chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report was received from a 62 year old female Licensed Practical Nurse (who is also the patient) regarding herself. The patient's current condition included seasonal allergies, high cholesterol and hypertension. On 14-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route not reported). No concomitant medications were reported. On 14-NOV-2012, the patient experienced red lump at the injection site. She did not develop rash. No treatment was provided. Approximately on 18-NOV-2012 (reported as which lasted 3-4 days), the patient recovered from the event of red lump at the injection site. The nurse did not seek medical attention. The nurse also stated that on 19-NOV-2012, she cared for a 12 year old patient who had spinal muscular atrophy and was on a medical ventilator. On 25-NOV-2012, the 12 year old patient developed a red, itchy and raised rash on her right arm and left lower leg. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Laboratory test abnormal, Neck pain, Retinal disorder, Thrombosis
Clinical narrative: Initial information has been received from a registered nurse concerning herself with a history of cataracts, who on 03-AUG-2012, was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. On 05-AUG-2012, the patient developed headache and experienced cloudiness in her vision when moving her eyes. On 06-AUG-2012, the patient visited an unspecified ophthalmologist, who by unspecified means found an unspecified problem with the retina in her right eye. The ophthalmologist sent the patient for further unspecified testing on an unspecified date which found a blood clot in the patient's branch artery of the right eye. The patient did not indicate how or if the blood clot in the right eye was treated, however she reported that the blood clot resolved on an unspecified date. On 21-AUG-2012, the patient visited an unspecified physician due to the continued headaches, cloudy vision and new onset of the neck pain with no nuchal rigidity at which time the unspecified physician prescribed unspecified dose of VALTREX. The patient reported that after starting VALTREX on an unspecified date, the headaches resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Initial information has been received from a registered nurse concerning herself with a history of cataracts, who on 03-AUG-2012, was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. On 05-AUG-2012, the patient developed headache and experienced cloudiness in her vision when moving her eyes. On 06-AUG-2012, the patient visited an unspecified ophthalmologist, who by unspecified means found an unspecified problem with the retina in her right eye. The ophthalmologist sent the patient for further unspecified testing on an unspecified date which found a blood clot in the patient's branch artery of the right eye. The patient did not indicate how or if the blood clot in the right eye was treated, however she reported that the blood clot resolved on an unspecified date. On 21-AUG-2012, the patient visited an unspecified physician due to the continued headaches, cloudy vision and new onset of the neck pain with no nuchal rigidity at which time the unspecified physician prescribed unspecified dose of VALTREX. The patient reported that after starting VALTREX on an unspecified date, the headaches resolved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: This spontaneous report was received from a psychiatrist concerning to a 61 years old female patient with rash after 8 days on amoxicillin. The patient's medical history included mild asthma. On 03-DEC-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (Lot and dose not reported). No other co-suspects were reported. Concomitant medications included SINGULAIR, ALLEGRA and cholecalciferol. Psychiatrist mentioned that at received ZOSTAVAX and had on her left arm at the injection site a 3.5 inch x 1.5 inch inflammation or erythema and her left arm was a little sore. Psychiatrist stated there was no rash. No treatment information was reported. No lab diagnostics were reported. The outcome of the events were not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of Pharmacy refers to a patient of unknown age and gender. The patient was vaccinated with dose 1 PNUEMOVAX 23 4-5 years ago, in approximately 2007 (route, dose unknown). The pharmacist mentioned that a nurse unfamiliar with PNEUMOVAX 23 multidose vial, on 06-DEC-2012, gave a patient the entire vial (5 doses) of the multidoses PNEUMOVAX 23 (route unknown). No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptom. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Pruritus, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician concerning to a female patient of unknown age. In July-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that a patient after received ZOSTAVAX months later in October 2012 developed a dry, itchy, red rash on her back. The outcomes of the event were unknown. The relatedness for the events were unknown for ZOSTAVAX. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Asthenia, Chills, Dizziness, Feeling of body temperature change, Gaze palsy
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a 13 year old male patient. The patient had a medical history of allergies. On 08-NOV-2012, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot number H014645, expiration date unknown, route intramuscularly in the left arm). On 08-NOV-2012, the patient was also administered with FLUMIST. Concomitant medications included FLOVENT. On 08-NOV-2012, less than a minute after the patient was administered with the GARDASIL, he became pale, his eyes rolled back in his head and he began to seize up with his arms flailing. The patient began to hyperventilate. The symptoms resolved spontaneously after 1 minute. The patient was monitored and he left the office with his parent without requiring medical treatment. The parent called the office later in the day to report that the patient had fully recovered (on 08-NOV-2012). There was no intervention to prevent serious criteria and no death was reported. Upon internal review, he began to seize up with his arms flailing was considered medically significant. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Hot flush, Hyperhidrosis, Nausea, Syncope, Tremor
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a 13 year old male patient. The patient had a medical history of allergies. On 08-NOV-2012, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot number H014645, expiration date unknown, route intramuscularly in the left arm). On 08-NOV-2012, the patient was also administered with FLUMIST. Concomitant medications included FLOVENT. On 08-NOV-2012, less than a minute after the patient was administered with the GARDASIL, he became pale, his eyes rolled back in his head and he began to seize up with his arms flailing. The patient began to hyperventilate. The symptoms resolved spontaneously after 1 minute. The patient was monitored and he left the office with his parent without requiring medical treatment. The parent called the office later in the day to report that the patient had fully recovered (on 08-NOV-2012). There was no intervention to prevent serious criteria and no death was reported. Upon internal review, he began to seize up with his arms flailing was considered medically significant. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a 13 year old male patient. The patient had a medical history of allergies. On 08-NOV-2012, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot number H014645, expiration date unknown, route intramuscularly in the left arm). On 08-NOV-2012, the patient was also administered with FLUMIST. Concomitant medications included FLOVENT. On 08-NOV-2012, less than a minute after the patient was administered with the GARDASIL, he became pale, his eyes rolled back in his head and he began to seize up with his arms flailing. The patient began to hyperventilate. The symptoms resolved spontaneously after 1 minute. The patient was monitored and he left the office with his parent without requiring medical treatment. The parent called the office later in the day to report that the patient had fully recovered (on 08-NOV-2012). There was no intervention to prevent serious criteria and no death was reported. Upon internal review, he began to seize up with his arms flailing was considered medically significant. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Convulsion, Dyskinesia, Gaze palsy, Hyperventilation, Pallor
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a 13 year old male patient. The patient had a medical history of allergies. On 08-NOV-2012, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot number H014645, expiration date unknown, route intramuscularly in the left arm). On 08-NOV-2012, the patient was also administered with FLUMIST. Concomitant medications included FLOVENT. On 08-NOV-2012, less than a minute after the patient was administered with the GARDASIL, he became pale, his eyes rolled back in his head and he began to seize up with his arms flailing. The patient began to hyperventilate. The symptoms resolved spontaneously after 1 minute. The patient was monitored and he left the office with his parent without requiring medical treatment. The parent called the office later in the day to report that the patient had fully recovered (on 08-NOV-2012). There was no intervention to prevent serious criteria and no death was reported. Upon internal review, he began to seize up with his arms flailing was considered medically significant. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram normal, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a mid to late forties years old female nurse (who was also the patient) with asthma, drug reaction/allergy to non-steroidal antiinflammatory drugs and a medical history of pneumonia as a child refers to herself. On 16-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported), just prior to her discharge from hospital, per hospital protocol. The patient was in the hospital for a hysterectomy. No other co-suspects were reported. No concomitant medications were reported. The patient reported that she developed hives, swelling on her face, mouth and tongue, and fever of 104.7 degrees F., 4 hours after receiving PNEUMOVAX 23. She also reported that it felt like a freight train was sitting on her chest. The patient returned to the hospital the same day she was discharged, and was readmitted. At the time of reporting the patient was feeling better (reported as recovering), but still had hives. BENADRYL and other unspecified medications were given as a treatment. The relatedness for the event were unknown for PNEUMOVAX 23. Hives, swelling of her face, mouth and tongue, fever of 104.7 degrees F and felt like a freight train was sitting on her chest were considered to be life threatening by the reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Respiratory distress, Urine analysis normal, Urticaria, Vomiting
Clinical narrative: This spontaneous report as received from a mid to late forties years old female nurse (who was also the patient) with asthma, drug reaction/allergy to non-steroidal antiinflammatory drugs and a medical history of pneumonia as a child refers to herself. On 16-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported), just prior to her discharge from hospital, per hospital protocol. The patient was in the hospital for a hysterectomy. No other co-suspects were reported. No concomitant medications were reported. The patient reported that she developed hives, swelling on her face, mouth and tongue, and fever of 104.7 degrees F., 4 hours after receiving PNEUMOVAX 23. She also reported that it felt like a freight train was sitting on her chest. The patient returned to the hospital the same day she was discharged, and was readmitted. At the time of reporting the patient was feeling better (reported as recovering), but still had hives. BENADRYL and other unspecified medications were given as a treatment. The relatedness for the event were unknown for PNEUMOVAX 23. Hives, swelling of her face, mouth and tongue, fever of 104.7 degrees F and felt like a freight train was sitting on her chest were considered to be life threatening by the reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chest discomfort, Oedema mouth, Pyrexia, Swelling face, Swollen tongue
Clinical narrative: This spontaneous report as received from a mid to late forties years old female nurse (who was also the patient) with asthma, drug reaction/allergy to non-steroidal antiinflammatory drugs and a medical history of pneumonia as a child refers to herself. On 16-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported), just prior to her discharge from hospital, per hospital protocol. The patient was in the hospital for a hysterectomy. No other co-suspects were reported. No concomitant medications were reported. The patient reported that she developed hives, swelling on her face, mouth and tongue, and fever of 104.7 degrees F., 4 hours after receiving PNEUMOVAX 23. She also reported that it felt like a freight train was sitting on her chest. The patient returned to the hospital the same day she was discharged, and was readmitted. At the time of reporting the patient was feeling better (reported as recovering), but still had hives. BENADRYL and other unspecified medications were given as a treatment. The relatedness for the event were unknown for PNEUMOVAX 23. Hives, swelling of her face, mouth and tongue, fever of 104.7 degrees F and felt like a freight train was sitting on her chest were considered to be life threatening by the reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a mid to late forties years old female nurse (who was also the patient) with asthma, drug reaction/allergy to non-steroidal antiinflammatory drugs and a medical history of pneumonia as a child refers to herself. On 16-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported), just prior to her discharge from hospital, per hospital protocol. The patient was in the hospital for a hysterectomy. No other co-suspects were reported. No concomitant medications were reported. The patient reported that she developed hives, swelling on her face, mouth and tongue, and fever of 104.7 degrees F., 4 hours after receiving PNEUMOVAX 23. She also reported that it felt like a freight train was sitting on her chest. The patient returned to the hospital the same day she was discharged, and was readmitted. At the time of reporting the patient was feeling better (reported as recovering), but still had hives. BENADRYL and other unspecified medications were given as a treatment. The relatedness for the event were unknown for PNEUMOVAX 23. Hives, swelling of her face, mouth and tongue, fever of 104.7 degrees F and felt like a freight train was sitting on her chest were considered to be life threatening by the reporter. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Autoimmune thrombocytopenia, Full blood count abnormal
Clinical narrative: This case was reported by a healthcare professional (paramedic also subject) and described the occurrence of thrombocytopenia in a 45-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included hyperlipidemia. Concurrent medications included cholesterol reducing agent ("statins or cholesterol"). On 24 October 2012 the subject received a dose of FLUARIX (unknown details). In November 2012, 2 weeks after vaccination with FLUARIX, the subject experienced thrombocytopenia. In 2012, less than a year after vaccination with FLUARIX, the subject experienced petechiae, stress and contusion ["bruising"]. The reporter stated that "he has loss of work days due to this event [thrombocytopenia]." He is trying to file a worker's compensation claim. Relevant diagnostic tests were "standard blood work" taken in November 2012 in which the results were thrombocytopenia. The healthcare professional considered the events clinically significant (or requiring intervention). At the time of reporting the events were resolved. In 2012 at an unknown time after vaccination with FLUARIX, the adverse events of thrombocytopenia, petechiae, stress and contusion resolved. The healthcare professional and his healthcare providers considered the events were possibly related to vaccination with FLUARIX. "After the results [of blood work] came back, two hematologists (his doctors) told him that the abnormal lab results were caused by his flu vaccination." The reporter stated that these events have been reported on VAERS.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Blood test abnormal, Contusion, Petechiae, Stress
Clinical narrative: This case was reported by a healthcare professional (paramedic also subject) and described the occurrence of thrombocytopenia in a 45-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included hyperlipidemia. Concurrent medications included cholesterol reducing agent ("statins or cholesterol"). On 24 October 2012 the subject received a dose of FLUARIX (unknown details). In November 2012, 2 weeks after vaccination with FLUARIX, the subject experienced thrombocytopenia. In 2012, less than a year after vaccination with FLUARIX, the subject experienced petechiae, stress and contusion ["bruising"]. The reporter stated that "he has loss of work days due to this event [thrombocytopenia]." He is trying to file a worker's compensation claim. Relevant diagnostic tests were "standard blood work" taken in November 2012 in which the results were thrombocytopenia. The healthcare professional considered the events clinically significant (or requiring intervention). At the time of reporting the events were resolved. In 2012 at an unknown time after vaccination with FLUARIX, the adverse events of thrombocytopenia, petechiae, stress and contusion resolved. The healthcare professional and his healthcare providers considered the events were possibly related to vaccination with FLUARIX. "After the results [of blood work] came back, two hematologists (his doctors) told him that the abnormal lab results were caused by his flu vaccination." The reporter stated that these events have been reported on VAERS.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Thrombocytopenia
Clinical narrative: This case was reported by a healthcare professional (paramedic also subject) and described the occurrence of thrombocytopenia in a 45-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included hyperlipidemia. Concurrent medications included cholesterol reducing agent ("statins or cholesterol"). On 24 October 2012 the subject received a dose of FLUARIX (unknown details). In November 2012, 2 weeks after vaccination with FLUARIX, the subject experienced thrombocytopenia. In 2012, less than a year after vaccination with FLUARIX, the subject experienced petechiae, stress and contusion ["bruising"]. The reporter stated that "he has loss of work days due to this event [thrombocytopenia]." He is trying to file a worker's compensation claim. Relevant diagnostic tests were "standard blood work" taken in November 2012 in which the results were thrombocytopenia. The healthcare professional considered the events clinically significant (or requiring intervention). At the time of reporting the events were resolved. In 2012 at an unknown time after vaccination with FLUARIX, the adverse events of thrombocytopenia, petechiae, stress and contusion resolved. The healthcare professional and his healthcare providers considered the events were possibly related to vaccination with FLUARIX. "After the results [of blood work] came back, two hematologists (his doctors) told him that the abnormal lab results were caused by his flu vaccination." The reporter stated that these events have been reported on VAERS.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Paraesthesia
Clinical narrative: Received vaccine on 12-6-12. Later that day pt had redness, pain, and inflammation at the injection site. Pt was seen by dr at urgent care on 12.9.12 & was treated with doxycycline 100mg bid x 10 days for cellulitis.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Received vaccine on 12-6-12. Later that day pt had redness, pain, and inflammation at the injection site. Pt was seen by dr at urgent care on 12.9.12 & was treated with doxycycline 100mg bid x 10 days for cellulitis.
Age: 2.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Blood culture negative, Chest X-ray normal, Convulsion, Culture urine negative, Cyanosis
Clinical narrative: Right after patient's well baby visit on 11/30/2012 her doctor told me to be on the lookout for a delayed fever or reaction to the shot within 7-10 days. 10 days later, patient woke up with a fever at 4:00 in the morning (around 102F), we gave her Tylenol. She couldn't go back to sleep, fever got worse by 9:30AM, so I gave her another dose, which still didn't bring it down. She was lethargic all day. We took her temperature at 2:15 and it was 104.1 F. She was in our bed resting a few minutes later, when she called for us to come see her. We got in the room, she looked at us, and then started seizing. She seized for about 60 seconds. Turned blue. I called the ambulance, they came and took her to the ER. She was not responsive. She was not responsive for hours after the seizure. Doctor said normally kids are somewhat back to normal by then, and so he wanted to do a spinal tap to see if it was meningitis. It was not. About 3 hours after her seizure, she finally started to look at us, recognize us as her parents and act a little normal. She was discharged from the hospital around 8:30PM, as having a febrile seizure. I am pissed that no one told me the risks associated with combining the two shots that she got that day on Nov 30 (HIB PRP-T Conjugate & Pheumococcal Conjugate). I would have never let them give them to her. Her current treatment is to give her round the clock Motrin & Tylenol for 3 days. All the tests that they ran (chest x ray, strep, blood cultures)...everything came back negative. Doctor didn't want to admit that her high fever which resulted in a very terrifying seizure could have been the cause, but we believe it was.
Age: 2.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Febrile convulsion, Lethargy, Lumbar puncture normal, Pyrexia, Streptococcus test negative
Clinical narrative: Right after patient's well baby visit on 11/30/2012 her doctor told me to be on the lookout for a delayed fever or reaction to the shot within 7-10 days. 10 days later, patient woke up with a fever at 4:00 in the morning (around 102F), we gave her Tylenol. She couldn't go back to sleep, fever got worse by 9:30AM, so I gave her another dose, which still didn't bring it down. She was lethargic all day. We took her temperature at 2:15 and it was 104.1 F. She was in our bed resting a few minutes later, when she called for us to come see her. We got in the room, she looked at us, and then started seizing. She seized for about 60 seconds. Turned blue. I called the ambulance, they came and took her to the ER. She was not responsive. She was not responsive for hours after the seizure. Doctor said normally kids are somewhat back to normal by then, and so he wanted to do a spinal tap to see if it was meningitis. It was not. About 3 hours after her seizure, she finally started to look at us, recognize us as her parents and act a little normal. She was discharged from the hospital around 8:30PM, as having a febrile seizure. I am pissed that no one told me the risks associated with combining the two shots that she got that day on Nov 30 (HIB PRP-T Conjugate & Pheumococcal Conjugate). I would have never let them give them to her. Her current treatment is to give her round the clock Motrin & Tylenol for 3 days. All the tests that they ran (chest x ray, strep, blood cultures)...everything came back negative. Doctor didn't want to admit that her high fever which resulted in a very terrifying seizure could have been the cause, but we believe it was.
Age: 2.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Unresponsive to stimuli
Clinical narrative: Right after patient's well baby visit on 11/30/2012 her doctor told me to be on the lookout for a delayed fever or reaction to the shot within 7-10 days. 10 days later, patient woke up with a fever at 4:00 in the morning (around 102F), we gave her Tylenol. She couldn't go back to sleep, fever got worse by 9:30AM, so I gave her another dose, which still didn't bring it down. She was lethargic all day. We took her temperature at 2:15 and it was 104.1 F. She was in our bed resting a few minutes later, when she called for us to come see her. We got in the room, she looked at us, and then started seizing. She seized for about 60 seconds. Turned blue. I called the ambulance, they came and took her to the ER. She was not responsive. She was not responsive for hours after the seizure. Doctor said normally kids are somewhat back to normal by then, and so he wanted to do a spinal tap to see if it was meningitis. It was not. About 3 hours after her seizure, she finally started to look at us, recognize us as her parents and act a little normal. She was discharged from the hospital around 8:30PM, as having a febrile seizure. I am pissed that no one told me the risks associated with combining the two shots that she got that day on Nov 30 (HIB PRP-T Conjugate & Pheumococcal Conjugate). I would have never let them give them to her. Her current treatment is to give her round the clock Motrin & Tylenol for 3 days. All the tests that they ran (chest x ray, strep, blood cultures)...everything came back negative. Doctor didn't want to admit that her high fever which resulted in a very terrifying seizure could have been the cause, but we believe it was.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Chills, Pain in extremity
Clinical narrative: Chills and pain in arm and underarm at exactly the same time.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Headache, Malaise, Pain
Clinical narrative: Aching all over, headache, weakenss, general malaise.
Age: 34.0
Sex: F
Vaccine: FLUX, TDAP, FLU3, TDAP
Symptoms: Arthralgia, Blood test abnormal, Rheumatoid arthritis
Clinical narrative: Started developing painful joints. More locations as time went on. First right middle knuckle, then left middle knuckle, left shoulder, ankles, big toes, wrists, left clavicle. Went to Rheumatologist and was diagnosed with Rheumatoid Arthritis on 12/10/2012.
Age: 34.0
Sex: F
Vaccine: FLUX, TDAP, FLU3, TDAP
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: Started developing painful joints. More locations as time went on. First right middle knuckle, then left middle knuckle, left shoulder, ankles, big toes, wrists, left clavicle. Went to Rheumatologist and was diagnosed with Rheumatoid Arthritis on 12/10/2012.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pain in shoulder, can't lift arm to certain point, pain upon rotation.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Arm swollen, painful to lift arm, redness. MD instructed to treat with ZYRTEC or antihistamine. Rph suggested MOTRIN.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Orthopox virus infection, Orthopoxvirus test positive, Secondary transmission
Clinical narrative: 19yo healthy female who had contact with primary Smallpox vaccinee (vaccination date 10/30/2012) between 14-25Nov while sleeping (the vaccinee discontinued covering the site on 11/17/12 when the site developed a scab.). The pt. noted a blister on the MCP joint of her left index finger on 11/19/12 which she "popped" releasing a small amount of liquid (of note, the pt. fell around 11/11/12 and scraped this knuckle which had not completely healed). The pt. was seen in a ER on 11/26/12 and the on 11/27/12 by her PCM and a dermatologist. The pt. was prescribed 3 oral antibiotics. The lesions tested positive for non-variola orthopox on 11/29/12.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dysstasia, Somnolence, Syncope
Clinical narrative: Patient received 0.5 mL FLUVIRIN, then fainted about 5 minutes later walking down a store aisle. Patient appeared groggy, clammy, and was unable to stand/sit without assistance. Paramedics arrived w/i 10 minutes.
Age: 70.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site haematoma, Injection site nodule
Clinical narrative: 12/10/12 Pt reports: Right upper arm, reddened x 10 days, knot & bruise at injection site. Left upper arm, large bruise, reddened x 14 days, knot & bruise at injection site; itchy front of left upper arm for 4 weeks. Eve of 11-14-12 chills & sweat x 1.
Age: 70.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pruritus
Clinical narrative: 12/10/12 Pt reports: Right upper arm, reddened x 10 days, knot & bruise at injection site. Left upper arm, large bruise, reddened x 14 days, knot & bruise at injection site; itchy front of left upper arm for 4 weeks. Eve of 11-14-12 chills & sweat x 1.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: CSF protein increased, Chest X-ray normal, Computerised tomogram head normal, Dehydration, Full blood count normal
Clinical narrative: On 12/2/12, after a 2 week upper respiratory illness, the patient developed numbness and weakness of the lower extremities. He was seen in a local ER and felt to be dehydrated. No specific Rx was given. The mother felt he might have Guillain-Barre syndrome and called me on 12/3/12. I advised going to the ER. He was hospitalized with the diagnosis of Guillain-Barre Syndrome.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Metabolic function test normal, Muscular weakness, Upper respiratory tract infection
Clinical narrative: On 12/2/12, after a 2 week upper respiratory illness, the patient developed numbness and weakness of the lower extremities. He was seen in a local ER and felt to be dehydrated. No specific Rx was given. The mother felt he might have Guillain-Barre syndrome and called me on 12/3/12. I advised going to the ER. He was hospitalized with the diagnosis of Guillain-Barre Syndrome.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Urine analysis normal
Clinical narrative: On 12/2/12, after a 2 week upper respiratory illness, the patient developed numbness and weakness of the lower extremities. He was seen in a local ER and felt to be dehydrated. No specific Rx was given. The mother felt he might have Guillain-Barre syndrome and called me on 12/3/12. I advised going to the ER. He was hospitalized with the diagnosis of Guillain-Barre Syndrome.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Neuralgic amyotrophy, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Vaccine given 10/15/12. Developed (L) arm pain & paresthesias two days later. Ultimately diagnosed w/ Turner Parsonage Syndrome.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Pt's throat swelled after flu shot. Had sticky exudate & redness in eyes. Took BENADRYL was OK. Went to MD next AM, got Rx for Prednisone taper.
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash appeared after 4 days after vaccines. Rash has spread all over the body - 12-10-12. Fever.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling face
Clinical narrative: States that the day after receiving flu vaccine her face became red and swollen. This has remained redness since then. Face and neck affected feels hot and is red.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: C/o severe redness and swelling (L) upper arm 2 hours after receiving Flu vaccine. She visited doctor in occupational health office and was followed there.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: C/o 12 hours after receiving vaccine, states lymph nodes under (L) arm were very painful and swollen for 3 days.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site approximately 24-48 hours after injection.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: C/o tingling down arm 10 minutes after vaccine given to patient states she has numbness & tingling down Rt arm to fingertips.
Age: 0.68
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Apnoea, Hypotonia
Clinical narrative: Apnoea with hypotonic 20 min after administration. Spontaneous recovery.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red & swelling developed 6 hours after vaccine given - progressively worse (larger & increased itching).
Age: 5.0
Sex: M
Vaccine: FLU3, IPV
Symptoms: Injection site erosion, Injection site rash, Rash papular
Clinical narrative: Mom reports rash appeared around injection site about 24 hrs post vaccine. 3 cm x 4 cm patch with scattered red papules approximately 2 mm & excoriations observed on 11/5/12 on exam by Dr.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash erythematous, Rash pruritic, Scab
Clinical narrative: On 12-6-12 patient noted an itchy, red skin eruption on (L) lateral chest wall (armpit area). On 12-7-12 employee developed a similar skin eruption on buttock, abdomen and neck. Some eruptions were fluid-filled. On 12-10-12 areas were scabbed over. No treatment.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Fatigue, Headache, Vomiting
Clinical narrative: Approximately 1130 PM on 12/3/12 child awoke complaining of headache, T=100.1 degrees F and within 15 minutes vomited x 2. Tired in morning by 12 noon 12/4/12 seemed to be better according to mother.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Ear pain, Headache, Injection site reaction, Pain, Pyrexia
Clinical narrative: Headache, (B) earache, low grade fever, body aches. Injection site reaction 10 cm x 13 cm on (L) arm. Apply ice to (L) arm, monitor for expansion. TYLENOL & Ibuprofen.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness
Clinical narrative: Patient reported that following the shot she had numbness & loss of strength in her (L) arm, pain at injection site.
Sex: F
Vaccine: FLUX
Symptoms: Aphasia, Throat tightness
Clinical narrative: Case number PHEH2012US024175 is an initial spontaneous report received from a consumer on 03 Dec 2012. This report refers to a patient of an unknown demographics. The patient's historical drugs included VIOXX for which she had to go to the emergency room and ended up in the intensive care unit, unable to breathe and elevated blood pressure, LEVAQUIN for which her legs swelled and the tendons in her legs hurt and many other blood pressure medications for which for her lips and mouth go numb and it felt like her throat closes. The patient received seasonal influenza vaccine (manufacture: unknown, batch number: unknown) on an unknown date at an unknown dose. On an unknown date, after vaccination, the patient reported her throat closed and she couldn't talk. Seriousness and outcome of the event were not reported.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Vaccination complication
Clinical narrative: Pt. had a reaction on the RD with the DTaP and MMR vaccine. The reaction is 50x60mm. The treatment is to apply heat.
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Redness and swelling on (L) arm, warm to touch. Treated with amoxicillin 400mg/5ml.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Injection administered on 11/5/12, patient called today, 11/9/12 to report adverse reaction of swelling at injection site. Which the patient went to the hospital for on 11/7/12.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site joint pain, Rash, Wheezing
Clinical narrative: Rash. Shoulder pain in arm of injection site. Headache. Wheezing.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Malaise, Nausea, Pain
Clinical narrative: Day after vaccine was given had chills, body aches & felt sick x 3 days. 4th days started feeling better has nausea & dizziness & that is decreasing.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discomfort, Injection site rash
Clinical narrative: Injection site rash & discomfort with some regional spread and headache - x 5 days,
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Abscess limb, Anaphylactic reaction, Blood culture negative, Chest pain, Dyspnoea
Clinical narrative: Patient called pharmacy at approximately 2 pm on 12/9/12 to report the following events: 11/28/12: Received flu shot at approximately 8:40pm and per pharmacist instructions she remained in store 15-20 minutes after vaccination, due to unspecified adverse rxn to flu shot 20 years ago. She was fine when she left the store, upon arriving home she was experiencing an "anaphylactic reaction". Symptoms: SOB and her throat was closing. She self-administered injectable diphenhydramine in her right arm and called 911. Paramedics administered oxygen and she refused transport to hospital. She says her arm was red and swollen at this time. I spoke with pharmacist on 12/10/12 that administered flu shot, he recalls that patient called pharmacy after she returned home to report red/swollen arm. He confirmed that she did not have SOB and suggested she take a BENADRYL and explained this is common. She did not mention 911 call. Patient did not report this phone call to me. Her arm got progressively worse and on 12/8/12 she sought treatment at immediate care clinic because the pain was so severe, there were red streaks on her arm, she had a high fever plus she was experiencing chest pains. On 12/9/12 she was admitted to hospital with strep infection in arm. 12/10/12: patient called to report that she was still awaiting test results but her blood culture was negative and ultrasound had confirmed abscess in left arm. Treatment includes surgery and IV antibiotics. This is patient account of events, pharmacy personnel has not verified with physician, 911 report.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain, Pyrexia, Streptococcal infection
Clinical narrative: Patient called pharmacy at approximately 2 pm on 12/9/12 to report the following events: 11/28/12: Received flu shot at approximately 8:40pm and per pharmacist instructions she remained in store 15-20 minutes after vaccination, due to unspecified adverse rxn to flu shot 20 years ago. She was fine when she left the store, upon arriving home she was experiencing an "anaphylactic reaction". Symptoms: SOB and her throat was closing. She self-administered injectable diphenhydramine in her right arm and called 911. Paramedics administered oxygen and she refused transport to hospital. She says her arm was red and swollen at this time. I spoke with pharmacist on 12/10/12 that administered flu shot, he recalls that patient called pharmacy after she returned home to report red/swollen arm. He confirmed that she did not have SOB and suggested she take a BENADRYL and explained this is common. She did not mention 911 call. Patient did not report this phone call to me. Her arm got progressively worse and on 12/8/12 she sought treatment at immediate care clinic because the pain was so severe, there were red streaks on her arm, she had a high fever plus she was experiencing chest pains. On 12/9/12 she was admitted to hospital with strep infection in arm. 12/10/12: patient called to report that she was still awaiting test results but her blood culture was negative and ultrasound had confirmed abscess in left arm. Treatment includes surgery and IV antibiotics. This is patient account of events, pharmacy personnel has not verified with physician, 911 report.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Surgery, Throat tightness, Ultrasound scan abnormal
Clinical narrative: Patient called pharmacy at approximately 2 pm on 12/9/12 to report the following events: 11/28/12: Received flu shot at approximately 8:40pm and per pharmacist instructions she remained in store 15-20 minutes after vaccination, due to unspecified adverse rxn to flu shot 20 years ago. She was fine when she left the store, upon arriving home she was experiencing an "anaphylactic reaction". Symptoms: SOB and her throat was closing. She self-administered injectable diphenhydramine in her right arm and called 911. Paramedics administered oxygen and she refused transport to hospital. She says her arm was red and swollen at this time. I spoke with pharmacist on 12/10/12 that administered flu shot, he recalls that patient called pharmacy after she returned home to report red/swollen arm. He confirmed that she did not have SOB and suggested she take a BENADRYL and explained this is common. She did not mention 911 call. Patient did not report this phone call to me. Her arm got progressively worse and on 12/8/12 she sought treatment at immediate care clinic because the pain was so severe, there were red streaks on her arm, she had a high fever plus she was experiencing chest pains. On 12/9/12 she was admitted to hospital with strep infection in arm. 12/10/12: patient called to report that she was still awaiting test results but her blood culture was negative and ultrasound had confirmed abscess in left arm. Treatment includes surgery and IV antibiotics. This is patient account of events, pharmacy personnel has not verified with physician, 911 report.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Swelling at site of injection 1 day after it was given - fever-felt tired.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Admin at 4:45pm, pt was taken to ER at 7pm. Reported of shortness of breath, dizziness, increase in heart rate.
Age: 31.0
Sex: M
Vaccine: FLU3, MNQ, TYP, YF
Symptoms: Injection site swelling, Throat irritation, Urticaria
Clinical narrative: Itchy throat, hives, swollen injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pain, Productive cough, Pyrexia
Clinical narrative: Patient developed severe body aches, chills/rigors and fever of 101.7F, wet productive cough. Treated with ibuprofen 400mg Q4h, acetaminophen 1000mg q6h. Patient showed subjective improvement after 7.5 hours.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood culture, CSF culture, Cellulitis, Gram stain negative, Incisional drainage
Clinical narrative: The patient (pt) had pain, redness and swelling over injection site. Pt developed fever over the following 24 hrs. She was admitted to the hospital for cellulitis. She was place on IV antibiotics. The pain and swelling increased with persistent fever. She had a surgical consult due to a MRI of her arm showing a fluid collection in the muscle with substantial edema. The patient had an incision and drainage in the operating room which showed purulent fluid (suspicious for infection)without abscess. There was no sign of necrotizing fasciitis or necrosis of the muscle. Pt is recovering in the hospital on IV antibiotics.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling, Muscle oedema
Clinical narrative: The patient (pt) had pain, redness and swelling over injection site. Pt developed fever over the following 24 hrs. She was admitted to the hospital for cellulitis. She was place on IV antibiotics. The pain and swelling increased with persistent fever. She had a surgical consult due to a MRI of her arm showing a fluid collection in the muscle with substantial edema. The patient had an incision and drainage in the operating room which showed purulent fluid (suspicious for infection)without abscess. There was no sign of necrotizing fasciitis or necrosis of the muscle. Pt is recovering in the hospital on IV antibiotics.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Purulent discharge, Pyrexia, White blood cell count increased
Clinical narrative: The patient (pt) had pain, redness and swelling over injection site. Pt developed fever over the following 24 hrs. She was admitted to the hospital for cellulitis. She was place on IV antibiotics. The pain and swelling increased with persistent fever. She had a surgical consult due to a MRI of her arm showing a fluid collection in the muscle with substantial edema. The patient had an incision and drainage in the operating room which showed purulent fluid (suspicious for infection)without abscess. There was no sign of necrotizing fasciitis or necrosis of the muscle. Pt is recovering in the hospital on IV antibiotics.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Compartment syndrome, Injection site erythema, Injection site pain, Injection site streaking, Laboratory test
Clinical narrative: The patient (pt) had pain, redness and swelling over injection site. Pt developed fever over the following 24 hrs. She was admitted to the hospital for cellulitis. She was place on IV antibiotics. The pain and swelling increased with persistent fever. She had a surgical consult due to a MRI of her arm showing a fluid collection in the muscle with substantial edema. The patient had an incision and drainage in the operating room which showed purulent fluid (suspicious for infection)without abscess. There was no sign of necrotizing fasciitis or necrosis of the muscle. Pt is recovering in the hospital on IV antibiotics.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Surgery
Clinical narrative: The patient (pt) had pain, redness and swelling over injection site. Pt developed fever over the following 24 hrs. She was admitted to the hospital for cellulitis. She was place on IV antibiotics. The pain and swelling increased with persistent fever. She had a surgical consult due to a MRI of her arm showing a fluid collection in the muscle with substantial edema. The patient had an incision and drainage in the operating room which showed purulent fluid (suspicious for infection)without abscess. There was no sign of necrotizing fasciitis or necrosis of the muscle. Pt is recovering in the hospital on IV antibiotics.