chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (lot# L050788, expiry date 12-OCT-2017; lot# M020521, expiry date 17-NOV-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Feeling hot, Inappropriate schedule of drug administration
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her son. A male patient of an unspecified age and ethnicity received, on 29Apr2016, the third dose of TRUMENBA at 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. The patient previously received the first dose of TRUMENBA on 18Dec2015 and the second dose on 18Feb2016, both at 0.5 ml, single dose. After the third shot, which was given by mistake 2 months after second dose, he felt warm. Clinical outcome was unknown at time of this report. Follow-up (24JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Erythema, Headache, Mobility decreased, Myalgia
Clinical narrative: This is a spontaneous report from a contactable registered nurse via a Pfizer sales representative and from a contactable physician. A 18-year-old female patient received TRUMENBA (Lot# M95612, Exp date 31Jul2017, NDC# 0005-0100-10 if it was a 10 pack or 0005-0100-05 if it was a 5 pack), intramuscular in the left shoulder on 05May2016 at 03:00 PM at 0.5 ml single. Medical history included innocent heart murmur and family history of rheum, arthritis, hypothyroidism. Drug history, drug or alcohol abuse and drug allergies were reported as no. Concomitant medication included unspecified birth control. On 05May2016 at 07:00 PM the patient experienced muscle aches in left shoulder, swelling almost the size of a golf ball, redness, fever and dizziness. On 06May2016 she experienced headache and nasal congestion. The patient was seen in the office at 03:00 PM the day of the report and still had a fever of 99.9 degrees Fahrenheit. The patient was complaining that the symptoms of muscle aches in left shoulder, swelling almost the size of a golf ball, redness, dizziness, headache and nasal congestion worsened. Her arm was so sore she cold not lift it. All other vitals were stable and no other lab testing was completed. The patient received Ibuprofen and BENADRYL as treatment for the events. The patient recovered from muscle ache, redness, swelling, fever and dizziness while did not recover from headache and nasal congestion. The patient provided information to the physician regarding the reported adverse events with the use of TRUMENBA. The reporter considered that the TRUMENBA has causal effect to the adverse events. Follow-up (31May2016): New information reported form contactable physician includes: medical history, events onset date, treatment required, physician acknowledgment of the occurrence of the events and causality assessment. Follow up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nasal congestion, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable registered nurse via a Pfizer sales representative and from a contactable physician. A 18-year-old female patient received TRUMENBA (Lot# M95612, Exp date 31Jul2017, NDC# 0005-0100-10 if it was a 10 pack or 0005-0100-05 if it was a 5 pack), intramuscular in the left shoulder on 05May2016 at 03:00 PM at 0.5 ml single. Medical history included innocent heart murmur and family history of rheum, arthritis, hypothyroidism. Drug history, drug or alcohol abuse and drug allergies were reported as no. Concomitant medication included unspecified birth control. On 05May2016 at 07:00 PM the patient experienced muscle aches in left shoulder, swelling almost the size of a golf ball, redness, fever and dizziness. On 06May2016 she experienced headache and nasal congestion. The patient was seen in the office at 03:00 PM the day of the report and still had a fever of 99.9 degrees Fahrenheit. The patient was complaining that the symptoms of muscle aches in left shoulder, swelling almost the size of a golf ball, redness, dizziness, headache and nasal congestion worsened. Her arm was so sore she cold not lift it. All other vitals were stable and no other lab testing was completed. The patient received Ibuprofen and BENADRYL as treatment for the events. The patient recovered from muscle ache, redness, swelling, fever and dizziness while did not recover from headache and nasal congestion. The patient provided information to the physician regarding the reported adverse events with the use of TRUMENBA. The reporter considered that the TRUMENBA has causal effect to the adverse events. Follow-up (31May2016): New information reported form contactable physician includes: medical history, events onset date, treatment required, physician acknowledgment of the occurrence of the events and causality assessment. Follow up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from two contactable nurses reporting on behalf of a nurse practitioner. A 16 years old female patient of unspecified ethnicity received the first dose of TRUMENBA (lot J29203, NDC number: 0005010010, expiry date: 01Jun2016) intramuscular in left arm on 09May2016 at 15:58 at 0.5 ml single dose. Medical history was not reported. Concomitant vaccine included the second dose of MENACTRA; (Manufacturer Sanofi, lot U5244AA) intramuscular in left arm on 09May2016 for immunization. The patient experienced hives on 11May2016. The patient was visited at doctor office. The patient was not admitted to hospital. PCP suggested skin testing at allergist with the following dose. The event resolved on 12May2016. The reporter considered that the vaccine had a causal effect to the adverse event. Follow up (01Jun2016): New information from a contactable nurse includes: patient age, vaccination time, concomitant vaccination, event onset date, details and outcome reporter causality assessment. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA on an unspecified date, at 0.5 ml, single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm pain on an unspecified date after vaccination, which resolved after 4 days. Follow-up (06JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: This spontaneous report from two contactable nurses via a sales representative, who reported similar events for two patients. This is the first case out of two reports. A 19 years old female patient of unspecified ethnicity received TRUMENBA; lot J29203, expiry date 30Jun2016, via intramuscular route of administration in the left arm on 27Apr2016 at 11:13, at 0.5 ml, single. Illness at time of vaccination was none. The patient medical history and concomitant medications were not reported. On 28Apr2016 the patient had a localized reaction in left arm of a sizeable lump with redness and swelling of the injection site on an unspecified date with outcome of unknown. The events did not require an emergency room or physician visit. The second reporting nurse considered the vaccine had a causal effect to the adverse events. Follow up (30Jun2016): New information from a contactable nurse includes: patient age, vaccine lot number, expiry date, route of administration, vaccination date, events onset date, details, causality assessment.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable Medical assistant on behalf of the physician received via a Pfizer sales representative, and from a contactable nurse. A 18-year-old female patient of an unspecified ethnicity received a second dose of TRUMENBA (Batch/Lot# M37314, Exp date Apr2017), intramuscular in left deltoid, at 0.5 ml single, on 03May2016. The patient's medical history and concomitant medications were none. Previously the patient received first dose of TRUMENBA on 16Dec2015. The patient experienced swollen left arm from upper arm to just above elbow on 03May2016 with outcome of recovered on 09May2016, pruritus of lateral left arm and elbow on 03May2016 with outcome of not recovered and 2 inch margin of redness surrounding the vaccination site on 03May2016 with outcome of recovered. The patient was seen by a physician 6 days after vaccination and described the adverse events. At the time of the visit, her left arm was slightly swollen from the upper arm to just above the elbow. The erythema was no longer present, but the arm was very itchy. The day of administration the patient has a 2 inch margin of redness surrounding the vaccine site, which spread down the arm, and progressed to swelling and pruritus over 2-3 days. Therapeutic measures were not taken as a result of swollen arm. The nurse considered that the Pfizer product had a causal effect to the adverse events. Follow-up (13Jun2016): New information received from a contactable nurse includes: patient's age, nurse causality assessment, TRUMENBA details, vaccine history, concomitant/relevant history details, events updated, treatment detail. Follow-up (05Aug2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Feeling cold, Somnolence
Clinical narrative: This is spontaneous report from a non-contactable Consumer reporting for her son. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced chills and drowsy on the same unspecified date of vaccine administration with outcome of not recovered. The patient received ADVIL and TYLENOL to treat the events. No Follow-up attempts possible. No further information expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: This is a spontaneous report from a contactable medical assistant calling on behalf of a physician. A 17-year-old female patient received TRUMENBA (Lot# L13515, Exp date Jul2016, NDC 0005010010), intramuscular in the left arm, on 29Apr2016, at 0.5 ml single. The patient's medical history was unknown. Concomitant medication included CYCLAFEM tablet, oral, from an unspecified date and ongoing, at 1 DF daily (1 mg (dot) 35 mcg), as birth control pill. On 29Apr2016 and for three days it was red and swollen on the upper arm and it was tender. The reporter considered the adverse events as related to meningococcal group b rlp2086. The events recovered. Follow-up (18JUN2016): Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia
Clinical narrative: This is a spontaneous report from a contractable physician via a Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity received first dose of TRUMENBA, via an unspecified route of administration on an unspecified date, single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced weakness on an unspecified date with outcome of unknown. Follow-up (10JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional who reported on behalf of a physician through a Company representative. A 18-year-old male patient received TRUMENBA (lot L131515, expiry date 31Jul2016) on 17May2016 at 2:44 PM, at 0.5 ml single, intramuscular in left deltoid. The patient did not receive any other vaccine on the same day. The patient medical history was none. On 10May2016 the patient took second dose of MENACTRA (Manufacturer Sanofi; Lot U526OAA) intramuscularly in the left arm, hepatitis A vaccine (manufactured by Merck; lot LO45713) intramuscularly in the left arm and GARDASIL (Manufacturer: Merck, lot LO19297) intramuscularly in the right arm. The patient experienced chill on 17May2016 with outcome of recovered, fever on 17May2016 with outcome of recovered, extreme headache on 17May2016 with outcome of recovered, sore throat on 17May2016 with outcome of recovered, soreness on 17May2016 with outcome of recovered, fatigue on an unspecified date with outcome of unknown, muscle pain on an unspecified date with outcome of unknown, not feeling well on an unspecified date with outcome of unknown. The patient came to the doctor's office on 18May2016 due to the events. The patient was advised to call back if the events continued. Treatment for events included: MOTRIN every 6 hours, increase fluids and ice/compression to the area. Follow up (19May2016 and 23May2016): New information from a contactable healthcare professional who reported on behalf of a physician through a Company representative includes: reporter type (case medically confirmed), vaccine lot number, expiry date, administration date, route and anatomical location of administration, concomitant vaccines, additional events 'fatigue', 'muscle pain', 'not feeling well', treatment received. Follow-up (06Jun2016): additional information received from the same contactable physician includes dose of vaccine previously administered. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable healthcare professional who reported on behalf of a physician through a Company representative. A 18-year-old male patient received TRUMENBA (lot L131515, expiry date 31Jul2016) on 17May2016 at 2:44 PM, at 0.5 ml single, intramuscular in left deltoid. The patient did not receive any other vaccine on the same day. The patient medical history was none. On 10May2016 the patient took second dose of MENACTRA (Manufacturer Sanofi; Lot U526OAA) intramuscularly in the left arm, hepatitis A vaccine (manufactured by Merck; lot LO45713) intramuscularly in the left arm and GARDASIL (Manufacturer: Merck, lot LO19297) intramuscularly in the right arm. The patient experienced chill on 17May2016 with outcome of recovered, fever on 17May2016 with outcome of recovered, extreme headache on 17May2016 with outcome of recovered, sore throat on 17May2016 with outcome of recovered, soreness on 17May2016 with outcome of recovered, fatigue on an unspecified date with outcome of unknown, muscle pain on an unspecified date with outcome of unknown, not feeling well on an unspecified date with outcome of unknown. The patient came to the doctor's office on 18May2016 due to the events. The patient was advised to call back if the events continued. Treatment for events included: MOTRIN every 6 hours, increase fluids and ice/compression to the area. Follow up (19May2016 and 23May2016): New information from a contactable healthcare professional who reported on behalf of a physician through a Company representative includes: reporter type (case medically confirmed), vaccine lot number, expiry date, administration date, route and anatomical location of administration, concomitant vaccines, additional events 'fatigue', 'muscle pain', 'not feeling well', treatment received. Follow-up (06Jun2016): additional information received from the same contactable physician includes dose of vaccine previously administered. Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: HPVX, MENB
Symptoms: Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 21-year-old female patient of unspecified ethnicity received first dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at, 0.5 ml single and first does of HPV, via an unspecified route of administration, on an unspecified date, at 1 DF single. The patient's medical history included idiopathic neuropathy. Concomitant medications were not reported. The patient experienced numbness starting in feet and going to the waist on an unspecified date. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Lethargy
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA, on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced lethargy, headache and severe redness at injection site. The outcome of the events was unknown. No follow-up attempts are possible.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Injection site discomfort, Injection site pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 18-year-old female patient received the second dose of TRUMENBA, (lot number M13066, expiration date 01Sep2016) at 0.5 ml single dose intramuscular in the left arm on 04Jan2016 at 19:45 as recommended for age group. Medical history included depression and anxiety started on 19May2014 and ongoing, migraine headache from Dec2013, acne from Dec2014. Concomitant medication included ongoing ZOLOFT at 37.5 mg once daily form Nov2014 and ongoing for depression, anxiety. On 04Jan2016 by 11 pm the patient she was complaining of an incredibly bad pressure headache, shivering, uncontrollable shaking, burning at injection site, and very uncomfortable. At midnight, the patient had vomited 4 times and had no fever at that point per the mother. The mom maybe thought the patient had a low grade temperature the following morning. No specific tests and/or treatment were required. The AEs did not require and emergency room or physician visit. The patient recovered on 05Jan2016. The patient was able to go to school on 05Jan2016. The pharmacist stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect. The pharmacist considered there was a reasonable possibility that the event is related to suspect product. The pharmacist was not willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (28Jun2016): New information reported form a contactable pharmacist on behalf of physician included: Medical History, concomitant medication therapy date/indication; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Tremor, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse. A 18-year-old female patient received the second dose of TRUMENBA, (lot number M13066, expiration date 01Sep2016) at 0.5 ml single dose intramuscular in the left arm on 04Jan2016 at 19:45 as recommended for age group. Medical history included depression and anxiety started on 19May2014 and ongoing, migraine headache from Dec2013, acne from Dec2014. Concomitant medication included ongoing ZOLOFT at 37.5 mg once daily form Nov2014 and ongoing for depression, anxiety. On 04Jan2016 by 11 pm the patient she was complaining of an incredibly bad pressure headache, shivering, uncontrollable shaking, burning at injection site, and very uncomfortable. At midnight, the patient had vomited 4 times and had no fever at that point per the mother. The mom maybe thought the patient had a low grade temperature the following morning. No specific tests and/or treatment were required. The AEs did not require and emergency room or physician visit. The patient recovered on 05Jan2016. The patient was able to go to school on 05Jan2016. The pharmacist stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect. The pharmacist considered there was a reasonable possibility that the event is related to suspect product. The pharmacist was not willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (28Jun2016): New information reported form a contactable pharmacist on behalf of physician included: Medical History, concomitant medication therapy date/indication; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative and then from a contactable physician. An 18-year-old female patient of an unspecified age and ethnicity received the initial dose of TRUMENBA, Batch/Lot # M95612, Exp: Jul2017) IM at 0.5 CC single dose at left deltoid on 23May2016 for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No adverse event following prior vaccination occurred. The patient experienced fever on an unspecified date in 2016 with outcome of recovering, hives on an unspecified date in 2016 with outcome unknown, muscle ache on an unspecified date in 2016 with outcome of unknown. No AE required an emergency room or physician visit. The reporter stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect. The reporter considered the Pfizer product had a Possible Not definite causal effect to the adverse event. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (21Jun2016): New information reported from a contactable physician includes: patient age; suspect data; reporter informed regarding the adverse events; AEs onset date; reporter event causality assessment; reporter further contactability. Follow-up (17AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Musculoskeletal disorder
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 17-year-old female patient received, on an unspecified date, TRUMENBA 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced fatigue and was unable to use her arm following vaccination. Clinical outcome of the events was unknown at time of this report. Follow-up (16JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer Sales representative. A patient of unknown age, gender and ethnicity received on an unspecified date first dose of TRUMENBA at 0.5 ml single dose. Concomitant medications and medical history were not reported. After use of product, the patient had a rash in both forearms that lasted for a couple of days. Outcome was not reported. Follow-up (16JUL2016): Follow-up attempts are completed. No further information is expected. Follow-up (16Aug2016): This is a follow-up spontaneous report form a contactable Physician. This Physician reported for a 23-year-old female patient in response to HCP letter sent that included: 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 Pfizer product had a causal effect to the adverse event: No Are you willing to be contacted again by Pfizer on the reported averse event (s): Yes Suspect vaccine: Suspect vaccine name and/ or generic name: TRUMENBA Bat/Lot #: J28923 Expiration date: 30Jun2016 Route of administration: IM Indication: vaccine Time vaccination was given (hour: minute - 24 hour clock): 18Apr206 15:14 Anatomical location of the administration of the vaccine: L Deltoid Did any of the AEs require and emergency room or physician visit: No Adverse event: Was the patient admitted to hospital: rash forearms Event onset date: 21Apr2016 Causal relationship: (Is there a reasonable possibility that the event is related to suspect product/s): Unknown Dechallenge/Rechallenge? Did reaction(s) recur on re-administration: No Were specific test and/or treatment required: No Relationship to patient: Vaccine provider, Patient/parent Vaccinated at: Private Physician's office/hospital Vaccine purchased with: Private funds Illness at time of vaccination (specify): None Have you reported this event previously: No May we contact you to request additional information if needed: Yes Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pyrexia, Tenderness
Clinical narrative: This is a spontaneous report from a contactable nurse, reporting for her son, via a sales representative. A 21 year-old male patient of an unspecified ethnicity received the first dose TRUMENBA, lot/batch number M37315 intramuscularly on the right deltoid on 16May2016 at 9:15 am at 0.5 ml single. The patient medical history and concomitant medications were not reported. On an unspecified date a red, feverish and tender spot on the patient's arm appeared. No treatment was received for the events. No emergency room or physician visit was required and the patient was not admitted to the hospital. At the time of this report the patient recovered from the reported events (it lasted for a couple of days then subsided). The nurse stated that her other son received the vaccine and had no reaction occurred. The nurse stated that the patient provided information to her regarding the reported adverse events with the use of the vaccine. The nurse considered that the Pfizer product had a causal effect to the adverse events. Follow-up (16Jul2016): Follow-up attempts are completed. No further information is expected. Follow-up (01Aug2016): New information reported from a contactable nurse includes: patient's date of birth, details of vaccination, lot/batch number of TRUMENBA, outcome, no emergency room, physician visit or hospitalization required for the events, confirmation that the patient provided information to the nurse regarding the events, causality assessment. Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse. A 20-year-old female patient received the first dose of TRUMENBA; NDC number 00005010001 on 25Nov2015, intramuscular, at 0.5 ml single. Medical history included rash (patient went to the dermatologist for a rash a long time ago). The patient's concomitant medications were not reported. The patient experienced severe soreness at the site, fever, nausea, vomiting, general body achiness, all in Nov2015 (within the first 3 days after receiving the first dose of vaccine) and resolved on an unknown date. The events did not require an emergency room or doctor visit. Follow-up (27May2016): New information reported from the same contactable nurse includes reporter's details. Follow-up (24JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Gait disturbance, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A 16-year-old patient of an unspecified ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose, and MENACTRA via an unspecified route of administration, both on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever for 3 days, 101, all over body aches that lasted for 3 days, had trouble walking even by 3rd day. The outcome of the events was unknown. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain, Eye pain, Pyrexia, Screaming
Clinical narrative: Mom calls to say son woke up at 3 am with fever 103.7, screaming. Saying "belly hurt" and "eyes hurt". Denies illness leading up to vaccines, but says he has asthma, and seems to react to things easily. TYLENOL/Ibuprofen are currently being used.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pustule, Pyrexia
Clinical narrative: Injection given 8/19/16 in (R) deltoid. 4 x 3 cm. Pustular reaction with induration 14 x 8 cm erythema. Fever.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Blister, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Injection site swelled up, welt the diameter of a baseball, lower arm has blisters, both on right arm.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Received 1st HPV9 vaccine - a few hours later developed a rash which became generalized, erythematous and urticaric - improved after BENADRYL the following day. Seen by provider.
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A male patient of unspecified 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 felt weird and had fever at 103 Fahrenheit. Clinical outcome of the events was unknown at time of this report. Follow up (29JUL2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Influenza, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative and from a contactable other HCP. This nurse reported similar event for two patients. This is the second of two reports. An adolescent (in the 16-18 year old age group) male patient received TRUMENBA (Lot # C13514) intramuscular in left arm at 0.5 ml single dose and the second dose of MENVEO (Lot # A15068) intramuscular in right arm as single dose, both on unknown date. Medical history and concomitant medications were not reported. The patient experienced arm pain at injection site, dizziness and flu symptoms. The arm pain lasted 1 week. Unknown how long dizziness or flu symptoms lasted. No specific tests and/or treatment were required. The outcome was unknown. Follow-up (27Jun2016): New information reported from a contactable other HCP includes: lot number, anatomical location, treatment details. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous report from a contactable Nurse via a Pfizer sales representative. This Nurse reported same events for two patients. This is the first of the two reports. A male patient of unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced low grade fever and aches both on an unspecified date with outcome of unknown. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Injection site hypoaesthesia, Injection site paraesthesia, Malaise
Clinical narrative: This is a spontaneous report from a contactable nurse. A 21-year-old male patient received the first dose of TRUMENBA (Lot Number M95612, Expiry date Jul2017), intramuscular at 0.5 ml single in the left deltoid on 01Jun2016 at 16:00. Medical history included asthma on ongoing (Does not know when diagnosed). Concomitant medication included BASIC, on ongoing for allergies. On 01Jun2016, the patient experienced numbness and tingling at injection site, pain, chills, fever, feels rotten. Also he developed nausea and headache on an unspecified date. The outcome of the events was unknown. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 21-year-old male patient received the first dose of TRUMENBA (Lot Number M95612, Expiry date Jul2017), intramuscular at 0.5 ml single in the left deltoid on 01Jun2016 at 16:00. Medical history included asthma on ongoing (Does not know when diagnosed). Concomitant medication included BASIC, on ongoing for allergies. On 01Jun2016, the patient experienced numbness and tingling at injection site, pain, chills, fever, feels rotten. Also he developed nausea and headache on an unspecified date. The outcome of the events was unknown. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable Physician via company representative. An 18-year-old female patient of an unspecified ethnicity started to receive TRUMENBA via an unspecified route of administration at 0.5 ml, single on 01Jun2016. The patient medical history was not reported. The patient's concomitant medications were not reported. No other shot was given at the same time with TRUMENBA. The patient experienced fainted on an unspecified date with outcome of unknown. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Discomfort, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 21-years-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 concomitant medications were not reported. The patient experienced a lot of discomfort, numbness, tingling, feeling bad all over, and chills all on an unspecified date with outcome of not recovered. No follow up attempts possible. No further information expected.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Muscle tightness
Clinical narrative: This is a spontaneous report from a contactable other health professional via a Pfizer sales representative and from a contactable nurse. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose for immunization and on the same date MENACTRA, via an unspecified route of administration for immunization. Medical history and concomitant medications were not reported. The patient experienced weakness, felt like right side of the body lost strength and jaw was tightened, all on an unspecified date with outcome unknown. Follow-up (05Jul2016): New information reported from a contactable nurse includes: country of incidence updated.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Headache
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 17-year-old male patient received, on 07Jun2016, at around 2:00 or 2:30 PM in the afternoon, the first dose of TRUMENBA at 0.5 ml, single dose. No other vaccines administered at that time. Relevant medical history and concomitant medications were unknown. On 08Jun2016, at roughly 11:00 AM, the mom called the doctor's office and said her son woke up and wasn't feeling well. His symptoms included: headache, stomach cramps, shaking, weakness, tired, and shivering. The patient was seen by the doctor that day, 08Jun2016 around 3:15 PM and apparently the patient was feeling a little bit better at that time. Clinical outcome of the events was recovering at time of this report. Follow-up (05AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Malaise, Tremor
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 17-year-old male patient received, on 07Jun2016, at around 2:00 or 2:30 PM in the afternoon, the first dose of TRUMENBA at 0.5 ml, single dose. No other vaccines administered at that time. Relevant medical history and concomitant medications were unknown. On 08Jun2016, at roughly 11:00 AM, the mom called the doctor's office and said her son woke up and wasn't feeling well. His symptoms included: headache, stomach cramps, shaking, weakness, tired, and shivering. The patient was seen by the doctor that day, 08Jun2016 around 3:15 PM and apparently the patient was feeling a little bit better at that time. Clinical outcome of the events was recovering at time of this report. Follow-up (05AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Chills, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a non-contactable nurse through a Pfizer sales representative. A 17-year-old patient of unspecified gender and ethnicity received, on an unspecified date, TRUMENBA single dose. The patient received concomitantly MENVEO. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced fever over 40 Centigrade, muscle pain, chills, vomiting, diarrhea and abdominal pain. Clinical outcome of the events was unknown at time of this report. The mother of the patient visit the hospital for handle the symptoms.
Age: 17.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report obtained from a non-contactable nurse through a Pfizer sales representative. A 17-year-old patient of unspecified gender and ethnicity received, on an unspecified date, TRUMENBA single dose. The patient received concomitantly MENVEO. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced fever over 40 Centigrade, muscle pain, chills, vomiting, diarrhea and abdominal pain. Clinical outcome of the events was unknown at time of this report. The mother of the patient visit the hospital for handle the symptoms.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Muscular weakness, Myalgia
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. A 13-year-old male patient received TRUMENBA (NDC # 0005010005, Lot. M95612, Expiry Date 30Jul2017), intramuscular, in left arm, on 06-Jun2016 at 15:10, 0.5 ml, single dose. Medical history included ongoing Complement C2 Deficiency, diagnosed at around age 7 and ongoing cyclic vomiting syndrome. Concomitant medications included oral omeprazole, 20 mg, once daily, from 01Oct2015 (ongoing); PERIACTIN ongoing and oral ZOFRAN 4 mg, as needed (1 tab every 8 hrs) ongoing. The patient experienced headache, muscle pain, leg weakness and fatigue on 07Jun2016. The events did not require emergency room or doctor visit. No hospitalization was required. The patient recovered on 08Jun2016. The reporter assessed the events as related to TRUMEMBA. Follow up (06Jun2016): New information received from a contactable physician includes: expiration date and route of administration of the vaccine provided, medical history, and concomitant medications. Follow-up attempts completed. No further information expected. Follow-up (05Aug2016): This is a follow-up report combining information from duplicate reports 2016297625 and 2016297767. The current and all subsequent information will be reported under manufacturer report number 2016297625. This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 13-year-old patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml, single. Medical history and concomitant medications were not reported. The patient experienced fatigue and muscle pain lasted 24 hours period, both on an unspecified date with outcome of recovered. Follow-up (05Aug2016): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported in response to the HCP letter sent in cross referenced case which included: Patient's full name received. Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dysstasia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16 year-old female patient received TRUMENBA via an unspecified route of administration, on unknown date, at single dose. The patient also received and tuberculin ppd (unknown manufacturer). Relevant medical history and concomitant medications were not reported. The patient felt faint and needed support to stand on unknown date after received the products. The action taken for tuberculin ppd was not reported. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sale representative. A female patient of unspecified age and ethnicity received the first single dose of TRUMENBA, lot number 1913065, expiry date Sep2016 via an unspecified route of administration, on unknown date. Relevant medical history and concomitant medications were not reported. The patient couldn't move arm for two weeks on unknown date. The outcome of the event was unknown. Follow-up (06AUG2016): 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 contactable Nurse via Pfizer sales representative. This nurse reported similar events for two patient. This is the second of two reports. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced low grade fever and aches on an unspecified date with outcome of unknown. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: 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 difference patients. This is the second of the two reports. A patient of unspecified age, ethnicity and gender 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 very 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: 21.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Injection site reaction, Rash erythematous
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.