chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Nausea, Pallor, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2013US000714 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471009) website on 02 Jan 2013, and with a follow up report received from QA department (QA reference: 209037) on 14 May 2014. This report refers to a 67-year-old female patient. Her medical history included gingivitis and low grade fevers which were off and on for the past few years. She was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in the right arm on 21 Oct 2012. The patient also received PNEUMOVAX (batch number: 1947AA, other manufacturer) intramuscularly on the right arm on the same date. On the same date, immediately after both the vaccinations the patient grabbed chest. She said it felt like air went out and felt funny like she cannot breathe. She grabbed EPI-PEN. The patient felt nauseous at that moment and after 17 mins her color and skin temperature returned. The patient seated and felt that the chest was tight and had no air. The patient followed up at 5:55 pm on the same date, she was at home and resting. The patient had 100 degrees fever and arm swollen. Patient said honestly that she felt as though she had flu with temp of 100. Patient called the MD who told her that this was not serious and not to be worried. The seriousness, outcome and causality of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1206201 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 (QA reference: 209037) on 14 May 2014. Batch review report updated.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Apnoea, Asthenia, Cellulitis, Erythema, Injection site pain
Clinical narrative: Case number PHHY2013US000714 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471009) website on 02 Jan 2013, and with a follow up report received from QA department (QA reference: 209037) on 14 May 2014. This report refers to a 67-year-old female patient. Her medical history included gingivitis and low grade fevers which were off and on for the past few years. She was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in the right arm on 21 Oct 2012. The patient also received PNEUMOVAX (batch number: 1947AA, other manufacturer) intramuscularly on the right arm on the same date. On the same date, immediately after both the vaccinations the patient grabbed chest. She said it felt like air went out and felt funny like she cannot breathe. She grabbed EPI-PEN. The patient felt nauseous at that moment and after 17 mins her color and skin temperature returned. The patient seated and felt that the chest was tight and had no air. The patient followed up at 5:55 pm on the same date, she was at home and resting. The patient had 100 degrees fever and arm swollen. Patient said honestly that she felt as though she had flu with temp of 100. Patient called the MD who told her that this was not serious and not to be worried. The seriousness, outcome and causality of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1206201 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 (QA reference: 209037) on 14 May 2014. Batch review report updated.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2013US000714 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 471009) website on 02 Jan 2013, and with a follow up report received from QA department (QA reference: 209037) on 14 May 2014. This report refers to a 67-year-old female patient. Her medical history included gingivitis and low grade fevers which were off and on for the past few years. She was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in the right arm on 21 Oct 2012. The patient also received PNEUMOVAX (batch number: 1947AA, other manufacturer) intramuscularly on the right arm on the same date. On the same date, immediately after both the vaccinations the patient grabbed chest. She said it felt like air went out and felt funny like she cannot breathe. She grabbed EPI-PEN. The patient felt nauseous at that moment and after 17 mins her color and skin temperature returned. The patient seated and felt that the chest was tight and had no air. The patient followed up at 5:55 pm on the same date, she was at home and resting. The patient had 100 degrees fever and arm swollen. Patient said honestly that she felt as though she had flu with temp of 100. Patient called the MD who told her that this was not serious and not to be worried. The seriousness, outcome and causality of the events were not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1206201 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 (QA reference: 209037) on 14 May 2014. Batch review report updated.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Blood pressure increased, Endotracheal intubation, Eosinophil count increased, Muscular weakness
Clinical narrative: Case number PHHY2013US069560, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471274) website on 03 Jul 2013, with the follow-up received from Quality Assurance Department (reference number: 239155) on 17 Dec 2013. This report refers to a 46-year-old female patient. Her medical history included Bells Palsy. Her current conditions included bronchitis and diarrhea. She was vaccinated with FLUVIRIN (batch number: 12265P, Expiry date: 30 Jun 2013) intramuscularly on 28 Sep 2012. On 14 Oct 2012, she experienced paralysis, tingling in lower legs, weakness in lower extremities, and elevated blood pressure (values not reported). She was unable to walk and she was intubated and received plasmapheresis. She was taken to the emergency room. Lab tests revealed neutrophils: 79 (units not reported), eosinophil: 10 (units not reported). The outcome was reported as condition unchanged as of 24 Oct 2012. The events were assessed as life threatening. The causality was not reported. Based on the investigation performed, QA department stated that, the concerned FLUVIRIN (batch number: 12265P) 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: 239155) on 17 Dec 2013: Updated batch review report.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Neutrophil count increased, Paraesthesia, Paralysis, Plasmapheresis
Clinical narrative: Case number PHHY2013US069560, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471274) website on 03 Jul 2013, with the follow-up received from Quality Assurance Department (reference number: 239155) on 17 Dec 2013. This report refers to a 46-year-old female patient. Her medical history included Bells Palsy. Her current conditions included bronchitis and diarrhea. She was vaccinated with FLUVIRIN (batch number: 12265P, Expiry date: 30 Jun 2013) intramuscularly on 28 Sep 2012. On 14 Oct 2012, she experienced paralysis, tingling in lower legs, weakness in lower extremities, and elevated blood pressure (values not reported). She was unable to walk and she was intubated and received plasmapheresis. She was taken to the emergency room. Lab tests revealed neutrophils: 79 (units not reported), eosinophil: 10 (units not reported). The outcome was reported as condition unchanged as of 24 Oct 2012. The events were assessed as life threatening. The causality was not reported. Based on the investigation performed, QA department stated that, the concerned FLUVIRIN (batch number: 12265P) 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: 239155) on 17 Dec 2013: Updated batch review report.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2013US000473, is an initial spontaneous report received from Vaccine Adverse Event Reporting system (VAERS reference number: 471437) web site on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 209074) on 18 Dec 2013: This report refers to 40-year-old female patient. Her medical history was not reported. Concomitant medications included NASONEX and ALLEGRA. She was vaccinated FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) intramuscularly on 23 Oct 2012. Patient fainted for a few seconds (briefly) after shot was administered. She quickly woke up and was given a cool compress, ibuprofen and Gatorade. She stayed seated for half hour afterwards. No serious injuries occurred. The outcome of the events was recovered. The seriousness and causality assessment was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204601) 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: 209074) on 18 Dec 2013: Updated batch review report.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Fall, Headache, Syncope
Clinical narrative: Case number PHHY2013US000606 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 471507) on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 209069) on 18 Dec 2013: This report refers to a 28-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date 31 May 2013) intramuscularly in left arm on 24 Oct 2012. On 24 Oct 2012, after the vaccination, she fainted and fell on floor. She woke up a minute later, but when she tried to sit up, she fainted again. So when she woke up again, she was made to lie down on the floor with pillow under her head until the paramedics came. She stated that her head and stomach hurt. She went to emergency room for the events. The outcome of events was reported as condition unchanged as 25 Oct 2012. The seriousness and causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204601) 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: 209069) on 18 Dec 2013: Updated batch review report.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Dizziness, Immediate post-injection reaction, Palpitations, Syncope
Clinical narrative: Case number PHHY2013US012315 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 477162) on 08 Feb 2013 and a follow-up received from Quality Assurance department (QA, reference number: 210564) on 15 Jan 2014. This report refers to a 10-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1207201, Expiry date: 30 Jun 2013) intramuscularly on left arm on 07 Dec 2012. After vaccination, she immediately started feeling dizzy, faint, threw up several times and felt like her heart was racing. Emergency was called and paramedics ultimately determined that she was severely dehydrated and had not eaten all day. Blood pressure, heart rate and pulse rate were all taken by paramedics reported that everything was normal. Outcome of the events were reported as condition unchanged. Seriousness and causality of the events was not reported. No further information was available. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1207201) 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 on 15 Jan 2014: Updated batch review report.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2013US012315 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 477162) on 08 Feb 2013 and a follow-up received from Quality Assurance department (QA, reference number: 210564) on 15 Jan 2014. This report refers to a 10-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1207201, Expiry date: 30 Jun 2013) intramuscularly on left arm on 07 Dec 2012. After vaccination, she immediately started feeling dizzy, faint, threw up several times and felt like her heart was racing. Emergency was called and paramedics ultimately determined that she was severely dehydrated and had not eaten all day. Blood pressure, heart rate and pulse rate were all taken by paramedics reported that everything was normal. Outcome of the events were reported as condition unchanged. Seriousness and causality of the events was not reported. No further information was available. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1207201) 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 on 15 Jan 2014: Updated batch review report.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Case number PHHY2013US069426, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 478562) website on 03 Jul 2013, with the follow-up received from Quality Assurance Department (reference number: 239223) on 03 Apr 2014. This report refers to a 10-year-old male patient. Her medical history was not reported. Concomitant medication included montelukast, FLOVENT and fluticasone. He was vaccinated with FLUVIRIN (batch number: 1206901) in the left arm on 08 Dec 2012. On the same day after vaccination he stated that he felt funny and fainted. He had an emergency doctor visit due to these events. The outcome was reported as completely recovered as of 08 Dec 2012. The seriousness and causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1206901) 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: 239223) on 03 Apr 2014: Updated batch review report.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Case number PHHY2013US069568 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 479451) web site on 03 Jul 2013, with a non-significant follow-up information received from Quality Assurance Department (reference number: 239150) on 01 Jul 2014. This report refers to a 42-year-old male patient. His medical history was not reported. He was not using any concomitant medications. He was vaccinated with FLUVIRIN (batch number: 122105 and expiry date: 31 Mar 2013) intramuscularly on 19 Dec 2012. On the same day, after vaccination, he experienced lightheadedness. He was seated on a chair. In two to three minutes he said that he was fine. After about 7-8 minutes of original lightheadedness, he fainted on to the floor. His face lost color. He was in that way for 2-3 minutes. He was made to lie down straight and emergency was called. It was reported that then he abruptly sat up and was coherent, but sweating. He was given water and he drank approximately 1 pint. His blood pressure was measured approximately 45 minutes later and it was 120/74 (units were not reported). He felt fine and left. He was called twice for follow up, but there was no response. The outcome of the event was reported as complete recovery. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 122105) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 239150) on 01 Jul 2014: Updated batch review report.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hot flush, Syncope
Clinical narrative: Case number PHHY2013US032669 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 482399) on 04 Apr 2013, with a non-significant follow-up information received from Quality Assurance Department (reference number: 221074) on 01 Jul 2014: This report refers to a 54-year-old female patient. Her medical history included TYLENOL allergy. Her concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1206801) intramuscularly into the left arm on 11 Jan 2013. On the same day, 30 minutes post immunization, the patient had chills and hot flashes then she fainted. She got up and then fainted again second time. Final outcome was reported as complete recovery of the patient on an unknown date. No further information about causality and seriousness was reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1206801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 221074) on 01 Jul 2014: Updated batch review report.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Pain, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2013US127689 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 502100) website on 11 Nov 2013. This report refers to a 48-year-old female patient. Her medical history included allergic to Sulfa and concomitant medication included LOESTRIN. She was vaccinated with FLUVIRIN (batch number: unknown) on 07 Sep 2013. On 08 Sep 2013, she experienced fever of 99.5 and 99.7 with a flush face and some redness. On the next day, she had a little redness on face but body and arms ached all the day. On 10 Sep 2013, she woke up with a rash on arms, shoulders, legs but with no fever. On 11 Sep 2013, she had a rash all over, chest, back, arms and legs with no fever. She went to physician on 11 Sep 2013 (as an emergency visit) and was told her to take ZYRTEC. Outcome of the fever was recovered and outcome of other events was not recovered as of 11 Sep 2013. No seriousness and causality were reported for the events.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2013US127689 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 502100) website on 11 Nov 2013. This report refers to a 48-year-old female patient. Her medical history included allergic to Sulfa and concomitant medication included LOESTRIN. She was vaccinated with FLUVIRIN (batch number: unknown) on 07 Sep 2013. On 08 Sep 2013, she experienced fever of 99.5 and 99.7 with a flush face and some redness. On the next day, she had a little redness on face but body and arms ached all the day. On 10 Sep 2013, she woke up with a rash on arms, shoulders, legs but with no fever. On 11 Sep 2013, she had a rash all over, chest, back, arms and legs with no fever. She went to physician on 11 Sep 2013 (as an emergency visit) and was told her to take ZYRTEC. Outcome of the fever was recovered and outcome of other events was not recovered as of 11 Sep 2013. No seriousness and causality were reported for the events.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Rash, Urticaria
Clinical narrative: Case number PHHY2014US000829 is an initial spontaneous report received from the vaccine adverse event reporting system (reference number: 507753) website on 06 Jan 2014. This report refers to a 51 year old male patient. His current condition included seasonal allergies and hypertension. His concomitant medications included TRIBENZOR and fluticasone propionate nasal spray. He was vaccinated with FLUVIRIN (batch number: 13315P) intramuscularly into right arm on 14 Oct 2013. On the same day, he broke out in hives and experienced itching under arms. After removing his shirt he witnessed that rash had gone across entire back, under arms, up neck and abdominal region. He contacted a nurse for medical support, who recommended urgent care as he had a swollen feeling in throat. He was taken to emergency room at 11:00 PM. He was confirmed with diagnosis of urticaria. He was treated with 10 mg dexamethasone sodium phosphate 1 mg 10 mg intramuscular. He was also prescribed prednisone tablet at a dose of 20 mg thrice a day for 3 days. The final outcome of all the events was reported as complete recovery. The causality and seriousness of the events were not reported.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ear pain, Feeling hot, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2014US000864 is an initial spontaneous report received from a physician via the Vaccine Adverse Event Reporting System (VAERS reference number: 507843) website on 06 Jan 2014. This report refers to a 67-year-old female patient. Her medical history included endometrial cancer. She was currently suffering from prophylaxis since 2012 and chronic sinusitis. Her concomitant medications were not reported. On 24 Sep 2013, she was vaccinated with seasonal Influenza vaccine (batch number: 66521011610) in the left arm along with PNEUMOVAX (other manufacturer, batch number: not reported) intramuscularly in the right arm at a dose of 0.5 ml. On 25 Sep 2013 after vaccination, the physician reported, that she developed redness and pain at the injection site. She also developed right ear pain and nasal congestion. On 27 Sep 2013, the physician experienced a warm sensation at the nape of her neck after walking for exercise. The sensation resolved after she drank sugar water. Later that evening, she developed welts on the right and left scapula area, which resolved with the use of BENADRYL and unspecified cortisone cream topically. On 30 Sep 2013, she developed a circular welt on her mid back. On 01 Oct 2013, she developed welts under both axillas. These welts also responded to BENADRYL and cortisone cream. The evening of 02 Oct 2013, she developed a large welt on her left forearm which she treated with BENADRYL and topical cortisone cream. The physician stated she was evaluated on 03 Oct 2013 by her unspecified healthcare provider who diagnosed an unspecified allergic reaction. It was suggested that the patient eliminated medications and foods one at a time in an attempt to determine the cause of her allergic reaction. Laboratory diagnostic studies were not performed for the events. The patient sought medical attention for the events. The events were resolving at the time of this report. The seriousness and causality of the events were not reported.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nasal congestion, Urticaria
Clinical narrative: Case number PHHY2014US000864 is an initial spontaneous report received from a physician via the Vaccine Adverse Event Reporting System (VAERS reference number: 507843) website on 06 Jan 2014. This report refers to a 67-year-old female patient. Her medical history included endometrial cancer. She was currently suffering from prophylaxis since 2012 and chronic sinusitis. Her concomitant medications were not reported. On 24 Sep 2013, she was vaccinated with seasonal Influenza vaccine (batch number: 66521011610) in the left arm along with PNEUMOVAX (other manufacturer, batch number: not reported) intramuscularly in the right arm at a dose of 0.5 ml. On 25 Sep 2013 after vaccination, the physician reported, that she developed redness and pain at the injection site. She also developed right ear pain and nasal congestion. On 27 Sep 2013, the physician experienced a warm sensation at the nape of her neck after walking for exercise. The sensation resolved after she drank sugar water. Later that evening, she developed welts on the right and left scapula area, which resolved with the use of BENADRYL and unspecified cortisone cream topically. On 30 Sep 2013, she developed a circular welt on her mid back. On 01 Oct 2013, she developed welts under both axillas. These welts also responded to BENADRYL and cortisone cream. The evening of 02 Oct 2013, she developed a large welt on her left forearm which she treated with BENADRYL and topical cortisone cream. The physician stated she was evaluated on 03 Oct 2013 by her unspecified healthcare provider who diagnosed an unspecified allergic reaction. It was suggested that the patient eliminated medications and foods one at a time in an attempt to determine the cause of her allergic reaction. Laboratory diagnostic studies were not performed for the events. The patient sought medical attention for the events. The events were resolving at the time of this report. The seriousness and causality of the events were not reported.
Age: 77.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Case number PHHY2014US000909, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507950) website on 06 Jan 2014. This report refers to a 77-year-old female patient. Past medical history was not reported. Concomitant medications included nifedipine (blood pressure medication) and ESTRAGON. She was vaccinated with FLUVIRIN (batch number: 13421P) intramuscularly and BOOSTRIX (other manufacturer, batch number: 4G995) intramuscularly on 08 Oct 2013. On the same day after vaccination, she experienced faint feeling, sweating, diarrhea, swollen tongue, hotness, nausea, shaking, pallor and upset stomach. She recovered as of 10 Oct 2013. The seriousness and causality of the events were not reported.
Age: 77.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Nausea, Pallor, Swollen tongue, Tremor
Clinical narrative: Case number PHHY2014US000909, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507950) website on 06 Jan 2014. This report refers to a 77-year-old female patient. Past medical history was not reported. Concomitant medications included nifedipine (blood pressure medication) and ESTRAGON. She was vaccinated with FLUVIRIN (batch number: 13421P) intramuscularly and BOOSTRIX (other manufacturer, batch number: 4G995) intramuscularly on 08 Oct 2013. On the same day after vaccination, she experienced faint feeling, sweating, diarrhea, swollen tongue, hotness, nausea, shaking, pallor and upset stomach. She recovered as of 10 Oct 2013. The seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Urticaria, Vomiting
Clinical narrative: Case number PHHY2014US001171 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 508436) on 06 Jan 2014. This report refers to a 60-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309501) intramuscularly to her left arm on 18 Oct 2013. She developed hives, nausea and vomiting on the same day (18 Oct 2013) after vaccination. Epinephrine 0.5 ml subcutaneous was administered as treatment to adverse reactions. Emergency service arrived and gave BENADRYL as treatment to the adverse reactions. Outcome of the event was reported as complete recovery. Seriousness and causality were not reported.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Wheezing
Clinical narrative: Case number PHHY2014US000849, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509001) website on 06 Jan 2014. This report refers to 31-year-old female patient. Her medical history included asthma. Her concomitant medications included albuterol inhaler. She was vaccinated with FLUVIRIN (batch number: 1309501) in the right arm on 22 Oct 2013 at 11:14 AM. On the same day, she experienced vaccination site redness, itching and wheezing in the right upper anterior lobe. She visited the emergency room. She was prescribed epinephrine 0.3 ml given subcutaneously in right arm. The event outcome was condition unchanged as of 22 Oct 2013. The seriousness and causality was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Erythema, Peripheral swelling, Pharyngeal oedema, Pruritus
Clinical narrative: Case number PHHY2014US000888, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509050) website on 06 Jan 2013. This report refers to 49-year-old female patient. her medical history included penicillin allergy. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13372P) in the right arm on 19 Sep 2013. On 20 Sep 2013, her face, arms and legs became swollen, itchy and red. Rash was flat and red. it was reported the she also experienced throat swelling. She herself took EPIPEN. She visited the emergency room. Blood and urine tests were performed (results not reported). The outcome was completely recovered as of 08 Oct 2013. The seriousness and causality were not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Swelling face, Urine analysis
Clinical narrative: Case number PHHY2014US000888, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509050) website on 06 Jan 2013. This report refers to 49-year-old female patient. her medical history included penicillin allergy. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13372P) in the right arm on 19 Sep 2013. On 20 Sep 2013, her face, arms and legs became swollen, itchy and red. Rash was flat and red. it was reported the she also experienced throat swelling. She herself took EPIPEN. She visited the emergency room. Blood and urine tests were performed (results not reported). The outcome was completely recovered as of 08 Oct 2013. The seriousness and causality were not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Swelling, Urticaria
Clinical narrative: Case number PHHY2014US001017, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509180) website on 06 Jan 2014. This report refers to 53-year-old female patient. Her medical history included asthma, allergies, aortic valve stenosis, egg, nut, seafood allergies. It was reported that she never had an allergic reaction before. Her concomitant medications included SYMBICORT, FLOVENT, SINGULAIR, PROAIR, DIOVAN, LIPITOR, BENADRYL, MOTRIN. She was vaccinated with FLUVIRIN (batch number: 66521011610) intramuscularly in the left arm on 14 Oct 2013. On 18 Oct 2013, she experienced severe hives, blisters, swelling over entire body. She took BENADRYL but did not help. She visited the physician on 21 Oct 2013. The physician prescribed prednisone 40 mg/day and antihistamines. The event outcome was completely recovered. The seriousness and causality was not reported.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Case number PHHY2014US001052, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509246) website on 06 Jan 2014. This report refers to 24-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with FLUVIRIN (batch number: 13425P) intramuscularly in the right arm on 23 Oct 2013. A few minutes after vaccination, he complained of chest pain and difficulty breathing. He was administered BENADRYL and water. He still complained of difficulty breathing and thought he would loose consciousness. He was administered EPIPEN and was taken to the emergency room. The event outcome was condition unchanged as of 24 Oct 2013. The seriousness and causality was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US001079, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number:509373) website on  06 Jan 2014. This report refers to 65-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly in the right arm and ZOSTAVAX (other manufacturer, batch number: J004268) subcutaneously on 19 Oct 2013. On the same day, she fainted. The event outcome was reported as completely recovered. The seriousness and causality were not reported. No additional information was available.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Flushing, Heart rate increased, Hypertension, Throat tightness
Clinical narrative: Case number PHHY2014US001118, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509425) website on 06 Jan 2014. This report refers to 26-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 1309501) intramuscularly in the right arm on 21 Oct 2013. On the same day at 11:46 AM, she had a flush feeling and dry mouth, blood pressure of 149/111, heart rate of 130 and respiratory rate of 22. She also felt like her throat was closing. She was administered 0.5 ml of epinephrine subcutaneously. BENADRYL at a dose of 50 mg was administered by the EMS and she refused to go to the emergency room. After an unspecified period of time, her blood pressure was 132/80, heart rate was 106 and respiratory rate was 22. It was reported that after six hours after incident she was feeling fine. The event outcome was completely recovered. The seriousness and causality was not reported.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Neck pain, Paraesthesia
Clinical narrative: Case number PHHY2014US001245, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509615) website on 06 Jan 2014. This report refers to 36-year-old male patient. his medical history and concomitant medications was not reported. He was vaccinated with FLUVIRIN (batch number: 1308601) in the right arm on 15 Oct 2013. On the same day after vaccination, he complained of shortness of breath, neck soreness and tingling of arms and hands and experienced pressure on chest. He was taken via ambulance to the hospital. He visited the emergency room also. The event outcome was completely recovered. The seriousness and causality was not reported.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Rash generalised, Urticaria
Clinical narrative: Case number PHHY2014US001254, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509643) website on 06 Jan 2014. This report refers to a 70-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number; 1308601) intramuscularly in the right arm and ZOSTAVAX (other manufacturer, batch number: J003360) subcutaneously in the left arm on 27 Sep 2013. On 28 Sep 2013, she developed hives and rash all over body. She was treated with diphenhydramine by mouth, which helped. Then she developed rash at injection site. She was told to continue diphenhydramine. Rash cleared after one-week. The outcome of the events was reported as completely recovered on an unspecified date, The seriousness and causality of the events were not reported. No additional information was available.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Pruritus generalised
Clinical narrative: Case number is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509822) website on 06 Jan 2014. This report refers to a 42-year-old female patient. Her concomitant medications included a regular intake of BENTYL, hydrochlorothiazide, Hydroxyzine pamoate, NOVOLOG, ondansetron, ramipril. Her medical history was not reported. On 09 Oct 2013 she was vaccinated with FLUVIRIN (batch number: 1308001) intramuscularly in the arm. On the same date, after vaccination she experienced swollen hands and fingers with numbness and tingling. It was reported that within 20 minutes of injection, she developed face tingling and was "itching all over". Following these events she was treated with intravenous fluids and BENADRYL intravenously. She reported that it was her first flu shot and her twin sister had a similar event following flu shot administration. The event outcome was reported as completely recovered as of 28 Oct 2013. The seriousness and causality of the events were not reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hypertension, Loss of consciousness, Nausea
Clinical narrative: Case number PHHY2014US000830 is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS reference number: 510172) web site on 06 Jan 2014. This case refers to a 55-year-old male patient. His medical history was not reported. Concomitant medications included CHANTIX, sertraline, metoprolol and lisinopril. He was vaccinated with FLUVIRIN (batch number 1309401) intramuscularly in the left arm on 26 Oct 2013. on the same night after vaccination he felt lightheaded, dizzy, nauseous, and even blacked out very briefly. He was still feeling nauseous the next day when moved head in one direction. On 27 Oct 2013 he was feeling much better. His blood pressure has been high 153/89. The outcome of the events was reported as condition unchanged as of 27 Oct 2013. The seriousness and causality assessment of the events were not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pruritus, Injection site urticaria, Urticaria
Clinical narrative: Case number PHHY2014US000920 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 510215) website on 06 Jan 2014. This report refers to a 24-year-old female patient. Her concomitant medications and medical history was not reported. On 09 Oct 2013 she was vaccinated with FLUVIRIN (batch number: 111332) intramuscularly in the right arm. On the same date, after vaccination she experienced symptoms of generalized body hives, itching and five centimeter welt at injection site. Following these events she took OTC BENADRYL. She reported to work on 10 Oct 2013 and continued with same symptoms. As a result, she was given BENADRYL at 8:15 am. She felt shortness of breath at about 8:45 am and was taken to Emergency room where intravenous fluids were administered. She was discharged the same day. It was reported that hives remained for four days. The event outcome was reported as completely recovered as of 29 Oct 2013. The seriousness and causality of the events were not reported.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Angioedema, Chest X-ray, Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2014US000994, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 510633) website on 06 Jan 2014. This report refers to a 27-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13393P) intramuscularly into the right arm on 11 Oct 2013. On the same day after vaccination, he experienced anaphylaxis reaction: angioedema with generalized reddened skin, urticaria, rash and swollen hands. He underwent chest x-ray (PCXR), however the result was not provided. The outcome of the events was reported as recovered. The seriousness and causality of the events were not reported.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Case number PHHY2014US000994, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 510633) website on 06 Jan 2014. This report refers to a 27-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13393P) intramuscularly into the right arm on 11 Oct 2013. On the same day after vaccination, he experienced anaphylaxis reaction: angioedema with generalized reddened skin, urticaria, rash and swollen hands. He underwent chest x-ray (PCXR), however the result was not provided. The outcome of the events was reported as recovered. The seriousness and causality of the events were not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Case number PHHY2014US001007, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 510681) website on 06 Jan 2014. This report refers to a 61-year-old female patient. Her current illness included sore throat one-week prior vaccination and preexisting conditions included type II diabetes mellitus, hypertension and hyperlipidemia. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13381P) in the left arm on 03 Oct 2013. She developed Guillain-Barre syndrome approximately one week after vaccination (06 Oct 2013). Lumbar puncture was performed in hospital (results were not reported). The outcome of the events was reported as completely recovered. The seriousness and causality of the events was not reported. No additional information was available.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Case number PHHY2014US001009 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 510697) website on 06 Jan 2014: This report refers to a 34-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in to the left arm on 30 Oct 2013. On the same day after vaccination, she experienced itchy red rashes that appeared initially on the scalp, upper back, neck, and chest. Rashes then spread to low back, arms, groin, and thighs by the following day, 24 hours after administration of the vaccine. At the time of reporting, she had raised welts consistent with hives, which were visible on 60% of the body. Final outcome of the events was reported as condition unchanged as on 31 Oct 2013. No further information about seriousness and causality was provided.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria, Wheezing
Clinical narrative: Case number PHHY2014US001057 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 510880) website on 06 Jan 2014: This report refers to a 22-year-old female patient. Her medical history and concomitant medications were not reported. She had never had any flu shots earlier in her life. She was vaccinated with thiomersal free FLUVIRIN (batch number: 13453P) intramuscularly in to the left arm on 22 Oct 2013 at 10:25 am. She was asked to wait for five minutes; during this time she developed localized hives on left arm and upper chest and stated she was wheezing. Her chest was checked and it was clear. Her blood pressure (BP) was 120/90 and pulse was 84. She was continued to monitor. She feels okay and went back to work at 10:55 am. Ten minutes later she complained of shortness of breath again. EPIPEN was given and she was monitored by health care professional at company health clinic. Final outcome of the events was reported as complete recovery as on 23 Oct 2013. No further information about seriousness and causality was provided.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Malaise, Posture abnormal
Clinical narrative: Case number PHHY2014US001087 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 510952) web site on 06 Jan 2014. This report refers to a 27-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309501) intramuscularly in the right arm on 28 Oct 2013. On the same day after vaccination, he slumped over and had loss of consciousness for 10 to 15 seconds. He was taken to emergency room. His pulse rate was 48 (units and normal values were not reported) at 4:34 pm and it increased to 80 at 4:37 pm. he did not want to lie on ground and he reported that he did not feel well. he was placed on floor with raised legs and was not given EPIPEN. he was fine the next day and went to work. The outcome was reported as complete recovery as of 01 Nov 2013. The seriousness and causality were not reported.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Case number PHHY2014US001088 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 510960) web site on 06 Jan 2014. This report refers to a 30-years-old male patient. His medical history and concomitant medications were not reported. His vaccination history included syncope following an unspecified vaccination. He was vaccinated with FLUVIRIN (batch number: 13471P) intramuscularly in the left arm on 01 Nov 2013. On the same day after vaccination, he had syncope. It was reported that immediately following vaccination, he was alert and responding, but he fainted a few minutes later when he was seated. He was accompanied by a companion. He was not given any treatment. The outcome of the events was reported as complete recovery after 5 to 10 minutes. The seriousness and causality were not reported.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Syncope
Clinical narrative: Case number PHHY2014US001142 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 511246) on 06 Jan 2014. This report refers to an 18-year-old female patient. Medical history of this patient includes fainting (after receiving an unspecified vaccination). She was vaccinated with FLUVIRIN (batch number: 1319201) intramuscularly in her left arm on 03 Nov 2013. She fainted a few minutes after vaccination. Outcome of the event was reported complete recovery. Seriousness and causality were not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia oral, Rash, Rash pruritic
Clinical narrative: Case number PHHY2014US000855 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 511658) website on 06 Jan 2014. This report refers to a 62-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307901) intramuscularly in the left arm on 15 Oct 2013. On the same day, post vaccination, her upper lip felt tingly and swelled a little. Next day she experienced a rash on her chest that itched which lasted several days then the itch stopped but the rash was still there two weeks later. Outcome of the other events was reported as condition unchanged as of 06 Nov 2013. Seriousness and causality of the events was not reported.