chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest discomfort, Echocardiogram normal, Electrocardiogram ST segment elevation, Hyperhidrosis, Musculoskeletal discomfort
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 579523. This case involves a 20 years old male patient who received the following vaccinations on 15-Apr-2015: A dose of Smallpox, (lot number VV04-003-A, manufacturer: unknown, route and site of administration were not reported) and a dose of BIOTHRAX, (manufacturer: Emergent, lot number: FAV407A) via intramuscular route in the right arm. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient's medical history, current illnesses and prior vaccination details were not provided. He did not take any concomitant medications. On 24-Apr-2015, 9 days post vaccination, the patient experienced acute onset of chest pressure which radiated to the left shoulder. It was associated with diaphoresis and slight improvement with leaning forward. The patient developed musculoskeletal discomfort, hyperhidrosis and pain. The patient required emergency visit and was hospitalized on an unspecified date. Laboratory investigations included Troponin I which peaked at 0.80 but trended downward during admission. Electrocardiogram displayed some ST-segment elevations. Echocardiogram was normal and did not display any pericardial effusion. He was discharged with MOTRIN for one week and Colchicine for three months for pain as corrective treatment. The patient recovered from the above mentioned events on an unspecified date. Hospital discharge date was not provided. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Pain, Troponin I increased
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 579523. This case involves a 20 years old male patient who received the following vaccinations on 15-Apr-2015: A dose of Smallpox, (lot number VV04-003-A, manufacturer: unknown, route and site of administration were not reported) and a dose of BIOTHRAX, (manufacturer: Emergent, lot number: FAV407A) via intramuscular route in the right arm. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient's medical history, current illnesses and prior vaccination details were not provided. He did not take any concomitant medications. On 24-Apr-2015, 9 days post vaccination, the patient experienced acute onset of chest pressure which radiated to the left shoulder. It was associated with diaphoresis and slight improvement with leaning forward. The patient developed musculoskeletal discomfort, hyperhidrosis and pain. The patient required emergency visit and was hospitalized on an unspecified date. Laboratory investigations included Troponin I which peaked at 0.80 but trended downward during admission. Electrocardiogram displayed some ST-segment elevations. Echocardiogram was normal and did not display any pericardial effusion. He was discharged with MOTRIN for one week and Colchicine for three months for pain as corrective treatment. The patient recovered from the above mentioned events on an unspecified date. Hospital discharge date was not provided. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest discomfort, Discomfort, Echocardiogram normal, Electrocardiogram ST segment elevation, Hyperhidrosis
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 579523. This case involves a 20 years old male patient who received the following vaccinations on 15-Apr-2015: A dose of Smallpox, (lot number VV04-003-A, manufacturer: unknown, route and site of administration were not reported) and a dose of BIOTHRAX, (manufacturer: Emergent, lot number: FAV407A) via intramuscular route in the right arm. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient's medical history, current illnesses and prior vaccination details were not provided. He did not take any concomitant medications. On 24-Apr-2015, 9 days post vaccination, the patient experienced acute onset of chest pressure which radiated to the left shoulder. It was associated with diaphoresis and slight improvement with leaning forward. The patient developed musculoskeletal discomfort, hyperhidrosis and pain. The patient required emergency visit and was hospitalized on an unspecified date. Laboratory investigations included Troponin I which peaked at 0.80 but trended downward during admission. Electrocardiogram displayed some ST-segment elevations. Echocardiogram was normal and did not display any pericardial effusion. He was discharged with MOTRIN for one week and Colchicine for three months for pain as corrective treatment. The patient recovered from the above mentioned events on an unspecified date. Hospital discharge date was not provided. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Musculoskeletal discomfort, Pain, Troponin I increased
Clinical narrative: This unsolicited case was received on 28-Sep-2015 via a third party query tool search on the VAERS database, under reference number 579523. This case involves a 20 years old male patient who received the following vaccinations on 15-Apr-2015: A dose of Smallpox, (lot number VV04-003-A, manufacturer: unknown, route and site of administration were not reported) and a dose of BIOTHRAX, (manufacturer: Emergent, lot number: FAV407A) via intramuscular route in the right arm. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. The patient's medical history, current illnesses and prior vaccination details were not provided. He did not take any concomitant medications. On 24-Apr-2015, 9 days post vaccination, the patient experienced acute onset of chest pressure which radiated to the left shoulder. It was associated with diaphoresis and slight improvement with leaning forward. The patient developed musculoskeletal discomfort, hyperhidrosis and pain. The patient required emergency visit and was hospitalized on an unspecified date. Laboratory investigations included Troponin I which peaked at 0.80 but trended downward during admission. Electrocardiogram displayed some ST-segment elevations. Echocardiogram was normal and did not display any pericardial effusion. He was discharged with MOTRIN for one week and Colchicine for three months for pain as corrective treatment. The patient recovered from the above mentioned events on an unspecified date. Hospital discharge date was not provided. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chest X-ray abnormal, Headache, Laboratory test normal, Myalgia, Pleural effusion
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer Sales representative. A 12-year-old female patient of an unspecified ethnicity received second dose of TRUMENBA, on 31Aug2015 at single dose. The patient medical history and concomitant medications were not reported. In the evening of 31Aug2015 patient started to have fever and on 01Sep2015 she had headache and myalgia and still fever. On 04Sep2015 patient was diagnosed with pneumonia and on 07Sep2015 she was admitted to the hospital. On 15Sep2015 patient was seen back at the office, and she still had pneumonia and upper respiratory issues; on 16Sep2015 at the office, she had still pneumonia and some fatigue. On 22Sep2015 patient improved. The final outcome of the event was reported as not recovered. The nurse stated that physician did not believe the pneumonia was related to TRUMENBA.
Age: 12.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pneumonia, Pyrexia, Respiratory viral panel
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer Sales representative. A 12-year-old female patient of an unspecified ethnicity received second dose of TRUMENBA, on 31Aug2015 at single dose. The patient medical history and concomitant medications were not reported. In the evening of 31Aug2015 patient started to have fever and on 01Sep2015 she had headache and myalgia and still fever. On 04Sep2015 patient was diagnosed with pneumonia and on 07Sep2015 she was admitted to the hospital. On 15Sep2015 patient was seen back at the office, and she still had pneumonia and upper respiratory issues; on 16Sep2015 at the office, she had still pneumonia and some fatigue. On 22Sep2015 patient improved. The final outcome of the event was reported as not recovered. The nurse stated that physician did not believe the pneumonia was related to TRUMENBA.
Age: 12.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Headache, Myalgia, Pneumonia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer Sales representative. A 12-year-old female patient of an unspecified ethnicity received second dose of TRUMENBA, on 31Aug2015 at single dose. The patient medical history and concomitant medications were not reported. In the evening of 31Aug2015 patient started to have fever and on 01Sep2015 she had headache and myalgia and still fever. On 04Sep2015 patient was diagnosed with pneumonia and on 07Sep2015 she was admitted to the hospital. On 15Sep2015 patient was seen back at the office, and she still had pneumonia and upper respiratory issues; on 16Sep2015 at the office, she had still pneumonia and some fatigue. On 22Sep2015 patient improved. The final outcome of the event was reported as not recovered. The nurse stated that physician did not believe the pneumonia was related to TRUMENBA.
Age: 1.08
Sex: F
Vaccine: MMR, MMR
Symptoms: C-reactive protein, Full blood count, Nausea, Pyrexia, Viral test
Clinical narrative: Elevated temps. Fever 105-107. Several doctor's visits and ER visit.
Age: 1.08
Sex: F
Vaccine: MMR, MMR
Symptoms: Vomiting
Clinical narrative: Elevated temps. Fever 105-107. Several doctor's visits and ER visit.
Age: 1.08
Sex: F
Vaccine: MMR, MMR
Symptoms: Laboratory test, Pyrexia
Clinical narrative: Elevated temps. Fever 105-107. Several doctor's visits and ER visit.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Subcutaneous haematoma
Clinical narrative: Initial unsolicited report received from a pharmacist on 28-Sep-2015.  This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD via intramuscular route (batch number: UI459AA, expiry date and site of administration were not provided) on 28-Sep-2015. The patient did not have any illness at the time of vaccination and no known pre-existing physician diagnosed allergies. Birth defects and medical conditions were not provided. Previous vaccinations were unknown. Concomitant medications were not reported. On 28-Sep-2015, few minutes post vaccination; the patient had some bleeding post vaccination. After about 2 hours, she developed a large red, hard, warm under the skin at injection site. There was no laboratory investigations done and corrective treatment was not provided. It was reported that the patient required ER/doctor visit. The patient had not yet recovered from the above mentioned events. Upon internal review this case was considered serious due to important medical event: bleeding post vaccination. List of documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haemorrhage, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist on 28-Sep-2015.  This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD via intramuscular route (batch number: UI459AA, expiry date and site of administration were not provided) on 28-Sep-2015. The patient did not have any illness at the time of vaccination and no known pre-existing physician diagnosed allergies. Birth defects and medical conditions were not provided. Previous vaccinations were unknown. Concomitant medications were not reported. On 28-Sep-2015, few minutes post vaccination; the patient had some bleeding post vaccination. After about 2 hours, she developed a large red, hard, warm under the skin at injection site. There was no laboratory investigations done and corrective treatment was not provided. It was reported that the patient required ER/doctor visit. The patient had not yet recovered from the above mentioned events. Upon internal review this case was considered serious due to important medical event: bleeding post vaccination. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Swelling face, Swollen tongue, Throat irritation, Urticaria
Clinical narrative: Ptr c/o'd of hives on back and neck along w/ tongue swelling 2 hours after being immunized at clinic.   Pt was instructed to call 911.  Took Benadryl 25mg at home and went to walk-in clinic where she received a 2nd dose of Benadryl 25mg.   Discharged home after observation.
Age: 19.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Ptr c/o'd of hives on back and neck along w/ tongue swelling 2 hours after being immunized at clinic.   Pt was instructed to call 911.  Took Benadryl 25mg at home and went to walk-in clinic where she received a 2nd dose of Benadryl 25mg.   Discharged home after observation.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Asthenia, Blood test, Chest pain, Dizziness
Clinical narrative: Information has been received from a 25 years old female referring to herself. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 21-SEP-2015 the patient was vaccinated with first dose of GARDASIL (strength, frequency were not reported) (lot # K016966 with an expiry date of 10-MAY-2017) 0.5 mL intramuscularly. The patient stated that after receiving the first dose of GARDASIL she had an adverse experience. On 21-SEP-2015, after vaccination patient experienced insomnia, headaches, chest pains and dizziness in the morning. The patient also stated that her urinary amount was not normal, she also had an unspecified pain in her right arm as well as pain in her left leg. Patient stated that her menstrual cycle came on a second time in the month of September which was not normal and that began with spotting on 30-SEP-2015. Patient stated most recently she had suffered with numbness in the right part of the face and the burning sensation in the stomach. Patient received treatment for the event insomnia with melatonin. Patient sought medical attention. Lab diagnostic studies were performed which included blood and urinary test and the results were not reported. The outcome of the events was reported as not recovered. Causal relation with GARDASIL was not reported. There was no product quality complaint. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dyspepsia, Headache, Hypoaesthesia, Immediate post-injection reaction, Insomnia
Clinical narrative: Information has been received from a 25 years old female referring to herself. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 21-SEP-2015 the patient was vaccinated with first dose of GARDASIL (strength, frequency were not reported) (lot # K016966 with an expiry date of 10-MAY-2017) 0.5 mL intramuscularly. The patient stated that after receiving the first dose of GARDASIL she had an adverse experience. On 21-SEP-2015, after vaccination patient experienced insomnia, headaches, chest pains and dizziness in the morning. The patient also stated that her urinary amount was not normal, she also had an unspecified pain in her right arm as well as pain in her left leg. Patient stated that her menstrual cycle came on a second time in the month of September which was not normal and that began with spotting on 30-SEP-2015. Patient stated most recently she had suffered with numbness in the right part of the face and the burning sensation in the stomach. Patient received treatment for the event insomnia with melatonin. Patient sought medical attention. Lab diagnostic studies were performed which included blood and urinary test and the results were not reported. The outcome of the events was reported as not recovered. Causal relation with GARDASIL was not reported. There was no product quality complaint. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Metrorrhagia, Pain in extremity, Thrombosis, Urine output decreased
Clinical narrative: Information has been received from a 25 years old female referring to herself. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 21-SEP-2015 the patient was vaccinated with first dose of GARDASIL (strength, frequency were not reported) (lot # K016966 with an expiry date of 10-MAY-2017) 0.5 mL intramuscularly. The patient stated that after receiving the first dose of GARDASIL she had an adverse experience. On 21-SEP-2015, after vaccination patient experienced insomnia, headaches, chest pains and dizziness in the morning. The patient also stated that her urinary amount was not normal, she also had an unspecified pain in her right arm as well as pain in her left leg. Patient stated that her menstrual cycle came on a second time in the month of September which was not normal and that began with spotting on 30-SEP-2015. Patient stated most recently she had suffered with numbness in the right part of the face and the burning sensation in the stomach. Patient received treatment for the event insomnia with melatonin. Patient sought medical attention. Lab diagnostic studies were performed which included blood and urinary test and the results were not reported. The outcome of the events was reported as not recovered. Causal relation with GARDASIL was not reported. There was no product quality complaint. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Insomnia, Pain, Vaginal haemorrhage
Clinical narrative: Information has been received from a 25 years old female referring to herself. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 21-SEP-2015 the patient was vaccinated with first dose of GARDASIL (strength, frequency were not reported) (lot # K016966 with an expiry date of 10-MAY-2017) 0.5 mL intramuscularly. The patient stated that after receiving the first dose of GARDASIL she had an adverse experience. On 21-SEP-2015, after vaccination patient experienced insomnia, headaches, chest pains and dizziness in the morning. The patient also stated that her urinary amount was not normal, she also had an unspecified pain in her right arm as well as pain in her left leg. Patient stated that her menstrual cycle came on a second time in the month of September which was not normal and that began with spotting on 30-SEP-2015. Patient stated most recently she had suffered with numbness in the right part of the face and the burning sensation in the stomach. Patient received treatment for the event insomnia with melatonin. Patient sought medical attention. Lab diagnostic studies were performed which included blood and urinary test and the results were not reported. The outcome of the events was reported as not recovered. Causal relation with GARDASIL was not reported. There was no product quality complaint. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Adverse reaction, Blood test, Chest pain, Dizziness, Dyspepsia
Clinical narrative: Information has been received from a 25 years old female referring to herself. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 21-SEP-2015 the patient was vaccinated with first dose of GARDASIL (strength, frequency were not reported) (lot # K016966 with an expiry date of 10-MAY-2017) 0.5 mL intramuscularly. The patient stated that after receiving the first dose of GARDASIL she had an adverse experience. On 21-SEP-2015, after vaccination patient experienced insomnia, headaches, chest pains and dizziness in the morning. The patient also stated that her urinary amount was not normal, she also had an unspecified pain in her right arm as well as pain in her left leg. Patient stated that her menstrual cycle came on a second time in the month of September which was not normal and that began with spotting on 30-SEP-2015. Patient stated most recently she had suffered with numbness in the right part of the face and the burning sensation in the stomach. Patient received treatment for the event insomnia with melatonin. Patient sought medical attention. Lab diagnostic studies were performed which included blood and urinary test and the results were not reported. The outcome of the events was reported as not recovered. Causal relation with GARDASIL was not reported. There was no product quality complaint. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Headache, Hypoaesthesia, Insomnia, Menstruation irregular, Metrorrhagia
Clinical narrative: Information has been received from a 25 years old female referring to herself. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 21-SEP-2015 the patient was vaccinated with first dose of GARDASIL (strength, frequency were not reported) (lot # K016966 with an expiry date of 10-MAY-2017) 0.5 mL intramuscularly. The patient stated that after receiving the first dose of GARDASIL she had an adverse experience. On 21-SEP-2015, after vaccination patient experienced insomnia, headaches, chest pains and dizziness in the morning. The patient also stated that her urinary amount was not normal, she also had an unspecified pain in her right arm as well as pain in her left leg. Patient stated that her menstrual cycle came on a second time in the month of September which was not normal and that began with spotting on 30-SEP-2015. Patient stated most recently she had suffered with numbness in the right part of the face and the burning sensation in the stomach. Patient received treatment for the event insomnia with melatonin. Patient sought medical attention. Lab diagnostic studies were performed which included blood and urinary test and the results were not reported. The outcome of the events was reported as not recovered. Causal relation with GARDASIL was not reported. There was no product quality complaint. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pain in extremity, Urine analysis, Urine output decreased
Clinical narrative: Information has been received from a 25 years old female referring to herself. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 21-SEP-2015 the patient was vaccinated with first dose of GARDASIL (strength, frequency were not reported) (lot # K016966 with an expiry date of 10-MAY-2017) 0.5 mL intramuscularly. The patient stated that after receiving the first dose of GARDASIL she had an adverse experience. On 21-SEP-2015, after vaccination patient experienced insomnia, headaches, chest pains and dizziness in the morning. The patient also stated that her urinary amount was not normal, she also had an unspecified pain in her right arm as well as pain in her left leg. Patient stated that her menstrual cycle came on a second time in the month of September which was not normal and that began with spotting on 30-SEP-2015. Patient stated most recently she had suffered with numbness in the right part of the face and the burning sensation in the stomach. Patient received treatment for the event insomnia with melatonin. Patient sought medical attention. Lab diagnostic studies were performed which included blood and urinary test and the results were not reported. The outcome of the events was reported as not recovered. Causal relation with GARDASIL was not reported. There was no product quality complaint. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Injection site erythema, Pruritus
Clinical narrative: Some localized itching after vaccination. Also, funny taste in mouth. Developed a silver dollar size red spot on L-arm at injection area the following day. Itching is not persistent.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Cataplexy, Narcolepsy, Sleep study, Somnolence
Clinical narrative: Sleepiness, Diagnosed with Narcolepsy and Cataplexy.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Woke up in AM with Swelling of upper lip, patient is a nurse at the hospital where she received the vaccine.  Took a Claritin 10mg & Benadryl 12.5mg and also applied topical hydrocortisone cream to affected area which had little effect.  One hour later repeated Benadryl 25mg and Zantac 150mg. Decreased swelling after, however still swelling 15 hours later, repeated Benadryl 25 mg & Zantac 150mg.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood test, Electroencephalogram normal, Eye pain, Generalised tonic-clonic seizure
Clinical narrative: This spontaneous report was received from a physical therapist (who is the mother of the patient) regarding a 14 year old male patient. The patient's medical history included seizure in 2011 for which he was treated with unspecified medication. Post this episode, the patient had not had a seizure. The patient had no drug reactions or allergies. On 23-SEP-2015, the patient was vaccinated with either GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) or GARDASIL 9 (lot number and expiry date unknown) (dosing regimen and frequency unknown) (the reporter was unsure). On 27-SEP-2015 at 03:30 hours, the patient experienced a grand mal seizure (medically significant). The patient sought immediate medical attention and was sent to the emergency room (details unspecified). The patient was treated for the grand mal seizure (treatment details unspecified) and was released on the same day. After the seizure had ended, on approximately 27-SEP-2015, the patient's eyes hurt, that lasted for 2-3 hours. On 28-SEP-2015 and 29-SEP-2015, the patient had slept the entire day. On 30-SEP-2015 patient slept for about half the day and then started to return to normal. On 01-OCT-2015, the patient attempted to go back to school, but his mother was called to come and pick him up from the half way. On 02-OCT-2015, patient was cleared to go back to school. The patient was awaiting for clearance to return to sports. The reporter concluded that the patient did not seem to be fully recovered from the incident. The outcome of somnolence was reported as not recovered. An electroencephalogram (EEG) performed was normal, blood work and MRI (magnetic resonance imaging) of the brain was performed on 05-OCT-2015, with no results reported. The outcome of grand mal seizure and eye pain was reported as recovered, while the outcome of somnolence and activities of daily life impaired were not recovered. The relatedness of the events to the suspect drug was unknown. No product quality complaint was reported. Upon internal review the event grand mal seizure was considered to be medically significant. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Hypersomnia, Nuclear magnetic resonance imaging brain, Somnolence
Clinical narrative: This spontaneous report was received from a physical therapist (who is the mother of the patient) regarding a 14 year old male patient. The patient's medical history included seizure in 2011 for which he was treated with unspecified medication. Post this episode, the patient had not had a seizure. The patient had no drug reactions or allergies. On 23-SEP-2015, the patient was vaccinated with either GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) or GARDASIL 9 (lot number and expiry date unknown) (dosing regimen and frequency unknown) (the reporter was unsure). On 27-SEP-2015 at 03:30 hours, the patient experienced a grand mal seizure (medically significant). The patient sought immediate medical attention and was sent to the emergency room (details unspecified). The patient was treated for the grand mal seizure (treatment details unspecified) and was released on the same day. After the seizure had ended, on approximately 27-SEP-2015, the patient's eyes hurt, that lasted for 2-3 hours. On 28-SEP-2015 and 29-SEP-2015, the patient had slept the entire day. On 30-SEP-2015 patient slept for about half the day and then started to return to normal. On 01-OCT-2015, the patient attempted to go back to school, but his mother was called to come and pick him up from the half way. On 02-OCT-2015, patient was cleared to go back to school. The patient was awaiting for clearance to return to sports. The reporter concluded that the patient did not seem to be fully recovered from the incident. The outcome of somnolence was reported as not recovered. An electroencephalogram (EEG) performed was normal, blood work and MRI (magnetic resonance imaging) of the brain was performed on 05-OCT-2015, with no results reported. The outcome of grand mal seizure and eye pain was reported as recovered, while the outcome of somnolence and activities of daily life impaired were not recovered. The relatedness of the events to the suspect drug was unknown. No product quality complaint was reported. Upon internal review the event grand mal seizure was considered to be medically significant. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage
Clinical narrative: Case number PHEH2015US019301, is an initial spontaneous report from consumer (patient) received on 25 Sep 2015. This report refers to a 28 years old female pregnant patient. Medical history and concomitant medications were not reported. She was bitten by bat on 26 Jul 2015. She was vaccinated with first dose of post exposure of RABAVERT (batch number: not reported) on 28 Jul 2015. She did not know she was pregnant at the time of vaccination. She found out on 31 Jul 2015 and her health care professional advised her to continue remaining vaccines. She was vaccinated with second dose of RABAVERT (batch number: not reported) on 31 Jul 2015. On the same day (31 Jul 2015) she experienced bleeding and miscarried on 19 Aug 2015. Outcome of the event bleeding was reported as recovered on 19 Aug 2015 and outcome of other event was not reported. The reporter assessed the events serious (medically significant). Causality of the events was not reported. The case was lost to follow-up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Injection site pain, Injection site reaction, Pruritus, Skin discolouration
Clinical narrative: This spontaneous report was received from a 67 years old male patient who was reporting on himself. None drug reactions/allergies were reported. The patient's concurrent conditions included high blood pressure, an unspecified cardiac disorder (reports as heart regulator) and high cholesterol. His concomitant therapies included unspecified medications for high blood pressure and for high cholesterol and an unspecified heart regulator. On 11-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneously; lot # and expiration date were not reported). On approximately 14-SEP-2015 (also reported as 3 or 4 days after receiving the vaccination), the patient experienced an unspecified injection site reaction, soreness and muscle pain. He also developed small black streaks on his back. He stated that he was itching but it was unspecified if he was itching all over his body or not. Blood work was performed and an unspecified specimen samples were taken. It was also reported that the patient did not seek medical attention and that no treatment was given for the adverse events. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLUC3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Tongue began swelling, hives on tongue and face; treated with Pepcid, Solumedrol, Benadryl, Medrol dose pack.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Eye discharge, Eye irritation, Insomnia, Nasal congestion, Nasopharyngitis
Clinical narrative: Cold symptoms, chest congestion, irritated eyes with discharge(redness, swelling) stuffed nose, aches/pains.  Difficulty sleeping, symptoms improved within 24 hr post vaccine admin and completely resolved by 36 hr post admin. Acetaminophen 650 mg once for pain relief.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pain, Respiratory tract congestion
Clinical narrative: Cold symptoms, chest congestion, irritated eyes with discharge(redness, swelling) stuffed nose, aches/pains.  Difficulty sleeping, symptoms improved within 24 hr post vaccine admin and completely resolved by 36 hr post admin. Acetaminophen 650 mg once for pain relief.
Age: 1.83
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO ADVERSE REACTION.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dyspnoea, Headache, Nausea, Pain
Clinical narrative: 3:30 pm noticed body aches - mostly in legs followed by sudden onset headache.  Headache progressed. Left work 4:15 pm went straight home. around 5:15 began vomitting/diarrhea, fever, body aches. Took 800 mg ibuprofen. Around 6:15 pm - 7:00 pm experienced difficulty breathing and nausea. No rash or swelling of throat, lips or tongue.  By 8:00 pm symptoms slowly improved so I did not seek medical treament.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: 3:30 pm noticed body aches - mostly in legs followed by sudden onset headache.  Headache progressed. Left work 4:15 pm went straight home. around 5:15 began vomitting/diarrhea, fever, body aches. Took 800 mg ibuprofen. Around 6:15 pm - 7:00 pm experienced difficulty breathing and nausea. No rash or swelling of throat, lips or tongue.  By 8:00 pm symptoms slowly improved so I did not seek medical treament.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain at injection site, redness and a red bump at injection site, itching at injection site, arm pain, unable to lift arm, fever, muscle aches, lethargic.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Lethargy, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Pain at injection site, redness and a red bump at injection site, itching at injection site, arm pain, unable to lift arm, fever, muscle aches, lethargic.
Age: 34.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Chest pain, Injection site erythema, Injection site induration, Injection site pain, Injection site urticaria
Clinical narrative: Per client:  redness at site, fever by noon and fever next day.  Firmness to site, hives extending outward from site down to left elbow; mid chest pain to left shoulder (left arm flu shot).
Age: 34.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Pyrexia
Clinical narrative: Per client:  redness at site, fever by noon and fever next day.  Firmness to site, hives extending outward from site down to left elbow; mid chest pain to left shoulder (left arm flu shot).
Age: 72.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site pain
Clinical narrative: Severe left shoulder pain started about 6 hours after the injections were given. Patient took over the counter pain medication for the pain.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: REDNESS AROUND INJECTION SITE ON THE RIGHT ARM. WARM TO TOUCH. SORE WHEN TOUCHED.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. Medical history and current conditions were not reported. On an unspecified dates in 2009, the patient received full series (dose 1, 2 and 3) of RECOMBIVAX HB (unspecified lots and strength). Concomitant medications were not reported. On an unknown date after the series of RECOMBIVAX HB in 2009, the patient received a liver transplant and had also experienced recurring Clostridium difficile infections. On 23-MAR-2015, the patient who was not on hemodialysis, started the new series of vaccination and received dose 4 which was an overdose of RECOMBIVAX HB 40 microgram (mcg) (lot number lot K011961). Again on 29-APR-2015 the patient was vaccinated with dose 5 of RECOMBIVAX HB 10 mcg (lot # K022265). The outcome of the events were unknown. The reporter stated that the events are not related to her receiving RECOMBIVAX HB in 2009. Upon internal review, the event liver transplant was determined to be medically significant. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to a 75 year or older female patient. Medical history and the concomitant medications of the patient were not provided. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 subcutaneous (lot number and expiry date not reported) (dose regimen, frequency and strength were not reported). Other suspect therapies included ZOSTAVAX (lot number and expiry date not reported) (dose regimen, frequency and strength was not reported). On an unspecified date, the patient experienced an allergic reaction. The patient was taken to the emergency room and sought medical attention. The patient was admitted to the hospital overnight, for observation. It was reported that the event was not an anaphylaxis. The treatment provided to the patient include epinephrine (route of administration unspecified). The outcome of event, allergic reaction was reported as recovered/resolved. Causality assessment between the event and the suspect products was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received FLULAVAL (batch number 93T79, expiry date June 2016). On 29th September 2015, the patient received FLULAVAL .5 ml. On 29th September 2015, several hours after receiving FLULAVAL, the patient experienced injection site erythema, injection site induration and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site induration were recovering/resolving and the outcome of the injection site itching was not recovered/not resolved. The reporter considered the injection site erythema, injection site induration and injection site itching to be almost certainly related to FLULAVAL. Additional details provided were as follows: This case was reported by a nurse practitioner. This case was previously reported to a doctor. On 29th September 2015, in the morning (exact time unsure), the patient received a dose of FLULAVAL vaccine in left deltoid. In the evening of the same day (exact time unsure), the patient experienced redness and induration around the injection site and an itching at the injection site. The reporter prescribed washing site with warm water and soap for consumer.
Age: 43.0
Sex: F
Vaccine: FLUR3
Symptoms: Arthralgia, Face oedema, Pruritus generalised, Rash erythematous, Rhinorrhoea
Clinical narrative: Hives, red rash and itching on entire body, joint pain, runny nose, slight facial edema. Patient reports taking Benadryl 50 mg PO liquid every 6 hours.
Age: 43.0
Sex: F
Vaccine: FLUR3
Symptoms: Urticaria
Clinical narrative: Hives, red rash and itching on entire body, joint pain, runny nose, slight facial edema. Patient reports taking Benadryl 50 mg PO liquid every 6 hours.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Muscle and joint aches, headache, malaise, low grade fever, chills.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Muscle and joint aches, headache, malaise, low grade fever, chills.
Age: 26.0
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Chills, Fatigue, Injection site pain, Pain
Clinical narrative: Chills, body aches, fatigue, sensitivity at injection site.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Shoulder and arm pain and stiffness.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Burning sensation, Injection site reaction, Meningitis, Pyrexia, Skin warm
Clinical narrative: Pt developed fever, arm felt warm/burning sensation. Pt does not know what tx was given b/c she was diagnosed w/meningitis, in the hospital, when injection site reaction was discovered.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Endocrine test abnormal, Exposure during pregnancy, Haematology test, Laboratory test
Clinical narrative: This spontaneous retrospective pregnancy report as received from the patient's mother refers to a 18 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On unknown dates (reported as "when she was in 8th grade"), the patient received the first and the second dose of GARDASIL (dose, route, lot# and expiry date were not reported). On 29-SEP-2015, the patient was vaccinated with the third dose of GARDASIL (dose, route, lot# and expiry date were not reported). No concomitant medications were administered. The patient became pregnant with last menstrual period (LMP) of 01-SEP-2015 (menstruation through 07-SEP-2015) and estimated date of delivery (EDD) of 07-JUN-2016. Initial exposure to GARDASIL was at 4 weeks (it was also reported by the patient's mother that "she could be 2-3 weeks pregnant"). On 29-SEP-2015, the patient performed multiple pregnancy tests, but the results were inconclusive, because the line was "so faint". On 30-SEP-2015, the patient was seen by the nurse practitioner and the pregnancy test was performed with a positive result. On 04-OCT-2015 (reported as "yesterday"), the patient was taken to the hospital (but per patient's mother she was not admitted to the hospital) due to vaginal bleeding and cramping. General hematology, general chemistry, urinalysis and other laboratory studies were performed in the hospital (results were not provided). The patient's hormone levels were also measured and they were very low, so the physicians thought that the patient lost the baby. Therefore the pregnancy outcome was spontaneous abortion unspecified date in 2015. Fetal outcome was not reported. On an unknown date in 2015, the patient developed urinary tract infection and unspecified medications were prescribed at the hospital for the treatment. At the time of report, the patient was still experiencing bleeding and cramping and the urinary tract infection was not completely resolved. The outcome of abortion spontaneous was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review the events of spontaneous abortion was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Pregnancy test positive, Urinary tract infection, Urine analysis, Vaginal haemorrhage
Clinical narrative: This spontaneous retrospective pregnancy report as received from the patient's mother refers to a 18 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On unknown dates (reported as "when she was in 8th grade"), the patient received the first and the second dose of GARDASIL (dose, route, lot# and expiry date were not reported). On 29-SEP-2015, the patient was vaccinated with the third dose of GARDASIL (dose, route, lot# and expiry date were not reported). No concomitant medications were administered. The patient became pregnant with last menstrual period (LMP) of 01-SEP-2015 (menstruation through 07-SEP-2015) and estimated date of delivery (EDD) of 07-JUN-2016. Initial exposure to GARDASIL was at 4 weeks (it was also reported by the patient's mother that "she could be 2-3 weeks pregnant"). On 29-SEP-2015, the patient performed multiple pregnancy tests, but the results were inconclusive, because the line was "so faint". On 30-SEP-2015, the patient was seen by the nurse practitioner and the pregnancy test was performed with a positive result. On 04-OCT-2015 (reported as "yesterday"), the patient was taken to the hospital (but per patient's mother she was not admitted to the hospital) due to vaginal bleeding and cramping. General hematology, general chemistry, urinalysis and other laboratory studies were performed in the hospital (results were not provided). The patient's hormone levels were also measured and they were very low, so the physicians thought that the patient lost the baby. Therefore the pregnancy outcome was spontaneous abortion unspecified date in 2015. Fetal outcome was not reported. On an unknown date in 2015, the patient developed urinary tract infection and unspecified medications were prescribed at the hospital for the treatment. At the time of report, the patient was still experiencing bleeding and cramping and the urinary tract infection was not completely resolved. The outcome of abortion spontaneous was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review the events of spontaneous abortion was considered to be medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Apparent life threatening event, Vaccination complication
Clinical narrative: Initial unsolicited report received from a physician (consumer) on 21 September 2015. This case involves a 65 years old male patient who was vaccinated with a dose FLUZONE HD (batch number, dose, site of administration was not reported) on an unspecified date. It was reported that the patient has been taking the flu vaccine for 40 some odd years. Concomitant medications were not reported. On an unspecified date, following the vaccination, patient reported that the vaccine almost killed him. Lab data and corrective treatments were not reported. The outcome of event was unknown. Upon internal review, the company decided to consider the event serious because of important medical event (FLUZONE HD vaccine that almost killed him). List of documents held by sender: none.