chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Electroencephalogram, Haemoptysis, Lumbar puncture, Mental status changes, Nuclear magnetic resonance imaging
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA, at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. 2-3 hours after the injection, the patient started having seizures, that required hospitalization. The outcome of the event was unknown.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Pyrexia, Screaming, Seizure like phenomena, Sensory loss, Unresponsive to stimuli
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 16-year-old male patient of an unspecified ethnicity received TRUMENBA, at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. 2-3 hours after the injection, the patient started having seizures, that required hospitalization. The outcome of the event was unknown.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Back pain, Blood test, Computerised tomogram, Computerised tomogram head, Electrocardiogram
Clinical narrative: This is a spontaneous report from a contactable office manager reporting on behalf of a physician. An 18-year-old male patient received TRUMENBA (Lot # M74091, Expiry date 30Jun2017), intramuscular at 0.5 ml, single on 19Jul2016. Medical history included allergy. Concomitant medication included albuterol HFA 2 DF, as needed every four to six hours for allergy. On 29Jul2016, the patient started developing fatigue, fever (he was running a fever about 100 degrees F to 101 degrees F) and achy, his eyes were very sore, he was achy, eyes were jerky, had a back ache, had a stiff neck, had a headache, he was nauseous and at one point he passed out. He was hospitalized on 31Jul2016 and discharged on 02Aug2016. Lab work on 31Jul2016 included computerised tomogram: orbital cellulitis; computerised tomogram head: performed; electrocardiogram: normal; spinal tap: normal; platelet count decreased: thrombocytopenia, white blood cell count: leukopenia. Office manager stated that the patient was leukopenic and thrombocytopenic. Causality: the doctor who saw him in the hospital said that they could not make a connection that they believe there was a viral syndrome. The outcome was recovered.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Eye movement disorder, Eye pain, Fatigue, Headache, Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable office manager reporting on behalf of a physician. An 18-year-old male patient received TRUMENBA (Lot # M74091, Expiry date 30Jun2017), intramuscular at 0.5 ml, single on 19Jul2016. Medical history included allergy. Concomitant medication included albuterol HFA 2 DF, as needed every four to six hours for allergy. On 29Jul2016, the patient started developing fatigue, fever (he was running a fever about 100 degrees F to 101 degrees F) and achy, his eyes were very sore, he was achy, eyes were jerky, had a back ache, had a stiff neck, had a headache, he was nauseous and at one point he passed out. He was hospitalized on 31Jul2016 and discharged on 02Aug2016. Lab work on 31Jul2016 included computerised tomogram: orbital cellulitis; computerised tomogram head: performed; electrocardiogram: normal; spinal tap: normal; platelet count decreased: thrombocytopenia, white blood cell count: leukopenia. Office manager stated that the patient was leukopenic and thrombocytopenic. Causality: the doctor who saw him in the hospital said that they could not make a connection that they believe there was a viral syndrome. The outcome was recovered.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Lumbar puncture, Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable office manager reporting on behalf of a physician. An 18-year-old male patient received TRUMENBA (Lot # M74091, Expiry date 30Jun2017), intramuscular at 0.5 ml, single on 19Jul2016. Medical history included allergy. Concomitant medication included albuterol HFA 2 DF, as needed every four to six hours for allergy. On 29Jul2016, the patient started developing fatigue, fever (he was running a fever about 100 degrees F to 101 degrees F) and achy, his eyes were very sore, he was achy, eyes were jerky, had a back ache, had a stiff neck, had a headache, he was nauseous and at one point he passed out. He was hospitalized on 31Jul2016 and discharged on 02Aug2016. Lab work on 31Jul2016 included computerised tomogram: orbital cellulitis; computerised tomogram head: performed; electrocardiogram: normal; spinal tap: normal; platelet count decreased: thrombocytopenia, white blood cell count: leukopenia. Office manager stated that the patient was leukopenic and thrombocytopenic. Causality: the doctor who saw him in the hospital said that they could not make a connection that they believe there was a viral syndrome. The outcome was recovered.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Back pain, Cellulitis orbital, Computerised tomogram head abnormal, Electrocardiogram normal, Eye movement disorder
Clinical narrative: This is a spontaneous report from a contactable office manager reporting on behalf of a physician. An 18-year-old male patient received TRUMENBA (Lot # M74091, Expiry date 30Jun2017), intramuscular at 0.5 ml, single on 19Jul2016. Medical history included allergy. Concomitant medication included albuterol HFA 2 DF, as needed every four to six hours for allergy. On 29Jul2016, the patient started developing fatigue, fever (he was running a fever about 100 degrees F to 101 degrees F) and achy, his eyes were very sore, he was achy, eyes were jerky, had a back ache, had a stiff neck, had a headache, he was nauseous and at one point he passed out. He was hospitalized on 31Jul2016 and discharged on 02Aug2016. Lab work on 31Jul2016 included computerised tomogram: orbital cellulitis; computerised tomogram head: performed; electrocardiogram: normal; spinal tap: normal; platelet count decreased: thrombocytopenia, white blood cell count: leukopenia. Office manager stated that the patient was leukopenic and thrombocytopenic. Causality: the doctor who saw him in the hospital said that they could not make a connection that they believe there was a viral syndrome. The outcome was recovered.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Eye pain, Fatigue, Headache, Leukopenia, Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable office manager reporting on behalf of a physician. An 18-year-old male patient received TRUMENBA (Lot # M74091, Expiry date 30Jun2017), intramuscular at 0.5 ml, single on 19Jul2016. Medical history included allergy. Concomitant medication included albuterol HFA 2 DF, as needed every four to six hours for allergy. On 29Jul2016, the patient started developing fatigue, fever (he was running a fever about 100 degrees F to 101 degrees F) and achy, his eyes were very sore, he was achy, eyes were jerky, had a back ache, had a stiff neck, had a headache, he was nauseous and at one point he passed out. He was hospitalized on 31Jul2016 and discharged on 02Aug2016. Lab work on 31Jul2016 included computerised tomogram: orbital cellulitis; computerised tomogram head: performed; electrocardiogram: normal; spinal tap: normal; platelet count decreased: thrombocytopenia, white blood cell count: leukopenia. Office manager stated that the patient was leukopenic and thrombocytopenic. Causality: the doctor who saw him in the hospital said that they could not make a connection that they believe there was a viral syndrome. The outcome was recovered.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Lumbar puncture normal, Musculoskeletal stiffness, Nausea, Pain, Platelet count decreased
Clinical narrative: This is a spontaneous report from a contactable office manager reporting on behalf of a physician. An 18-year-old male patient received TRUMENBA (Lot # M74091, Expiry date 30Jun2017), intramuscular at 0.5 ml, single on 19Jul2016. Medical history included allergy. Concomitant medication included albuterol HFA 2 DF, as needed every four to six hours for allergy. On 29Jul2016, the patient started developing fatigue, fever (he was running a fever about 100 degrees F to 101 degrees F) and achy, his eyes were very sore, he was achy, eyes were jerky, had a back ache, had a stiff neck, had a headache, he was nauseous and at one point he passed out. He was hospitalized on 31Jul2016 and discharged on 02Aug2016. Lab work on 31Jul2016 included computerised tomogram: orbital cellulitis; computerised tomogram head: performed; electrocardiogram: normal; spinal tap: normal; platelet count decreased: thrombocytopenia, white blood cell count: leukopenia. Office manager stated that the patient was leukopenic and thrombocytopenic. Causality: the doctor who saw him in the hospital said that they could not make a connection that they believe there was a viral syndrome. The outcome was recovered.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Pyrexia, Thrombocytopenia, Viral infection, White blood cell count decreased
Clinical narrative: This is a spontaneous report from a contactable office manager reporting on behalf of a physician. An 18-year-old male patient received TRUMENBA (Lot # M74091, Expiry date 30Jun2017), intramuscular at 0.5 ml, single on 19Jul2016. Medical history included allergy. Concomitant medication included albuterol HFA 2 DF, as needed every four to six hours for allergy. On 29Jul2016, the patient started developing fatigue, fever (he was running a fever about 100 degrees F to 101 degrees F) and achy, his eyes were very sore, he was achy, eyes were jerky, had a back ache, had a stiff neck, had a headache, he was nauseous and at one point he passed out. He was hospitalized on 31Jul2016 and discharged on 02Aug2016. Lab work on 31Jul2016 included computerised tomogram: orbital cellulitis; computerised tomogram head: performed; electrocardiogram: normal; spinal tap: normal; platelet count decreased: thrombocytopenia, white blood cell count: leukopenia. Office manager stated that the patient was leukopenic and thrombocytopenic. Causality: the doctor who saw him in the hospital said that they could not make a connection that they believe there was a viral syndrome. The outcome was recovered.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain, Asthenia, Chills, Decreased appetite, Excoriation
Clinical narrative: This spontaneous report was received from a 56 year old female patient concerning herself via company representative. The patient's concurrent conditions included diabetes mellitus and hypertension. On 18-AUG-2016, the patient was vaccinated with a dose of VAQTA in the muscle in her arm (also reported as intramuscular injection) (lot #, dose, route and indication were not provided). The patient had no concomitant medications. On 19-AUG-2016 (reported as next day of vaccination), the patient experienced several side effects that consisted of itchiness of severe intensity, terrible stomach cramps, loss of appetite, inability to sleep, headaches, nausea, weakness (asthenia) and extreme tiredness. The patient mentioned that she went to the Emergency Room (ER) two times at local hospital since being vaccinated, however she was not admitted to the hospital on either days. Patient clarified her ER visits occurred "the day before yesterday (20-AUG-2016) and today (22-AUG-2016)". No treatment was given for the adverse events. Unspecified lab tests were performed (results were not provided). At the time of the reporting, the outcome of insomnia, fatigue, asthenia, nausea, headache, decreased appetite, abdominal pain upper and pruritus was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Fatigue, Headache, Heart rate increased, Pruritus, Swelling
Clinical narrative: This spontaneous report was received from a 56 year old female patient concerning herself via company representative. The patient's concurrent conditions included diabetes mellitus and hypertension. On 18-AUG-2016, the patient was vaccinated with a dose of VAQTA in the muscle in her arm (also reported as intramuscular injection) (lot #, dose, route and indication were not provided). The patient had no concomitant medications. On 19-AUG-2016 (reported as next day of vaccination), the patient experienced several side effects that consisted of itchiness of severe intensity, terrible stomach cramps, loss of appetite, inability to sleep, headaches, nausea, weakness (asthenia) and extreme tiredness. The patient mentioned that she went to the Emergency Room (ER) two times at local hospital since being vaccinated, however she was not admitted to the hospital on either days. Patient clarified her ER visits occurred "the day before yesterday (20-AUG-2016) and today (22-AUG-2016)". No treatment was given for the adverse events. Unspecified lab tests were performed (results were not provided). At the time of the reporting, the outcome of insomnia, fatigue, asthenia, nausea, headache, decreased appetite, abdominal pain upper and pruritus was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Fatigue, Headache
Clinical narrative: This spontaneous report was received from a 56 year old female patient concerning herself via company representative. The patient's concurrent conditions included diabetes mellitus and hypertension. On 18-AUG-2016, the patient was vaccinated with a dose of VAQTA in the muscle in her arm (also reported as intramuscular injection) (lot #, dose, route and indication were not provided). The patient had no concomitant medications. On 19-AUG-2016 (reported as next day of vaccination), the patient experienced several side effects that consisted of itchiness of severe intensity, terrible stomach cramps, loss of appetite, inability to sleep, headaches, nausea, weakness (asthenia) and extreme tiredness. The patient mentioned that she went to the Emergency Room (ER) two times at local hospital since being vaccinated, however she was not admitted to the hospital on either days. Patient clarified her ER visits occurred "the day before yesterday (20-AUG-2016) and today (22-AUG-2016)". No treatment was given for the adverse events. Unspecified lab tests were performed (results were not provided). At the time of the reporting, the outcome of insomnia, fatigue, asthenia, nausea, headache, decreased appetite, abdominal pain upper and pruritus was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Insomnia, Nausea, Pruritus
Clinical narrative: This spontaneous report was received from a 56 year old female patient concerning herself via company representative. The patient's concurrent conditions included diabetes mellitus and hypertension. On 18-AUG-2016, the patient was vaccinated with a dose of VAQTA in the muscle in her arm (also reported as intramuscular injection) (lot #, dose, route and indication were not provided). The patient had no concomitant medications. On 19-AUG-2016 (reported as next day of vaccination), the patient experienced several side effects that consisted of itchiness of severe intensity, terrible stomach cramps, loss of appetite, inability to sleep, headaches, nausea, weakness (asthenia) and extreme tiredness. The patient mentioned that she went to the Emergency Room (ER) two times at local hospital since being vaccinated, however she was not admitted to the hospital on either days. Patient clarified her ER visits occurred "the day before yesterday (20-AUG-2016) and today (22-AUG-2016)". No treatment was given for the adverse events. Unspecified lab tests were performed (results were not provided). At the time of the reporting, the outcome of insomnia, fatigue, asthenia, nausea, headache, decreased appetite, abdominal pain upper and pruritus was reported as not recovered. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Lethargy, Pyrexia, Skin discolouration
Clinical narrative: High fever, lethargic, ashen skin coloring. The fever was treated with Tylenol (maxing out the appropriate 24 dosage).
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Chest pain, Malaise, Myalgia, Nausea
Clinical narrative: Initial unsolicited report received from a nurse on 18 August 2016. This case involves a 17-years-old male patient who was vaccinated with a dose of MENACTRA (batch number U5416AA, expiry date, dose, route of administration were not reported) in left arm on 11 August 2016. Illness at time of vaccination reported as denies and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 17 August 2016, six days following the vaccination the patient experienced, chest pain, n/v (nausea and vomiting), increase in body temperature as 102.8, general muscle aches, sore throat. It was reported that patient visited to doctor. Lab data and corrective treatment was not reported. The outcome of events reported as unknown. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Initial unsolicited report received from a nurse on 18 August 2016. This case involves a 17-years-old male patient who was vaccinated with a dose of MENACTRA (batch number U5416AA, expiry date, dose, route of administration were not reported) in left arm on 11 August 2016. Illness at time of vaccination reported as denies and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 17 August 2016, six days following the vaccination the patient experienced, chest pain, n/v (nausea and vomiting), increase in body temperature as 102.8, general muscle aches, sore throat. It was reported that patient visited to doctor. Lab data and corrective treatment was not reported. The outcome of events reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Swelling
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) on 19 August 2016. Manufacturer Report Number: 2016394959. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS AND DIPHTHERIA TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had swelling.  Severity was reported as severe. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Glossodynia
Clinical narrative: CLIENT STATES BURNING OF TONGUE TWO DAYS AFTER RECEIVING IMOVAX.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: Constant itching. Dr. prescribed antihistamine Xyzal 5 mg - one tab daily. This has controlled my itching for the last 9 years.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Discomfort, Injection site pain, Injection site swelling, Pain, Pruritus
Clinical narrative: 08/24/2016 The patient is a 21 year old male presenting to the clinic today with a CC of rash. States he received a Meningitis vaccination (TRUMENBA) in the left deltoid region last week on 8/18 at home at his PCP's office. Directly after the injection he noted swelling and soreness in the left deltoid region and felt slightly achy. He reports a rash started on Sunday 8/21. He reports it is red and bumpy in appearance. States the area is achy and somewhat itchy. He reports his discomfort as a 3/10. He has been applying OTC hydrocortisone 3 times over the past day and 1/2 which doesn't really help (slightly reduces the itch). He did not contact his PCP's office. Denies any fevers, difficulty swallowing or breathing. Never had a rash like this before. Aware that he is to have 2 more vaccinations to complete the series. Use LIDEX cream 0.05% to AA's twice daily for no > 2 weeks. Discontinue Kw/ resolution. Discussed side effects. Recommended use of OTC antihistamines to aide Kw/ itch and reaction. Recommended CLARITIN 10 mg during the day and BENADRYL 25 - 50 mg in addition every 6 hours PRN. Discussed future immunizations of TRUMENBA. Recommend he continues to receive the vaccination series, but suggested pre-medication Kw/ CLARITIN. May use LIDEX as currently prescribed if rash were to occur again.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Rash, Rash erythematous
Clinical narrative: 08/24/2016 The patient is a 21 year old male presenting to the clinic today with a CC of rash. States he received a Meningitis vaccination (TRUMENBA) in the left deltoid region last week on 8/18 at home at his PCP's office. Directly after the injection he noted swelling and soreness in the left deltoid region and felt slightly achy. He reports a rash started on Sunday 8/21. He reports it is red and bumpy in appearance. States the area is achy and somewhat itchy. He reports his discomfort as a 3/10. He has been applying OTC hydrocortisone 3 times over the past day and 1/2 which doesn't really help (slightly reduces the itch). He did not contact his PCP's office. Denies any fevers, difficulty swallowing or breathing. Never had a rash like this before. Aware that he is to have 2 more vaccinations to complete the series. Use LIDEX cream 0.05% to AA's twice daily for no > 2 weeks. Discontinue Kw/ resolution. Discussed side effects. Recommended use of OTC antihistamines to aide Kw/ itch and reaction. Recommended CLARITIN 10 mg during the day and BENADRYL 25 - 50 mg in addition every 6 hours PRN. Discussed future immunizations of TRUMENBA. Recommend he continues to receive the vaccination series, but suggested pre-medication Kw/ CLARITIN. May use LIDEX as currently prescribed if rash were to occur again.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain
Clinical narrative: Extreme, flashes of pain in back upper left of head. Never moved, stationary for up to even today.  Intense flash of pain then resides, another intense flash of pain then resides continually 2,3,4 times a minute.  It's like torture.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Diarrhoea, Headache, Injection site vesicles, Pain in extremity
Clinical narrative: Patient had arm soreness, headache, diarrhea.  Had one blister on arm initially but has spread and now has 5 fluid filled blisters around injection site.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Pt. reported feeling faint at check out after receiving a Tdap vaccine. Had pt. immediately sit down on floor. Dr. took pt. into a exam room to lie down on table while nurse go a juice from refrigerator. Pt. vital signs were as follows: P: 75, O2: 99%, BP:104/70. Pt. drank some water, did not want juice. Mom watched pt. while he lied down for 15 min. Pt. left with mother after the 15 min.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Lethargy, Malaise, Pyrexia
Clinical narrative: Fever of 103, malaise and lethargy lasting 5 days.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to 44 female patients of unknown age. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. The physician found out about the event reported below from an online article. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot #, expiration date, exact dose, site and route of administration were not reported). On unknown dates, the patients died as a result of receiving GARDASIL (also reported as they died from these vaccines). The relatedness between the event and GARDASIL was assessed as related. Upon internal review, the event of death was determined to be medically significant. This is one of two reports received from the same source. Additional information is not expected as there was no consent for follow-up.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of cellulitis of arm in a 12-year-old male patient who received MENVEO (batch number M15079, expiry date 30th April 2017). On 21st July 2016, the patient received MENVEO .5 ml. In July 2016, less than a week after receiving MENVEO, the patient experienced cellulitis of arm (serious criteria GSK medically significant), erythema, swelling arm and limbs stiffness. The patient was treated with KEFLEX. On 25th July 2016, the outcome of the cellulitis of arm, erythema, swelling arm and limbs stiffness were recovered/resolved. The reporter considered the cellulitis of arm and erythema to be related to MENVEO. It was unknown if the reporter considered the swelling arm and limbs stiffness to be related to MENVEO. Additional details were provided as follows: A medical science liaison (MSL) reported that the patient experienced erythema, stiffness and swelling in the arm after receiving the MENVEO vaccine. On 22nd July 2016, the patient was admitted to the emergency room (ER). The patient was diagnosed with cellulitis. The physician prescribed KEFLEX antibiotic for 10 days. The physician reported that the erythema was in correlation with the MENVEO. Another sales representative also reported this adverse event.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Petechiae, Rash
Clinical narrative: PETECHIAL RASH OFF/ON ON TORSO, BUT MOSTLY ON LEFT ARM.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPAB, MMRV, PPV
Symptoms: Injection site rash, Urticaria
Clinical narrative: Started as a small rash on thigh around injection site. Then spread to other thigh and then developed hives on back, neck, chest and abdomen. Called doctors office and the nurse I talked to said this was normal reaction for 7 day out from vaccinations.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and hard to the touch on the left deltoid arm.
Sex: U
Vaccine: MENB
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician assistant communicated to a sales representative report similar events for four patients. This is the 4th of four reports. A patient of unspecified age ethnicity and gender received TRUMENBA, intramuscular at 0.5 ml, single on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chills/rigors, high fever and muscle achiness all over that required hospitalization. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Redness, pain and swelling in L arm.Felt warm to touch.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Feeding disorder, Gastrointestinal inflammation, Immune system disorder, Inflammation
Clinical narrative: Case number PHEH2016US021236, is an initial spontaneous report received from other health professional on 23 Aug 2016. This report refers to a 40-year-old male patient. Historical condition was not reported. Current condition included allergic to bees. Concomitant medication was not reported. The patient was vaccinated with one single dose FLUVIRIN 2011/2012 (lot number: 1103001) at a dose of 0.5 ml intramuscularly on an unknown date in 2011. The patient experienced with severe pain in lymph nodes and chest. Next day pus was coming out of his ears and inflamed gastrointestinal system. He stated that his immune system has started attacking his body and the flu shot was messing him up. His whole body felt inflamed and ears were constantly ringing. He could not get out of bed for 6-8 months and could not eat any food. He stated that he was going to the doctor at least twice a week and the physician did not know what was wrong. The patient stated that, there was bumps in his ileum which could be Crohn's. He stated that his immune system was attacking his body because of the flu shot. Patient reported this same side effects he experienced multiple times in the past year. Outcome of the events was reported as condition unchanged. Seriousness of the events were reported as serious (disability and medically significant). This case is considered as lost to follow up.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Lymph node pain, Mobility decreased, Otorrhoea, Tinnitus
Clinical narrative: Case number PHEH2016US021236, is an initial spontaneous report received from other health professional on 23 Aug 2016. This report refers to a 40-year-old male patient. Historical condition was not reported. Current condition included allergic to bees. Concomitant medication was not reported. The patient was vaccinated with one single dose FLUVIRIN 2011/2012 (lot number: 1103001) at a dose of 0.5 ml intramuscularly on an unknown date in 2011. The patient experienced with severe pain in lymph nodes and chest. Next day pus was coming out of his ears and inflamed gastrointestinal system. He stated that his immune system has started attacking his body and the flu shot was messing him up. His whole body felt inflamed and ears were constantly ringing. He could not get out of bed for 6-8 months and could not eat any food. He stated that he was going to the doctor at least twice a week and the physician did not know what was wrong. The patient stated that, there was bumps in his ileum which could be Crohn's. He stated that his immune system was attacking his body because of the flu shot. Patient reported this same side effects he experienced multiple times in the past year. Outcome of the events was reported as condition unchanged. Seriousness of the events were reported as serious (disability and medically significant). This case is considered as lost to follow up.
Sex: U
Vaccine: MENB
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician assistant communicated to a sales representative report similar events for four patients. This is the 3rd of four reports. A patient of unspecified age ethnicity and gender received TRUMENBA, intramuscular at 0.5 ml, single on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chills/rigors, high fever and achy all over that required hospitalization. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Bruxism, Cardiac flutter, Dizziness
Clinical narrative: Fever, lightheaded, labored breathing fluttering heart, spasms, weakness, fatigue, clenching jaws, unexplainable head muscle joint aches, nausea, stiffness. On 11-11-11, there was this strange incident that occurred with my health. I felt lightheaded, as I might pass out. It was difficulty to breathe. My heart felt as if it were fluttering. I felt weak but no real pain, much fatigue. The left side of my jaw appeared to clench close, but it was like I had to force it from closing, and to take deep breaths to breathe and not pass out. Today is Sunday, near 9:00 PM, and I'm still having these feelings. The first night the problems began, I was afraid to go to sleep, so I wrote a letter to my children's mother. I also spoke with the dorm Sat. and Ofr. about my problems just in case something happened to me. They asked if I wanted to declare a medical emergency, but I wasn't sure. My kidneys/blood pressure? On 11/14/11 you were transferred to the main unit for care. You are being seen by the clinician. This morning I had explained to the nurses that I had come to Medical on Tuesday afternoon because I was having the same problems with my head and arms. I also explained that later that night I had remembered that I had taken a "flu shot" last Thursday and that I didn't start having these problems until the next day (Friday). I now wonder if the problems I'm having are due to side effects from the "flu shot". Wednesday morning (today) I had asked the nurses to leave the doctor a note about my concerns of the "flu shot", and was subsequently told to submit a sick call or try to come to medical on the day shift to ensure that the doctor is informed of my concerns.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Muscle spasms, Musculoskeletal stiffness, Myalgia
Clinical narrative: Fever, lightheaded, labored breathing fluttering heart, spasms, weakness, fatigue, clenching jaws, unexplainable head muscle joint aches, nausea, stiffness. On 11-11-11, there was this strange incident that occurred with my health. I felt lightheaded, as I might pass out. It was difficulty to breathe. My heart felt as if it were fluttering. I felt weak but no real pain, much fatigue. The left side of my jaw appeared to clench close, but it was like I had to force it from closing, and to take deep breaths to breathe and not pass out. Today is Sunday, near 9:00 PM, and I'm still having these feelings. The first night the problems began, I was afraid to go to sleep, so I wrote a letter to my children's mother. I also spoke with the dorm Sat. and Ofr. about my problems just in case something happened to me. They asked if I wanted to declare a medical emergency, but I wasn't sure. My kidneys/blood pressure? On 11/14/11 you were transferred to the main unit for care. You are being seen by the clinician. This morning I had explained to the nurses that I had come to Medical on Tuesday afternoon because I was having the same problems with my head and arms. I also explained that later that night I had remembered that I had taken a "flu shot" last Thursday and that I didn't start having these problems until the next day (Friday). I now wonder if the problems I'm having are due to side effects from the "flu shot". Wednesday morning (today) I had asked the nurses to leave the doctor a note about my concerns of the "flu shot", and was subsequently told to submit a sick call or try to come to medical on the day shift to ensure that the doctor is informed of my concerns.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, lightheaded, labored breathing fluttering heart, spasms, weakness, fatigue, clenching jaws, unexplainable head muscle joint aches, nausea, stiffness. On 11-11-11, there was this strange incident that occurred with my health. I felt lightheaded, as I might pass out. It was difficulty to breathe. My heart felt as if it were fluttering. I felt weak but no real pain, much fatigue. The left side of my jaw appeared to clench close, but it was like I had to force it from closing, and to take deep breaths to breathe and not pass out. Today is Sunday, near 9:00 PM, and I'm still having these feelings. The first night the problems began, I was afraid to go to sleep, so I wrote a letter to my children's mother. I also spoke with the dorm Sat. and Ofr. about my problems just in case something happened to me. They asked if I wanted to declare a medical emergency, but I wasn't sure. My kidneys/blood pressure? On 11/14/11 you were transferred to the main unit for care. You are being seen by the clinician. This morning I had explained to the nurses that I had come to Medical on Tuesday afternoon because I was having the same problems with my head and arms. I also explained that later that night I had remembered that I had taken a "flu shot" last Thursday and that I didn't start having these problems until the next day (Friday). I now wonder if the problems I'm having are due to side effects from the "flu shot". Wednesday morning (today) I had asked the nurses to leave the doctor a note about my concerns of the "flu shot", and was subsequently told to submit a sick call or try to come to medical on the day shift to ensure that the doctor is informed of my concerns.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Headache, Loss of consciousness, Malaise
Clinical narrative: This is a spontaneous report from a contactable physician who reported for her daughter. An 18-year-old female patient received TRUMENBA (Lot # M68769, Expiry Date 30Apr2017, NDC number 0005010001), intramuscular at 0.5 ml, single in the left deltoid on 15Aug2016 13:37. The patient medical history and concomitant medications were not reported. On 15Aug2016 about 8 hours after the injection, the patient experienced severe headache with outcome of not recovered, nausea with outcome of not recovered, vomiting with outcome of not recovered, fever/ill with a high fever with outcome of unknown, chills with outcome of not recovered, syncopal episode with outcome of unknown, arm pain with outcome of unknown. On an unspecified date she passing out, white count of 16000, weakness, thinkable episode, all with outcome of unknown.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Pyrexia, Syncope, Thinking abnormal
Clinical narrative: This is a spontaneous report from a contactable physician who reported for her daughter. An 18-year-old female patient received TRUMENBA (Lot # M68769, Expiry Date 30Apr2017, NDC number 0005010001), intramuscular at 0.5 ml, single in the left deltoid on 15Aug2016 13:37. The patient medical history and concomitant medications were not reported. On 15Aug2016 about 8 hours after the injection, the patient experienced severe headache with outcome of not recovered, nausea with outcome of not recovered, vomiting with outcome of not recovered, fever/ill with a high fever with outcome of unknown, chills with outcome of not recovered, syncopal episode with outcome of unknown, arm pain with outcome of unknown. On an unspecified date she passing out, white count of 16000, weakness, thinkable episode, all with outcome of unknown.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable physician who reported for her daughter. An 18-year-old female patient received TRUMENBA (Lot # M68769, Expiry Date 30Apr2017, NDC number 0005010001), intramuscular at 0.5 ml, single in the left deltoid on 15Aug2016 13:37. The patient medical history and concomitant medications were not reported. On 15Aug2016 about 8 hours after the injection, the patient experienced severe headache with outcome of not recovered, nausea with outcome of not recovered, vomiting with outcome of not recovered, fever/ill with a high fever with outcome of unknown, chills with outcome of not recovered, syncopal episode with outcome of unknown, arm pain with outcome of unknown. On an unspecified date she passing out, white count of 16000, weakness, thinkable episode, all with outcome of unknown.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood urine present, Gingival bleeding, Hyperhidrosis, Laboratory test, Pain in extremity
Clinical narrative: The night she received vaccinations, she experienced fever and sweats (102°F). The area is swollen and hot to the touch. Very red. She states entire arm hurts. She has also experienced bleeding of the gums and blood in urine (today) 8/26.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Skin reaction, Skin warm, Swelling
Clinical narrative: The night she received vaccinations, she experienced fever and sweats (102°F). The area is swollen and hot to the touch. Very red. She states entire arm hurts. She has also experienced bleeding of the gums and blood in urine (today) 8/26.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Arm where shot was given was swollen and red. Pt went to MD and was diagnosed with cellulitis. MD gave pt KEFLEX.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Irritability, Pyrexia, Viral infection
Clinical narrative: Fussy after vaccines. Fever x 3 days. No redness or tenderness of site. Dx with viral illness 8-19-16.
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased
Clinical narrative: Lack of mobility unable to lift arm over head 7-10 days post vaccine. Mom reported 8/29/16.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Disorientation, Dizziness, Gait disturbance, Loss of consciousness, Muscular weakness
Clinical narrative: Patient blacked out for a moment. Was disoriented, felt dizzy, muscle stiffness and weakness - experienced difficulty walking.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient blacked out for a moment. Was disoriented, felt dizzy, muscle stiffness and weakness - experienced difficulty walking.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Overdose
Clinical narrative: Giving vaccines to 15mo. female-inadvertently drew up and was given 2 HIB vaccines along with her other routine DTAP, PCV and flu.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Diarrhoea, Headache, Injection site pain, Joint range of motion decreased, Myalgia
Clinical narrative: Pt woke up next morning with headache (top of head), nausea, diarrhea, upper arm pain extending down below site of injection but above elbow. Limited range of motion, cannot lift arm, states it is muscular pain. Advised pt to contact physician. She has been icing, bracing (compression and taking ibuprofen). Pain limited range of motion has persisted since 8/18 - present.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nausea
Clinical narrative: Pt woke up next morning with headache (top of head), nausea, diarrhea, upper arm pain extending down below site of injection but above elbow. Limited range of motion, cannot lift arm, states it is muscular pain. Advised pt to contact physician. She has been icing, bracing (compression and taking ibuprofen). Pain limited range of motion has persisted since 8/18 - present.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Diarrhoea, Headache, Injected limb mobility decreased, Injection site pain, Nausea
Clinical narrative: Pt woke up next morning with headache (top of head), nausea, diarrhea, upper arm pain extending down below site of injection but above elbow. Limited range of motion, cannot lift arm, states it is muscular pain. Advised pt to contact physician. She has been icing, bracing (compression and taking ibuprofen). Pain limited range of motion has persisted since 8/18 - present.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased
Clinical narrative: Lack of mobility. Unable to lift arm 7-10 days post vaccine. Mom reports incidents 8-29-16.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Nausea, Pain
Clinical narrative: The morning after vaccine, pt. felt physically ill. He was exhausted, sore, and stated he didn't know if he ran a fever. He was nauseated but mostly whole body soreness. He felt better after about 36 hours. Didn't go to doctor.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphemia
Clinical narrative: Parents reported that child began to stutter the morning after being vaccinated.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cough, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Redness, swelling, down right side of bicep up to sight of injections, itchy, rash, cough, pain. 8/27/16 Follow-up, rash and pain gone now-everything is ok.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Redness, swelling, down right side of bicep up to sight of injections, itchy, rash, cough, pain. 8/27/16 Follow-up, rash and pain gone now-everything is ok.
Age: 1.28
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Abnormal behaviour, Hypersomnia, Rash, Viral rash
Clinical narrative: Pt. rec'd 15 mo. imm. on 8/24/16 in office and WCE on 8/26/16. Pt was seen back in office - Mom reports A.M. after shots pt. "acting off". Rash to hands, feet - spread to arms, legs, cheeks. Afebrile, increased sleeping. DX with viral exanthem/suspected Hep. A vaccine?
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Foreign body sensation in eyes, Ophthalmic herpes zoster
Clinical narrative: On 8-22-16 patient states she "felt like something was in my eye". She went to see OD, on 8-25-16 and was diagnosed with "shingles L eye with cornea involvement". She was given Rx homatropine gtts to the eye and p.o. Rx famciclovir 500 mg T.I.D. #21. She was told to take p.o. Tylenol OTC prn for pain. She states that she "forgets" to take the Tylenol and that the pain is not too bad now. She has f/u appointments with ophthalmologist, on 8-30-16 and she also has an appointment for f/u with her PCP on 9-1-16.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Patient was given the shingles vaccination. Zostavax subcutaneously. Patient was given the VIS sheet and also was counseled on expected side effects such as swelling, redness and tenderness. Patient went to her PCP and was given cephalexin 500 mg capsules and mupirocin oint to be applied locally as a preventative care.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Full blood count, Parotitis, Viral test
Clinical narrative: Unilateral Right Side Parotitis.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Nausea
Clinical narrative: Began feeling dizzy and lightheaded. After about ten minutes became nauseous, bp and pulse elevated for about 30 minutes.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Contusion, Swelling
Clinical narrative: Patient exhibits swelling and bruising that got progressively worse over the following two days.  Swelling and brusing were still significant at the time of reporting 3 days later.
Age: 68.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, Swelling, Tenderness.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Fine erythematous papular rash over trunk, arms, and legs, B/L.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced swelling, redness, and extreme pain in the left arm near the injection site.  Patient started taking Tylenol and then consulted the pharmacist on duty on Saturday, 8/27/16.  Per pharmacist instructions, patient continued to take Tylenol and also took Benadryl as well as applying ice to the affected area.  Reaction was resolved by Monday, 8/29/16.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Seizure like phenomena
Clinical narrative: Pt tolerated injection well. After approximately 5 mins following vaccine administration, pt was noted to have had a vaso-vagal response/seizure-like activity in the waiting room. Pt was assisted to supine position on the floor with feet up on a chair. Vitals were assessed. Pt was assisted to a patient care room with mother and sister. Dr. assessed and evaluated patient. After 30 minutes in the room and drinking H2O, patient was discharged with mom. A note was written for her to return to volleyball practice although late.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 25.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Nausea, Pain in extremity, Pyrexia, Somnolence, Vomiting
Clinical narrative: Fever 102.3, sleepy, sore arm on 8/27/16. On 8/28 fever 100.1, nauseated and vomited after ingesting of Gatorade.
Age: 25.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hypersomnia, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever 102.3, sleepy, sore arm on 8/27/16. On 8/28 fever 100.1, nauseated and vomited after ingesting of Gatorade.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Generalized red rash on back of arm at injection site. Itchy, smooth rash with no blistering. Told patient to use Benadryl cr. Patient is nurse and marked location of rash to see if any increase. Patient checked back with me on Monday to say cr has reduced itching and no increase in size of rash.