chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a clinical medical assistant referring to a 4 month old patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 06-JAN-2016 the patient was inadvertently vaccinated with a dose of VAQTA, lot # L015460, expiration date on 20-JUL-2017 (route, anatomical location and dose were not provided). Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Back pain, Chest pain, Exposure during pregnancy, Neck pain, Pain in extremity
Clinical narrative: This is a prospective pregnancy case. This 32-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV Dresden (intramuscular) on 16th December 2015. Concomitant products included Prenatal Vitamins. The subject's last menstrual period was on 23rd September 2015 and estimated date of delivery was 21st June 2016. The subject received Flu Seasonal QIV Dresden at week 12 of the pregnancy and during the first trimester of pregnancy. On 17th December 2015, 1 days after receiving Flu Seasonal QIV Dresden, the subject developed pain in arm. Serious criteria included other: as per reporter. Additional event(s) included neck pain on 17th December 2015 with serious criteria of other: as per reporter, back pain on 17th December 2015 with serious criteria of other: as per reporter, chest pain on 17th December 2015 with serious criteria of other: as per reporter and vaccine exposure during pregnancy. The subject was treated with TYLENOL. The outcome of pain in arm was unknown. The outcome(s) of the additional event(s) included neck pain (unknown), back pain (unknown), chest pain (unknown) and vaccine exposure during pregnancy (unknown). It was unknown if the investigator considered the pain in arm, neck pain, back pain and chest pain to be related to Flu Seasonal QIV Dresden. Additional details were provided as follows: The medical assistant reported that, one day after receiving the FLUARIX QUADRIVALENT vaccine (batch number 5MJ7R, expiry date 30 June 2016), the patient started experiencing pain from the tip of her finger, up to her arm, into her neck, back and chest. The patient took some TYLENOL when the pain started and it subsided, but came back as soon as the TYLENOL wore off. The patient called the office about the pain and the office sent her to the emergency room.
Age: 32.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Neuralgia, Nuclear magnetic resonance imaging
Clinical narrative: This is a prospective pregnancy case. This 32-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV Dresden (intramuscular) on 16th December 2015. Concomitant products included Prenatal Vitamins. The subject's last menstrual period was on 23rd September 2015 and estimated date of delivery was 21st June 2016. The subject received Flu Seasonal QIV Dresden at week 12 of the pregnancy and during the first trimester of pregnancy. On 17th December 2015, 1 days after receiving Flu Seasonal QIV Dresden, the subject developed pain in arm. Serious criteria included other: as per reporter. Additional event(s) included neck pain on 17th December 2015 with serious criteria of other: as per reporter, back pain on 17th December 2015 with serious criteria of other: as per reporter, chest pain on 17th December 2015 with serious criteria of other: as per reporter and vaccine exposure during pregnancy. The subject was treated with TYLENOL. The outcome of pain in arm was unknown. The outcome(s) of the additional event(s) included neck pain (unknown), back pain (unknown), chest pain (unknown) and vaccine exposure during pregnancy (unknown). It was unknown if the investigator considered the pain in arm, neck pain, back pain and chest pain to be related to Flu Seasonal QIV Dresden. Additional details were provided as follows: The medical assistant reported that, one day after receiving the FLUARIX QUADRIVALENT vaccine (batch number 5MJ7R, expiry date 30 June 2016), the patient started experiencing pain from the tip of her finger, up to her arm, into her neck, back and chest. The patient took some TYLENOL when the pain started and it subsided, but came back as soon as the TYLENOL wore off. The patient called the office about the pain and the office sent her to the emergency room.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since 28-NOV-2015, an unspecified number of improperly stored doses of ZOSTAVAX (lot # L028280, expiration date: 28-OCT-2016) were inadvertently administered to the unspecified number of patients. No adverse effects have been reported. The reporter refers that was not product quality complaints involved. Additional l information  has been requested.
Sex: U
Vaccine: RV5
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 ROTATEQ oral solution (lot # L022447 with expiration date 26-FEB-2017; dose was 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.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cough, Pharyngeal erythema, Pruritus generalised, Rash generalised
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 6-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 21 in the literature article. The subject's past medical history included anaphylaxis, allergic rhinitis and reactive airways disease. Previously experienced adverse reactions included flu vaccination. On an unknown date, 1 hr after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included red throat, generalized pruritus, generalized rash and cough. The subject was treated with epinephrine and antihistamine. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included red throat (recovered/resolved), generalized pruritus (recovered/resolved), generalized rash (recovered/resolved) and cough (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, red throat, generalized pruritus, generalized rash 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 6-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 anaphylaxis, allergic rhinitis, reactive airway disease and trivalent influenza vaccine allergy. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On unspecified dates, between the 1st of January of 2009 and the 31st of December of 2011, the patient received 5 test doses of an unspecified trivalent influenza vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 60 and less than 90 minutes after the 5 test dose vaccination, the patient developed throat erythema, generalized pruritus and rash and cough. This was classified as anaphylaxis by the allergist. 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 and 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: 15.0
Sex: F
Vaccine: HPVX, TDAP
Symptoms: Abdominal pain, Anaphylactic reaction, Angioedema, Dyspnoea, Erythema
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 Tdap vaccine. This case refers to patient 4 in the literature article. Co-suspect products included HPV Quadrivalent vaccine. Concurrent medical conditions included asthma and allergy to vaccine (DTaP). On an unknown date, 2 hrs after receiving Tdap 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, generalized urticaria, erythema, pruritus, shortness of breath and abdominal pain. The subject was treated with antihistamine and Bronchodilator. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved), generalized urticaria (recovered/resolved), erythema (recovered/resolved), pruritus (recovered/resolved), shortness of breath (recovered/resolved) and abdominal pain (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema, generalized urticaria, erythema, pruritus, shortness of breath and abdominal pain may have been caused by Tdap vaccine and HPV 4 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 15-year-old female patient who had received an unspecified Tdap vaccine (manufacturer unknown) and an unspecified quadrivalent HPV vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with asthma and other allergy (DTaP vaccine). 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 quadrivalent HPV vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, 2 hours after the vaccination, the patient developed angioedema, generalized urticaria, erythema and pruritus, shortness of breath and abdominal pain. 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: 15.0
Sex: F
Vaccine: HPVX, TDAP
Symptoms: Pruritus, Urticaria
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 Tdap vaccine. This case refers to patient 4 in the literature article. Co-suspect products included HPV Quadrivalent vaccine. Concurrent medical conditions included asthma and allergy to vaccine (DTaP). On an unknown date, 2 hrs after receiving Tdap 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, generalized urticaria, erythema, pruritus, shortness of breath and abdominal pain. The subject was treated with antihistamine and Bronchodilator. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved), generalized urticaria (recovered/resolved), erythema (recovered/resolved), pruritus (recovered/resolved), shortness of breath (recovered/resolved) and abdominal pain (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema, generalized urticaria, erythema, pruritus, shortness of breath and abdominal pain may have been caused by Tdap vaccine and HPV 4 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 15-year-old female patient who had received an unspecified Tdap vaccine (manufacturer unknown) and an unspecified quadrivalent HPV vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with asthma and other allergy (DTaP vaccine). 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 quadrivalent HPV vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, 2 hours after the vaccination, the patient developed angioedema, generalized urticaria, erythema and pruritus, shortness of breath and abdominal pain. 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: 36.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Anaphylactic reaction, Angioedema, Choking, Cough, Heart rate increased
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 36-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 10 in the literature article. Historical conditions included contact dermatitis and allergic rhinitis. On an unknown date, 3 hrs 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, choking with serious criteria of GSK medically significant, cough and nausea. 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 angioedema (recovered/resolved), choking (recovered/resolved), cough (recovered/resolved) and nausea (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema, choking, cough and nausea may have been caused by Flu seasonal TIV Dresden and dTpa vaccine. 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 unknown. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 36-year-old female patient who had received an unspecified Tdap vaccine (manufacturer unknown) and an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with contact dermatitis and allergic 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 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, 3 hours after the vaccination, the patient developed angioedema, "choking" cough, heart rate increased and nausea. This was classified as anaphylaxis by the urgent care 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, oral steroid and cool compress. 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: 36.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Laboratory test, Nausea
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 36-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 10 in the literature article. Historical conditions included contact dermatitis and allergic rhinitis. On an unknown date, 3 hrs 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, choking with serious criteria of GSK medically significant, cough and nausea. 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 angioedema (recovered/resolved), choking (recovered/resolved), cough (recovered/resolved) and nausea (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema, choking, cough and nausea may have been caused by Flu seasonal TIV Dresden and dTpa vaccine. 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 unknown. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 36-year-old female patient who had received an unspecified Tdap vaccine (manufacturer unknown) and an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with contact dermatitis and allergic 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 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, 3 hours after the vaccination, the patient developed angioedema, "choking" cough, heart rate increased and nausea. This was classified as anaphylaxis by the urgent care 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, oral steroid and cool compress. 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: HEPA
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 medications or drug allergies/drug reactions described.  The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of VAQTA injection (lot # K018181 with expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. It was unknown if the patient's 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.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 injection, lot # reported as K010215, expiration date: 05-MAY-2017 (exact dose, dose number and route of administration were not reported) and lot # L036245, expiration date: 09-SEP-2018 (exact dose, dose number and route of administration were not reported). There were no concomitant medications provided. There were  no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 120 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Lot number K010215 is an invalid number for GARDASIL 9. Additional information is not expected as reporter refused additional contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II injection, lot # L002242, expiration date: 21-JAN-2017, therapy type: rHA (exact dose and route of administration were not reported). There were no concomitant medications provided. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 120 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected as reporter refused additional contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # L030864, expiration date: 07-JUN-2018 (exact dose and route of administration were not reported) and lot # L033690, expiration date: 14-JUN-2018 (exact dose and route of administration were not reported). There were no concomitant medications provided. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 120 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected as reporter refused additional contact.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Rash
Clinical narrative: Patient states that he has a z shaped bumpy rash on his chest, he also has a small line of rash on his bicep as well as his left shoulder blade. He states that nerve pain is accompanying these rashes.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Heart rate increased, Pallor
Clinical narrative: Increased heart rate, dizziness, pale coloring around lips. No treatment. BP 129/81, resp 20, pulse 95 T. 97.7, SPO2 99%.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm Soreness on and off since 1/10/16. Patient let us know of complaint on 1/18/16.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot number were not reported). ON an unknown date in 2012, the patient developed shingles. No further adverse event (AE) information was provided. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide causal relationship between the event and suspect therapy. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Hypersomnia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm is red, hot, swollen from shoulder to elbow, irradiating to the chest. She was sleeping all day. When she woke up her bed was soaking in sweat. She applied ice.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash erythematous
Clinical narrative: 7 days after receiving PREVNAR; Patient had red rash on arm; no streaks. Asked if fever - pt stated not known. Advised pt to take TYLENOL; use ice pack. Consult physician if worse.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: 01/13/16 after injection pt reported feeling nauseous and very warm. Pt instructed to lie down - gave pretzel and H20. Pt left office feeling back to normal within 1/2 hr. Pt returned to office 2 days later for PPD read. Injection site of TRUMENBA erythematous, tender. Pt reports pain and difficulty raising her arm for the 24 hours post injection.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: 01/13/16 after injection pt reported feeling nauseous and very warm. Pt instructed to lie down - gave pretzel and H20. Pt left office feeling back to normal within 1/2 hr. Pt returned to office 2 days later for PPD read. Injection site of TRUMENBA erythematous, tender. Pt reports pain and difficulty raising her arm for the 24 hours post injection.
Age: 1.0
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Conjunctivitis, Measles, Measles antibody, Pyrexia, Rash erythematous
Clinical narrative: Red maculopapular rash with conjunctivitis, watery discharge, runny nose and koplik spots after low grade fever started 1/15, rash originally on nape of neck and spreading ant and down c/w measles.
Age: 1.0
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash maculo-papular, Rhinorrhoea
Clinical narrative: Red maculopapular rash with conjunctivitis, watery discharge, runny nose and koplik spots after low grade fever started 1/15, rash originally on nape of neck and spreading ant and down c/w measles.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Swelling of arm and face after receiving FLUVIRIN 0.5 mg ml.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Within a few hours of receiving PNEUMOVAX injection pt reported itching and slight temp (99 deg F). Reports itching persists this morning, fever resolved. BENADRYL given. Fever and Urticaria, Pruritus. Diphenhydramine 50 mg once.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Serratia infection, Skin lesion, Staphylococcal infection
Clinical narrative: Reported to the ED on 06/05/2013 with redness and inflammatory response on left arm. Patient was started on minocycline on the same day of vaccine (06/03/2013) for lesion on his back +MRSA and serratia. Redness and local inflammation of arm.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Patient described feeling lightheaded and dizzy, increased heart rate within 5 minutes after vaccine was given. This continued but lessened over 20-25 minutes. I called her Dr and her husband escorted her to the Dr where they monitored her and sent her home.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 14-JUN-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # J009382, expiration date 08-AUG-2015, albumin status HSA), 0.5 ml, subcutaneous, anatomical location was unspecified. No concomitant medications were specified. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
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 M-M-R II injection (lot # K004949 with expiration date 04-APR-2016, albumin status rHA and lot # K016153 with expiration date 24-SEP-2016 albumin status rHA; 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.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness at injection site, itching, mild swelling, area felt hot and painful. She was told to take an antihistamine and apply a cold compress to the area.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain
Clinical narrative: The pain started within a few days, but I thought it was just a reaction from the shot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Pruritus, Swelling
Clinical narrative: Swelling, puffiness, redness, itchy/scratchy, bruising.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site bruising, Injection site discolouration, Pruritus, Scab
Clinical narrative: One week after vaccination, pt had redness, itching, and an irregular-shaped scab. On 1/14/16, the scab became more regular in shape (round), but harder and thicker and black. Pt still has this scab. (Day after vaccine, pt has site bruising; day 2 had purple discoloration.)
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Extreme chills, extreme pain in arm where shot given, could barely move arm, overall aches and pain, but especially in back shoulder blade area and neck.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Extreme chills, extreme pain in arm where shot given, could barely move arm, overall aches and pain, but especially in back shoulder blade area and neck.
Age: 0.52
Sex: F
Vaccine: DTAPH, IPV, PPV
Symptoms: Decreased eye contact, Developmental regression, Lethargy, Pyrexia, Respiratory arrest
Clinical narrative: Minutes after DTaP vaccine daughter spiked fever within an hour came home and she stopped breathing, father blew into her mouth and she was breathing normal, still have fever and was extremely lethargic with fever for 3 days. Day 4 woke up and was a different child. She wasn't making eye contact, stopped giggling and saying words like momma dadda baba, she regressed. Now resulting in early intervention with speech and OT, when prior the child was advanced. Diagnosed with sensory processing disorder.
Age: 0.52
Sex: F
Vaccine: DTAPH, IPV, PPV
Symptoms: Sensory integrative dysfunction
Clinical narrative: Minutes after DTaP vaccine daughter spiked fever within an hour came home and she stopped breathing, father blew into her mouth and she was breathing normal, still have fever and was extremely lethargic with fever for 3 days. Day 4 woke up and was a different child. She wasn't making eye contact, stopped giggling and saying words like momma dadda baba, she regressed. Now resulting in early intervention with speech and OT, when prior the child was advanced. Diagnosed with sensory processing disorder.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Pt had just left the office and we heard parents call out from the hallway that child had passed out.  When RN responded, dad had lifted child by the waist and she was bent forward and unconscious. Once patient was laid back on the floor, she was immediately responsive.
Age: 1.63
Sex: M
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Blood glucose normal, Blood test, Cardiovascular examination, Dyspnoea, Echocardiogram normal
Clinical narrative: Syncope due to unknown cause. Loss of consciousness events transpired on 5/15/2015, 6/18/2015, 7/23/2015, 8/19/2015 and 1/10/2016. Incidents are <1 minute in duration. Upon regaining consciousness, patient experiences shortness of breath, watery eyes.  Nausea and headache follow episodes. Patient has NO prior history of fainting (syncope), is athletic, has no other known conditions and is otherwise considered in excellent health.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Electrocardiogram ambulatory normal, Electroencephalogram normal, Headache, Lacrimation increased, Loss of consciousness
Clinical narrative: Syncope due to unknown cause. Loss of consciousness events transpired on 5/15/2015, 6/18/2015, 7/23/2015, 8/19/2015 and 1/10/2016. Incidents are <1 minute in duration. Upon regaining consciousness, patient experiences shortness of breath, watery eyes.  Nausea and headache follow episodes. Patient has NO prior history of fainting (syncope), is athletic, has no other known conditions and is otherwise considered in excellent health.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Nausea, Neurological examination normal, Nuclear magnetic resonance imaging, Syncope, Tilt table test normal
Clinical narrative: Syncope due to unknown cause. Loss of consciousness events transpired on 5/15/2015, 6/18/2015, 7/23/2015, 8/19/2015 and 1/10/2016. Incidents are <1 minute in duration. Upon regaining consciousness, patient experiences shortness of breath, watery eyes.  Nausea and headache follow episodes. Patient has NO prior history of fainting (syncope), is athletic, has no other known conditions and is otherwise considered in excellent health.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Ultrasound abdomen normal
Clinical narrative: Syncope due to unknown cause. Loss of consciousness events transpired on 5/15/2015, 6/18/2015, 7/23/2015, 8/19/2015 and 1/10/2016. Incidents are <1 minute in duration. Upon regaining consciousness, patient experiences shortness of breath, watery eyes.  Nausea and headache follow episodes. Patient has NO prior history of fainting (syncope), is athletic, has no other known conditions and is otherwise considered in excellent health.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Injection site red and swollen day of injection and for 3-4 days following, then tingling in lower arm.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Paraesthesia oral, Vaccination complication
Clinical narrative: Chest tight, light headed and lips tingling 5 minutes after vaccination.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site inflammation, Vaccination site nodule, Vaccination site swelling
Clinical narrative: Patient's vaccine site is red and swollen and nodular. It is inflamed and has been so since the vaccine was administered 1/18/16. Patient is monitoring reaction.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Asthenia, Body temperature decreased, Chills, Decreased appetite
Clinical narrative: Chills, Low temp, Arm swollen. Rash on neck. Red rash 5" high and 9" around width of arm. Felt sick. Too weak to continue normal functions. Loss of appetite. Sick in bed 2 days. After 4 days arm still has big rash 5" x 9" & swollen & hot to touch but rest of body feels ok.  Will call doctor tomorrow to report symptoms.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Chills, Low temp, Arm swollen. Rash on neck. Red rash 5" high and 9" around width of arm. Felt sick. Too weak to continue normal functions. Loss of appetite. Sick in bed 2 days. After 4 days arm still has big rash 5" x 9" & swollen & hot to touch but rest of body feels ok.  Will call doctor tomorrow to report symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Mild rash surrounding each eye and extending to each ear.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: At the injection site a lump the size of a gold ball formed and took well over 10 days to diminish.  I had to continue to put hot compresses and it still isn't totally gone.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: 1-16-16 pt noted left arm swelling and itching. Pt. in clinic 1-18-16 declined to wait for no show to see provider app 1-19-16 with MD.
Age: 0.51
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Redness noted at injection site on left anterior thigh a few hours post-immunization. Next morning red, raised bump developed on same thigh. Rash spreading, extending from knee to hip. Child also ran fever x 2 days max 101.6. No rash or redness on right thigh. No band-aids applied to either site. 5 days post-imms - redness and fever resolved. Rash still resolving. Mom reports same rash after Hib#1 given.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, MENB
Symptoms: Back pain, Electrocardiogram, Nausea, Oropharyngeal pain, Paraesthesia
Clinical narrative: Patient complained of nausea after receiving GARDASIL vaccine. She complained of blurry vision, back aches, tingling sensation in body and throat pain. Patient given oxygen via face mask. Patient vital signs stable alert and no loss of consciousness patient monitored on exam table and alert and oriented, blood pressure, HR and oxygen stable and sent for EKG.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, MENB
Symptoms: Vision blurred
Clinical narrative: Patient complained of nausea after receiving GARDASIL vaccine. She complained of blurry vision, back aches, tingling sensation in body and throat pain. Patient given oxygen via face mask. Patient vital signs stable alert and no loss of consciousness patient monitored on exam table and alert and oriented, blood pressure, HR and oxygen stable and sent for EKG.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Pt describes intolerable pain in (R) arm and getting worse at night. Pain stays constant per patient. Doctor recommending physical therapy for relief.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient having pain (aching pain) in LA where PREVNAR shot was given. Pain extends from should to hand.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Patient has a very bad site reaction - today 10 days after administration. It is very red and itchy. MD gave him triamcinolone.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swelled up, red, itchy, not sore (entire upper arm swelled up).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since on an unknown date, an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (lot # L024253, expiration date 01-JUL-2017) were inadvertently administered to an unspecified number of patients. No adverse effects have been reported. The reporter refers that was not product quality complaints involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, refers to a 13 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. The certified medical assistant stated that on 05-JAN-2016, the patient was inadvertently vaccinated with doses of both VARIVAX (route, dosage, frequency, lot# and expiration date were not reported) and PROQUAD (route, dosage, frequency and lot# were not reported). No adverse effect was reported. It was unknown if the patient sought medical attention. No product quality complain was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm pain for 3 days, patient states she can't move (L) arm due to pain.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea haemorrhagic, Muscle spasms
Clinical narrative: Case number PHHY2015US138480, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 584144) website on 23 Oct 2015. This report refers to a 22 year old male patient. Medical history was not reported. Past medications included Dairy and Sulfa drug. Concomitant medication included PAXIL. The patient was vaccinated with RABAVERT (batch number: 564011A) intramuscularly, into the right arm on 16 Jun 2015. On 18 Jun 2015, the patient developed bloody diarrhoea and bad cramping. Outcome of the events was not provided. Events were reported to be non serious. Seriousness assessment of the event diarrhoea haemorrhagic was upgraded (medically significant) based on the information available in source document. The causality of the events was not reported. Following an internal review on 04 Nov 2015, a case correction was performed for the report received on 23 Nov 2015: event (diarrhoea haemorrhagic) was upgraded. Non-significant follow-up received on 16 December 2015 from QA department: 408003. Follow-up information received on 12 January 2016: Conclusions of the QA statement were as follows: All investigations are closed and within the existing quality system the deviations were properly investigated. As no deviations were reported, a product impact can be excluded.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling to large area surrounding injection site (injection was administered to deltoid)- lasted 5 days. Patient reported these symptoms/reaction on 1/19/16 at routine office visit and did show doctor pictures of the deltoid.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blood test, Chills, Dehydration, Exposure during pregnancy, Heart rate increased
Clinical narrative: Case number PHHY2015US151570, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 594882) website on 16 Nov 2015. This report refers to a 29 years old female patient. The patient was 37 weeks pregnant and her last menstrual date was not reported. Concomitant medications included as prenatal vitamins and Vitamin D. The patient was vaccinated with FLUVIRIN (batch number: 15731P) intramuscularly into left arm along with BOOSTRIX (other manufacturer, batch number: NL7K3) intramuscularly into right arm on 01 Sep 2015. On 02 Sep 2015 at 03:30 am, the patient woke up with chills and shaking but had no fever. She again woke up at 10:00 am with 100.5 degrees fever. She was admitted to medical center because she still had fever, heart rate was 130 bpm and her baby's heart rate was around 200 bpm. She received an intravenous drip for dehydration and stayed for observation. She underwent blood tests (results: not reported). Her fever continued until 03 Sep 2015 04:00 am and at 06:00 am her body temperature became normal. She was released from the hospital at 12:00 pm on the same date. The outcome of the other events reported as complete recovery. The outcome of vaccine exposure during pregnancy was unknown. The causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: Case number PHHY2015US151570, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 594882) website on 16 Nov 2015. This report refers to a 29 years old female patient. The patient was 37 weeks pregnant and her last menstrual date was not reported. Concomitant medications included as prenatal vitamins and Vitamin D. The patient was vaccinated with FLUVIRIN (batch number: 15731P) intramuscularly into left arm along with BOOSTRIX (other manufacturer, batch number: NL7K3) intramuscularly into right arm on 01 Sep 2015. On 02 Sep 2015 at 03:30 am, the patient woke up with chills and shaking but had no fever. She again woke up at 10:00 am with 100.5 degrees fever. She was admitted to medical center because she still had fever, heart rate was 130 bpm and her baby's heart rate was around 200 bpm. She received an intravenous drip for dehydration and stayed for observation. She underwent blood tests (results: not reported). Her fever continued until 03 Sep 2015 04:00 am and at 06:00 am her body temperature became normal. She was released from the hospital at 12:00 pm on the same date. The outcome of the other events reported as complete recovery. The outcome of vaccine exposure during pregnancy was unknown. The causality of the events was not reported.