chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Nerve injury, Pain in extremity
Clinical narrative: Patient left message on 12/30/15 to state arm was painful with periods of numbness. Unable to lift past a 45 degree angle. Had not seen a physician at this time. On 1/4/16 facility provided resources encouraging patient to be seen by medical provider. Facility spoke to patient on 1/12/16. Still with pain and still has not been seen by physician. Doctor appointment set up for patient on 1/15/2016 at Medical Clinic. Patient left a message on 1/16/2016 that doctor states she had nerve damage. Anti-inflammatory and pain med presribed.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Swelling face, VIIth nerve paralysis
Clinical narrative: Swelling of left side of face with paralysis.
Age: 56.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea, Fatigue, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 56-year-old male subject who received Flu seasonal TIV Dresden. This case refers to patient 9 in the literature article. Concurrent medical conditions included penicillin allergy. On an unknown date, 1 hr after receiving Flu seasonal TIV Dresden and dTpa vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included angioedema with serious criteria of GSK medically significant, shortness of breath, vomiting and fatigue. The subject was treated with antihistamine. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved), shortness of breath (recovered/resolved), vomiting (recovered/resolved) and fatigue (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema, shortness of breath, vomiting and fatigue may have been caused by Flu seasonal TIV Dresden and dTpa vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of vaccine-triggered anaphylaxis in a 56-year-old male patient who had received an unspecified Tdap (manufacturer unknown) and an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a male. The subject's medical history included atopic disease with amoxicillin allergy. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January 2009 and the 31st of December 2011, the patient received an unspecified dose of an unspecified Tdap and an unspecified trivalent influenza vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 60 minutes and less than 90 minutes after the vaccination, the patient developed angioedema, shortness of breath, vomiting and fatigue. This was classified as anaphylaxis by the family practice doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by oral antihistamine. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Cough, Pruritus generalised, Vomiting, Wheezing
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 5-year-old male subject who received DTaP-IPV vaccine. This case refers to patient 1 in the literature article. Co-suspect products included varicella vaccine and epinephrine. Concurrent medical conditions included fish allergy, peanut allergy and egg allergy. On an unknown date, several minutes after receiving DTaP-IPV vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included general pruritus, wheezing, cough and vomiting. The subject was treated with epinephrine, antihistamine and antiemetic. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included general pruritus (recovered/resolved), wheezing (recovered/resolved), cough (recovered/resolved) and vomiting (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, general pruritus, wheezing, cough and vomiting may have been caused by DTaP-IPV vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 5-year-old male patient who had received an unspecified MMR vaccine (manufacturer unknown), an unspecified DTaP and IPV vaccine (manufacturer unknown) and an unspecified varicella vaccine (manufacturer unknown). The patient was a male. The subject's medical history included atopic disease with fish, peanuts and eggs allergies. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified MMR vaccine, an unspecified DTaP and IPV vaccine and an unspecified varicella vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within less than 30 minutes after the vaccination, the patient developed general pruritus, wheeze, cough and vomiting. This was classified as anaphylaxis by the paediatrician. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by epinephrine, oral antihistamine and antiemetic. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Wheezing
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 26-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 2 in the literature article. Co-suspect products included 23-valent pneumococcal polysaccharide vaccine. Concurrent medical conditions included asthma. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included wheezing, shortness of breath, nasal congestion and nausea. The subject was treated with nebulizer (name unknown). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included wheezing (recovered/resolved), shortness of breath (recovered/resolved), nasal congestion (recovered/resolved) and nausea (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, wheezing, shortness of breath, nasal congestion and nausea may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab test performed on unknown date Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, heart rate result was increased. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 26-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown) and an unspecified 23-valent pneumococcal polysaccharide vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with asthma. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine and an unspecified 23-valent pneumococcal polysaccharide vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, an unknown period after the vaccination, the patient developed bilateral wheeze, shortness of breath, heart rate increased, nasal congestion and nausea. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was the emergency department. The patient was treated by nebulizer. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Respiratory distress, Urticaria, Vomiting, Wheezing
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 4-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 3 in the literature article. Concurrent medical conditions included asthma. Historical condition included atopic dermatitis. On an unknown date, less than an hour after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized urticaria, wheezing, respiratory distress with serious criteria of GSK medically significant and vomiting. The subject was treated with epinephrine, antihistamine, oxygen and albuterol nebulizer. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized urticaria (recovered/resolved), wheezing (recovered/resolved), respiratory distress (recovered/resolved) and vomiting (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized urticaria, wheezing, respiratory distress and vomiting may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 4-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The subject's medical history included atopic dermatitis with asthma and atopic dermatitis. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, within 30 minutes and less than 1 hour after the vaccination, the patient developed generalized urticaria, wheeze, respiratory distress and vomiting. This was classified as anaphylaxis by the family nurse practitioner. According to the authors the case was considered as Brighton level 1 and setting of initial evaluation was clinic. The patient was treated by epinephrine, oral antihistamine, oxygen and albuterol nebulizer. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Body temperature increased, Dyspnoea, Erythema, Fatigue, Pain in extremity
Clinical narrative: Arm red and sore, temperature at 101, hard to breathe (used Symbicort), very tired, went  to bed 8:00.  Today is 01/18/2016 and arm still red and hurts.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Central nervous system inflammation, Computerised tomogram, Constipation, Hypoaesthesia
Clinical narrative: NUMBNESS BOTTOM LEFT FOOT FROM KNEE TO FOOT. UNABLE KEEP OVERALL BODY BALANCE. CONSTIPATION. UNABLE CONTROL BLADDER.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging thoracic, Urinary incontinence
Clinical narrative: NUMBNESS BOTTOM LEFT FOOT FROM KNEE TO FOOT. UNABLE KEEP OVERALL BODY BALANCE. CONSTIPATION. UNABLE CONTROL BLADDER.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Central nervous system inflammation, Constipation, Hypoaesthesia, Nuclear magnetic resonance imaging brain
Clinical narrative: NUMBNESS BOTTOM LEFT FOOT FROM KNEE TO FOOT. UNABLE KEEP OVERALL BODY BALANCE. CONSTIPATION. UNABLE CONTROL BLADDER.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging thoracic, Urinary incontinence
Clinical narrative: NUMBNESS BOTTOM LEFT FOOT FROM KNEE TO FOOT. UNABLE KEEP OVERALL BODY BALANCE. CONSTIPATION. UNABLE CONTROL BLADDER.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus, Rash, Urticaria
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 5-year-old male subject who received Flu seasonal TIV Dresden. This case refers to patient 12 in the literature article. Concurrent medical conditions included asthma and allergy to nuts (cashew and pistachio). On an unknown date, 3 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized urticaria, pruritus, rash and shortness of breath. The subject was treated with antihistamine and Steroid (Unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized urticaria (recovered/resolved), pruritus (recovered/resolved), rash (recovered/resolved) and shortness of breath (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized urticaria, pruritus, rash and shortness of breath may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 5-year-old male patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a male. The subject's medical history included atopic disease with asthma, cashew and pistachio nuts allergies. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, 3 hours after the vaccination, the patient developed generalized urticaria, pruritus, rash and shortness of breath. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine and oral steroids. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This is 1 of the 28 valid cases reported in the same literature article.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Angioedema, Cough
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 9-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 17 in the literature article. On an unknown date, several minutes after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included angioedema with serious criteria of GSK medically significant and cough. The subject was treated with epinephrine, antihistamine, steroid (unspecified), bronchodilator and ice pack (Nos). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved) and cough (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema and cough may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 9-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). No information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, less than 30 minutes after the vaccination, the patient developed eyelid angioedema and cough. This was classified as anaphylaxis by the emergency department doctor and the paediatrician. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by epinephrine, oral antihistamine, oral steroids, bronchodilators and icepack. At the time of reporting the outcome of the events was recovered.  The patient was referred to a paediatrician. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Angioedema, Cough, Dyspnoea, Enlarged uvula
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 29-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 13 in the literature article. On an unknown date, 8 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included pruritus, angioedema with serious criteria of GSK medically significant, cough, swelling, generalized urticaria, rash and shortness of breath. The subject was treated with antihistamine, H2 blocker and steroid (unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included pruritus (recovered/resolved), angioedema (recovered/resolved), cough (recovered/resolved), swelling (recovered/resolved), generalized urticaria (recovered/resolved), rash (recovered/resolved) and shortness of breath (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, pruritus, angioedema, cough, swelling, generalized urticaria, rash and shortness of breath may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 29-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). The following day, 8 hours after the vaccination, the patient developed angioedema, lips, uvula and mouth swelling, generalized urticaria, pruritus, rash, shortness of breath and cough. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 1 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine, oral H2-blocker and oral steroids. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Mouth swelling, Pruritus, Rash, Swelling
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 29-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 13 in the literature article. On an unknown date, 8 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included pruritus, angioedema with serious criteria of GSK medically significant, cough, swelling, generalized urticaria, rash and shortness of breath. The subject was treated with antihistamine, H2 blocker and steroid (unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included pruritus (recovered/resolved), angioedema (recovered/resolved), cough (recovered/resolved), swelling (recovered/resolved), generalized urticaria (recovered/resolved), rash (recovered/resolved) and shortness of breath (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, pruritus, angioedema, cough, swelling, generalized urticaria, rash and shortness of breath may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 29-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). The following day, 8 hours after the vaccination, the patient developed angioedema, lips, uvula and mouth swelling, generalized urticaria, pruritus, rash, shortness of breath and cough. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 1 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine, oral H2-blocker and oral steroids. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 29-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 13 in the literature article. On an unknown date, 8 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included pruritus, angioedema with serious criteria of GSK medically significant, cough, swelling, generalized urticaria, rash and shortness of breath. The subject was treated with antihistamine, H2 blocker and steroid (unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included pruritus (recovered/resolved), angioedema (recovered/resolved), cough (recovered/resolved), swelling (recovered/resolved), generalized urticaria (recovered/resolved), rash (recovered/resolved) and shortness of breath (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, pruritus, angioedema, cough, swelling, generalized urticaria, rash and shortness of breath may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 29-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). The following day, 8 hours after the vaccination, the patient developed angioedema, lips, uvula and mouth swelling, generalized urticaria, pruritus, rash, shortness of breath and cough. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 1 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine, oral H2-blocker and oral steroids. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Eye pruritus, Ocular hyperaemia, Wheezing
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 55-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 14 in the literature article. On an unknown date, 6 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included wheezing, shortness of breath, eye red and eye pruritus. The subject was treated with antihistamine, steroids nos, bronchodilator (nos) and medication unknown (fluids). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included wheezing (recovered/resolved), shortness of breath (recovered/resolved), eye red (recovered/resolved) and eye pruritus (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, wheezing, shortness of breath, eye red and eye pruritus may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 55-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, 6 hours after the vaccination, the patient developed wheeze, shortness of breath and red and itchy eyes. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine, oral steroids, bronchodilators, fluids and rest. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dysstasia, Fall, Hypoaesthesia, Influenza
Clinical narrative: Flu and diarrhea from 4 to 11 Nov. 12 Nov. numbness in arms and legs. 13 Nov fell while walking, 14 Nov. couldn't stand. 15 Nov. unable to move, taken and admitted to hospital by ambulance.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Flu and diarrhea from 4 to 11 Nov. 12 Nov. numbness in arms and legs. 13 Nov fell while walking, 14 Nov. couldn't stand. 15 Nov. unable to move, taken and admitted to hospital by ambulance.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus generalised, Swollen tongue, Throat tightness
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 35-year-old  female subject who received Flu seasonal TIV Dresden. This case refers to patient 32 in the literature article. Concurrent medical conditions included shellfish allergy, latex allergy, penicillin allergy, allergic reaction to antibiotics and allergic reaction to antibiotics. On an unknown date, several minutes after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized pruritus, swollen tongue, shortness of breath and throat tightness. The subject was treated with epinephrine, antihistamine, antihistamine and albuterol. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized pruritus (recovered/resolved), swollen tongue (recovered/resolved), shortness of breath (recovered/resolved) and throat tightness (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized pruritus, swollen tongue, shortness of breath and throat tightness may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 35-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown).  The patient was a female. The subject's medical history included atopic disease with shellfish, latex, amoxicillin, ciprofloxacin and gentamicin allergies. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, within less than 30 minutes after the vaccination, the patient developed generalized pruritus, tongue swelling, shortness of breath and throat closure. This was classified as anaphylaxis by the family practice doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by epinephrine, parenteral antihistamine, intravenous therapy and albuterol. At the time of reporting the outcome orf the events was recovered. The event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Vomiting, Wheezing
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 14-year-old female subject who received Flu seasonal TIV Dresden. This cases refers to patient 11 in the literature article. Concurrent medical conditions included asthma. Historical conditions included allergic conjunctivitis and rhinitis. On an unknown date, 2 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included wheezing and vomiting. The subject was treated with antihistamine and Bronchodilator. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included wheezing (recovered/resolved) and vomiting (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, wheezing and vomiting may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 14-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with asthma and allergic conjunctivitis and rhinitis. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided.  On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, 2 hours after the vaccination, the patient developed wheeze and vomiting. This was classified as anaphylaxis by the paediatrician. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by oral antihistamine and bronchodilators. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 62.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Abdominal pain, Anaphylactic reaction, Dyspnoea, Flushing, Nausea
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 62-year-old female subject who received Tdap vaccine. This case refers to patient 6 in the literature article. Previously experienced adverse reactions included hives (after sulfa and cephalexin). On an unknown date, less than an hour after receiving Tdap vaccine and hepatitis vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included vomiting, flushing, shortness of breath, nausea and abdominal pain. The subject was treated with epinephrine, antihistamine, H2 blocker, Steroid (Unspecified), oxygen, ASA, Nitroglycerin and morphine sulfate controlled release. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included vomiting (recovered/resolved), flushing (recovered/resolved), shortness of breath (recovered/resolved), nausea (recovered/resolved) and abdominal pain (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, vomiting, flushing, shortness of breath, nausea and abdominal pain may have been caused by Tdap vaccine and hepatitis vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 62-year-old female patient who had received unspecified Tdap vaccine (manufacturer unknown) and an unspecified hepatitis vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with hives after sulfa and cephalexin. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified Tdap vaccine and an unspecified hepatitis vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 30 minutes and less than 1 hour after the vaccination, the patient developed flushing, shortness of breath, nausea, vomiting and abdominal pain. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by parenteral antihistamine and, parenteral H2-blocker, parenteral steroid, oxygen, aspirin, nitroglycerin and morphine sulfate controlled-release. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 62.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 62-year-old female subject who received Tdap vaccine. This case refers to patient 6 in the literature article. Previously experienced adverse reactions included hives (after sulfa and cephalexin). On an unknown date, less than an hour after receiving Tdap vaccine and hepatitis vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included vomiting, flushing, shortness of breath, nausea and abdominal pain. The subject was treated with epinephrine, antihistamine, H2 blocker, Steroid (Unspecified), oxygen, ASA, Nitroglycerin and morphine sulfate controlled release. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included vomiting (recovered/resolved), flushing (recovered/resolved), shortness of breath (recovered/resolved), nausea (recovered/resolved) and abdominal pain (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, vomiting, flushing, shortness of breath, nausea and abdominal pain may have been caused by Tdap vaccine and hepatitis vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 62-year-old female patient who had received unspecified Tdap vaccine (manufacturer unknown) and an unspecified hepatitis vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with hives after sulfa and cephalexin. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified Tdap vaccine and an unspecified hepatitis vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 30 minutes and less than 1 hour after the vaccination, the patient developed flushing, shortness of breath, nausea, vomiting and abdominal pain. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by parenteral antihistamine and, parenteral H2-blocker, parenteral steroid, oxygen, aspirin, nitroglycerin and morphine sulfate controlled-release. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and complaints of pain to injection site (left upper arm). Applied ice pack for 10 minutes and held patient in clinic for 20 minute observation to rule out possible adverse reaction.
Age: 29.0
Sex: M
Vaccine: FLUC3
Symptoms: Abdominal pain, Vomiting
Clinical narrative: I ate eggs for dinner and about 30 minutes later I had abdominal pain. Not long after that I started vomiting. Now, every time I eat eggs I have abdominal pain with or without vomiting.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: Patient had body aches so bad it was hard to move, fever, nausea and a red bump developed where vaccine was administered.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site swelling
Clinical narrative: Patient had body aches so bad it was hard to move, fever, nausea and a red bump developed where vaccine was administered.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Anaphylactic reaction, Angioedema, Swollen tongue
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 15-year-old female subject who received dTpa vaccine. This case refers to patient 30 in the literature article. Co-suspect products included Varicella vaccine. The subject's past medical history included allergic rhinitis. Concurrent medical conditions included shellfish allergy and drug allergy. On an unknown date, several minutes after receiving dTpa vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included angioedema with serious criteria of GSK medically significant and swollen tongue. The subject was treated with epinephrine, antihistamine and Steroid (Unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved) and swollen tongue (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema and swollen tongue may have been caused by dTpa vaccine and varicella vaccine. Additional information was reported: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 15-year-old female patient who had received an unspecified Tdap vaccine (manufacturer unknown) and an unspecified varicella vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with allergic rhinitis and shellfish and methylprednisolone allergies. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified Tdap vaccine and an unspecified varicella vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 30 and less than 60 minutes after the vaccination, the patient developed lips angioedema and tongue swelling. This was classified as anaphylaxis by the family practice provider. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by epinephrine, oral antihistamine and oral steroid. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare professional referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB injection (lot # L019298 with expiration date 22-JUN-2017; dose and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.