chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practitioner nurse referring to ten unspecified patients of unknown age and gender. Since 17-JUN-2015, the patients were each administered an improperly stored dose of PEDVAXHIB (dose, strength and frequency were not reported, lot # K026533, expiry date: 07-AUG-2017). All the patients received improperly stored doses from the same lot of PEDVAXHIB. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age. On an unknown date in between 02-JUL-2015 and 04-AUG-2015, the unspecified number of patients were vaccinated with improperly stored ROTATEQ (lot# K013410, expiry date: 27-FEB-2016 and lot # K015841, expiry date: 01-MAY-2016). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Cheilitis, Herpes simplex, Musculoskeletal pain, Pain in extremity, Skin lesion
Clinical narrative: Initial report received from a consumer on 20 June 2012. A 70-year-old male patient, who had had several allergies like molds and no illness at the time of vaccination and concomitant medications, had received dose of ADACEL vaccine on 15 Feb 2012 (lot number: unknown, route and site of vaccination were not reported). It was reported that 5 weeks after vaccination the patient experienced "neurological feelings" of upper left leg from left buttock to just above the knee, which extended to lower leg. It was reported that patient had soreness and pain at area, also reported that he had same feelings at left shoulder. Then had break out of sores from buttocks down leg and now had sore on lower lip. The patient cleaned the sores with white iodine and HIBICLENS, as the sores were cleaned by the patient the HCP didn't know what exactly those were. As of 20 June 2012, the outcome was reported as not recovered. Documents held by sender: none. Follow-up information was received on 24 September 2012. The lot number for ADACEL was reported as: U4308BA. It was reported that the patient did not receive any vaccine prior to Tdap vaccine. Follow-up information was received from a healthcare professional on 16 November 2012: It was reported that the patient visited the office 3 months post ADACEL injection and prior to that visit, there was no information regarding any symptoms or reactions with vaccine. The patient received ADACEL vaccine in lower right hand corner. Laboratory investigations: An exam on 15 May 2012 demonstrated healing lesion on Buttock consistent with HSV and Staph. No other abnormal findings were noted.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Skin ulcer, Staphylococcal infection
Clinical narrative: Initial report received from a consumer on 20 June 2012. A 70-year-old male patient, who had had several allergies like molds and no illness at the time of vaccination and concomitant medications, had received dose of ADACEL vaccine on 15 Feb 2012 (lot number: unknown, route and site of vaccination were not reported). It was reported that 5 weeks after vaccination the patient experienced "neurological feelings" of upper left leg from left buttock to just above the knee, which extended to lower leg. It was reported that patient had soreness and pain at area, also reported that he had same feelings at left shoulder. Then had break out of sores from buttocks down leg and now had sore on lower lip. The patient cleaned the sores with white iodine and HIBICLENS, as the sores were cleaned by the patient the HCP didn't know what exactly those were. As of 20 June 2012, the outcome was reported as not recovered. Documents held by sender: none. Follow-up information was received on 24 September 2012. The lot number for ADACEL was reported as: U4308BA. It was reported that the patient did not receive any vaccine prior to Tdap vaccine. Follow-up information was received from a healthcare professional on 16 November 2012: It was reported that the patient visited the office 3 months post ADACEL injection and prior to that visit, there was no information regarding any symptoms or reactions with vaccine. The patient received ADACEL vaccine in lower right hand corner. Laboratory investigations: An exam on 15 May 2012 demonstrated healing lesion on Buttock consistent with HSV and Staph. No other abnormal findings were noted.
Sex: M
Vaccine: TDAP
Symptoms: Axillary mass, Axillary pain, Oedema peripheral
Clinical narrative: A male patient (age not specified; the patient receives cortisone shot every few months, had received an intramuscular dose of ADACEL vaccine (batch number: C4136BA, Site of vaccination not reported) on 04 May 2012. On 07 May 2012, the patient developed lump in the armpit which became sore and swollen. The patient was evaluated by his own PCP and orthopedic, however no diagnosis was reported. Corrective medications were not reported. The outcome of the event was reported as unknown at the time of report. List of documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Abnormal behaviour, Aplastic anaemia, Asthenia, Cardiac function test normal, Chest pain
Clinical narrative: This medically confirmed report (initial receipt 27-Jul-2015) concerns a 43 year old male patient who had a medical history of allergy to plants (poison oak) and sumac. The patient had a history of first vaccinations with MMR, IMOVAX and VARIVAX on unspecified dates. Between the 29-May-2012 and 30-Jul-2012, the patient received the influenza vaccine (manufacturer and batch number not reported). During this period, the patient also received MENACTRA (batch number not reported), pneumococcal vaccine (manufacturer and batch number not reported), IPOL (batch number not reported), ADACEL (batch number not reported) and PPD skin test. On the 12-Jul-2012, the patient received his second dose of IXIARO (batch number JEV1IOM73E (most likely JEV10M73E) via the subcutaneous route in his left arm. The date of the first dose was not reported. On the same day, the patient also received a second dose of MMRII (batch number not reported) via the subcutaneous route in his right arm, IMOVAX (batch number not reported) via the intramuscular route in his left arm and VARIVAX (batch number not reported) via the subcutaneous route in the left arm. Early Oct-2012 or 01-Oct-2012, the patient started to feel lethargic. He was sleeping more and had less energy and felt like he had a sinus cold. By the 02-Nov-2012, the patient reported to feel more tired. Starting on the 09-Nov-2012, a change in behaviour was noted; he was less energetic, less enthusiastic, weak, acted depressed, kept quiet and to himself. The symptoms worsened. On the 01-Dec-2012, during a family meal, the patient interacted little with his family, was quiet and tired. While walking to his car, he had to stop three times to catch his breath, was breathing very heavily and was unable to catch his breath and was very weak and his chest hurt. The initial emergency room treatment was for a heart attack which was however excluded. Blood tests revealed a decrease in haemoglobin (5.1), upon which he received blood transfusions. The white blood cell count was decreased (08.), as well as a platelet count of 6. Based on these results, the patient was diagnosed with severe aplastic anaemia. Outcome was reported as not recovered. Reporter comments: The events were assessed as serious as they were life-threatening. The reporter (drug company) assessed the suspect drugs to be IXIARO, IMOVAX, VARIVAX and MMRII and also reported the event 'Incorrect route of drug administration' in regards to their suspect drugs. The Drug Company reported the events as not related to IXIARO and not applicable to IMOVAX, VARIVAX and MMRII. The health care practitioner or VAERS assessed the events as possible in relation to IXIARO, IMOVAX, MMRII and VARIVAX.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Depressed mood, Dyspnoea, Fatigue, Haemoglobin decreased, Hypersomnia
Clinical narrative: This medically confirmed report (initial receipt 27-Jul-2015) concerns a 43 year old male patient who had a medical history of allergy to plants (poison oak) and sumac. The patient had a history of first vaccinations with MMR, IMOVAX and VARIVAX on unspecified dates. Between the 29-May-2012 and 30-Jul-2012, the patient received the influenza vaccine (manufacturer and batch number not reported). During this period, the patient also received MENACTRA (batch number not reported), pneumococcal vaccine (manufacturer and batch number not reported), IPOL (batch number not reported), ADACEL (batch number not reported) and PPD skin test. On the 12-Jul-2012, the patient received his second dose of IXIARO (batch number JEV1IOM73E (most likely JEV10M73E) via the subcutaneous route in his left arm. The date of the first dose was not reported. On the same day, the patient also received a second dose of MMRII (batch number not reported) via the subcutaneous route in his right arm, IMOVAX (batch number not reported) via the intramuscular route in his left arm and VARIVAX (batch number not reported) via the subcutaneous route in the left arm. Early Oct-2012 or 01-Oct-2012, the patient started to feel lethargic. He was sleeping more and had less energy and felt like he had a sinus cold. By the 02-Nov-2012, the patient reported to feel more tired. Starting on the 09-Nov-2012, a change in behaviour was noted; he was less energetic, less enthusiastic, weak, acted depressed, kept quiet and to himself. The symptoms worsened. On the 01-Dec-2012, during a family meal, the patient interacted little with his family, was quiet and tired. While walking to his car, he had to stop three times to catch his breath, was breathing very heavily and was unable to catch his breath and was very weak and his chest hurt. The initial emergency room treatment was for a heart attack which was however excluded. Blood tests revealed a decrease in haemoglobin (5.1), upon which he received blood transfusions. The white blood cell count was decreased (08.), as well as a platelet count of 6. Based on these results, the patient was diagnosed with severe aplastic anaemia. Outcome was reported as not recovered. Reporter comments: The events were assessed as serious as they were life-threatening. The reporter (drug company) assessed the suspect drugs to be IXIARO, IMOVAX, VARIVAX and MMRII and also reported the event 'Incorrect route of drug administration' in regards to their suspect drugs. The Drug Company reported the events as not related to IXIARO and not applicable to IMOVAX, VARIVAX and MMRII. The health care practitioner or VAERS assessed the events as possible in relation to IXIARO, IMOVAX, MMRII and VARIVAX.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Hyperventilation, Lethargy, Myocardial infarction, Nasopharyngitis, Packed red blood cell transfusion
Clinical narrative: This medically confirmed report (initial receipt 27-Jul-2015) concerns a 43 year old male patient who had a medical history of allergy to plants (poison oak) and sumac. The patient had a history of first vaccinations with MMR, IMOVAX and VARIVAX on unspecified dates. Between the 29-May-2012 and 30-Jul-2012, the patient received the influenza vaccine (manufacturer and batch number not reported). During this period, the patient also received MENACTRA (batch number not reported), pneumococcal vaccine (manufacturer and batch number not reported), IPOL (batch number not reported), ADACEL (batch number not reported) and PPD skin test. On the 12-Jul-2012, the patient received his second dose of IXIARO (batch number JEV1IOM73E (most likely JEV10M73E) via the subcutaneous route in his left arm. The date of the first dose was not reported. On the same day, the patient also received a second dose of MMRII (batch number not reported) via the subcutaneous route in his right arm, IMOVAX (batch number not reported) via the intramuscular route in his left arm and VARIVAX (batch number not reported) via the subcutaneous route in the left arm. Early Oct-2012 or 01-Oct-2012, the patient started to feel lethargic. He was sleeping more and had less energy and felt like he had a sinus cold. By the 02-Nov-2012, the patient reported to feel more tired. Starting on the 09-Nov-2012, a change in behaviour was noted; he was less energetic, less enthusiastic, weak, acted depressed, kept quiet and to himself. The symptoms worsened. On the 01-Dec-2012, during a family meal, the patient interacted little with his family, was quiet and tired. While walking to his car, he had to stop three times to catch his breath, was breathing very heavily and was unable to catch his breath and was very weak and his chest hurt. The initial emergency room treatment was for a heart attack which was however excluded. Blood tests revealed a decrease in haemoglobin (5.1), upon which he received blood transfusions. The white blood cell count was decreased (08.), as well as a platelet count of 6. Based on these results, the patient was diagnosed with severe aplastic anaemia. Outcome was reported as not recovered. Reporter comments: The events were assessed as serious as they were life-threatening. The reporter (drug company) assessed the suspect drugs to be IXIARO, IMOVAX, VARIVAX and MMRII and also reported the event 'Incorrect route of drug administration' in regards to their suspect drugs. The Drug Company reported the events as not related to IXIARO and not applicable to IMOVAX, VARIVAX and MMRII. The health care practitioner or VAERS assessed the events as possible in relation to IXIARO, IMOVAX, MMRII and VARIVAX.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Platelet count decreased, Transfusion, White blood cell count decreased
Clinical narrative: This medically confirmed report (initial receipt 27-Jul-2015) concerns a 43 year old male patient who had a medical history of allergy to plants (poison oak) and sumac. The patient had a history of first vaccinations with MMR, IMOVAX and VARIVAX on unspecified dates. Between the 29-May-2012 and 30-Jul-2012, the patient received the influenza vaccine (manufacturer and batch number not reported). During this period, the patient also received MENACTRA (batch number not reported), pneumococcal vaccine (manufacturer and batch number not reported), IPOL (batch number not reported), ADACEL (batch number not reported) and PPD skin test. On the 12-Jul-2012, the patient received his second dose of IXIARO (batch number JEV1IOM73E (most likely JEV10M73E) via the subcutaneous route in his left arm. The date of the first dose was not reported. On the same day, the patient also received a second dose of MMRII (batch number not reported) via the subcutaneous route in his right arm, IMOVAX (batch number not reported) via the intramuscular route in his left arm and VARIVAX (batch number not reported) via the subcutaneous route in the left arm. Early Oct-2012 or 01-Oct-2012, the patient started to feel lethargic. He was sleeping more and had less energy and felt like he had a sinus cold. By the 02-Nov-2012, the patient reported to feel more tired. Starting on the 09-Nov-2012, a change in behaviour was noted; he was less energetic, less enthusiastic, weak, acted depressed, kept quiet and to himself. The symptoms worsened. On the 01-Dec-2012, during a family meal, the patient interacted little with his family, was quiet and tired. While walking to his car, he had to stop three times to catch his breath, was breathing very heavily and was unable to catch his breath and was very weak and his chest hurt. The initial emergency room treatment was for a heart attack which was however excluded. Blood tests revealed a decrease in haemoglobin (5.1), upon which he received blood transfusions. The white blood cell count was decreased (08.), as well as a platelet count of 6. Based on these results, the patient was diagnosed with severe aplastic anaemia. Outcome was reported as not recovered. Reporter comments: The events were assessed as serious as they were life-threatening. The reporter (drug company) assessed the suspect drugs to be IXIARO, IMOVAX, VARIVAX and MMRII and also reported the event 'Incorrect route of drug administration' in regards to their suspect drugs. The Drug Company reported the events as not related to IXIARO and not applicable to IMOVAX, VARIVAX and MMRII. The health care practitioner or VAERS assessed the events as possible in relation to IXIARO, IMOVAX, MMRII and VARIVAX.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Depressed mood, Dyspnoea, Fatigue, Haemoglobin decreased, Hyperventilation
Clinical narrative: This medically confirmed report (initial receipt 27-Jul-2015) concerns a 43 year old male patient who had a medical history of allergy to plants (poison oak) and sumac. The patient had a history of first vaccinations with MMR, IMOVAX and VARIVAX on unspecified dates. Between the 29-May-2012 and 30-Jul-2012, the patient received the influenza vaccine (manufacturer and batch number not reported). During this period, the patient also received MENACTRA (batch number not reported), pneumococcal vaccine (manufacturer and batch number not reported), IPOL (batch number not reported), ADACEL (batch number not reported) and PPD skin test. On the 12-Jul-2012, the patient received his second dose of IXIARO (batch number JEV1IOM73E (most likely JEV10M73E) via the subcutaneous route in his left arm. The date of the first dose was not reported. On the same day, the patient also received a second dose of MMRII (batch number not reported) via the subcutaneous route in his right arm, IMOVAX (batch number not reported) via the intramuscular route in his left arm and VARIVAX (batch number not reported) via the subcutaneous route in the left arm. Early Oct-2012 or 01-Oct-2012, the patient started to feel lethargic. He was sleeping more and had less energy and felt like he had a sinus cold. By the 02-Nov-2012, the patient reported to feel more tired. Starting on the 09-Nov-2012, a change in behaviour was noted; he was less energetic, less enthusiastic, weak, acted depressed, kept quiet and to himself. The symptoms worsened. On the 01-Dec-2012, during a family meal, the patient interacted little with his family, was quiet and tired. While walking to his car, he had to stop three times to catch his breath, was breathing very heavily and was unable to catch his breath and was very weak and his chest hurt. The initial emergency room treatment was for a heart attack which was however excluded. Blood tests revealed a decrease in haemoglobin (5.1), upon which he received blood transfusions. The white blood cell count was decreased (08.), as well as a platelet count of 6. Based on these results, the patient was diagnosed with severe aplastic anaemia. Outcome was reported as not recovered. Reporter comments: The events were assessed as serious as they were life-threatening. The reporter (drug company) assessed the suspect drugs to be IXIARO, IMOVAX, VARIVAX and MMRII and also reported the event 'Incorrect route of drug administration' in regards to their suspect drugs. The Drug Company reported the events as not related to IXIARO and not applicable to IMOVAX, VARIVAX and MMRII. The health care practitioner or VAERS assessed the events as possible in relation to IXIARO, IMOVAX, MMRII and VARIVAX.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Lethargy, Nasopharyngitis, Platelet count decreased, Somnolence, Transfusion
Clinical narrative: This medically confirmed report (initial receipt 27-Jul-2015) concerns a 43 year old male patient who had a medical history of allergy to plants (poison oak) and sumac. The patient had a history of first vaccinations with MMR, IMOVAX and VARIVAX on unspecified dates. Between the 29-May-2012 and 30-Jul-2012, the patient received the influenza vaccine (manufacturer and batch number not reported). During this period, the patient also received MENACTRA (batch number not reported), pneumococcal vaccine (manufacturer and batch number not reported), IPOL (batch number not reported), ADACEL (batch number not reported) and PPD skin test. On the 12-Jul-2012, the patient received his second dose of IXIARO (batch number JEV1IOM73E (most likely JEV10M73E) via the subcutaneous route in his left arm. The date of the first dose was not reported. On the same day, the patient also received a second dose of MMRII (batch number not reported) via the subcutaneous route in his right arm, IMOVAX (batch number not reported) via the intramuscular route in his left arm and VARIVAX (batch number not reported) via the subcutaneous route in the left arm. Early Oct-2012 or 01-Oct-2012, the patient started to feel lethargic. He was sleeping more and had less energy and felt like he had a sinus cold. By the 02-Nov-2012, the patient reported to feel more tired. Starting on the 09-Nov-2012, a change in behaviour was noted; he was less energetic, less enthusiastic, weak, acted depressed, kept quiet and to himself. The symptoms worsened. On the 01-Dec-2012, during a family meal, the patient interacted little with his family, was quiet and tired. While walking to his car, he had to stop three times to catch his breath, was breathing very heavily and was unable to catch his breath and was very weak and his chest hurt. The initial emergency room treatment was for a heart attack which was however excluded. Blood tests revealed a decrease in haemoglobin (5.1), upon which he received blood transfusions. The white blood cell count was decreased (08.), as well as a platelet count of 6. Based on these results, the patient was diagnosed with severe aplastic anaemia. Outcome was reported as not recovered. Reporter comments: The events were assessed as serious as they were life-threatening. The reporter (drug company) assessed the suspect drugs to be IXIARO, IMOVAX, VARIVAX and MMRII and also reported the event 'Incorrect route of drug administration' in regards to their suspect drugs. The Drug Company reported the events as not related to IXIARO and not applicable to IMOVAX, VARIVAX and MMRII. The health care practitioner or VAERS assessed the events as possible in relation to IXIARO, IMOVAX, MMRII and VARIVAX.
Age: 43.0
Sex: M
Vaccine: JEV1, MMR, RAB, VARCEL, JEV1, MMR, RAB, VARCEL
Symptoms: Tuberculin test, White blood cell count decreased
Clinical narrative: This medically confirmed report (initial receipt 27-Jul-2015) concerns a 43 year old male patient who had a medical history of allergy to plants (poison oak) and sumac. The patient had a history of first vaccinations with MMR, IMOVAX and VARIVAX on unspecified dates. Between the 29-May-2012 and 30-Jul-2012, the patient received the influenza vaccine (manufacturer and batch number not reported). During this period, the patient also received MENACTRA (batch number not reported), pneumococcal vaccine (manufacturer and batch number not reported), IPOL (batch number not reported), ADACEL (batch number not reported) and PPD skin test. On the 12-Jul-2012, the patient received his second dose of IXIARO (batch number JEV1IOM73E (most likely JEV10M73E) via the subcutaneous route in his left arm. The date of the first dose was not reported. On the same day, the patient also received a second dose of MMRII (batch number not reported) via the subcutaneous route in his right arm, IMOVAX (batch number not reported) via the intramuscular route in his left arm and VARIVAX (batch number not reported) via the subcutaneous route in the left arm. Early Oct-2012 or 01-Oct-2012, the patient started to feel lethargic. He was sleeping more and had less energy and felt like he had a sinus cold. By the 02-Nov-2012, the patient reported to feel more tired. Starting on the 09-Nov-2012, a change in behaviour was noted; he was less energetic, less enthusiastic, weak, acted depressed, kept quiet and to himself. The symptoms worsened. On the 01-Dec-2012, during a family meal, the patient interacted little with his family, was quiet and tired. While walking to his car, he had to stop three times to catch his breath, was breathing very heavily and was unable to catch his breath and was very weak and his chest hurt. The initial emergency room treatment was for a heart attack which was however excluded. Blood tests revealed a decrease in haemoglobin (5.1), upon which he received blood transfusions. The white blood cell count was decreased (08.), as well as a platelet count of 6. Based on these results, the patient was diagnosed with severe aplastic anaemia. Outcome was reported as not recovered. Reporter comments: The events were assessed as serious as they were life-threatening. The reporter (drug company) assessed the suspect drugs to be IXIARO, IMOVAX, VARIVAX and MMRII and also reported the event 'Incorrect route of drug administration' in regards to their suspect drugs. The Drug Company reported the events as not related to IXIARO and not applicable to IMOVAX, VARIVAX and MMRII. The health care practitioner or VAERS assessed the events as possible in relation to IXIARO, IMOVAX, MMRII and VARIVAX.
Sex: U
Vaccine: HEPA, HPV9, HEPA
Symptoms: Asthenia, Eye movement disorder, Fall, Tremor
Clinical narrative: Information has been received from the health professional referring to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unknown dates, these patients were vaccinated with improperly stored VAQTA (lot # K019560, expiry date: 02-JUN-2017; lot # L009445, expiry date: 01-JUN-2017). Concomitant medications were not reported. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV9, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the health professional referring to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unknown dates, these patients were vaccinated with improperly stored VAQTA (lot # K019560, expiry date: 02-JUN-2017; lot # L009445, expiry date: 01-JUN-2017). Concomitant medications were not reported. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: C-reactive protein increased, Groin pain, Injection site reaction, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: On 6/24/15 vaccine given, on 6/30/15 pain shoulders, legs, couldn't sleep, walk, turn. 7/2/15 Dr. told to take ALEVE and put Arnica Gel no improvement on 7/13/15 had to Dr. she had Sed and other lab work results off the chart. Recommended to Rheumatology, started prednisone 15 mg increase to 20 mg. On 7/30 ran test again normal but still need medication.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Vaccination site pain
Clinical narrative: On 6/24/15 vaccine given, on 6/30/15 pain shoulders, legs, couldn't sleep, walk, turn. 7/2/15 Dr. told to take ALEVE and put Arnica Gel no improvement on 7/13/15 had to Dr. she had Sed and other lab work results off the chart. Recommended to Rheumatology, started prednisone 15 mg increase to 20 mg. On 7/30 ran test again normal but still need medication.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Abasia, C-reactive protein increased, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: On 6/24/15 vaccine given, on 6/30/15 pain shoulders, legs, couldn't sleep, walk, turn. 7/2/15 Dr. told to take ALEVE and put Arnica Gel no improvement on 7/13/15 had to Dr. she had Sed and other lab work results off the chart. Recommended to Rheumatology, started prednisone 15 mg increase to 20 mg. On 7/30 ran test again normal but still need medication.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: On 6/24/15 vaccine given, on 6/30/15 pain shoulders, legs, couldn't sleep, walk, turn. 7/2/15 Dr. told to take ALEVE and put Arnica Gel no improvement on 7/13/15 had to Dr. she had Sed and other lab work results off the chart. Recommended to Rheumatology, started prednisone 15 mg increase to 20 mg. On 7/30 ran test again normal but still need medication.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Blood test, Malaise, Myalgia, Pain in extremity
Clinical narrative: On 6/24/15 vaccine given, on 6/30/15 pain shoulders, legs, couldn't sleep, walk, turn. 7/2/15 Dr. told to take ALEVE and put Arnica Gel no improvement on 7/13/15 had to Dr. she had Sed and other lab work results off the chart. Recommended to Rheumatology, started prednisone 15 mg increase to 20 mg. On 7/30 ran test again normal but still need medication.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding a female patient of unknown age. Medical history and concurrent conditions were not reported. On 02-JUL-2015, the patient received improperly stored VARIVAX (Merck) (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: TTOX, TTOX, VARZOS
Symptoms: Burning sensation, Headache, Nausea, Pain, Paraesthesia
Clinical narrative: Skin eruptions, body pain and headaches booming, itching, tingling, swelling tissue (arms).
Age: 64.0
Sex: F
Vaccine: TTOX, TTOX, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Skin eruptions, body pain and headaches booming, itching, tingling, swelling tissue (arms).
Age: 64.0
Sex: F
Vaccine: TTOX, TTOX, VARZOS
Symptoms: Headache, Herpes zoster, Neuralgia, Pain, Paraesthesia
Clinical narrative: Skin eruptions, body pain and headaches booming, itching, tingling, swelling tissue (arms).
Age: 64.0
Sex: F
Vaccine: TTOX, TTOX, VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Skin eruptions, body pain and headaches booming, itching, tingling, swelling tissue (arms).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 61 year old female patient with hypertension, hypercholesterolaemia, depression and allergy to iodinated contrast dye. On 31-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (Lot # K024031; expiration date: 20-FEB-2016) (dose and route not provided). The patient's concomitant therapy was not provided. On 02-AUG-2015, the patient developed a rash on her face and neck. The patient also developed a blister on her head. The patient was evaluated, on 02-AUG-2015, at a local walk-in clinic. She was administered an unspecified steroid injection and was prescribed acyclovir (manufacturer unknown). There were no laboratory tests or diagnostic studies performed. At the tine of the report, the patient was recovering. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 61 year old female patient with hypertension, hypercholesterolaemia, depression and allergy to iodinated contrast dye. On 31-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (Lot # K024031; expiration date: 20-FEB-2016) (dose and route not provided). The patient's concomitant therapy was not provided. On 02-AUG-2015, the patient developed a rash on her face and neck. The patient also developed a blister on her head. The patient was evaluated, on 02-AUG-2015, at a local walk-in clinic. She was administered an unspecified steroid injection and was prescribed acyclovir (manufacturer unknown). There were no laboratory tests or diagnostic studies performed. At the tine of the report, the patient was recovering. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood bicarbonate, Blood calcium, Blood creatine, Blood glucose, Blood urea
Clinical narrative: Seizure w/in 30 seconds on GARDASIL vaccine (2nd dose).
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count, Metabolic function test, Platelet count, Seizure, White blood cell count
Clinical narrative: Seizure w/in 30 seconds on GARDASIL vaccine (2nd dose).
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Seizure
Clinical narrative: Seizure w/in 30 seconds on GARDASIL vaccine (2nd dose).
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Colonoscopy abnormal, Diarrhoea, Endoscopy abnormal, Haematochezia, Inflammatory bowel disease
Clinical narrative: Vomiting, diarrhea over the course of a few hours, then significant blood loss in bowel movements over the next week.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting, diarrhea over the course of a few hours, then significant blood loss in bowel movements over the next week.
Age: 24.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Redness, itchy and welt at injection site.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Skin discolouration
Clinical narrative: Right bicep and shoulder had severe swelling accompanied by severe pain and discoloration of right hand. His bicep swelled almost as large as my thigh. Went to emergency room around 4:30 PM, advised to apply ice every 20 minutes and was given Naproxen by emergency room doctor.
Age: 0.42
Sex: M
Vaccine: PPV
Symptoms: Eyelid oedema
Clinical narrative: He woke up with swollen eyelids.
Sex: U
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date approximately in 2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date approximately in 2009, the patient experienced an unspecified anaphylactic reaction. The outcome of the event was not reported. The relatedness between the event and the ZOSTAVAX was not reported. The event of anaphylactic reaction was considered as life threatening by the reporter. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event; patient was administered vaccine 9 days too early than the indicated due date.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Injection site reaction, Varicella post vaccine, Wound
Clinical narrative: BLISTER, DX AS LOCALIZED VARICELLA REACTION BY PA-C. BACTROBAN USED TOPICALLY TO SITE D/T PATIENT OPENED AREA.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Laceration, Syncope
Clinical narrative: Syncope event resulting in laceration to head.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Fall, Haemorrhage, Laceration, Syncope
Clinical narrative: Syncope event resulting in laceration to head.
Age: 0.62
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: 8/7/15-Given 3rd dose of ROTATEQ, admit to hospital on 8/11/15 for intussusception.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Pyrexia, Rash generalised
Clinical narrative: This is a spontaneous report obtained from a non-contactable nurse through a Pfizer sales representative. A 85 year-old male patient received, on an unspecified date, in Jul2015, PREVNAR 13 single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Jul2015, the patient experienced rash all over his body, fever, and cellulitis. Clinical outcome of the events was unknown and causality was not available at time of this report.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Nausea, Syncope
Clinical narrative: Initial unsolicited report received from a nurse on 31 July 2015. A 16-year-old female patient had received a dose of MENACTRA (batch number: U5026CA, expiry date: 24 August 2016, dose, dose in series and site of administration were not reported) intramuscularly on 22 July 2015. Patient's illness at time of vaccination reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. Patient was nervous about receiving vaccination. On 22 July 2015, after having it administered (few seconds after vaccination), she began to feel nauseous and dizzy, but did not tell anyone. She went into the waiting room, slumped in her chair and she fainted. Her loss of consciousness was less than one minute long. She recovered, felt better and went home with her parent. Laboratory investigations were reported as none. Corrective treatments were not reported. On 22 July 2015, the patient recovered from all the events. Upon medical review, the case was considered as serious due to important medical event: loss of consciousness. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Feeling dizzy & started passing out.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Chills, Dizziness, Electrocardiogram, Erythema
Clinical narrative: Vaccination administered at approximately 10:30 a.m. on Thursday, May 28, 2015. Immediately following the vaccination my arm felt like I had been stung. 7:30 p.m. started to get chills/shivers. 9:45 p.m. went to bed. Throughout the night I had dizziness, fever, fast heart rate. May 29, 2015 In the morning, contacted physician. Other events during the afternoon were continued dizziness, projectile vomiting, a very enlarged lymph node on the left side of my neck and passing out. Other events were that my arm, which had been swollen and very painful a few hours after the vaccination, was now brilliant red, swollen, and very hot. Went to The walk-in clinic. I passed out at the clinic. My blood pressure was very low. The doctor referred me to go immediately to the Emergency Room at Medical Center. I was admitted to hospital. The hospitalist diagnosed me with a severe reaction to the PCV 13 and cellulitis. I was prescribed Cephalexin 500 mg three times a day. I was discharged from hospital May 30th. I suffered some dizzy spells for five weeks. Had I been given the information sheet before the vaccination was administered, I would not have had this vaccination. (See #19 on form).
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Heart rate increased, Hypotension, Immediate post-injection reaction, Laboratory test, Loss of consciousness
Clinical narrative: Vaccination administered at approximately 10:30 a.m. on Thursday, May 28, 2015. Immediately following the vaccination my arm felt like I had been stung. 7:30 p.m. started to get chills/shivers. 9:45 p.m. went to bed. Throughout the night I had dizziness, fever, fast heart rate. May 29, 2015 In the morning, contacted physician. Other events during the afternoon were continued dizziness, projectile vomiting, a very enlarged lymph node on the left side of my neck and passing out. Other events were that my arm, which had been swollen and very painful a few hours after the vaccination, was now brilliant red, swollen, and very hot. Went to The walk-in clinic. I passed out at the clinic. My blood pressure was very low. The doctor referred me to go immediately to the Emergency Room at Medical Center. I was admitted to hospital. The hospitalist diagnosed me with a severe reaction to the PCV 13 and cellulitis. I was prescribed Cephalexin 500 mg three times a day. I was discharged from hospital May 30th. I suffered some dizzy spells for five weeks. Had I been given the information sheet before the vaccination was administered, I would not have had this vaccination. (See #19 on form).
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Vaccination administered at approximately 10:30 a.m. on Thursday, May 28, 2015. Immediately following the vaccination my arm felt like I had been stung. 7:30 p.m. started to get chills/shivers. 9:45 p.m. went to bed. Throughout the night I had dizziness, fever, fast heart rate. May 29, 2015 In the morning, contacted physician. Other events during the afternoon were continued dizziness, projectile vomiting, a very enlarged lymph node on the left side of my neck and passing out. Other events were that my arm, which had been swollen and very painful a few hours after the vaccination, was now brilliant red, swollen, and very hot. Went to The walk-in clinic. I passed out at the clinic. My blood pressure was very low. The doctor referred me to go immediately to the Emergency Room at Medical Center. I was admitted to hospital. The hospitalist diagnosed me with a severe reaction to the PCV 13 and cellulitis. I was prescribed Cephalexin 500 mg three times a day. I was discharged from hospital May 30th. I suffered some dizzy spells for five weeks. Had I been given the information sheet before the vaccination was administered, I would not have had this vaccination. (See #19 on form).
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Vaccination complication, Vomiting projectile, X-ray
Clinical narrative: Vaccination administered at approximately 10:30 a.m. on Thursday, May 28, 2015. Immediately following the vaccination my arm felt like I had been stung. 7:30 p.m. started to get chills/shivers. 9:45 p.m. went to bed. Throughout the night I had dizziness, fever, fast heart rate. May 29, 2015 In the morning, contacted physician. Other events during the afternoon were continued dizziness, projectile vomiting, a very enlarged lymph node on the left side of my neck and passing out. Other events were that my arm, which had been swollen and very painful a few hours after the vaccination, was now brilliant red, swollen, and very hot. Went to The walk-in clinic. I passed out at the clinic. My blood pressure was very low. The doctor referred me to go immediately to the Emergency Room at Medical Center. I was admitted to hospital. The hospitalist diagnosed me with a severe reaction to the PCV 13 and cellulitis. I was prescribed Cephalexin 500 mg three times a day. I was discharged from hospital May 30th. I suffered some dizzy spells for five weeks. Had I been given the information sheet before the vaccination was administered, I would not have had this vaccination. (See #19 on form).
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site swelling, Injection site vesicles, Pruritus
Clinical narrative: Pt states she had immediate swelling at site; itching/burning next day, fever & developed 1cm x 0.5 cm bulla at site on 8/9/2015.  Seen in clinic 8/9/15, tx: cephalexin 500mg tid x 7d, Zyrtec 10mg i po qhs x 15d, Triamcinolone 0.1% cream to site bid x 14 days.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt states she had immediate swelling at site; itching/burning next day, fever & developed 1cm x 0.5 cm bulla at site on 8/9/2015.  Seen in clinic 8/9/15, tx: cephalexin 500mg tid x 7d, Zyrtec 10mg i po qhs x 15d, Triamcinolone 0.1% cream to site bid x 14 days.
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Hypoaesthesia, Muscle disorder
Clinical narrative: Patient states 4 days after vaccine, lost feeling in arms. Been having muscle problems since. On HUMIRA and leflunomide.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Guillain-Barre syndrome, Lumbar puncture normal
Clinical narrative: Systemic weakness following PREVNAR. Dx: Guillain-Barre Syndrome.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Allergy test negative, Computerised tomogram normal, Electroencephalogram normal, Epilepsy, Immunology test normal
Clinical narrative: 3/12/14 Received vaccines listed below. 3/15/14 1st seizure lasting approximately 10 min. Dx as febrile. T101. Lump noted to left thigh at injection site. CT labs to follow arrival to ER. +RSV-required nebulizers for tx. This was the first seizure that started what has been 50+ to follow. In the meantime patient has received numerous lab tests MRIs, EEGs, MD appt, medications to rule out and/or treat. Received dx of epilepsy 3/2015.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Injection site mass, Laboratory test normal, Nuclear magnetic resonance imaging normal, Pyrexia, Respiratory syncytial virus test positive
Clinical narrative: 3/12/14 Received vaccines listed below. 3/15/14 1st seizure lasting approximately 10 min. Dx as febrile. T101. Lump noted to left thigh at injection site. CT labs to follow arrival to ER. +RSV-required nebulizers for tx. This was the first seizure that started what has been 50+ to follow. In the meantime patient has received numerous lab tests MRIs, EEGs, MD appt, medications to rule out and/or treat. Received dx of epilepsy 3/2015.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Seizure
Clinical narrative: 3/12/14 Received vaccines listed below. 3/15/14 1st seizure lasting approximately 10 min. Dx as febrile. T101. Lump noted to left thigh at injection site. CT labs to follow arrival to ER. +RSV-required nebulizers for tx. This was the first seizure that started what has been 50+ to follow. In the meantime patient has received numerous lab tests MRIs, EEGs, MD appt, medications to rule out and/or treat. Received dx of epilepsy 3/2015.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, TDAP, VARCEL
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient said she felt faint and then passed out. She was passed out for less than 1 minute. Blood pressure and pulse were taken and were within normal limits. Patient recovered quickly and was taken to her physician by her parents as they wanted her to be checked out.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood test, Dizziness, Electrocardiogram, Electroencephalogram
Clinical narrative: Fainting, dizziness, brain fog, shaking sensation, rapid heartbeat, abdominal pain, headaches.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Headache, Heart rate increased, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: Fainting, dizziness, brain fog, shaking sensation, rapid heartbeat, abdominal pain, headaches.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Ultrasound scan
Clinical narrative: Fainting, dizziness, brain fog, shaking sensation, rapid heartbeat, abdominal pain, headaches.
Sex: F
Vaccine: DTAP, HEP
Symptoms: Cerebral palsy
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Medical history and concurrent conditions of the patient was not reported. On an unknown date approximately in 1988 (reported as "approximately 27 years ago"), the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) injection of strength 10/1.0 microgram/milliliter (MCRG/ML), (lot number, dose, route and site of administration was not reported/possibly manufactured by Merck) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as DTAP). No concomitant medications were reported. On an unknown date, the patient developed cerebral palsy (medically significant). The outcome of cerebral palsy was unknown. The causality assessment was not provided. No further information was provide. No product quality complaint (PQC) was filed. Upon internal review the event of cerebral palsy was determined to be medically significant. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Autism, Developmental delay
Clinical narrative: Developmental delays. Being observed for autism. Signs of autism. 01-24-15 until present.