chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Full blood count normal, Pyrexia, Sinus tachycardia, Tremor, White blood cell count increased
Clinical narrative: Case number PHHY2014US047133 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522171) web site on 14 Apr 2014 and a follow up received from Quality Assurance Department (QA, reference number: 295525) on 21 May 2014. This report refers to an 80 year old female patient. Her past medical history included coronary artery disease (CAD), status post aortic valve replacement, multiple sclerosis (MS), anemia, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), atrial fibrillation (AFIB), cerebrovascular accident (CVA), hyperlipidemia and vaginal hysterectomy. Her concomitant medications included LASIX, aspirin, SYMBICORT and ZOCOR. Her vaccination history included administration of tetanus toxoid (manufacturer and batch number: not reported) which was well tolerated. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly on 31 Oct 2013. It was reported that she drove herself to a retail pharmacy and got vaccination and there was no complaints of illness at the time of vaccination. On 31 Oct 2013, she presented with fever, chills and shortness of breath (SOB). The patient stated that prior evening; she suddenly started having shaking chills, fever and her shortness of breath got worse and the events had been increasingly worsening over the past couple of days. There was no real cough or productive sputum noted and she denied any other symptoms. She went to emergency room and was hospitalized for 2 days. She had sinus tachycardia with a heart rate of 114. Her chest X-ray and Computerised Tomogram was normal. Her complete blood count (CBC) was done and was within normal limits. White blood cell count (WBC) was reported as 10.1 (units and normal values were not reported). Her blood pressure was 141/100, body temperature was 100.5 F, pulse rate was 114, respiratory rate was 22, Oxygen saturation was 98% on 2L/NC and blood glucose was 102 (units and normal values of laboratory tests were not reported). The outcome was reported as complete recovery. The event was reported as serious due to hospitalization. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309401) 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: 295525) on 21 May 2014: Updated batch review report.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Blood pressure increased, Chest X-ray normal, Chills, Computerised tomogram normal
Clinical narrative: Case number PHHY2014US047133 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522171) web site on 14 Apr 2014 and a follow up received from Quality Assurance Department (QA, reference number: 295525) on 21 May 2014. This report refers to an 80 year old female patient. Her past medical history included coronary artery disease (CAD), status post aortic valve replacement, multiple sclerosis (MS), anemia, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), atrial fibrillation (AFIB), cerebrovascular accident (CVA), hyperlipidemia and vaginal hysterectomy. Her concomitant medications included LASIX, aspirin, SYMBICORT and ZOCOR. Her vaccination history included administration of tetanus toxoid (manufacturer and batch number: not reported) which was well tolerated. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly on 31 Oct 2013. It was reported that she drove herself to a retail pharmacy and got vaccination and there was no complaints of illness at the time of vaccination. On 31 Oct 2013, she presented with fever, chills and shortness of breath (SOB). The patient stated that prior evening; she suddenly started having shaking chills, fever and her shortness of breath got worse and the events had been increasingly worsening over the past couple of days. There was no real cough or productive sputum noted and she denied any other symptoms. She went to emergency room and was hospitalized for 2 days. She had sinus tachycardia with a heart rate of 114. Her chest X-ray and Computerised Tomogram was normal. Her complete blood count (CBC) was done and was within normal limits. White blood cell count (WBC) was reported as 10.1 (units and normal values were not reported). Her blood pressure was 141/100, body temperature was 100.5 F, pulse rate was 114, respiratory rate was 22, Oxygen saturation was 98% on 2L/NC and blood glucose was 102 (units and normal values of laboratory tests were not reported). The outcome was reported as complete recovery. The event was reported as serious due to hospitalization. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309401) 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: 295525) on 21 May 2014: Updated batch review report.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Full blood count normal, Heart rate increased, Pyrexia, Sinus tachycardia
Clinical narrative: Case number PHHY2014US047133 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522171) web site on 14 Apr 2014 and a follow up received from Quality Assurance Department (QA, reference number: 295525) on 21 May 2014. This report refers to an 80 year old female patient. Her past medical history included coronary artery disease (CAD), status post aortic valve replacement, multiple sclerosis (MS), anemia, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), atrial fibrillation (AFIB), cerebrovascular accident (CVA), hyperlipidemia and vaginal hysterectomy. Her concomitant medications included LASIX, aspirin, SYMBICORT and ZOCOR. Her vaccination history included administration of tetanus toxoid (manufacturer and batch number: not reported) which was well tolerated. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly on 31 Oct 2013. It was reported that she drove herself to a retail pharmacy and got vaccination and there was no complaints of illness at the time of vaccination. On 31 Oct 2013, she presented with fever, chills and shortness of breath (SOB). The patient stated that prior evening; she suddenly started having shaking chills, fever and her shortness of breath got worse and the events had been increasingly worsening over the past couple of days. There was no real cough or productive sputum noted and she denied any other symptoms. She went to emergency room and was hospitalized for 2 days. She had sinus tachycardia with a heart rate of 114. Her chest X-ray and Computerised Tomogram was normal. Her complete blood count (CBC) was done and was within normal limits. White blood cell count (WBC) was reported as 10.1 (units and normal values were not reported). Her blood pressure was 141/100, body temperature was 100.5 F, pulse rate was 114, respiratory rate was 22, Oxygen saturation was 98% on 2L/NC and blood glucose was 102 (units and normal values of laboratory tests were not reported). The outcome was reported as complete recovery. The event was reported as serious due to hospitalization. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309401) 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: 295525) on 21 May 2014: Updated batch review report.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor, White blood cell count increased
Clinical narrative: Case number PHHY2014US047133 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 522171) web site on 14 Apr 2014 and a follow up received from Quality Assurance Department (QA, reference number: 295525) on 21 May 2014. This report refers to an 80 year old female patient. Her past medical history included coronary artery disease (CAD), status post aortic valve replacement, multiple sclerosis (MS), anemia, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), atrial fibrillation (AFIB), cerebrovascular accident (CVA), hyperlipidemia and vaginal hysterectomy. Her concomitant medications included LASIX, aspirin, SYMBICORT and ZOCOR. Her vaccination history included administration of tetanus toxoid (manufacturer and batch number: not reported) which was well tolerated. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly on 31 Oct 2013. It was reported that she drove herself to a retail pharmacy and got vaccination and there was no complaints of illness at the time of vaccination. On 31 Oct 2013, she presented with fever, chills and shortness of breath (SOB). The patient stated that prior evening; she suddenly started having shaking chills, fever and her shortness of breath got worse and the events had been increasingly worsening over the past couple of days. There was no real cough or productive sputum noted and she denied any other symptoms. She went to emergency room and was hospitalized for 2 days. She had sinus tachycardia with a heart rate of 114. Her chest X-ray and Computerised Tomogram was normal. Her complete blood count (CBC) was done and was within normal limits. White blood cell count (WBC) was reported as 10.1 (units and normal values were not reported). Her blood pressure was 141/100, body temperature was 100.5 F, pulse rate was 114, respiratory rate was 22, Oxygen saturation was 98% on 2L/NC and blood glucose was 102 (units and normal values of laboratory tests were not reported). The outcome was reported as complete recovery. The event was reported as serious due to hospitalization. The causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309401) 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: 295525) on 21 May 2014: Updated batch review report.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Atrial fibrillation, Back pain, Dizziness, Dysphemia
Clinical narrative: Case number PHHY2014US046490, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522197) website on 14 Apr 2014 and a follow up report from the QA department (QA reference number: 295275) received on 21 May 2014. This report refers to a 84-year-old male patient. Concomitant drugs included Diovan and Celebrex. He was vaccinated with FLUVIRIN (batch number: 1307701) intramuscularly in the left arm on 04 Sep 2013. On 25 Dec 2013, he started to feel dizzy. On 31 Dec 2013, it started to hurt in upper back for the patient. On 02 Jan 2014, the patient stutter stepped when walking and could no longer walk with pain in back which was unbearable. It was reported that after one week at hospital, the patient was diagnosed with GBS (guillain-barre syndrome) and moved to another hospital for treatment. The patient was released to rehabilitation hospital but the next day he was admitted to a third hospital for sepsis. The patient had shallow breathing and a-fib (atrial fibrillation) but has recovered a lot of feeling sensation after treatment was given. The final outcome of the events was unknown. The events were reported as serious (hospitalization for 40 days). The causality of the events was not reported. Based on the review performed, it was concluded that this batch 1307701 of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report from the QA department (QA reference number: 295275) received on 21 May 2014: Updated batch review report.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypopnoea, Sepsis
Clinical narrative: Case number PHHY2014US046490, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522197) website on 14 Apr 2014 and a follow up report from the QA department (QA reference number: 295275) received on 21 May 2014. This report refers to a 84-year-old male patient. Concomitant drugs included Diovan and Celebrex. He was vaccinated with FLUVIRIN (batch number: 1307701) intramuscularly in the left arm on 04 Sep 2013. On 25 Dec 2013, he started to feel dizzy. On 31 Dec 2013, it started to hurt in upper back for the patient. On 02 Jan 2014, the patient stutter stepped when walking and could no longer walk with pain in back which was unbearable. It was reported that after one week at hospital, the patient was diagnosed with GBS (guillain-barre syndrome) and moved to another hospital for treatment. The patient was released to rehabilitation hospital but the next day he was admitted to a third hospital for sepsis. The patient had shallow breathing and a-fib (atrial fibrillation) but has recovered a lot of feeling sensation after treatment was given. The final outcome of the events was unknown. The events were reported as serious (hospitalization for 40 days). The causality of the events was not reported. Based on the review performed, it was concluded that this batch 1307701 of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report from the QA department (QA reference number: 295275) received on 21 May 2014: Updated batch review report.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypopnoea, Sensory loss, Sepsis
Clinical narrative: Case number PHHY2014US046490, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522197) website on 14 Apr 2014 and a follow up report from the QA department (QA reference number: 295275) received on 21 May 2014. This report refers to a 84-year-old male patient. Concomitant drugs included Diovan and Celebrex. He was vaccinated with FLUVIRIN (batch number: 1307701) intramuscularly in the left arm on 04 Sep 2013. On 25 Dec 2013, he started to feel dizzy. On 31 Dec 2013, it started to hurt in upper back for the patient. On 02 Jan 2014, the patient stutter stepped when walking and could no longer walk with pain in back which was unbearable. It was reported that after one week at hospital, the patient was diagnosed with GBS (guillain-barre syndrome) and moved to another hospital for treatment. The patient was released to rehabilitation hospital but the next day he was admitted to a third hospital for sepsis. The patient had shallow breathing and a-fib (atrial fibrillation) but has recovered a lot of feeling sensation after treatment was given. The final outcome of the events was unknown. The events were reported as serious (hospitalization for 40 days). The causality of the events was not reported. Based on the review performed, it was concluded that this batch 1307701 of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report from the QA department (QA reference number: 295275) received on 21 May 2014: Updated batch review report.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, FLU3, HEPA, HPV4, MNQ
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Case number PHHY2014US047023, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522288) website on 14 Apr 2014 and a follow up report from the QA department (QA number: 295094) received on 22 May 2014. This report refers to an 11-year-old female patient. Past medical history and concomitant medications were not reported. She had a well child visit prior vaccination. She was vaccinated with MENVEO (batch number AX13012), along with FLUZONE (other manufacturer, batch number: UH921AA), HAVRIX (other manufacturer, batch number: 99P59) intramuscularly into the left arm and GARDASIL (other manufacturer, batch number: J006850) intramuscularly into the right arm on 29 Jan 2014. On an unknown date after vaccination, her left upper arm was red, itchy and edematous. A diagnosis of cellulitis and abscess of unspecified sites was made. Treatment for the events was rendered with KEFLEX 500 mg for 10 days. The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported. Based on the batch review report, it was concluded that the concerned MENVEO batch number (AX13012) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department (QA number: 295094) received on 22 May 2014: Updated batch review report.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: Chills, Erythema, Feeling hot, Inflammation, Injection site reaction
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 43-year-old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asthma, both vaccines received in the same arm. On an unspecified date, the patient also received Tdap (manufacturer and batch number not reported) in the opposite arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 102.8 degrees Fahrenheit. She developed rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. She had a significant leucocytosis with white blood cell count at 22 K/ul with the predominance of neutrophils. The reaction was presumed to be cellulitis. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: Leukocytosis, Local reaction, Pyrexia, Swelling, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 43-year-old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asthma, both vaccines received in the same arm. On an unspecified date, the patient also received Tdap (manufacturer and batch number not reported) in the opposite arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 102.8 degrees Fahrenheit. She developed rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. She had a significant leucocytosis with white blood cell count at 22 K/ul with the predominance of neutrophils. The reaction was presumed to be cellulitis. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: Cellulitis, Chills, Inflammation, Injection site erythema, Injection site oedema
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 43-year-old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asthma, both vaccines received in the same arm. On an unspecified date, the patient also received Tdap (manufacturer and batch number not reported) in the opposite arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 102.8 degrees Fahrenheit. She developed rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. She had a significant leucocytosis with white blood cell count at 22 K/ul with the predominance of neutrophils. The reaction was presumed to be cellulitis. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: Injection site warmth, Leukocytosis, Local reaction, Local swelling, Pyrexia
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 43-year-old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asthma, both vaccines received in the same arm. On an unspecified date, the patient also received Tdap (manufacturer and batch number not reported) in the opposite arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 102.8 degrees Fahrenheit. She developed rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. She had a significant leucocytosis with white blood cell count at 22 K/ul with the predominance of neutrophils. The reaction was presumed to be cellulitis. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 43-year-old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asthma, both vaccines received in the same arm. On an unspecified date, the patient also received Tdap (manufacturer and batch number not reported) in the opposite arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 102.8 degrees Fahrenheit. She developed rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. She had a significant leucocytosis with white blood cell count at 22 K/ul with the predominance of neutrophils. The reaction was presumed to be cellulitis. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine.
Age: 28.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Inflammation, Injection site erythema, Injection site oedema, Injection site warmth, Leukocytosis
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 28-year-old male patient. The patient had received PS23 vaccine prior to this reaction. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asplenia, both vaccines received in the same arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 104.5 degree Fahrenheit. The patient also developed vomiting. He experienced erythema, edema and warmth of the pneumococcal and influenza injection sites. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination and was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 29.7 K/ul with the predominance of neutrophils. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were not checked. The patient received full course of antibiotics to cover for skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The patient was discharged with antibiotics. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patient who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The reporter stated that the patient experienced fever and systemic symptoms which local erythema with 24 hours of vaccination who was treated with antibiotics did not improve as would be expected if these local reactions represented cellulitis infection.
Age: 28.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 28-year-old male patient. The patient had received PS23 vaccine prior to this reaction. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asplenia, both vaccines received in the same arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 104.5 degree Fahrenheit. The patient also developed vomiting. He experienced erythema, edema and warmth of the pneumococcal and influenza injection sites. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination and was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 29.7 K/ul with the predominance of neutrophils. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were not checked. The patient received full course of antibiotics to cover for skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The patient was discharged with antibiotics. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patient who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The reporter stated that the patient experienced fever and systemic symptoms which local erythema with 24 hours of vaccination who was treated with antibiotics did not improve as would be expected if these local reactions represented cellulitis infection.
Age: 28.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Cellulitis, Inflammation, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 28-year-old male patient. The patient had received PS23 vaccine prior to this reaction. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asplenia, both vaccines received in the same arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 104.5 degree Fahrenheit. The patient also developed vomiting. He experienced erythema, edema and warmth of the pneumococcal and influenza injection sites. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination and was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 29.7 K/ul with the predominance of neutrophils. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were not checked. The patient received full course of antibiotics to cover for skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The patient was discharged with antibiotics. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patient who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The reporter stated that the patient experienced fever and systemic symptoms which local erythema with 24 hours of vaccination who was treated with antibiotics did not improve as would be expected if these local reactions represented cellulitis infection.
Age: 28.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Leukocytosis, Local reaction, Local swelling, Neutrophil count increased, Pyrexia
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 28-year-old male patient. The patient had received PS23 vaccine prior to this reaction. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asplenia, both vaccines received in the same arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 104.5 degree Fahrenheit. The patient also developed vomiting. He experienced erythema, edema and warmth of the pneumococcal and influenza injection sites. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination and was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 29.7 K/ul with the predominance of neutrophils. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were not checked. The patient received full course of antibiotics to cover for skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The patient was discharged with antibiotics. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patient who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The reporter stated that the patient experienced fever and systemic symptoms which local erythema with 24 hours of vaccination who was treated with antibiotics did not improve as would be expected if these local reactions represented cellulitis infection.
Age: 28.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 28-year-old male patient. The patient had received PS23 vaccine prior to this reaction. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS23 injection (manufacturer and batch number not provided) for asplenia, both vaccines received in the same arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degrees Fahrenheit. The patient had maximum temperature of 104.5 degree Fahrenheit. The patient also developed vomiting. He experienced erythema, edema and warmth of the pneumococcal and influenza injection sites. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination and was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 29.7 K/ul with the predominance of neutrophils. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were not checked. The patient received full course of antibiotics to cover for skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The patient was discharged with antibiotics. The outcome was reported as recovering for the skin findings and recovered for the systemic symptoms. Reporter's comments: The reporter stated that the local reaction experienced by the patient who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The reporter stated that the patient experienced fever and systemic symptoms which local erythema with 24 hours of vaccination who was treated with antibiotics did not improve as would be expected if these local reactions represented cellulitis infection.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Per mother patient had prolonged crying (7 hrs) not consolable, starting one hour after last vaccines which was 03/24/14. Mother never reported this until 5/20/2014.
Sex: M
Vaccine: HEP
Symptoms: Death
Clinical narrative: NO information available to describe any adverse effects.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Aphonia, Inappropriate schedule of drug administration, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 18 year old female patient. There was no information about medical history/concurrent conditions and concomitant medication. The doctor mentioned that "about a year and a half ago", in approximately November 2012, the patient was vaccinated with the second dose of GARDASIL (lot#, dose and route unspecified). When receiving the second dose, the patient experienced syncope for about two to three minutes. She was in an unconscious state and could respond to questions with motions but unable to verbalize. The patient did not seek medical attention. No treatment was given. She eventually completed the series of injections about a year after this episode in approximately November 2013 and she was fine by the time of this report. Upon internal review, unconscious state and unable to verbalize were considered to be medically significant. Additional information is not expected.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 year old patient of unknown gender. On 31-JAN-2014 the patient was vaccinated with VARIVAX (Merck), lot # H018014, expiration date 01-OCT-2014, 0.5 ml once, subcutaneous (dose in series unspecified) that was improperly stored at 11.5F due to defrost cycling for an unspecified time frame. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding to the patients was available. On an unknown date the patients were vaccinated with improperly stored M-M-R II. Strength, dose, route and lot number were not provided. M-M-R II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the vaccine M-M-R II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The M-M-R II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476 to 1405USA012479, 1405USA012481, 1405USA012482 and 1405USA004216). Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Body temperature increased, Injection site urticaria, Oedema peripheral, Urticaria
Clinical narrative: Patient developed hives on face, abdomen, arms, and legs the evening of day of immunization. Some edema of hands and feet. Temperature 99-100 degrees Fahrenheit. Benadryl and Ibuprofen given over next 2.5 days. Symptoms resolved on beginning of third day without residual effects.   Per mother, private physician recommended no immunizations for 6 months.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash across up abdomen and part of breasts.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Unable to move arms and legs after 12 days of vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Swelling face
Clinical narrative: Swelling of right cheek.  Worse in mornings.  No treatment - just monitored.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Neck pain, Oropharyngeal pain, Pain in extremity, Pain in jaw
Clinical narrative: The patient states that the day following administration of the vaccine she developed severe pain in her right arm and could not lift it above shoulder level.  She had received the vaccine in her right arm.  She then reported that the symptoms seemed to travel and effect the right side of her body.  First her arm, then her neck/throat, and then her jaw.  The symptoms were moderate and were worse when swallowing/talking/eating.  The symptoms slwly improved and had completely resolved by 4 days post-immunization.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Dyskinesia, Muscle twitching, Tic
Clinical narrative: Initial report received from a healthcare professional on 22 May 2014. A five-year-old male patient, with a history of asthma, received an intramuscular left deltoid injection of INFLUENZA QUADRIVAL A-B VACCINE (lot number U4820BA) on 29 January 2014. Two days post-vaccination, on 31 January 2014, the patient developed a tic, with twitching and jerking of the arms, legs, and head. Symptoms not occur when the patient was sleeping, and worsened when the patient was tired or ill; they did not interfere with school or play. The patient was seen in the emergency room, where symptoms were documented on video. He had been seen by a neurologist and diagnosed with transient tic disorder of acute onset. Treatment included amoxicillin and ZITHROMAX with no improvement of symptoms. At the time of the report, the patient had not recovered. Documents held by sender: None.
Sex: M
Vaccine: DTP
Symptoms: Hypotonia, Unresponsive to stimuli
Clinical narrative: Initial report received on 21 May 2014 from a healthcare provider (physician). A male patient was vaccinated as an infant on an unreported date with the third or fourth dose of DPT (manufacturer, batch, route and site of vaccination not reported). Hours after vaccination, the patient became "limp" and "was non-responsive for a while". The patients concomitant medications and medical history was not reported. The patient recovered at an unreported date and time. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect storage of drug, Injection site cellulitis, Injection site rash
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site cellulitis in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine; manufacturer unspecified; unknown; unknown given on 20 May 2014; MMR vaccine, strain not specified; manufacturer unspecified; unknown; unknown given on 20 May 2014; IPV (non-gsk); manufacturer unspecified; unknown; unknown given on 20 May 2014; varicella virus vaccine; manufacturer unspecified; unknown; unknown given on 20 May 2014. There were no concomitant medications or relevant medical history. There were no adverse reactions following previous vaccinations. On 20 May 2014 the subject received a dose of INFANRIX (1 dose, unknown route, right thigh) as the last dose in the DTaP series. In May 2014, within days after receiving INFANRIX, the patient experienced injection site cellulitis, injection site rash and incorrect storage of drug. Per the nurse, the INFANRIX that was administered was not viable as it was exposed to temperatures of 52.1 degrees Fahrenheit for 188 hours. The patient experienced a 3.5 centimeter sized rash on her right thigh and visited the emergency room. The patient was diagnosed with immunization reaction and cellulitis. The patient was treated with ZITHROMAX. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events of injection site cellulitis and injection site rash were related to vaccination with INFANRIX. Per the nurse, "the doctor thinks the cellulitis was caused by INFANRIX."
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Post vaccination autoinoculation
Clinical narrative: Auto inoculation from smallpox.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Fatigue, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Severe pain near injection site, which is the left arm, burning, half the upper arm had a huge red mark, could barely lift the arm, chills, followed by being very hot and sweaty, stiff neck, headache in the back of the head and extreme fatigue, slight nausea no vomiting. On 5/25/2014 9:00 AM went for treatment. It was determined that it was a reaction from the vaccine. Was put on an antibiotic. Told I should probably not continue with the remaining injections and watch for any further signs. On day of treatment started to feel somewhat better around 4:00 PM. Pain in arm got much better and fever went away. Feel back to normal now still have a slight tenderness near injection sight and all redness has disappeared.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Severe pain near injection site, which is the left arm, burning, half the upper arm had a huge red mark, could barely lift the arm, chills, followed by being very hot and sweaty, stiff neck, headache in the back of the head and extreme fatigue, slight nausea no vomiting. On 5/25/2014 9:00 AM went for treatment. It was determined that it was a reaction from the vaccine. Was put on an antibiotic. Told I should probably not continue with the remaining injections and watch for any further signs. On day of treatment started to feel somewhat better around 4:00 PM. Pain in arm got much better and fever went away. Feel back to normal now still have a slight tenderness near injection sight and all redness has disappeared.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Severe pain near injection site, which is the left arm, burning, half the upper arm had a huge red mark, could barely lift the arm, chills, followed by being very hot and sweaty, stiff neck, headache in the back of the head and extreme fatigue, slight nausea no vomiting. On 5/25/2014 9:00 AM went for treatment. It was determined that it was a reaction from the vaccine. Was put on an antibiotic. Told I should probably not continue with the remaining injections and watch for any further signs. On day of treatment started to feel somewhat better around 4:00 PM. Pain in arm got much better and fever went away. Feel back to normal now still have a slight tenderness near injection sight and all redness has disappeared.