaccine the patient experienced significant muscle soreness and he did not want to flex his deltoid due to this. Outcome was unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Syncope, Vomiting
Clinical narrative: This is a spontaneous report from a contactable office manager reporting on behalf of a physician. A 17-year-old male patient received a dose of TRUMENBA, NDC 00050100-01, lot M74091, expiry date Jun2017) intramuscular in the right arm on 15Jul2016 between 11-11:30 am at 0.5 ml single. He did have a history of fainting once after a blood draw, he had ongoing allergy to latex and tomatoes, and he had ongoing pain on shoulder on both sides that was hurting his neck to turn side to side for years. The patient had received MENACTRA, lot U5180AH) administered intramuscular in the right arm on 06Jun2016 without any adverse event. The patient's concomitant medications were not reported. Immediately after having received the vaccine, the patient fainted, he was nauseous, dizzy, and was vomiting. It was reported that he began slipping off the table after it was administered, his dad assisted him back onto the table. They gave him some orange juice and they observed him for 1 hour before wheeling him out in a wheelchair to the vehicle to go home, when he was recovering. No emergency or doctor visit was required due to the events. No test was performed. They thought it was more of the trauma instead of the vaccine that caused the side effects.
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable pharmacist 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. On an unspecified date, after vaccination, the patient experienced fainting with outcome of unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Fatigue, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml single in the left arm on an unspecified date in Jul2016. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, nausea, headache and feeling weak on an unspecified date in Jul2016 with outcome of unknown. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Full blood count, Human chorionic gonadotropin, Influenza virus test, Metabolic function test
Clinical narrative: This is a spontaneous report from a contactable physician through Pfizer sales representative. A 18-year-old female patient of unspecified ethnicity received first dose of TRUMENBA; (Batch/Lot # M37314; expiration date 30Apr2017) intramuscular on deltoid muscle at 0.5 ml single on 04May2016 at around 12:30 pm. The patient medical history was not reported. Concomitant medications included fluoxetine for anxiety at 10- mg daily since two and half years and ORTHO EVRA transdermal patch, for birth control once a week, since 6 months. On 04May 2016 at around 5:00 pm the patient developed body aches, chills and nausea. She was seen in the emergency room (ER) but was not hospitalized. Lab tests done on an unknown date included urinalysis, full blood count (CBC), comprehensive metabolic panel (CMP), rapid flu test and urine human chorionic gonadotropin (HGC);she was diagnosed to have urinary tract infection (UTI) based on urinalysis findings. She was prescribed MACROBID oral and ZOFRAN and her symptoms resolved within the next 2 days. She recovered from the events on 06May2016. Follow up (12Jun2016): New information received from a contactable physician includes:vaccine details, concomitants, event onset/outcome, lab tests. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain, Urinary tract infection, Urine analysis
Clinical narrative: This is a spontaneous report from a contactable physician through Pfizer sales representative. A 18-year-old female patient of unspecified ethnicity received first dose of TRUMENBA; (Batch/Lot # M37314; expiration date 30Apr2017) intramuscular on deltoid muscle at 0.5 ml single on 04May2016 at around 12:30 pm. The patient medical history was not reported. Concomitant medications included fluoxetine for anxiety at 10- mg daily since two and half years and ORTHO EVRA transdermal patch, for birth control once a week, since 6 months. On 04May 2016 at around 5:00 pm the patient developed body aches, chills and nausea. She was seen in the emergency room (ER) but was not hospitalized. Lab tests done on an unknown date included urinalysis, full blood count (CBC), comprehensive metabolic panel (CMP), rapid flu test and urine human chorionic gonadotropin (HGC);she was diagnosed to have urinary tract infection (UTI) based on urinalysis findings. She was prescribed MACROBID oral and ZOFRAN and her symptoms resolved within the next 2 days. She recovered from the events on 06May2016. Follow up (12Jun2016): New information received from a contactable physician includes:vaccine details, concomitants, event onset/outcome, lab tests. Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is first of two reports. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA, Lot Number L13514, Expiration Date: 31Jul2016, intramuscular on 30Nov2015 at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced hives of arm injected on 30Nov2015 with outcome of recovered. Therapeutic measures were taken as a result of event: BENADRYL. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: DTAP, MENB, MNQ, TDAP
Symptoms: Blood pressure fluctuation, Loss of consciousness, Syncope
Clinical narrative: This is spontaneous report from a contactable Physician via Pfizer sales representative and from a contactable other healthcare professional. A 11-year-old male patient of an unspecified ethnicity received TRUMENBA, lot number M37315, expiry date 30Apr2017, at 0.5 ml single in the right arm; diphtheria vaccine, pertussis vaccine, tetanus vaccine (DTAP) at 0.5 ml (frequency not reported) in the left arm, MENACTRA, lot number 45390AA, expiry date 12Sep2017 at 0.5 ml (frequency not reported) in the left arm and diphtheria vaccine, pertussis vaccine, tetanus vaccine (TDAP, Sanofi Pasteur, lot number 41543AA, expiry date 05Jun2018) at 0.5 ml (frequency not reported) in the left arm all via an unspecified route of administration on 02Jun2016 at 15:30. Relevant medical history and concomitant medications were not reported. The patient passed out after vaccinations and experienced blood pressure fluctuation on 02Jun2016. The patient was not admitted to the hospital due to the events and no emergency room or physician visit was required. Blood pressure was 80/68 when entered office. The patient passed out after vaccinations. He came right to. He was alert and oriented. They had him lay down in a patient room with cold compress for approximately 20 minutes. Blood pressure after 20 minutes was 92/60. Patient was released to go home. The patient recovered from faint while the outcome of blood pressure fluctuation was unknown. The other healthcare professional stated that the patient did not provide to him/her information regarding the reported adverse events with the use of the vaccines. Follow-up (28Jun2016): New information reported from a contactable other healthcare professional includes: time of vaccination, dose, lot number and expiry date of vaccines, new suspect vaccine (TDAP), no admission to the hospital due to the events and no emergency room or physician visit was required, outcome, the patient did not provide to the other healthcare professional information regarding the reported adverse events with the use of the vaccines.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from Pfizer-sponsored program, from a contactable consumer reporting for his son. This 16 year-old male patient of an unspecified ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient had a sore arm on an unspecified date with outcome of unknown.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Lethargy, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 18-year-old female patient of unspecified ethnicity received 2nd dose of TRUMENBA (Batch/Lot # L13515, expiration date 31Jul2016), intramuscular on an unspecified at single dose. Concomitant medications were not reported. The patient did not have drug or alcohol abuse, drug allergies, family history or relevant medical history. On 17Dec2015 the patient experienced fatigue and lethargy and on 18Dec2015 chills, fever and body aches. The patient was not admitted to hospital. No treatment required for the events. The events chills, fever and body aches recovered on an unknown date, while the outcome of fatigue and lethargy was unknown. Nurse stated that chills, fever and body aches recurred after re-administration of the vaccine, but no further details were reported. There was a reasonable possibility that the events were related to the vaccine. Comment: these side effects were seen with roughly 20-30% of the patients getting the meningococcal group b rlp2086 and nurse educated them that it can occur. Patients take Ibuprofen as needed and call if symptoms persist >24. Follow-up (18Jul2016): New information received from the same nurse includes: events details, events updated (body aches added, recurrent events reported), comment.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from contactable physician received via a sales representative and then from a contactable nurse. A 13-year-old patient of unspecified age, gender and ethnicity received on an unspecified date for immunization a single dose of TRUMENBA (Batch/Lot# M37314; expiration date 30Apr2017) IM 0.5 ml single at right deltoid and another unspecified vaccine on 24May2016 02:53 PM for immunization. The patient medical history was not reported. The concomitant medications included MENACTRA (Lot: 45228BA) IM at right deltoid on 24May2016. On 24May2016 the patient experienced significant swelling in the arm. The outcome of the event was recovered on 24May2016. The AE required an emergency room or physician visit. No specific tests and/or treatment were required. The reporting physician was not sure if swelling was related to meningococcal group b or to the other unspecified vaccine. The nurse stated that the patient did provide to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was not a reasonable possibility that the event is related to suspect product. The nurse was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow up (27Jun2016): New information reported from a contactable nurse included: patient age: TRUMENBA data; concomitants; Event onset/recovery date; outcome; course of events; nurse informed regarding the adverse events; nurse event causality assessment; nurse further contactability.
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml, single on unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tremendous pain at the injection site, flu like reaction, achiness, fever, feeling sick. The outcome of the events was unknown. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Piloerection
Clinical narrative: This is a spontaneous report from a non-contactable consumer (the patient) via Pfizer sales representative. A 18-year-old patient of unspecified ethnicity received the first dose of TRUMENBA via an unspecified route of administration on unknown date (on 15Jun, year not reported) at 0.5 ml single. Relevant medical history and concomitant medications were not reported. On unknown date, 24 hours after the vaccination, the patient experienced goose bumps on fingers right hand and arm was a little stiff on unknown date. The outcome of the events was unknown. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA, intramuscular at 0.5 ml single and the first dose of MENVEO, intramuscular at 1 DF single, both on the same unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced stiff neck that night on same day vaccines were given. The patient recovered completely. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Liver function test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the first of eight reports. 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 was not reported. The patient's concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine. Follow-up (16Aug2016): This is a follow-up spontaneous report from a contactable physician. This physician reported for a patient that: Suspect products: TRUMENBA. Adverse events: No new adverse event. Patient Details: Is the patient also the reporter: No. Reporter Details: Is it ok for us to contact you should we have further questions about this report: Yes. What happened: No new adverse event. Products: Suspect products: TRUMENBA. Is this a Pfizer product: Yes. History: Additional Context: Other Reference(s): Forwarded to agency. Additional Context: This is the first report. This is for the first report #. The physician mentioned that he was responding to the mailing he got from the Pfizer asking him to fill out some fax regarding a safety issue for TRUMENBA about which he had called and inquire back in Jul, at that time he indicated to the Pfizer's agent that he did not have any direct information as he was seeing the patient but the vaccine was given by Primary Care Physician and he used to file various reports, so in his understanding it was sufficient and he did not want to do all the reporting as the Primary Healthcare Physician already done that and he also did not have any direct involvement or responsibility with the administration of them. He received multiple page questionnaires. He provided the report# as # and #. The first letter identifies the patient by his initial and second one said unknown but all of his conversations was about the one patient so it was looking like they have generated the second report which was really the same. He wanted Pfizer to stop sending him the letters as it was either helpful or necessary because the paediatrician have administered the vaccine and had already reported all the information. Causality was not available over the call. This case is in cross linked with #. Is there a product complaint to report?: No. Follow-up (16Aug2016): This follow up report contains no new safety information. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Liver function test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the second of eight reports. 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 was not reported. The patient's concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable Nurse received via a sales representative. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA, at 0.5 ml, single and the first dose of MENVEO, at 1DF single, both intramuscular on the same unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced fever, nausea, vomiting and dizziness all on an unspecified date (same date of vaccination) with outcome of recovered. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Liver function test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the third of eight reports. A patient of unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable physician, reported for his son, via a Pfizer sales representative. A 17-year-old male patient of an unspecified ethnicity received first dose of TRUMENBA, intramuscular on an unspecified date at 0.5ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced tenderness at site of injection and generally achy, both assessed as non-serious on an unspecified date with outcome of recovered. Follow-up (12AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Myalgia, Tremor
Clinical narrative: This is a spontaneous report from a contactable physician reported for her son. A 19-year-old male patient received first dose of TRUMENBA (NDC number: 00005-0100-05), intramuscular on 16Jun2016 at 0.5 ml, single. The patient medical history was not reported. There were no concomitant medications. The patient experienced severe headache, chills, shaking, muscle soreness all on 16Jun2016. The outcome of the event headache was reported as recovering, the outcome of the event muscle soreness was reported as not recovered and for the other adverse events recovered. Treatment was gave TYLENOL and BENADRYL. The vaccine was not prescribed by any doctor, the University required that he had his vaccine before he came back to school because they had meningitis outbreak. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's mother). A 18 year old male patient of an unspecified ethnicity received, on an unspecified date, TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the next day after the vaccination, the patient was unable to lift or mover arm and it was painful. The mother mentioned that her son was still in pain; while clinical outcome of the other adverse event was unknown.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Tremor, Visual impairment
Clinical narrative: This is a spontaneous report from a Pfizer colleague reporting for her daughter. A 17-year-old female patient of an unspecified ethnicity received third dose of TRUMENBA, via an unspecified route of administration on an unspecified date at 0,5ml single dose. The patient medical history and the patient's concomitant medications were not reported. About 45 minutes or so after the dose administered the patient experienced dizzy, vision became darken and started to shake. The patient previously had received the first and second dose of the same vaccine on unknown date. The mother, a non-practicing nurse sat her down, covered her with a blanket and got her some OJ and protein. The outcome of the events was unknown. Follow-up (11AUG2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Chills, Discomfort, Fatigue, Myalgia
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a sales representative. A male patient of an unspecified age and ethnicity received, on an unspecified date, the first dose of TRUMENBA (Lot. M37316, Expiration date: 30Apr2017) single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced fatigue, muscle and joint paint, and chills. He took TYLENOL. The patient developed also discomfort but was getting better at time of this report. Clinical outcome of the other events was unknown. Patient did not have shortness of breath, dizziness or rapid heart rate. Follow-up (11AUG2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report from a contactable nurse. 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's medical history and concomitant medications were not reported. The patient experienced a very large local reaction on an unspecified date with outcome of unknown. Follow-up (11AUG2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Injection site erythema, Pain, Rash, Tenderness
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative who reported the same events for two different patients. This is the first of two reports. A male patient of unspecified age and ethnicity received TRUMENBA in May2016, at 0.5 ml, single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced red spot on the arm that was large, visible, tender to the touch and very painful and rashes, all in May2016. Red spot was really big and it was like covering up whole top half of the arm where they were injected. The events lasted approximately for 5 days. The reporting nurse believed that red spots were due to the vaccine, as developed after being vaccinated.
Age: 18.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Dizziness, Pallor
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A 18-year-old male patient of an unspecified ethnicity received TRUMENBA, at 0.5 ml, single and human papilloma vaccine (HPV9), both via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced dizzy and lips were pale on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via sales representative. This physician reported similar events for four patients. This is 4th of 4 reports. An adolescent (Age: 16-17) patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date, at single dose for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced arm pain, swelling and fever, all on an unspecified date with outcome unknown.
Sex: U
Vaccine: MENB
Symptoms: Liver function test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the fourth of eight report. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration, on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. This Physician reported similar events for four patients. This is 3rd of 4 reports. An adolescent (Age: 16-17) patient of an unspecified ethnicity and gender received TRUMENBA , via an unspecified route of administration on an unspecified date, at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced arm pain, swelling and fever, all on an unspecified date with outcome unknown.
Sex: U
Vaccine: MENB
Symptoms: Liver function test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is the fifth of eight reports. 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 was not reported. The patient's concomitant medications were not reported. The patient experienced abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
Sex: U
Vaccine: MENB
Symptoms: Liver function test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician who reported the same event for eight different patients. This is sixth of eight reports. 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 abnormal liver function tests on an unspecified date with unknown outcome. The reporting physician did not consider the event was associated to the administered vaccine.
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician sales representative. This physician reported similar events for four patients. This is 2nd of 4 reports. An adolescent (Age: 16-17) patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date, at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced arm pain, swelling and fever, all on an unspecified date with outcome unknown.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 17-year-old female patient of an unspecified ethnicity received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient received a shot of TRUMENBA and complained of a very sore arm on an unspecified date. She took ibuprofen to ease the pain. The patient was still complaining of a sore arm and she has continued to take ibuprofen to manage the pain. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via sales representative. This Physician reported similar events for four patients. This is 1st of 4 reports. An adolescent (Age: 16-17) patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date, at single dose for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced arm pain, swelling and fever, all on an unspecified date with outcome unknown.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse. A 19-years-old female patient of an unspecified ethnicity received TRUMENBA, intramuscular in the arm on an unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient experienced nausea, dizziness, chills on 21Jun2016 with outcome of not recovered. The symptoms were worsening and they started worsening after she worked out, after exercising. The patient was treated with TYLENOL dose in the night. Follow-up (18AUG20160): Follow-up attempts are completed. No further information is expected.