chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dyspnoea exertional, Fatigue
Clinical narrative: Case number PHHY2013US000440, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 471893) web site on 02 Jan 2013 with a follow up report received from Quality Assurance Department (QA reference number: 209047) on 14 May 2014. This report refers to 58-year-old male patient. His medical history included sulfa allergy and sinus congestion. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1205601, expiry date: Jun 2013) IM into the right arm on 12 Oct 2012. On the 13 Oct 2012, the patient developed weakness, fatigue, dyspnea on exertion, loss of appetite, diarrhea, sinus congestion and headaches. The outcome of the events was recovered. The seriousness and causality assessment was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1205601 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received from QA department on 14 May 2014: Updated batch review report.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Sinus congestion
Clinical narrative: Case number PHHY2013US000440, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 471893) web site on 02 Jan 2013 with a follow up report received from Quality Assurance Department (QA reference number: 209047) on 14 May 2014. This report refers to 58-year-old male patient. His medical history included sulfa allergy and sinus congestion. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1205601, expiry date: Jun 2013) IM into the right arm on 12 Oct 2012. On the 13 Oct 2012, the patient developed weakness, fatigue, dyspnea on exertion, loss of appetite, diarrhea, sinus congestion and headaches. The outcome of the events was recovered. The seriousness and causality assessment was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1205601 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received from QA department on 14 May 2014: Updated batch review report.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Throat irritation
Clinical narrative: Case number PHHY2013US000543 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 472136) on 02 Jan 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 208928) on 14 May 2014. This report refers to a 37-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 122202, Expiry date: 31 May 2013) in right arm on 23 Oct 2012. On 24 Oct 2012, after the vaccination, she experienced scratchy throat, chest tightness and chest pain. She went to the emergency room for the events. The outcome of events was reported as complete recovery as on 29 Oct 2012. The seriousness and causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 122202) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 208928) on 14 May 2014: Updated batch review report.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Paraesthesia
Clinical narrative: Case number PHHY2013US000584, is an initial report from the Vaccine Adverse Event Reporting System (VAERS reference number: 472202) website on 02 Jan 2013 with the following internal review on 16 Jan 2013 of the data received on 02 Jan 2013 and a follow-up information was received from Quality Assurance Department (reference number: 209058) on 14 May 2014. This report refers to 62-year-old female patient. Her medical history was not reported and concomitant medication included Morphine. She was vaccinated with FLUVIRIN (batch number: 1205201, batch number: Jun 2013) intramuscularly in the arm on 26 Oct 2012. About 15-minutes after vaccination, she experienced tingling in face and difficulty swallowing. She was treated with BENADRYL 50 mg and she recovered quickly within 15-minutes. The outcome of the events was reported as completely recovered as of 26 Oct 2012. The causality and seriousness of the events was not reported. Batch review report (reference number: 209058) received from quality assurance department on 14 May 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1205201, expiry date: Jun 2013) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Following internal review on 16 Jan 2013 of data received on 02 Jan 2013: Following significant correction was done, the case upgraded from non-serious to serious (medically significant) for difficulty swallowing. Follow up received from Quality Assurance Department (reference number: 209058) on 14 May 2014: Updated batch review report and expiry date of vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Nasal congestion, Nasopharyngitis, Photopsia, Visual impairment
Clinical narrative: Case number PHHY2013US000698, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 472548) website on 02 Jan 2013 with a follow up report received from the Quality Assurance department (QA reference number: 209038) on 14 May 2014. This report refers to a 65-year-old female patient. Her medical history included allergic to bees and some high blood pressure medicine (HUMIBID, hydrochlorothiazide, ALDOMET, atenolol, lisinopril, codeine, VISTARIL, VANTIN) and metals except gold. Her concomitant medications included DIOVAN, fosinopril sodium and levothyroxine. Her vaccinated history included administration of influenza vaccines for ten years without any problem. She was vaccinated with FLUVIRIN (batch number: 1206201, expiry date: Jun 2013) into left arm on 15 Oct 2012. On 16 Oct 2012, her vision was affected and she was seeing sparks to the left, flashing lights and floaters on left eye. On 17 Oct 2012, after consulting the physician (emergency visit), she was diagnosed with post-vitreous detachment on left eye (optic nerve was fine at this point). On second day after vaccination, she experienced cold symptoms including stuff nose, hoarseness, but no scratchy throat. She took some cough drops (unspecified). The outcome of the events was reported as not recovered. The causality and seriousness of the events were not reported. Based on the review performed, it was concluded that the FLUVIRIN batch: 1206201 was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report received from the Quality Assurance department (QA reference number: 209038) on 14 May 2014: The expiry date of FLUVIRIN, and the batch review report were updated.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vitreous detachment, Vitreous floaters
Clinical narrative: Case number PHHY2013US000698, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 472548) website on 02 Jan 2013 with a follow up report received from the Quality Assurance department (QA reference number: 209038) on 14 May 2014. This report refers to a 65-year-old female patient. Her medical history included allergic to bees and some high blood pressure medicine (HUMIBID, hydrochlorothiazide, ALDOMET, atenolol, lisinopril, codeine, VISTARIL, VANTIN) and metals except gold. Her concomitant medications included DIOVAN, fosinopril sodium and levothyroxine. Her vaccinated history included administration of influenza vaccines for ten years without any problem. She was vaccinated with FLUVIRIN (batch number: 1206201, expiry date: Jun 2013) into left arm on 15 Oct 2012. On 16 Oct 2012, her vision was affected and she was seeing sparks to the left, flashing lights and floaters on left eye. On 17 Oct 2012, after consulting the physician (emergency visit), she was diagnosed with post-vitreous detachment on left eye (optic nerve was fine at this point). On second day after vaccination, she experienced cold symptoms including stuff nose, hoarseness, but no scratchy throat. She took some cough drops (unspecified). The outcome of the events was reported as not recovered. The causality and seriousness of the events were not reported. Based on the review performed, it was concluded that the FLUVIRIN batch: 1206201 was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report received from the Quality Assurance department (QA reference number: 209038) on 14 May 2014: The expiry date of FLUVIRIN, and the batch review report were updated.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Electromyogram, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: Case number PHHY2013US000950, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 472916) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208889) on 14 May 2014. This case refers to a 38-year-old female patient. Her medical history included allergy to mold, dust, pollen and shellfish. Her concomitant medication included MOTRIN and vitamins (unspecified). She was vaccinated with FLUVIRIN (batch number: 12232P) intramuscularly into right arm on 22 Oct 2012. On the same day, after vaccination, she had right arm pain, swelling at vaccination site, pain in the right scapula (right side), leg weakness, tingling in the feet and finger tips (off and on). Her weakness in leg was like jelly with numbness, which stops at pubic area. She visited the emergency room and had undergone MRI (nuclear magnetic resonance imaging), EMG (electromyogram), EKG (electrocardiogram), spinal tap (lumbar puncture) and other laboratory tests, but the results were not reported. The outcome of the event was reported as not recovered. The causality and seriousness of the events were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 12232P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 208889) on 14 May 2014: Updated batch review report.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2013US000950, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 472916) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208889) on 14 May 2014. This case refers to a 38-year-old female patient. Her medical history included allergy to mold, dust, pollen and shellfish. Her concomitant medication included MOTRIN and vitamins (unspecified). She was vaccinated with FLUVIRIN (batch number: 12232P) intramuscularly into right arm on 22 Oct 2012. On the same day, after vaccination, she had right arm pain, swelling at vaccination site, pain in the right scapula (right side), leg weakness, tingling in the feet and finger tips (off and on). Her weakness in leg was like jelly with numbness, which stops at pubic area. She visited the emergency room and had undergone MRI (nuclear magnetic resonance imaging), EMG (electromyogram), EKG (electrocardiogram), spinal tap (lumbar puncture) and other laboratory tests, but the results were not reported. The outcome of the event was reported as not recovered. The causality and seriousness of the events were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 12232P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 208889) on 14 May 2014: Updated batch review report.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site swelling
Clinical narrative: Case number PHHY2013US000950, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 472916) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 208889) on 14 May 2014. This case refers to a 38-year-old female patient. Her medical history included allergy to mold, dust, pollen and shellfish. Her concomitant medication included MOTRIN and vitamins (unspecified). She was vaccinated with FLUVIRIN (batch number: 12232P) intramuscularly into right arm on 22 Oct 2012. On the same day, after vaccination, she had right arm pain, swelling at vaccination site, pain in the right scapula (right side), leg weakness, tingling in the feet and finger tips (off and on). Her weakness in leg was like jelly with numbness, which stops at pubic area. She visited the emergency room and had undergone MRI (nuclear magnetic resonance imaging), EMG (electromyogram), EKG (electrocardiogram), spinal tap (lumbar puncture) and other laboratory tests, but the results were not reported. The outcome of the event was reported as not recovered. The causality and seriousness of the events were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 12232P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 208889) on 14 May 2014: Updated batch review report.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Speech disorder
Clinical narrative: Case number PHHY2013US000707 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 473317) website on 02 Jan 2013 with a follow up report received from the Quality Assurance department (QA reference number: 209044) on 14 May 2014. This report refers to a 41-year-old female patient. Her current conditions included unspecified allergies and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205601, expiry date: Jun 2013) on to right arm on 30 Oct 2012. On the same day she complained of itching at vaccination site. She was alert and speaking and was given Benadryl 50 mg. She returned to emergency room at 4:20 pm and had trouble speaking. She was given Epipen 0.3 mg. Emergency medical service was called. The final outcome was reported as complete recovery as of 30 Oct 2012. Based on the investigation performed, it was concluded that the FLUVIRIN batch: 1205601 was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 209044) on 14 May 2014: The expiry date, EMEA labeling and the batch review report were updated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature, Chills, Colitis, Decreased appetite
Clinical narrative: Case number PHHY2013US000845, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 473441) website on 02 Jan 2013, and with a follow up report received from QA department (reference number: 208854) on 14 May 2014. This report refers to a 70-year-old female patient. Her medical history included thyroid disease (unspecified), hypertension and colon cancer with surgery in 2008. Her vaccinated history included administration of pneumococcal vaccine on an unspecified date, with which she developed high fever and felt sick for about two weeks. Her concomitant medications included levothyroxine, simvastatin, fosinopril hydrochlorothiazide, OTC acid reflux, vitamins D, C, B12 pills, Coenzyme Q10 and fish oil. She was vaccinated with FLUVIRIN (batch number: 123104) intramuscularly into left arm on 02 Oct 2012. On the same day (at 5.00 pm), she stated that she was not feeling well with low grade fever (99.7-99.8), chills, weakness, no appetite (could not eat) and diarrhea. She went to contact the physician and was diagnosed with colitis on 03 Oct 2012. She was there in bed for seven days and was able to return to full duty on 16 Oct 2012. The outcome of the events was reported as recovered. The causality and seriousness of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 123104 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (reference number: 208854) on 14 May 2014. Updated batch review report.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Malaise, Pyrexia
Clinical narrative: Case number PHHY2013US000845, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 473441) website on 02 Jan 2013, and with a follow up report received from QA department (reference number: 208854) on 14 May 2014. This report refers to a 70-year-old female patient. Her medical history included thyroid disease (unspecified), hypertension and colon cancer with surgery in 2008. Her vaccinated history included administration of pneumococcal vaccine on an unspecified date, with which she developed high fever and felt sick for about two weeks. Her concomitant medications included levothyroxine, simvastatin, fosinopril hydrochlorothiazide, OTC acid reflux, vitamins D, C, B12 pills, Coenzyme Q10 and fish oil. She was vaccinated with FLUVIRIN (batch number: 123104) intramuscularly into left arm on 02 Oct 2012. On the same day (at 5.00 pm), she stated that she was not feeling well with low grade fever (99.7-99.8), chills, weakness, no appetite (could not eat) and diarrhea. She went to contact the physician and was diagnosed with colitis on 03 Oct 2012. She was there in bed for seven days and was able to return to full duty on 16 Oct 2012. The outcome of the events was reported as recovered. The causality and seriousness of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 123104 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department (reference number: 208854) on 14 May 2014. Updated batch review report.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Extrasystoles, Heart rate increased
Clinical narrative: Case number PHHY2013US000569 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 474064) on 02 Jan 2013 with follow-up received on 14 May 2014. This case refers to a 45-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 122204) intramuscularly in her right arm on 15 Oct 2012. On the same day of vaccination, she had increase in her heart rate and skipped beats. The final outcome was reported as completely recovered on an unspecified date. The seriousness and causality were not reported. No other information was available. Based on the investigation performed by the QA department, it was confirmed that FLUVIRIN batch number 122204 was manufactured in accordance with the effective company procedure and was in compliance with corporate quality requirements. Non-significant follow-up received from QA department on 06 Feb 2013: Updated QA reference number as 208914. Follow-up received from QA department on 14 May 2014: Updated batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Feeling abnormal, Heart rate decreased, Ocular hyperaemia, Sluggishness
Clinical narrative: Case number PHHY2013US000592 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 474200) on 02 Jan 2013 with follow-up received on 14 May 2014. This report refers to a 54-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1205301) intramuscularly in left arm on 01 Nov 2012. On 03 Nov 2012, after the vaccination, she had a feeling of sluggishness, beefy tongue and reddened eyes. She also had a weird feeling in her mouth. The electrocardiogram (EKG) revealed average heart rate of (AHR) of 40 BPM. She went to emergency room for the events. The outcome of events was reported as complete recovery as of 12 Nov 2012. The seriousness and causality of the events was not reported. Based on the investigation performed by the QA department, it was confirmed that FLUVIRIN batch number 1205301, was manufactured in accordance with approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from quality assurance department (QA reference number: 209053) on 07 Feb 2013: Updated reference number. Follow-up received from quality assurance department (QA reference number: 209053) on 14 May 2013: Updated batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue disorder
Clinical narrative: Case number PHHY2013US000592 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 474200) on 02 Jan 2013 with follow-up received on 14 May 2014. This report refers to a 54-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1205301) intramuscularly in left arm on 01 Nov 2012. On 03 Nov 2012, after the vaccination, she had a feeling of sluggishness, beefy tongue and reddened eyes. She also had a weird feeling in her mouth. The electrocardiogram (EKG) revealed average heart rate of (AHR) of 40 BPM. She went to emergency room for the events. The outcome of events was reported as complete recovery as of 12 Nov 2012. The seriousness and causality of the events was not reported. Based on the investigation performed by the QA department, it was confirmed that FLUVIRIN batch number 1205301, was manufactured in accordance with approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from quality assurance department (QA reference number: 209053) on 07 Feb 2013: Updated reference number. Follow-up received from quality assurance department (QA reference number: 209053) on 14 May 2013: Updated batch review report.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Loss of consciousness, Vision blurred
Clinical narrative: Case number PHHY2014US043108 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 520288) website on 08 Apr 2014, with the follow-up received from Quality Assurance Department (reference number: 293991) on 14 May 2014. This report refers to an 18-year-old female patient. She had no known drug allergies and no medical conditions reported. She was vaccinated with FLUVIRIN (batch number: 13405P) intramuscularly into left arm on 20 Jan 2014 and passed out a few minutes later while still in the store. She complained of dizziness and slightly blurred vision after regaining consciousness moments later. Ambulance was called and she was taken to emergency room. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Outcome of the events was reported as recovered. Causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 13405P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 293991) on 14 Apr 2014: Updated QA reference number. Follow-up received from Quality Assurance Department (reference number: 293991) on 14 May 2014: Updated batch review report.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Death
Clinical narrative: Case number PHHY2014US045765, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522177) website on 14 Apr 2014 and a follow-up received from Quality Assurance Department (QA, reference number: 294364) on 14 May 2014. This report refers to a 57 year old male patient. His current conditions included a recent hospitalization due to pneumonia and hypertension. His past history included chronic obstructive pulmonary disease, chronic home oxygen use, obstructive sleep disorder, skin cancer, pulmonary hypertension, congestive heart failure, chronic back pain and dyspnea. His concomitant medications included SPIRIVA inhaler, SYMBICORT inhaler, furosemide at a dose of 20 mg once a day, AMBIEN at a dose of 10 mg HS, XANAX at a dose of 1 mg twice a day, LORTAB at a dose of 10 mg thrice a day, prednisone at a dose of 10 mg, ASA at a dose of 325 mg once a day and albuterol nebulizer. He was vaccinated with FLUVIRIN (batch number: 1340 1P) intramuscularly in his arm on 28 Jan 2014. On 31 Jan 2014, the patient died (reason unknown). It was not known if any autopsy was performed. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1340 1P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 294364) on 14 May 2014: Updated batch review report.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: This case was received on 12 May 2014 via a third party query tool search on the VAERS database under reference number 52243. A 29 year old male patient had received the following vaccinations on 26 January 2014: ACAM2000 (SP Biologics Co. lot number VV04003A) and Anthrax vaccine Emergent lot number FAV341A intramuscularly into the right arm. On 06 February 2014, the patient experienced 24 hours of chest pain and shortness of breath and was found to have ST elevation in lateral leads, then across his precordium at HHH. He was diagnosed with myocarditis and pericarditis at the hospital after finding positive cardiac markers. He was treated with Motrin and Colchicine with improvement after 4 days. Laboratory tests performed were EKG, Echocardiogram and cardiac markers. Other medications were reported as none. The patient medical history and current illnesses were reported as none. The patient was seen in the emergency and had prolonged hospitalization, dates not reported. The report considered the event as life threatening. The patient outcome was recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram ST segment elevation, Myocarditis, Pericarditis
Clinical narrative: This case was received on 12 May 2014 via a third party query tool search on the VAERS database under reference number 52243. A 29 year old male patient had received the following vaccinations on 26 January 2014: ACAM2000 (SP Biologics Co. lot number VV04003A) and Anthrax vaccine Emergent lot number FAV341A intramuscularly into the right arm. On 06 February 2014, the patient experienced 24 hours of chest pain and shortness of breath and was found to have ST elevation in lateral leads, then across his precordium at HHH. He was diagnosed with myocarditis and pericarditis at the hospital after finding positive cardiac markers. He was treated with Motrin and Colchicine with improvement after 4 days. Laboratory tests performed were EKG, Echocardiogram and cardiac markers. Other medications were reported as none. The patient medical history and current illnesses were reported as none. The patient was seen in the emergency and had prolonged hospitalization, dates not reported. The report considered the event as life threatening. The patient outcome was recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: This case was received on 12 May 2014 via a third party query tool search on the VAERS database under reference number 52243. A 29 year old male patient had received the following vaccinations on 26 January 2014: ACAM2000 (SP Biologics Co. lot number VV04003A) and Anthrax vaccine Emergent lot number FAV341A intramuscularly into the right arm. On 06 February 2014, the patient experienced 24 hours of chest pain and shortness of breath and was found to have ST elevation in lateral leads, then across his precordium at HHH. He was diagnosed with myocarditis and pericarditis at the hospital after finding positive cardiac markers. He was treated with Motrin and Colchicine with improvement after 4 days. Laboratory tests performed were EKG, Echocardiogram and cardiac markers. Other medications were reported as none. The patient medical history and current illnesses were reported as none. The patient was seen in the emergency and had prolonged hospitalization, dates not reported. The report considered the event as life threatening. The patient outcome was recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Myocarditis, Pericarditis
Clinical narrative: This case was received on 12 May 2014 via a third party query tool search on the VAERS database under reference number 52243. A 29 year old male patient had received the following vaccinations on 26 January 2014: ACAM2000 (SP Biologics Co. lot number VV04003A) and Anthrax vaccine Emergent lot number FAV341A intramuscularly into the right arm. On 06 February 2014, the patient experienced 24 hours of chest pain and shortness of breath and was found to have ST elevation in lateral leads, then across his precordium at HHH. He was diagnosed with myocarditis and pericarditis at the hospital after finding positive cardiac markers. He was treated with Motrin and Colchicine with improvement after 4 days. Laboratory tests performed were EKG, Echocardiogram and cardiac markers. Other medications were reported as none. The patient medical history and current illnesses were reported as none. The patient was seen in the emergency and had prolonged hospitalization, dates not reported. The report considered the event as life threatening. The patient outcome was recovered. Documents held by sender: None.
Age: 52.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Initial case received on 12 May 2014 via a third party query tool search on the VAERS database, under reference number 522844. A 52-year-old male patient had received a percutaneous injection of ACAM2000 on 06 February 2014 (lot number VV04003A, site of administration not reported). He was also receiving concomitant medications: liprosin and Nexium. On 09 February, approximately 3 days post vaccination, pox marks and rashes appeared all over the body, but concentrated in the armpit and inner thighs. He was prescribed corrective treatment with topical steroids. Lab data, prior vaccinations were not reported. Current illness and history were reported as none. Outcome was reported as not recovered. Documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash generalised
Clinical narrative: Initial case received on 12 May 2014 via a third party query tool search on the VAERS database, under reference number 522844. A 52-year-old male patient had received a percutaneous injection of ACAM2000 on 06 February 2014 (lot number VV04003A, site of administration not reported). He was also receiving concomitant medications: liprosin and Nexium. On 09 February, approximately 3 days post vaccination, pox marks and rashes appeared all over the body, but concentrated in the armpit and inner thighs. He was prescribed corrective treatment with topical steroids. Lab data, prior vaccinations were not reported. Current illness and history were reported as none. Outcome was reported as not recovered. Documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Inflammation, Injection site discharge, Injection site vesicles, Local swelling, Neck mass
Clinical narrative: This case was received on 12 May 2014 via a third party query tool search on the VAERS database, under reference number 523174. A 45 year-old female patient with no past medical history had received the following vaccinations on 08 February 2014: a ACAM2000 (lot number and site of administration not reported), a right injection of Typhoid vaccine (lot number not reported and route of administration reported as oral however site was reported as right arm) and a right arm injection of Anthrax (other manufacturer lot number and route of administration not reported) and 9 days later on 17 February 2014, the patient noticed a lump on the left side of neck, about an hour later there was another lump above the first one. As the day progressed the swelling continued to get worse. The patient also reported multiple blisters and oozing at smallpox vaccination site. The next day the right side of her neck was swollen and the inflammation was traveling down her arm. The patient was evaluated by her doctor. Treatment included Ciprofloxacin HLC started on 08 February 2014. Concomitant medications included Nexium, Estradiol, Losartan HCTZ and move free. Current illnesses were reported as none. Outcome was unknown. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Swelling
Clinical narrative: This case was received on 12 May 2014 via a third party query tool search on the VAERS database, under reference number 523174. A 45 year-old female patient with no past medical history had received the following vaccinations on 08 February 2014: a ACAM2000 (lot number and site of administration not reported), a right injection of Typhoid vaccine (lot number not reported and route of administration reported as oral however site was reported as right arm) and a right arm injection of Anthrax (other manufacturer lot number and route of administration not reported) and 9 days later on 17 February 2014, the patient noticed a lump on the left side of neck, about an hour later there was another lump above the first one. As the day progressed the swelling continued to get worse. The patient also reported multiple blisters and oozing at smallpox vaccination site. The next day the right side of her neck was swollen and the inflammation was traveling down her arm. The patient was evaluated by her doctor. Treatment included Ciprofloxacin HLC started on 08 February 2014. Concomitant medications included Nexium, Estradiol, Losartan HCTZ and move free. Current illnesses were reported as none. Outcome was unknown. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Pericarditis
Clinical narrative: This case was received on 12 May 2014 via a third party query tool search on the VAERS database, under reference number 523904. A 21 year-old male patient with no reported past medical history had received on 10 February 2014 a dose 0 ACAM2000 (lot number VV04003A) site of administration unknown), and on 19 February 2014 had substernal chest pain. The patient had chest pain for two days and was seen in the emergency department on 21 February 2014. According to the report, the patient was admitted for one day for pericarditis and discharged on 21 February 2014. Lab data, prior vaccinations and other medications were unknown. Current illnesses and history were none reported. Outcome was recovered. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Pericarditis, Troponin I normal
Clinical narrative: This case was received on 12 May 2014 via a third party query tool search on the VAERS database, under reference number 523904. A 21 year-old male patient with no reported past medical history had received on 10 February 2014 a dose 0 ACAM2000 (lot number VV04003A) site of administration unknown), and on 19 February 2014 had substernal chest pain. The patient had chest pain for two days and was seen in the emergency department on 21 February 2014. According to the report, the patient was admitted for one day for pericarditis and discharged on 21 February 2014. Lab data, prior vaccinations and other medications were unknown. Current illnesses and history were none reported. Outcome was recovered. Documents held by sender: none.
Age: 9.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Chest discomfort, Chest pain, Injection site pain
Clinical narrative: Case number PHHY2014US055871 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524273) website on 06 May 2014, with a follow-up received from Quality Assurance Department (QA) on 13 May 2014. This report refers to a 09-year-old female child. Her medical history and current illness was not reported. Her concomitant medication included cyproheptadine. On 15 Dec 2013, she was vaccinated with FLUCELVAX (batch number: T3959) intramuscularly in the left arm. Following the vaccination on 16 Dec 2013, she experienced chest pain, chest discomfort and pain in her arm at the site of vaccine administration. Due to the events, the patient visited the emergency room (primary care provider's office) and received prescription for pain and was released. No other adverse events were reported. She completely recovered from the events the next day (date unspecified). The causality of the events was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. It was reported that the batch number T3959 for FLUCELVAX was not a valid batch number. Therefore batch review investigation will not be performed. Following an internal review received on 13 May 2014, it was identified that the batch number received in the initial report on 06 May 2014 was not captured in the product tab, but only in the narrative hence it has been corrected now. Follow-up received from Quality Assurance Department (QA) on 13 May 2014: Updated QA comment.
Age: 9.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Chest discomfort, Chest pain, Drug administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Case number PHHY2014US055871 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 524273) website on 06 May 2014, with a follow-up received from Quality Assurance Department (QA) on 13 May 2014. This report refers to a 09-year-old female child. Her medical history and current illness was not reported. Her concomitant medication included cyproheptadine. On 15 Dec 2013, she was vaccinated with FLUCELVAX (batch number: T3959) intramuscularly in the left arm. Following the vaccination on 16 Dec 2013, she experienced chest pain, chest discomfort and pain in her arm at the site of vaccine administration. Due to the events, the patient visited the emergency room (primary care provider's office) and received prescription for pain and was released. No other adverse events were reported. She completely recovered from the events the next day (date unspecified). The causality of the events was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. It was reported that the batch number T3959 for FLUCELVAX was not a valid batch number. Therefore batch review investigation will not be performed. Following an internal review received on 13 May 2014, it was identified that the batch number received in the initial report on 06 May 2014 was not captured in the product tab, but only in the narrative hence it has been corrected now. Follow-up received from Quality Assurance Department (QA) on 13 May 2014: Updated QA comment.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Gastrostomy, Laboratory test normal, Lumbar puncture normal, Muscular weakness, Myelitis transverse
Clinical narrative: This spontaneous report as received from a healthcare worker via field representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL amount of doses and route of administration were not provided. In the last two weeks (estimated as on an approximately 28-APR-2014), the patient experienced paralysis from the neck down. At the time of reporting, the patient was hospitalized (hospitalization start date estimated as an 2014). The outcome of paralysis was reported as not recovered/not resolved. Relatedness between paralysis and vaccination with GARDASIL was not reported. Upon internal review, the patient's event described as paralysis from the neck down was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Quadriplegia, Tracheostomy
Clinical narrative: This spontaneous report as received from a healthcare worker via field representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL amount of doses and route of administration were not provided. In the last two weeks (estimated as on an approximately 28-APR-2014), the patient experienced paralysis from the neck down. At the time of reporting, the patient was hospitalized (hospitalization start date estimated as an 2014). The outcome of paralysis was reported as not recovered/not resolved. Relatedness between paralysis and vaccination with GARDASIL was not reported. Upon internal review, the patient's event described as paralysis from the neck down was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Paralysis
Clinical narrative: This spontaneous report as received from a healthcare worker via field representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL amount of doses and route of administration were not provided. In the last two weeks (estimated as on an approximately 28-APR-2014), the patient experienced paralysis from the neck down. At the time of reporting, the patient was hospitalized (hospitalization start date estimated as an 2014). The outcome of paralysis was reported as not recovered/not resolved. Relatedness between paralysis and vaccination with GARDASIL was not reported. Upon internal review, the patient's event described as paralysis from the neck down was considered to be medically significant. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Fatigue, Pyrexia, Vaccination complication
Clinical narrative: Patient received smallpox vaccine which has spread around site of admission. Patient has developed a low grade fever and fatigue.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 19 year old female patient (not pregnant). The patient's medical history included cancer and chemotherapy on three separate occasions. On an unspecified date, the physician administered MMR II subcutaneously (dose, lot#, expiration date not reported) to a patient. Then, on an unknown date, when the physician checked titers, the patient had no immunity to the measles, mumps and rubella. No concomitant therapy was reported. The outcome of event was unknown. The relatedness between event and MMR II was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 18 year old male patient with no pertinent medical history and no drug reactions or allergies. On 12-MAY-2014, the patient was vaccinated with a first dose out of three shots of GARDASIL route reported as injection (anatomical location and lot number not reported). There were no concomitant medications. On 12-MAY-2014, the patient told the reporter (before he fainted) that his head hurt but he could not describe how it hurt. He said it felt like when your foot goes to sleep, a numbness like pain. On 12-MAY-2014, at 3 minutes after the first dose of GARDASIL, the patient fainted and fell forward. After the reporter picked him up, the patient fell backwards, shaking while he was on the floor. This lasted about 30 seconds (also reported as not recovered). The physician had the patient monitored for 15 minutes. The reporter said, he lay down for 5 minutes, sat up for 10 minutes, and then the physician released him to go home. The reporter said the patient still felt, and looked, woozy or spacey. The treatment given for the AE was reported as: Yes: doctor watched him for 15 minutes. No laboratory diagnostic studies were performed. The patient sought medical attention via contacting the physician. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Upon internal review shaking while he was on the floor was considered medically significant. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Tremor
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 18 year old male patient with no pertinent medical history and no drug reactions or allergies. On 12-MAY-2014, the patient was vaccinated with a first dose out of three shots of GARDASIL route reported as injection (anatomical location and lot number not reported). There were no concomitant medications. On 12-MAY-2014, the patient told the reporter (before he fainted) that his head hurt but he could not describe how it hurt. He said it felt like when your foot goes to sleep, a numbness like pain. On 12-MAY-2014, at 3 minutes after the first dose of GARDASIL, the patient fainted and fell forward. After the reporter picked him up, the patient fell backwards, shaking while he was on the floor. This lasted about 30 seconds (also reported as not recovered). The physician had the patient monitored for 15 minutes. The reporter said, he lay down for 5 minutes, sat up for 10 minutes, and then the physician released him to go home. The reporter said the patient still felt, and looked, woozy or spacey. The treatment given for the AE was reported as: Yes: doctor watched him for 15 minutes. No laboratory diagnostic studies were performed. The patient sought medical attention via contacting the physician. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Upon internal review shaking while he was on the floor was considered medically significant. Additional information has been requested.