chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 11-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX23 0.5 ml once, lot # L014876, expiration date 13-JAN-2017, subcutaneously in the area "just below" the deltoid. On an unknown date in September 2015, the patient returned to the pharmacy and stated that "it was more painful than he or she thought it should have been". The reporter stated that she (the pharmacist) visualized the injection site and found area to be "perfectly normal, not red or warm or anything like that". The reporter stated that no other effects were reported. The patient did not receive any treatment. The outcome of the event was unknown. The patient sought medical attention via visiting the pharmacy. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Abdominal pain, Nausea, Pruritus, Urticaria
Clinical narrative: Patient received 3 intramuscular vaccines mentioned below. The last vaccine given 10:09 am. While walking to another area with examining physician, pt started (10:10 am) complaining of itchiness on the neck, within minutes itching increased and report of abd pain and nausea. Vitals stable. Pt developed hives. 1 hr after last vaccine BENADRYL 50 mg given by mouth with resolution of symptoms. After 2 hr 10 min, disch to home.
Age: 27.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Head injury, Syncope
Clinical narrative: Syncope approx. 10 minutes after vaccinations. Observed in treatment room for 1 hr. Vital signs, observed for head injury.
Age: 1.97
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Mom called on 9/14/15. She reported that her son developed fever of 104 on 8/1/15 in the event she administered Ibuprofen Q6 hrs x 4 for 24 hours. His fever reduced to 100 after medication given. Fever resolved in 24 hours.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and medical assistant refers to a patient of unknown age. On 15-SEP-2015 the patient was vaccinated with improperly stored M-M-R II (incorrect product storage) (lot#L009213, expiry date: 17-MAR-2017). No adverse symptoms reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's pertinent medical histories, concomitant medications, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot # J002641, expiration date 10-DEC-2015; lot# J008423, expiration date 21-JAN-2016; lot # J013324 expiration date 12-FEB-2016; lot # J006236, expiration date 25-FEB-2016; lot # J009788, expiration date 17-MAR-2016; lot # J006850, expiration date 31-MAR-2016, doses, route and site of administration were not reported). There were no adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Pt called - stated hives and itching over entire body - 6 hrs after injection. PO BENADRYL taken.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood culture, Blood glucose, Clostridium test, Culture urine, Full blood count
Clinical narrative: Slept x5 hrs then patient became very pale after nursing. Threw up several times (10 episodes in about 2 hours). EMS called and patient taken to ER. Had weak breathing. After each episode emesis. Mom reports patient felt a little better.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Laboratory test, Metabolic function test, Pallor, Respiration abnormal, Urine analysis
Clinical narrative: Slept x5 hrs then patient became very pale after nursing. Threw up several times (10 episodes in about 2 hours). EMS called and patient taken to ER. Had weak breathing. After each episode emesis. Mom reports patient felt a little better.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Vomiting
Clinical narrative: Slept x5 hrs then patient became very pale after nursing. Threw up several times (10 episodes in about 2 hours). EMS called and patient taken to ER. Had weak breathing. After each episode emesis. Mom reports patient felt a little better.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt left stable after vaccination and later that night the left arm felt hot, red, started swelling up almost 3x size. She went to ER and was given IV antibiotics and swelling went down 3d later.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Blood pressure increased, Heart rate increased, Hyperhidrosis, Muscle spasms
Clinical narrative: Patient experienced increased BP and pulse. Diaphoresis along with muscle spasming. Sent to ER - given IVF. Symptoms completely resolved today. Staff has entered exception.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Fever. Pain where the shot was given. Headache, nausea, body aches, dizziness.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever. Pain where the shot was given. Headache, nausea, body aches, dizziness.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: Patient here for follow up left arm cellulitis following immunization with PREVNAR 13. Patient has tolerated KEFLEX and arm is feeling much better. No further pain. Redness has almost completely faded. Denies fever, chills, nausea, headache, numbness or tingling.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, pain, redness.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Lg area swollen, rash within swollen area.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itching and pain in left arm where the injection was given. Most of the anterior surface of the arm affected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K010215 and expiration date 05-MAY-2017) (dose and route were not reported).  No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Secondary transmission
Clinical narrative: Information was received regarding a case for ZOSTAVAX (Marrs#1509USA008590) from a consumer and a pharmacist who refers to her husband, of unspecified age. On 31-JUL-2015, the consumer was vaccinated with ZOSTAVAX, and reported that her husband has been diagnosed with "shingles" (secondary transmission) within the last week (date not provided). The consumer explained that her husband visited the local hospital emergency room with a red rash across his chest. Her husband was not admitted. The outcome of the event was not reported. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot # K019560 and expiration date 02-JUN-2017, lot # L002717 and expiration date 02-JUN-2017) (dose and route were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L007558 and expiration date 10-NOV-2016) (dose and route were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received form the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient reported rash/swelling about the size of a bandaid at injection site on 9/11/15.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Confusional state, Seizure like phenomena
Clinical narrative: I had given Tdap, then HPV, 30 seconds after pt, had seizure like symptoms, boarded up lasting 45 seconds, upon coming out of it pt was real confused.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt. fainted approximately 5 min. after vaccines.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Marked swelling more than 20cm with erythema at injection site with slight.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L008054 and expiration date 05-AUG-2016) (dose and route were not reported). No adverse effects were reported. No Product Quality Compliant (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pruritus, Swelling, Tenderness
Clinical narrative: Red, swollen, itch started about 24 hrs after administered. Know, hurts to touch.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose normal, Cold sweat, Fear of injection, Pallor
Clinical narrative: Less than 2 min after injection pt. was clammy and pale. O2 given at 2LPM via N/C. EMS called. Cold pack applied to back of neck and Gatorade given per pts request. Pt stated that she has a fear of needles and this has happened in the past when she gets an injection. EMS arrived, pt refused to go, pt states she "felt fine". Pt's normal pallor returned, pt left without further complication. V/S 110/64; P-74; R-18; O2-98% on RA; Glucose 107.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia, Stomatitis
Clinical narrative: Low grade fever. Sores in mouth - painful - 48 hours after vaccine. - mild flu like symptoms. Treatment - Magic mouthwash.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling hot, Loss of consciousness, Pallor, Tinnitus
Clinical narrative: Student became very hot, pale, had ringing in her ears, and passed out for a few seconds, approximately 3 minutes after vaccine was given, student's BP decreased 68/40 P 50, ammonia inhalant used to arouse, cool cloths placed on nape of neck and forehead. Student came to quickly and VS as follows 11:55 - BP - 98/50 P -16 R -16 respirations easy and unlabored. student given PO snack of ginger ale and crackers. Feel better after interventions. VS at 12:05 - BP 103/71 P 72 R -16. Mother notified.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Information has been received from a nurse via a company representative referring to a female patient of unknown age. On unknown dates, the patient was vaccinated with the first and the second dose of GARDASIL 9 (lot#, dose and route not reported). The patient experienced headaches after the first and second doses of GARDASIL 9 on unspecified dates. The headaches went away within the next few days after the GARDASIL 9 was administered (specific dates unknown). The outcome of the events were reported as recovered. The therapy of GARDASIL 9 was continued. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician referring to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates the patients were vaccinated with PNEUMOVAX23 (lot number, expiration dates, strength, dose and route were unknown). The patients concomitant medications were not reported. On unknown dates the patient had a "serious" injection site reaction to PNEUMOVAX23. The reporter stated that the injection site reactions lasted two to four weeks and the patients were treated with an unspecified steroid. The outcome of injection site reaction is unknown. The doctor treated the event to PNEUNOVAX23. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. No medical history nor concurrent conditions were reported for the patients. On an unknown date, the  unspecified patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # K010438, expiration date 22-JUL-2016 (strength, dose, route and frequency were not reported. No concomitant therapies were reported. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to a 62 year old female patient with tape allergy. On 30-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX23 injection in the arm (lot # K008927; dose, strength, route and expiration date were not provided). There was no concomitant medication described. The nurse stated that on 02-FEB-2015, the patient experienced cellulitis reaction at the injection site (injection site cellulitis). IT was unknown if the patient sought medical attention or received treatment. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of injection site cellulitis was unknown. The relatedness between the event, mentioned above to PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that since 08-JUN-2015, the patients were administered with an unspecified number of improperly stored dose of RECOMBIVAX HB injection (lot # K021444 with expiration date 17-SEP-2016 and lot# K008986 with expiration date 01-APR-2016; dose and route were not provided). There was no concomitant medication reported. It was unknown if the patients sought medical attention. Product quality complaint was not involved. No adverse experiences were reported. This is one of several reports receive from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided. On an unknown date, the patient was vaccinated with the first dose of VAQTA intramuscular injection (strength, dose, route of administration, lot number and expiration date were not provided). Subsequently, on an unspecified date 5 months following the first dose, the patient was vaccinated with the second dose of VAQTA (strength, dose and route of administration were not reported), lot number L004745 with expiration date on 28-APR-2017. Leading to an inappropriate schedule of drug administration; no adverse event or product quality complaints were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Information has been received from a pharmacy technician referring to a 61 years old female patient. On 14-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX (strength, 19400 PFU; lot # L021612, expiration date 10-SEP-2016, dose, frequency were not reported). In September 2015, the patient developed redness, swelling and pruiritus at the injection site following the administration of ZOSTAVAX. The reporter stated the affected area "was about the size of a silver dollar". THe reporter mentioned a rash later spread down the patients arm and the patient's physician diagnosed the ras as shingles. THe patient sought medical attention via contacting the pharmacy technician. These events were treated with ice and BENADRYL. No lab diagnostics studies were performed. The outcome of these events was reported as not recovered/not resolved. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Medical history and concurrent condition of the patients were not reported. On 12-SEP-2014 the patient was vaccinated with the first dose of ZOSTAVAX, (lot #, dose and route not reported). On 17-SEP-2015, the patient received a second dose of ZOSTAVAX (Extra dose administered). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to six female patients of unknown age. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (lot#, dose, route unspecified). Other suspect and concomitant therapies were not reported. On unknown dates, the six patients developed injection site reactions after receiving ZOSTAVAX. The reactions for each patient were the size of an "egg" and the injection sites involved swelling and itching. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine manager (healthcare worker) referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with ZOSTAVAX (lot number, dose and route were unknown0 that had been improperly stored. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine manager (healthcare worker) referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with (Oka/Merck) VARIVAX (lot number, dose and route were unknown)  that had been improperly stored. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. on unknown dates the patient was vaccinated with three doses of (Oka/Merck) VARIVAX (dose, lot #, route and application site was not reported). Concomitant therapy was not reported. The patient did not experience any adverse reactions from receiving three doses of (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Inflammation, Local reaction
Clinical narrative: Inflammation - local reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Patient received vaccine 9-19-15 approx 215 PM. Patient noted red welt at admin site 9-20-15 evening and marked with pen at outline. On 9-21-15 contacted pharmacy with 3"x3" egg sized welt worse than   night before. Patient went to urgent care and was diagnosed with cellulitis and prescribed antibiotics.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Pt. fainted after administering vaccines of HPV and MENACTRA. Pt. had a bagel and pop tart for breakfast blueberry and raspberries for lunch.
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache
Clinical narrative: This is a spontaneous report from a non clinical study program from a contactable consumer who reported for her daughter (patient). A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on 25Feb2015 at single dose. The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of unknown, chills/shivering on an unspecified date with outcome of unknown, and shaking on an unspecified date with outcome of unknown. Follow-up (24APR2015): Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Nasal discomfort
Clinical narrative: This is a spontaneous report from a Pfizer Colleague who reported on behalf of contactable consumer (friend) reporting for a patient (friend's daughter). A 19-year-old female patient received TRUMENBA (lot# 09203, exp date Jun2016), via an unspecified route of administration on 08Feb2015, at single dose, as she had case of meningitis at her college. Relevant medical history was not reported. Concomitant medication included SYNTHROID from 2013 and ongoing. On an unspecified date the patient experienced nostril flared with outcome of unknown. Follow-up (17Mar2015): new information received from a contactable consumer includes: TRUMENBA details, concomitant medication. Follow-up attempts completed. No further information expected. Follow-up (15MAY-2015): Follow-up attempts completed. No further information expected.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: This is a spontaneous report from a consumer (a Pfizer Employee) who reported for his son. This 11-year-old male patient received on 23Dec2014 at 16:00 a single dose of TRUMENBA in left arm. The patient did not take any other concomitant medications or vaccine and did not have any relevant medical conditions. Approximately one half hour after receiving the vaccine, the patient noticed soreness in his arm and shortly after he had difficulty moving arm. On 24Dec2014 in the morning, the patient threw up a couple times and swelling arm was noticed. Two of his other children received the vaccine at the same time, and they have not experienced any adverse events. Outocme was not recovered.
Sex: F
Vaccine: MEN
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a none-clinical study report. A contactable consumer reported that his/her currently 15-year-old daughter received meningococcal group B rlp2086 from an unspecified date to an unspecified date at 1 DF, single, influenza vaccine from an unspecified date to an unspecified date at 1 DF, single. The patient medical history was not reported. The patient have never had a flu shot or  meningitis. The patient's concomitant medications were not reported. The patient got sicker than she had ever been on an unspecified date with outcome of unknown. Narrative as reported: Myself or my daughter (who is now 18) have never had a flu shot or meningitis, my daughter got both vaccines this year and have gotten sicker than she had ever been. No follow-up attempts possible. No further information provided.
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from   a contactable pharmacist via a physician and via a consumer (patient mother) and then the contractable physician. A 19-year-old female patient received TRUMENBA (lot number J29203, expiration date JUN2016) at 0.5 ml single dose intramuscular in the left deltoid on 23FEB2015 at 15:20. Relevant medical history was not reported. The patient had no illness at time of vaccination. Concomitant medications included ongoing methylphenidate ER 36mg once daily since 23FEB2015, ongoing methylphenidate 5mg tablet since 23FEB2015 and ongoing citalopram 20mg at 1.5 DF daily since 24FEB2015. On 24FEB2015, 24 hours after vaccination, the patient experienced blinding headache (reported as headache by the pharmacist) and fever (>101F>24hr). On 25FEB2015, 48 hours after vaccination, the patient experienced joints/muscles neck spine shoulders hurt. Additional the pharmacist reported that the patient had muscle pain all over on unspecified date in FEB2015. According to the reporting physician blinding headache and fever recovered 24 hr after onset on 25FEB2015, joints/muscles neck spine shoulders hurt recovered 48  hrs after onset on 27FEB2015. Outcome of the event muscle pain all over was unknown. No specified tests or treatment were required. The physician considered there a reasonable possibility that the events were related to TRUMENBA. Follow-up (20MAR2015): New information received from a cont actable physician includes: gender, causality assessment, product details, new events (fever and joints/muscles neck spine shoulders hurt), updated event description( (from headache to blinding headache), concomitant medications, info on treatment/tests, outcome. Follow-up (27APR2015): This is a spontaneous report from the non-clinical study program"IBCC (Inbound Call Center for HCP's)". No additional information was obtained.  Follow up attempts completed. No further information expected.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Decreased appetite, Fatigue, Injection site pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (calling on behalf of her son) and a contactable physician. An 11-year-old male patient received TURMENBA (Lot # J29203, expiration date01JUN2016), intramuscular at 0.5 ml single in left upper arm, on 19FEB2015 at 04:10 PM. Relevant medical history was none. The patient was not ill at the time of vaccination, had no adverse event following prior vaccination. Concomitant medication included a vaccine for subtype A, injection unknown manufacturer, in the left arm on 13FEB2015. The patient complained of left upper arm pain on 19FEB2015 (right after injection of a few hours later). The pain lasted for about one week and then recovered. In the early morning of 20FEB2015 the patient was feeling tired. The reporter still sent him to school, b ut by lunch time the school called and said the patient had high temperature at 100.3 degrees F. The patient didn't want to eat anything, had no appetite. Treatment received for high temperature included Tylenol every 4 to 6 hours. When the Tylenol wore off, his temperature went to 102.3 degrees F. High temperature, feeling tired and no appetite recovered on 22FEB2015. The physician described the event fever at 102 degrees F. x2 days and also reported the event soreness at injection site on 19FEB2015 with outcome of recovered. The physician assessed the events as non-serious and possible related to suspect product. Follow-up (17MAR2015): New information received from a contactable physician includes: Lot # and expiration date, dose and time for TRUMENBA, additional event (soreness at injection site) and details of fever, outcome and physician's assessment.  Follow-up (14MAY2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Discomfort, Headache, Somnolence
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for her roommate A female patient of unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration, on unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. A couple of hours after vaccination the patient felt heavy, her body was feeling very heavy; had a really bad headache and felt very drowsy. Outcome of the reported events was unknown at the time of this report. No follow-up attempts possible. No further information expected.
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Pyrexia, Vision blurred
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist (mother) reported same event for two patients. This is the first of two reports. A 14-year-old male patient received, on 17Apr2015, TRUMENBA intramuscularly in deltoid, at 0.5 ml, single dose. Vaccines given on the same date along with TRUMENBA were none. Vaccines given within four weeks of administration of TRUMENBA were none. Relevant medical history and concomitant medications were unknown. On 18Apr2015 at 1:30 AM, the patient experienced fever, chills. In the afternoon of the same day, on 18Apr2015, the dizziness and blurred vision began. Clinical outcome of the events was unknown at time of this report.
Sex: M
Vaccine: HPV4, MENB
Symptoms: Erythema, Pain in extremity
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 TRUMENBA and GARDASIL, both via an unspecified route of administration on 27Mar2015. The patient medical history and concomitant medications were not reported. On unknown date, the patient experienced little bit of redness with outcome of unknown and pain in arm with outcome of recovered. The reporter mentioned that she did not take her son to any doctor for the pain that occurred after vaccination.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 21-year-old other ethnic group female patient received the fist single dose of TRUMENBA via an unspecified route of administration on 03MAR2015 around 4:30 PM. The patient medical history was not reported. Concomitant medication included KELNOR one capsule by mouth daily for birth control. On 03MAR2015 at 6:00 PMJ the patient experienced high temperature (100.7 degrees F) and a very intense body fatigue on her legs and her back. She administered ibuprofen for the high temperature and temperature was down to 100.3 degrees F on an unspecified date in MAR2015. It was reported that at the time of this report symptoms were still persisting. The consumer asked if it was normal to experience these events after the vaccination.  Follow-up (24MAR2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Back pain, Balance disorder, Dizziness, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a Non Clinical Study Program from a contactable consumer who reported for her son. A male patient of an unspecified age received a single dose of TRUMENBA via an unspecified route of administration in the arm on an unspecified date as Meningitis vaccine. The patient medical history and concomitant medications were not reported. After the vaccination on an unspecified date the patient experienced fever, headache, stiff neck, back pain, muscle pain, he was dizzy, lot of pain in the arm and area where vaccine was injected, pain in hand, lot of fatigue, sensitivity to light, he was unstable. The reporter mentioned that her son had multiple effects and she was wondering how long these side effects would have lasted and expected to last and whether they were normal. Outcome of events was unknown. Follow-up (06MAY2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Musculoskeletal stiffness, Myalgia, Pain in extremity, Photophobia
Clinical narrative: This is a spontaneous report from a Non Clinical Study Program from a contactable consumer who reported for her son. A male patient of an unspecified age received a single dose of TRUMENBA via an unspecified route of administration in the arm on an unspecified date as Meningitis vaccine. The patient medical history and concomitant medications were not reported. After the vaccination on an unspecified date the patient experienced fever, headache, stiff neck, back pain, muscle pain, he was dizzy, lot of pain in the arm and area where vaccine was injected, pain in hand, lot of fatigue, sensitivity to light, he was unstable. The reporter mentioned that her son had multiple effects and she was wondering how long these side effects would have lasted and expected to last and whether they were normal. Outcome of events was unknown. Follow-up (06MAY2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a Non Clinical Study Program from a contactable consumer who reported for her son. A male patient of an unspecified age received a single dose of TRUMENBA via an unspecified route of administration in the arm on an unspecified date as Meningitis vaccine. The patient medical history and concomitant medications were not reported. After the vaccination on an unspecified date the patient experienced fever, headache, stiff neck, back pain, muscle pain, he was dizzy, lot of pain in the arm and area where vaccine was injected, pain in hand, lot of fatigue, sensitivity to light, he was unstable. The reporter mentioned that her son had multiple effects and she was wondering how long these side effects would have lasted and expected to last and whether they were normal. Outcome of events was unknown. Follow-up (06MAY2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Pain in extremity, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 19-year-old female patient received the first single dose of TRUMENBA via an unspecified route of administration on 02MAR2015. The patient medical history and concomitant medications were not reported. She had stopped an unspecified antibiotic two weeks prior to the vaccination. On 03MAR2015 the patient experienced swelling and warm to touch underneath the area where she received the vaccination, tiredness, chills and her arm hurt. The patient did not recover from the events swelling and warm to touch underneath the area where she received the vaccination and arm hurt, she recovered from tiredness and chills on an unspecified day in MAR2015. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This female patient of an unspecified age received a single dose of TRUMENBA in the arm on an unspecified date in Mar2015. The patient medical history and concomitant medications were not reported. The patient mentioned that her arm started swelling and turned red and hot to the touch on an unspecified date in Mar2015. She wanted to know if this adverse reactions were normal with TRUMENBA. Outcome of the reported events was unknown. No follow-up attempts possible. No further information expected.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Decreased appetite, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from two contactable pharmacists via a sales representative. A 13-year-old male patient received TRUMENBA (Lot # J28923, Expires 30Jun2016), intramuscular in left deltoid at 0.5 ml, single on 14Feb2015 at 20:30. The following vaccinations were schedule for 15Apr2015 and for 15Aug2015. The patient medical history was not reported. Concomitant medications were none. On 17Feb2015, the patient experienced high fever of 102 degrees F, no appetite, self nauseated and blew up and sore arms. The events resolved after 2 or 3 days without treatments. The events did not require an emergency room or physician visit. No specific tests and/or treatments were required. According to the second reporting pharmacist, there was a reasonable possibility that all the events was related to suspect product. Follow up (06Apr2015): New information from another contactable pharmacist includes: updated patient age, updated vaccine lot number, route of administration, anatomical location, vaccination date/time, following vaccination schedule. Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her daughter. A 21 year-old female 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 experienced fuzziness, dizziness, fatigue, bad headache, weakness, shivering/cold, she slept for very long time, she had rash, red rash of about 2 by 2 on her arm and it was itchy, she could not think straight, all on an unspecified date. The outcome of the events was unknown. The reporter inquired if the patient should see her doctor and if the reported symptoms could be allergic reactions. He also asked if it would be ok if the patient would miss the second and the third vaccination, and just got the first one. Follow-up (06Mar2015): New information reported from the same contactable consumer includes: patient age, vaccine dose number, reaction data (new events weakness, could not think straight, shivering/cold were added), reporter questions. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Feeling cold, Headache, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her daughter. A 21 year-old female 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 experienced fuzziness, dizziness, fatigue, bad headache, weakness, shivering/cold, she slept for very long time, she had rash, red rash of about 2 by 2 on her arm and it was itchy, she could not think straight, all on an unspecified date. The outcome of the events was unknown. The reporter inquired if the patient should see her doctor and if the reported symptoms could be allergic reactions. He also asked if it would be ok if the patient would miss the second and the third vaccination, and just got the first one. Follow-up (06Mar2015): New information reported from the same contactable consumer includes: patient age, vaccine dose number, reaction data (new events weakness, could not think straight, shivering/cold were added), reporter questions. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Thinking abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her daughter. A 21 year-old female 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 experienced fuzziness, dizziness, fatigue, bad headache, weakness, shivering/cold, she slept for very long time, she had rash, red rash of about 2 by 2 on her arm and it was itchy, she could not think straight, all on an unspecified date. The outcome of the events was unknown. The reporter inquired if the patient should see her doctor and if the reported symptoms could be allergic reactions. He also asked if it would be ok if the patient would miss the second and the third vaccination, and just got the first one. Follow-up (06Mar2015): New information reported from the same contactable consumer includes: patient age, vaccine dose number, reaction data (new events weakness, could not think straight, shivering/cold were added), reporter questions. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a non-contactable consumer. A male patient of unspecified age and ethnicity received TRUMENBA on 05Mar2015. Relevant medical history and concomitant medications were unknown. On 05Mar2015, in the afternoon and all of the night the patient experienced fever, weakness and headache. The patient did not recover from the event at time of this report. No follow up attempts possible. No further information expected.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 22-year-old female patient received the first single dose of TRUMENBA via an unspecified route of administration on 02Mar2015 at 10:30 AM. The patient medical history was not reported, no illness was present at the time of vaccination. Concomitant medication included ALLEGRA 180 mg once a day orally. On 02Mar2015 in the evening the patient experienced bad chill, severe headache, overall sense of fatigue, lack of energy, injection site rash. She did not have to go to the medical doctor or to the emergency room due to the reported events. The patient did not recover from severe headache, she recovered from bad chills, overall sense of fatigue, lack of energy, injection site rash on 05Mar 2015. Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal, Headache, Malaise, Sluggishness
Clinical narrative: A 21 year-old male patient received, on 03MAR2015 at 15:15 TRUMENBA (lot and expiration date not available) intramuscular on right shoulder at 0.5 ml, single dose. No other vaccines were received. Relevant medical history included left ventricular dysfunction (part of pericardium of left ventricle was missing since birth). Concomitant medications were unknown. On 04MAR2015, at 1:00 AM, the patient was feeling unwell, was sluggish, had slight headache and was feeling very slow (his whole body and blah. No hospitalization was required. The patient did not recover from the events at time of this report. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Inflammation
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. This Pharmacist reported for 8 patients (students). Only 4 experienced an adverse event. This case refers to patient 2. A patient of unknown unspecified age, gender and ethnicity received TRUMENBA on an unknown date, single dose. Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced severe redness/inflammation (10 cm). Clinical outcome of the events was unknown at time of this report. No follow up attempt possible. No further information expected.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Feeling cold, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer. This 20-year-old male patient reported that received on 03Mar2015 at noon a single dose of TRUMENBA. Medical history was not reported. Concomitant medications were none. On 03Mar2015, the reporter mentioned that experienced side effects: really bad headache and his body was cold and he had shivers and chills. The reporter mentioned that he did not take any medicine for side effects. Outcome was unknown. Follow-up (30APR2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician. A 18 year old male patient (reporter's son) received TRUMENBA on 19MAR2015, single dose in upper arm. The patient was in good health. The patient complained that  his upper arm was sore for about 1 day afterwards. It did not limit his normal activity. Follow-up (30APR015): Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (the mother of the patient). A 20-years-old female patient received TRUMENBA, single dose in the arm via unspecified route of administration on unknown date. The patient on 13Mar2015 experienced pain in her arm and chills. The patient recovered from the events on 16Mar2015. No follow up attempts possible. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received TRUMENBA intramuscular at 0.5 ml single on an unspecified date in Mar2015. Relevant medical history and patient concomitant medications were not reported. The patient experienced headache at 4 pm on the day of the vaccination. No investigations were performed, no treatment was given for the reported event. The headache was lasting for over 18 hours and the patient was not recovered at the time of this report. Follow-up (14MAY2015): Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself. This 18-year-old male patient received the first dose of TRUMENBA at 0.5 ml single via an unspecified route of administration in the right arm on 05Mar2015 at 04:00 pm. The patient had not any other relevant medical conditions and he had not received any concomitant medications. His arm has been sore since he got the vaccine on 05Mar2015. In the morning of 07Mar2015 when he woke up at 07:00 am he had 3-4 red patches where he had to the vaccination. On 5 pm they hurt to the touch, not like bad, but just enough to be annoying when he touched them. He was not necessarily worried about it. The patient did not require an emergency room or doctor visit due to the reported events. The patient did not recover from the reported events at the time of this report. Follow-up (15APR2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on 03Mar2015 to an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced fever on 04Mar2015 with outcome of not recovered. Follow-up attempts completed. No further information expected.