chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Blood test normal, Chest X-ray normal, Chills, Diarrhoea, Fatigue
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 561653. A 37-year-old female patient had received a dose of ACAM2000 (lot number: VV004003A, manufacturer: Sanofi Pasteur Biologics Co.) in the left arm via unknown route on 11-Jan-2015. The patient had a history of hypothyroidism (8 years) and reoccurring skin rash of unknown etiology (10 years off and on). She was taking Loratadine every other day to prevent the rash. There were no known allergies. The current illnesses and other medications were reported as none. Prior vaccination details were not provided. On 13-Jan-2015, 2 days post-vaccination, she experienced body ache, fatigue and chills overnight. It was reported that the patient thought she was die. She drank a lot of hot honey water and took ibuprofen after which she felt sweaty and all her clothes got soaked. The symptoms continued with fever of 103-104 (unit not provided) for 2 days, by the third day she went to Emergency Department. The patient had reported only "watery stools" at that time. She stated that she felt better. Laboratory investigations included blood tests, chest x-ray, urine analysis and influenza virus test which were done in the Emergency Department. The results for blood tests, chest x-ray and urine analysis were normal. The result for influenza virus test was negative. The patient was prescribed TAMIFLU medication. At the time of this report, the outcome of events was not reported. List of Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Hyperhidrosis, Influenza virus test negative, Pain, Pyrexia, Urine analysis normal
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 561653. A 37-year-old female patient had received a dose of ACAM2000 (lot number: VV004003A, manufacturer: Sanofi Pasteur Biologics Co.) in the left arm via unknown route on 11-Jan-2015. The patient had a history of hypothyroidism (8 years) and reoccurring skin rash of unknown etiology (10 years off and on). She was taking Loratadine every other day to prevent the rash. There were no known allergies. The current illnesses and other medications were reported as none. Prior vaccination details were not provided. On 13-Jan-2015, 2 days post-vaccination, she experienced body ache, fatigue and chills overnight. It was reported that the patient thought she was die. She drank a lot of hot honey water and took ibuprofen after which she felt sweaty and all her clothes got soaked. The symptoms continued with fever of 103-104 (unit not provided) for 2 days, by the third day she went to Emergency Department. The patient had reported only "watery stools" at that time. She stated that she felt better. Laboratory investigations included blood tests, chest x-ray, urine analysis and influenza virus test which were done in the Emergency Department. The results for blood tests, chest x-ray and urine analysis were normal. The result for influenza virus test was negative. The patient was prescribed TAMIFLU medication. At the time of this report, the outcome of events was not reported. List of Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Feeling abnormal, Hyperhidrosis, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 561653. A 37-year-old female patient had received a dose of ACAM2000 (lot number: VV004003A, manufacturer: Sanofi Pasteur Biologics Co.) in the left arm via unknown route on 11-Jan-2015. The patient had a history of hypothyroidism (8 years) and reoccurring skin rash of unknown etiology (10 years off and on). She was taking Loratadine every other day to prevent the rash. There were no known allergies. The current illnesses and other medications were reported as none. Prior vaccination details were not provided. On 13-Jan-2015, 2 days post-vaccination, she experienced body ache, fatigue and chills overnight. It was reported that the patient thought she was die. She drank a lot of hot honey water and took ibuprofen after which she felt sweaty and all her clothes got soaked. The symptoms continued with fever of 103-104 (unit not provided) for 2 days, by the third day she went to Emergency Department. The patient had reported only "watery stools" at that time. She stated that she felt better. Laboratory investigations included blood tests, chest x-ray, urine analysis and influenza virus test which were done in the Emergency Department. The results for blood tests, chest x-ray and urine analysis were normal. The result for influenza virus test was negative. The patient was prescribed TAMIFLU medication. At the time of this report, the outcome of events was not reported. List of Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Urine analysis normal
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 561653. A 37-year-old female patient had received a dose of ACAM2000 (lot number: VV004003A, manufacturer: Sanofi Pasteur Biologics Co.) in the left arm via unknown route on 11-Jan-2015. The patient had a history of hypothyroidism (8 years) and reoccurring skin rash of unknown etiology (10 years off and on). She was taking Loratadine every other day to prevent the rash. There were no known allergies. The current illnesses and other medications were reported as none. Prior vaccination details were not provided. On 13-Jan-2015, 2 days post-vaccination, she experienced body ache, fatigue and chills overnight. It was reported that the patient thought she was die. She drank a lot of hot honey water and took ibuprofen after which she felt sweaty and all her clothes got soaked. The symptoms continued with fever of 103-104 (unit not provided) for 2 days, by the third day she went to Emergency Department. The patient had reported only "watery stools" at that time. She stated that she felt better. Laboratory investigations included blood tests, chest x-ray, urine analysis and influenza virus test which were done in the Emergency Department. The results for blood tests, chest x-ray and urine analysis were normal. The result for influenza virus test was negative. The patient was prescribed TAMIFLU medication. At the time of this report, the outcome of events was not reported. List of Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Body temperature increased, Decreased appetite, Headache, Malaise, Rash
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 562262. A 21-year-old male patient had received a dose of ACAM2000 (lot number: VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the right arm via "intradermal" route on 13-Jan-2015. The patient did not have any medical history and no illness at time of smallpox vaccination. Other medications and prior vaccination details were not provided. On 24-Jan-2015, 11 days post-vaccination, the patient developed small bumps over his back and anterior collar bone area that did not itch. He also developed the small bumps on his lower legs and his ankles itched. On an unspecified date (also reported as "last week"), he experienced headache, elevated temperature, malaise and decreased appetite. Laboratory data and corrective treatment was not provided. At the time of this report, the outcome for the events was not reported. List of Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash pruritic
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 562262. A 21-year-old male patient had received a dose of ACAM2000 (lot number: VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the right arm via "intradermal" route on 13-Jan-2015. The patient did not have any medical history and no illness at time of smallpox vaccination. Other medications and prior vaccination details were not provided. On 24-Jan-2015, 11 days post-vaccination, the patient developed small bumps over his back and anterior collar bone area that did not itch. He also developed the small bumps on his lower legs and his ankles itched. On an unspecified date (also reported as "last week"), he experienced headache, elevated temperature, malaise and decreased appetite. Laboratory data and corrective treatment was not provided. At the time of this report, the outcome for the events was not reported. List of Documents held by sender: none.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number: 564734. A 30-year-old male patient received the following vaccinations on 25-Jan-2015: A dose of ACAM2000 (lot number VV04003A, manufacturer: Sanofi Pasteur Biologics Co), route was not reported and site of administration was unknown, a first dose of BIOTHRAX (lot number FAV387A, manufacturer: Emergent) intramuscularly in the left arm. On 29-Jan-2015, 4 days post-vaccination, the patient developed redness, swelling, warmness and tenderness to touch in his right upper arm. On an unspecified date, the patient had an emergency visit in the hospital and was diagnosed with cellulitis. He was admitted immediately and stayed in the hospital for four days. He received IV antibiotics as a corrective treatment. Laboratory investigations were not provided. At the time of this report, the outcome of the event was unknown. List of Documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Arthralgia, Blood albumin decreased, Blood lactate dehydrogenase increased, Liver function test abnormal, Myalgia
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number 566102. A 35-year-old male patient received the following vaccinations on 24-Jan-2015: A dose of ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co), route was not reported and site of administration was unknown, a dose of IXIARO (lot number: JEV12J24E, manufacturer: Intercell) route and site were reported as unknown and sixth dose of BIOTHRAX (lot number: FAV390A, manufacturer: Emergent), route and site were reported as unknown. The patient had no medical history, other medications or current illnesses. The prior vaccination details were not reported. On 26-Jan-2014, 2 days post-vaccination, the patient developed myalgia, arthralgia, testicular swelling, testicular pain, febrile illness-body temperature was 103-104 (units was not provided). On an unspecified date, the patient had an emergency visit and was hospitalized. The results for the laboratory investigations were low albumin, increased Blood Lactate Dehydrogenase, elevated ferritin, elevated liver function tests (LFTs), elevated erythrocyte sedimentation rate (ESR) and a normal scrotal ultrasound. Corrective treatment was not reported. At the time of this report, the patient recovered from the events: testicular pain and swelling after three weeks. The outcome of myalgia, arthralgia and febrile illness were not reported. List of documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Serum ferritin increased, Testicular pain, Testicular swelling
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number 566102. A 35-year-old male patient received the following vaccinations on 24-Jan-2015: A dose of ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co), route was not reported and site of administration was unknown, a dose of IXIARO (lot number: JEV12J24E, manufacturer: Intercell) route and site were reported as unknown and sixth dose of BIOTHRAX (lot number: FAV390A, manufacturer: Emergent), route and site were reported as unknown. The patient had no medical history, other medications or current illnesses. The prior vaccination details were not reported. On 26-Jan-2014, 2 days post-vaccination, the patient developed myalgia, arthralgia, testicular swelling, testicular pain, febrile illness-body temperature was 103-104 (units was not provided). On an unspecified date, the patient had an emergency visit and was hospitalized. The results for the laboratory investigations were low albumin, increased Blood Lactate Dehydrogenase, elevated ferritin, elevated liver function tests (LFTs), elevated erythrocyte sedimentation rate (ESR) and a normal scrotal ultrasound. Corrective treatment was not reported. At the time of this report, the patient recovered from the events: testicular pain and swelling after three weeks. The outcome of myalgia, arthralgia and febrile illness were not reported. List of documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Ultrasound testes normal, White blood cell count increased
Clinical narrative: This unsolicited case was received on 22-May-2015 via a third party query tool search on the VAERS database, under reference number 566102. A 35-year-old male patient received the following vaccinations on 24-Jan-2015: A dose of ACAM2000 (lot number: VV04-003-A, manufacturer: Sanofi Pasteur Biologics Co), route was not reported and site of administration was unknown, a dose of IXIARO (lot number: JEV12J24E, manufacturer: Intercell) route and site were reported as unknown and sixth dose of BIOTHRAX (lot number: FAV390A, manufacturer: Emergent), route and site were reported as unknown. The patient had no medical history, other medications or current illnesses. The prior vaccination details were not reported. On 26-Jan-2014, 2 days post-vaccination, the patient developed myalgia, arthralgia, testicular swelling, testicular pain, febrile illness-body temperature was 103-104 (units was not provided). On an unspecified date, the patient had an emergency visit and was hospitalized. The results for the laboratory investigations were low albumin, increased Blood Lactate Dehydrogenase, elevated ferritin, elevated liver function tests (LFTs), elevated erythrocyte sedimentation rate (ESR) and a normal scrotal ultrasound. Corrective treatment was not reported. At the time of this report, the patient recovered from the events: testicular pain and swelling after three weeks. The outcome of myalgia, arthralgia and febrile illness were not reported. List of documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Axillary pain, Culture wound, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: This unsolicited case was received on 13-Jul-2015 via a third party query tool search on the VAERS database, under reference number 568528. A 37 years old male patient had received a dose of ACAM2000 (lot number VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route on 08-Feb-2015). The patient did not take any concomitant medications. He did not have any medical history and current illnesses. The prior vaccination details were not provided. On 16-Feb-2015, eight days post vaccination, the patient had a hard time sleeping. He had woken up feeling tender and his left arm (from shoulder to elbow) and armpit were swollen. The patient went to emergency room where he was prescribed BENADRYL and discharged. On 17-Feb-2015, he woke up with the left arm further irritated with red streaks from vaccination site to armpit. He returned to the emergency room to reactive intravenous antibiotics and was prescribed amoxicillin-clavulanate "875-125 mg" bid for 10 days. Laboratory investigations included culture wound and smear test (the date of the investigations and findings were not provided). At the time of this report, the patient had recovered from the above mentioned events on an unspecified date. List of documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site streaking, Injection site swelling, Insomnia, Oedema peripheral, Smear test
Clinical narrative: This unsolicited case was received on 13-Jul-2015 via a third party query tool search on the VAERS database, under reference number 568528. A 37 years old male patient had received a dose of ACAM2000 (lot number VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route on 08-Feb-2015). The patient did not take any concomitant medications. He did not have any medical history and current illnesses. The prior vaccination details were not provided. On 16-Feb-2015, eight days post vaccination, the patient had a hard time sleeping. He had woken up feeling tender and his left arm (from shoulder to elbow) and armpit were swollen. The patient went to emergency room where he was prescribed BENADRYL and discharged. On 17-Feb-2015, he woke up with the left arm further irritated with red streaks from vaccination site to armpit. He returned to the emergency room to reactive intravenous antibiotics and was prescribed amoxicillin-clavulanate "875-125 mg" bid for 10 days. Laboratory investigations included culture wound and smear test (the date of the investigations and findings were not provided). At the time of this report, the patient had recovered from the above mentioned events on an unspecified date. List of documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Culture wound, Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: This unsolicited case was received on 13-Jul-2015 via a third party query tool search on the VAERS database, under reference number 568528. A 37 years old male patient had received a dose of ACAM2000 (lot number VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route on 08-Feb-2015). The patient did not take any concomitant medications. He did not have any medical history and current illnesses. The prior vaccination details were not provided. On 16-Feb-2015, eight days post vaccination, the patient had a hard time sleeping. He had woken up feeling tender and his left arm (from shoulder to elbow) and armpit were swollen. The patient went to emergency room where he was prescribed BENADRYL and discharged. On 17-Feb-2015, he woke up with the left arm further irritated with red streaks from vaccination site to armpit. He returned to the emergency room to reactive intravenous antibiotics and was prescribed amoxicillin-clavulanate "875-125 mg" bid for 10 days. Laboratory investigations included culture wound and smear test (the date of the investigations and findings were not provided). At the time of this report, the patient had recovered from the above mentioned events on an unspecified date. List of documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Insomnia, Local swelling, Smear test, Tenderness
Clinical narrative: This unsolicited case was received on 13-Jul-2015 via a third party query tool search on the VAERS database, under reference number 568528. A 37 years old male patient had received a dose of ACAM2000 (lot number VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route on 08-Feb-2015). The patient did not take any concomitant medications. He did not have any medical history and current illnesses. The prior vaccination details were not provided. On 16-Feb-2015, eight days post vaccination, the patient had a hard time sleeping. He had woken up feeling tender and his left arm (from shoulder to elbow) and armpit were swollen. The patient went to emergency room where he was prescribed BENADRYL and discharged. On 17-Feb-2015, he woke up with the left arm further irritated with red streaks from vaccination site to armpit. He returned to the emergency room to reactive intravenous antibiotics and was prescribed amoxicillin-clavulanate "875-125 mg" bid for 10 days. Laboratory investigations included culture wound and smear test (the date of the investigations and findings were not provided). At the time of this report, the patient had recovered from the above mentioned events on an unspecified date. List of documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: JEV1, SMALL, JEV1, SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - IMPORTANT MEDICAL EVENT. This unsolicited case was reported on 13-Jul-2015 via a third party query tool search on the VAERS database, under reference number 569866. A 22-year-old male patient received the following vaccinations on 04-Mar-2015: A dose of ACAM2000 (lot number VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the right arm via unknown route and a first dose of IXIARO (lot number JEV12J24E, manufacturer: Intercell) in the left arm via unknown route. The patient did not have any medical history and current illnesses. The laboratory data, other medications and prior vaccination details were not provided. On 16-Mar-2015, 12 days post-vaccination, patient had an auto-inoculation of the upper right arm which was adjacent to original site of vaccination. At the time of this report, the patient had recovered from the above mentioned event on an unspecified date. Upon internal review, the case was considered serious due to the important medical event: Post vaccination autoinoculation. List of documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin lesion
Clinical narrative: This unsolicited case was received on 13-Jul-2015 via a third party query tool search on the VAERS database, under reference number 572017. A 36-year old male patient had received a dose of ACAM2000 (lot number VV04003A, manufacturer: Sanofi Pasteur Biologics Co) in the right arm via an unknown route on 18-Mar-2015. The patient took MOTRIN (800 mg as a concomitant medication. He had a history of surgery in the left shoulder (35 days prior). He did not have any current illnesses. The prior vaccination details and laboratory data were not provided. On 28-Mar-2015, 10 days post-vaccination, the patient developed two additional lesions which appeared distal to original site. There were no symptoms observed. It was reported that the lesions would be highly contagious for 18-21 days from the onset. The patient required emergency visit. At the time of this report, the patient had not recovered from the above mentioned event. List of documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Abdominal pain upper, Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse (a patient's wife) refers to a 66 year old male patient with allergy to sulfa and penicillin. The patient had no pertinent medical history. On 23-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L003227, expiry date 13-OCT-2016 (dose, route and site of administration were not reported). Concomitant therapies included losartan, atenolol, meloxicam, simvastatin and FLONASE. On 25-SEP-2015, at 2:00 in the morning, the patient woke with fever, chills, the PNEUMOVAX 23 injection site was red, hot and swollen. The patient went to the emergency room on 25-SEP-2015. He took TYLENOL for the treatment "multiple times" however "he still had a 101 F, has been sleeping all day and all his other symptoms were still present" (outcome of the events was: not recovered). The relatedness between the PNEUMOVAX 23 and the events was not rated by the registered nurse but the physician in the emergency room told to the patient that the adverse reactions were related to the PNEUMOVAX 23. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a registered nurse (a patient's wife) refers to a 66 year old male patient with allergy to sulfa and penicillin. The patient had no pertinent medical history. On 23-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L003227, expiry date 13-OCT-2016 (dose, route and site of administration were not reported). Concomitant therapies included losartan, atenolol, meloxicam, simvastatin and FLONASE. On 25-SEP-2015, at 2:00 in the morning, the patient woke with fever, chills, the PNEUMOVAX 23 injection site was red, hot and swollen. The patient went to the emergency room on 25-SEP-2015. He took TYLENOL for the treatment "multiple times" however "he still had a 101 F, has been sleeping all day and all his other symptoms were still present" (outcome of the events was: not recovered). The relatedness between the PNEUMOVAX 23 and the events was not rated by the registered nurse but the physician in the emergency room told to the patient that the adverse reactions were related to the PNEUMOVAX 23. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse (a patient's wife) refers to a 66 year old male patient with allergy to sulfa and penicillin. The patient had no pertinent medical history. On 23-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L003227, expiry date 13-OCT-2016 (dose, route and site of administration were not reported). Concomitant therapies included losartan, atenolol, meloxicam, simvastatin and FLONASE. On 25-SEP-2015, at 2:00 in the morning, the patient woke with fever, chills, the PNEUMOVAX 23 injection site was red, hot and swollen. The patient went to the emergency room on 25-SEP-2015. He took TYLENOL for the treatment "multiple times" however "he still had a 101 F, has been sleeping all day and all his other symptoms were still present" (outcome of the events was: not recovered). The relatedness between the PNEUMOVAX 23 and the events was not rated by the registered nurse but the physician in the emergency room told to the patient that the adverse reactions were related to the PNEUMOVAX 23. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse (a patient's wife) refers to a 66 year old male patient with allergy to sulfa and penicillin. The patient had no pertinent medical history. On 23-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L003227, expiry date 13-OCT-2016 (dose, route and site of administration were not reported). Concomitant therapies included losartan, atenolol, meloxicam, simvastatin and FLONASE. On 25-SEP-2015, at 2:00 in the morning, the patient woke with fever, chills, the PNEUMOVAX 23 injection site was red, hot and swollen. The patient went to the emergency room on 25-SEP-2015. He took TYLENOL for the treatment "multiple times" however "he still had a 101 F, has been sleeping all day and all his other symptoms were still present" (outcome of the events was: not recovered). The relatedness between the PNEUMOVAX 23 and the events was not rated by the registered nurse but the physician in the emergency room told to the patient that the adverse reactions were related to the PNEUMOVAX 23. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Painful arm - unable to move without pain. Disrupted sleep-started within 2 hrs of injection-taking ibuprofen to pain under control-she feels injection given to high on her arm.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Painful arm - unable to move without pain. Disrupted sleep-started within 2 hrs of injection-taking ibuprofen to pain under control-she feels injection given to high on her arm.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Tremor
Clinical narrative: Woke from sleep feeling dizzy and shaky.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient received a DTap instead of a Tdap.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye swelling, Fatigue, Headache, Pyrexia
Clinical narrative: Trouble breathing, tight throat, swollen eyes, fever, headache, fatigue.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Trouble breathing, tight throat, swollen eyes, fever, headache, fatigue.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria, Vaccination site pain, Vaccination site warmth
Clinical narrative: Large red welt at vaccination site with skin hot to the touch and pain.  Welt is the size of a half-day coin.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Urticaria
Clinical narrative: Broke out in hives over entire face..also has fever but medicated with Tylenol.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Joint swelling, Pain, Pyrexia
Clinical narrative: High fever (103.7); Body aches; Swollen knees; Headache
Age: 1.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Electroencephalogram, Seizure
Clinical narrative: 2x seizure 1 day after vaccines child sent to ER. EEG.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 18 years old male patient. The patient's medical history and concomitant medications were not provided. It was reported that the patient was healthy, very fit and very active in sport. There were no known allergies. There was no previous exposure to this or related drug. No concomitant medication was reported. On 11-JUN-2015, the patient was vaccinated with the first dose of GARDASIL 9 (in the left arm: dose, route of administration, lot # and expiration date were not reported). On 12-JUN-2015, the patient noticed an enlarged lymph node on the left site (same site of body as injection) of the neck in the collarbone area. The patient was examined and referred to the surgeon for examination and a possible biopsy. The prescriber opted to wait for possible resolution. After 2-3 weeks, the patient noticed that the lymph node enlargement was decreased. Approximately 2 months later, it was not noticeable anymore. It was also reported that the patient did not resume the vaccination and that no biopsy was done. No treatment was given for the adverse event. The outcome of the adverse event was reported as recovered in approximately August 2015 (approximately 2 months after vaccination, duration also reported as 3-5 weeks). The relatedness between the adverse event and GARDASIL 9 was not reported. The reporting pharmacist considered the adverse event to be medically significant, because the patient required consultation to prevent on of the serious criteria. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Fever to 101 F, feels achy all over.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was given the MMR vaccine while pregnant. Patient did not inform administering provider of pregnancy. Patient is in her first trimester.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Eye contusion, Fall, Head injury
Clinical narrative: Felt dizzy shortly after the vaccine was administered. Sat down, but continued to feel weaker. Passed out, fell out of chair and onto the floor. Regained consciousness on the floor, a minute or two after sitting down. Was given water and an ice pack. 911 was called, and responders noted that I had hit my forehead and looked pale, but otherwise seemed ok. Feeling better, I refused an offer of transport to the hospital. 10/01/2015 (a few days after vaccine): I developed a "black eye" on the right side of my face (which I presume is due to to the head injury). 10/02/2015 (date of this report): No new symptoms or changes.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Felt dizzy shortly after the vaccine was administered. Sat down, but continued to feel weaker. Passed out, fell out of chair and onto the floor. Regained consciousness on the floor, a minute or two after sitting down. Was given water and an ice pack. 911 was called, and responders noted that I had hit my forehead and looked pale, but otherwise seemed ok. Feeling better, I refused an offer of transport to the hospital. 10/01/2015 (a few days after vaccine): I developed a "black eye" on the right side of my face (which I presume is due to to the head injury). 10/02/2015 (date of this report): No new symptoms or changes.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cochlea implant, VIIth nerve paralysis
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old female patient. The patient's concurrent condition and medical history were not reported. On 25-SEP-2014, the patient was vaccinated with PNEUMOVAX 23, (lot #, dose number and dosage were not reported). Concomitant medication was not reported. The pharmacist reported that on an unknown date in June 2015, the patient was inserted with a cochlear implant for an unspecified reason. On an unspecified date in 2015 (reported as 1 week later, since the insertion of cochlear implant), the patient developed Bell's Palsy. The pharmacist considered Bell's Palsy to be a significant disability. The patient was not recovered at the time of reporting and was still experiencing Bell's Palsy. The reporter did not provide the relatedness of the event and the suspect therapy. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Muscular weakness, Nausea, Presyncope, Vision blurred
Clinical narrative: Pt c/o vasovagal near syncope sx: dizziness, blurred vision, muscle weakness, nausea. Sat pt down, applied cold packs to neck and face, instructed to lower head. Vitals taken, WNL. Sx resolved fully within 5-10 minutes.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Injection site erythema, Pain in extremity
Clinical narrative: Have a small fluid filled blister half an inch from injection site, some redness around site.  Don't think its from the band-aid because no usual rash associated with adhesive sensitivity.  Arm still sore.  Not seeking treatment at this time.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, MMR
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme. Recommended symptomatic treatment with Acetaminophen or Diphenhydramine as needed.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Fall, Laboratory test, Muscular weakness, Nerve conduction studies
Clinical narrative: Pt loss muscle control in legs, legs went weak and fell onto bed. Wife reports they had had CT scans to rule out TIA and are waiting on results from muscle and nerve tests.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash pruritic
Clinical narrative: Patient complained of itchy rash on right arm, very pruritic.  Patient tried hydrocortisone cream.  Saw NP in office on 9/29/2015.  NP suggested a cold pack/ aloe and to contact us if the injection site becomes develops signs of infection such as drainage, pain, increase redness.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised, Urticaria
Clinical narrative: Severe rash covering all body parts. Diagnosed as Urticaria.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Gait disturbance, Injection site pain, Injection site rash
Clinical narrative: Began to get a severe ache in injection site, became worse by Friday and began limping.  Asthma breathing started on Friday and on Saturday he began to break out in a rash or hives on his forearms, then the backs of his legs, then his chest and stomach and his thighs.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Rash generalised, Urticaria
Clinical narrative: Began to get a severe ache in injection site, became worse by Friday and began limping.  Asthma breathing started on Friday and on Saturday he began to break out in a rash or hives on his forearms, then the backs of his legs, then his chest and stomach and his thighs.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Alanine aminotransferase normal, Albumin urine present, Anion gap normal, Bacterial test positive, Basophil count normal
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Basophil percentage, Bilirubin urine, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Blood calcium increased, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Blood sodium normal, Blood urea increased, Blood urine present, Carbon dioxide normal, Chills
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eosinophil count normal, Eosinophil percentage, Glomerular filtration rate decreased, Glucose urine absent
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Granulocyte count increased, Haematocrit increased, Haemoglobin normal, Lymphocyte count decreased, Lymphocyte percentage decreased
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count normal
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Monocyte percentage, Neutrophil percentage increased, Nitrite urine present, Platelet count decreased, Protein total normal
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Red cell distribution width normal, Specific gravity urine normal, Troponin I normal, Urinary sediment present
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Urine ketone body absent, Urine leukocyte esterase positive, White blood cells urine positive, pH urine normal
Clinical narrative: Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of the site- required admission to the hospital for IV antibiotics.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt woke up with her left deltoid red and painful. It was also warm to the touch.  As the day went on, the redness became bigger and swollen.  It continued to be red, warm to the touch, painful, and itchy.  Mom brought pt in to be seen and she was dx w/ cellulitis and started on Augmentin.  Sxs started within 24hs of injection.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Pt woke up with her left deltoid red and painful. It was also warm to the touch.  As the day went on, the redness became bigger and swollen.  It continued to be red, warm to the touch, painful, and itchy.  Mom brought pt in to be seen and she was dx w/ cellulitis and started on Augmentin.  Sxs started within 24hs of injection.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Chest discomfort, Condition aggravated, Vaccine positive rechallenge
Clinical narrative: Employee with known hx of asthma. She was out of her medication. She received the flu vaccine and then 2 days later complained of chest tightness and had an asthmatic episode. Employee stated that she had the same reaction last year, but forgot about it.She did not disclose this at the time of the vaccine administration.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Arm pit swollen, pain.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Erythema, Induration, Myalgia, Pruritus
Clinical narrative: Large hot, hard red area with significan itching. Returned to pharmacy and purchased Benadryl 25mg. Awoke the next morning with significant muscle aches and joint pain. Returned to bed and slept until 2PM. Felt better by round 6pm.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Somnolence
Clinical narrative: Large hot, hard red area with significan itching. Returned to pharmacy and purchased Benadryl 25mg. Awoke the next morning with significant muscle aches and joint pain. Returned to bed and slept until 2PM. Felt better by round 6pm.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cough, Insomnia, Malaise, Nasal congestion
Clinical narrative: I have had a flu shot every year since I was a child. Upon getting this years shot I started to feel ill. I also had severe am pain. Two days later I am sick in bed with a cough, stuffy nose and no energy to lift myself up for more than a few minutes. I also have the worst arm pain of my life. It has not gotten better but worse. I cannot sleep or even wear a shirt with a sleeve because it hurts so much when it touches anything.  I have never had this happen before. I am in extreme pain.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Tenderness
Clinical narrative: I have had a flu shot every year since I was a child. Upon getting this years shot I started to feel ill. I also had severe am pain. Two days later I am sick in bed with a cough, stuffy nose and no energy to lift myself up for more than a few minutes. I also have the worst arm pain of my life. It has not gotten better but worse. I cannot sleep or even wear a shirt with a sleeve because it hurts so much when it touches anything.  I have never had this happen before. I am in extreme pain.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Extensive swelling of vaccinated limb, Incorrect route of drug administration, Paraesthesia oral, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of delayed type hypersensitivity in a 47-year-old female patient who received FLUARIX QUADRIVALENT (batch number C242G, expiry date 30th June 2016). Previously administered products included Flu vaccine (no problems with previous flu vaccinations). On 25th September 2015, the patient received FLUARIX QUADRIVALENT (subcutaneous) .5 ml. On 25th September 2015, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria other: serious as per reporter), rash (serious criteria other: serious as per reporter), tingling mouth (serious criteria other: serious as per reporter), extensive swelling of vaccinated limb (serious criteria other: serious as per reporter) and intramuscular formulation administered by other route. The patient was treated with BENADRYL (nos). On an unknown date, the outcome of the delayed type hypersensitivity, rash, tingling mouth, extensive swelling of vaccinated limb and intramuscular formulation administered by other route were unknown. The reporter considered the delayed type hypersensitivity, rash, tingling mouth and extensive swelling of vaccinated limb to be almost certainly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the intramuscular formulation administered by other route to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT, subcutaneously which led to inappropriate route of vaccine administration. This patient received the vaccination in her right deltoid and experienced a delayed hypersensitivity reaction approximately two hours after the vaccination. She had swelling in her right hand to the point that she could not make a fist. She also developed a fine pinpoint rash extending up her arms and tingling around mouth. Her vitals were accessed and she was not experiencing any difficulty breathing, her blood sugar was normal and lungs clear. She was advised to take BENADRYL and seek medical attention if any symptoms worsened.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Type IV hypersensitivity reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of delayed type hypersensitivity in a 47-year-old female patient who received FLUARIX QUADRIVALENT (batch number C242G, expiry date 30th June 2016). Previously administered products included Flu vaccine (no problems with previous flu vaccinations). On 25th September 2015, the patient received FLUARIX QUADRIVALENT (subcutaneous) .5 ml. On 25th September 2015, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced delayed type hypersensitivity (serious criteria other: serious as per reporter), rash (serious criteria other: serious as per reporter), tingling mouth (serious criteria other: serious as per reporter), extensive swelling of vaccinated limb (serious criteria other: serious as per reporter) and intramuscular formulation administered by other route. The patient was treated with BENADRYL (nos). On an unknown date, the outcome of the delayed type hypersensitivity, rash, tingling mouth, extensive swelling of vaccinated limb and intramuscular formulation administered by other route were unknown. The reporter considered the delayed type hypersensitivity, rash, tingling mouth and extensive swelling of vaccinated limb to be almost certainly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the intramuscular formulation administered by other route to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT, subcutaneously which led to inappropriate route of vaccine administration. This patient received the vaccination in her right deltoid and experienced a delayed hypersensitivity reaction approximately two hours after the vaccination. She had swelling in her right hand to the point that she could not make a fist. She also developed a fine pinpoint rash extending up her arms and tingling around mouth. Her vitals were accessed and she was not experiencing any difficulty breathing, her blood sugar was normal and lungs clear. She was advised to take BENADRYL and seek medical attention if any symptoms worsened.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Joint range of motion decreased, Muscle tightness
Clinical narrative: Muscle Tightness, Limited range of motion, difficulty sleeping.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Headache, Vertigo
Clinical narrative: Headache, Dizziness, Brain Fog, Vertigo like symptoms. Shortness of breath.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Chills, Dizziness, Dyspnoea, Feeling hot
Clinical narrative: Dizzy, lightheaded, nausea, emesis, smothering sensation, warm sensation over entire body, chills and decrease blood pressure.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Nausea, Vomiting
Clinical narrative: Dizzy, lightheaded, nausea, emesis, smothering sensation, warm sensation over entire body, chills and decrease blood pressure.