chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Aug-2012. The patient experienced weakness which started on 12-Sep-2012 and body aches, strep pneumoniae, nausea, sore throat, fever and headache which started on 04-Sep-2012. The patient recovered from the event of body aches, strep pneumoniae, nausea, sore throat, fever, headache and weakness on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune from medical representative on 16-Nov-2012: new event, new reporter, lot number and expiration date. Summary of follow-up information received by AstraZeneca/MedImmune 26-Nov-2012 from HCP was provided new event: Weakness the outcome of events changed to recovered. Corrected report 06-Dec-2012 reporter tab corrected.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Pneumonia streptococcal, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Aug-2012. The patient experienced weakness which started on 12-Sep-2012 and body aches, strep pneumoniae, nausea, sore throat, fever and headache which started on 04-Sep-2012. The patient recovered from the event of body aches, strep pneumoniae, nausea, sore throat, fever, headache and weakness on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune from medical representative on 16-Nov-2012: new event, new reporter, lot number and expiration date. Summary of follow-up information received by AstraZeneca/MedImmune 26-Nov-2012 from HCP was provided new event: Weakness the outcome of events changed to recovered. Corrected report 06-Dec-2012 reporter tab corrected.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 38 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced sore throat and serious runny nose. The outcome of the event of sore throat and serious runny nose is unknown. The report was considered to be non-serious by company physician. Corrected report 24-Aug-2012: Initial unit corrected.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood creatine phosphokinase, Full blood count, Laboratory test abnormal, Metabolic function test, Pain in extremity
Clinical narrative: A report has been received from VAERS concerning an 8 years old male patient. The patient had a history of asthma and upper respiratory infections. Other medication was not provided. On 15-Oct-2009, the patient received nasal FLUMIST (lot number: 500693P) for unknown indication. On 20-Oct-2009, the patient experienced leg pain and lab result showed rhabdomyolysis. The patient recovered from the event of rhabdomyolysis on an unspecified date. The company physician assessed the event rhabdomyolysis to be serious due to important medical event. Follow-up of up information received AstraZeneca/MedImmune on 02-Aug-2012 from VAERS upgraded this case to expeditable. According to the company physician the event rhabdomyolysis was upgraded as serious event due to important medical event criterion. Vaccine was purchased with public funds.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Red blood cell sedimentation rate, Rhabdomyolysis, Urine analysis
Clinical narrative: A report has been received from VAERS concerning an 8 years old male patient. The patient had a history of asthma and upper respiratory infections. Other medication was not provided. On 15-Oct-2009, the patient received nasal FLUMIST (lot number: 500693P) for unknown indication. On 20-Oct-2009, the patient experienced leg pain and lab result showed rhabdomyolysis. The patient recovered from the event of rhabdomyolysis on an unspecified date. The company physician assessed the event rhabdomyolysis to be serious due to important medical event. Follow-up of up information received AstraZeneca/MedImmune on 02-Aug-2012 from VAERS upgraded this case to expeditable. According to the company physician the event rhabdomyolysis was upgraded as serious event due to important medical event criterion. Vaccine was purchased with public funds.
Sex: U
Vaccine: FLUN3
Symptoms: Anaphylactic reaction
Clinical narrative: A report has been received from a Health Authority, concerning a patient of unknown gender. The patient's concurrent disease included known egg allergy. No relevant medical history or concurrent disease has been reported. The patient had been receiving nasal FLUMIST started on an unknown date. The patient experienced anaphylactic allergic reaction. The outcome of the event of anaphylactic allergic reaction was unknown. The report was considered to be serious due to important medical event by the reporter. Follow up of information received by AstraZeneca/MedImmune on 22-Jun-2012 upgraded this case to serious expeditable: the event of anaphylactic allergic reaction was upgraded to be serious due to important medical event.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: Erythema & itching at injection site. No fever, facial swelling or resp difficulty noted.
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced sore throat and runny nose. The outcome of the event of sore throat and runny nose is unknown. The report was considered to be non-serious. Corrected report 24-Aug-2012: Initial unit corrected.
Sex: U
Vaccine: FLUN3
Symptoms: Otitis media
Clinical narrative: A report has been received from a Physician concerning, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced otitis media. The outcome of the event of otitis media is unknown. The report was considered to be non-serious.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Head injury, Syncope
Clinical narrative: Pt fainted after injection & struck head. Has hx of vasovagal/fainting response to needles she did not disclose beforehand.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A report has been received from a physician concerning a two year-old male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. The patient was administered nasal FLUMIST on 06-Sep-2012. The dosage, frequency and indication for use of this medication were not provided. The patient developed generalized hives which started on 06-Sep-2012. The patient recovered from the event of generalized hives on 06-Sep-2012. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune 02-Nov-2012: Outcome of the event was updated. Patient and reporter details were updated. Stop date of the suspect drug was added. Narrative was updated. Information of vaccinated at and vaccine purchased were added.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Conjunctivitis, Headache, Upper respiratory tract infection
Clinical narrative: A report has been received from a Physician concerning a 40 year old, Female subject, who had been receiving a Nasal FLUMIST, 1.0 Dosage Form, Once/Single administration. FLUMIST started on 04-Nov-2011. The patient experienced upper respiratory tract infections and conjunctivitis which started on 10-Nov-2011 and headache which started on 05-Nov-2011. FLUMIST was discontinued on 04-Nov-2011. The patient recovered from the event of headache on an unspecified date and the patient recovered from the event of upper respiratory tract infections and conjunctivitis on 16-Nov-2011. The report was considered to be non-serious. The reporter considered that there was no causal relationship between upper respiratory tract infections and FLUMIST, conjunctivitis and FLUMIST and headache and FLUMIST.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Conjunctivitis, Headache, Upper respiratory tract infection
Clinical narrative: A report has been received from a Physician via agency concerning a 40 year old, Female subject, who had been receiving Nasal FLUMIST, 1 in 1 total. FLUMIST started on 04-Nov-2011. The patient experienced UPPER RESPIRATORY TRACT INFECTIONS and CONJUNCTIVITIS which started on 10-Nov-2011 and HEADACHE which started on 05-Nov-2011. The patient recovered from the event of UPPER RESPIRATORY TRACT INFECTIONS and HEADACHE on 16-Nov-2011 and The outcome of the event of CONJUNCTIVITIS is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between UPPER RESPIRATORY TRACT INFECTIONS and FLUMIST, CONJUNCTIVITIS and FLUMIST and HEADACHE and FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A report has been received from a Physician concerning a 4 year old, Male subject who had been receiving Nasal FLUMIST, 0.2 Millilitres, Once/Single administration. Vaccine given within prior 4 weeks included MMR vaccine. FLUMIST started on 29-Oct-2012. The patient experienced patient received FLUMIST 6 days after MMR vaccine which started on 29-Oct-2012. The outcome of the event of patient received FLUMIST 6 days after MMR vaccine is unknown. The report was considered to be non-serious by the reporting physician.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza B virus test positive, Nasal congestion, Pain
Clinical narrative: A report has been received from a Physician concerning a 49 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced positive for influenza B, body aches and stuffy nose which started on 13-Nov-2012. At the time of reporting, the event of positive for influenza B, body aches and stuffy nose was improving. The report was considered to be non-serious.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 04-Dec-2012. The patient experienced received expired FLUMIST which started on 04-Dec-2012. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling hot, Palpitations
Clinical narrative: After vaccination, patient became dizzy, felt hot and c/o heart racing. Pt c/o having difficulty breathing 0.3cc epinephrine given IM. EMS called and pt transported to ER.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: A report has been received from a Physician concerning a 6 year old, female patient. The patient's concurrent disease included asthma. On 28-Sep-2012 the patient had been receiving nasal FLUMIST. On 29-Sep-2012 the patient experienced wheezing a couple of days after receiving FLUMIST and was managed at home. Patient's mother is a nurse practitioner and did not bring the child into the office. Treated the child at home with VENTOLIN and FLOVENT. The patient recovered from the event of wheezing on an unspecified date. The report was considered to be non-serious by reporter.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Left upper extremity severe pain from shoulder to elbow, including axilla that limited ability to move arm. Occasional numbness. Slight area of redness at injection site. Pain med, ibuprofen, heat, rest and trial of BENADRYL - no change by day 3 so far.
Age: 58.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Feeling hot, Headache, Pyrexia
Clinical narrative: A report has been received from a Pharmacist concerning a 58 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 02-Dec-2012. The patient experienced burning joints, fever, burning up and headaches. The outcome of the event of burning joints, fever, burning up and headaches is unknown. The report was considered to be non-serious. The reporter considered that there was causal relationship between burning joints, fever, burning up and headaches and FLUMIST.
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Flu vaccine heavy dose. Next day I experienced bad pain in neck which in the next few days extended into my right hand and left thigh.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 7 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 08-Nov-2012. The patient experienced fever which started on 08-Nov-2012. At the time of reporting, the event of fever was ongoing. The report was considered to be non-serious.
Age: 1.33
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Nov-2012. The patient experienced gave 16 month old FLUMIST which started on 27-Nov-2012. The outcome of the event of gave 16 month old FLUMIST is unknown. The report was considered to be non-serious.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye swelling, Rash, Swelling face
Clinical narrative: A report has been received from a patient's mother concerning her daughter of age 10 years. No concomitant medication or relevant medical history has been reported. The patient received Nasal FLUMIST on 22-Oct-2012 at school. On 22-Oct-2012, the patient had a peppered rash on face and in the morning 23-Oct-2012, the face was swollen and eyes were swollen. Mother has not taken daughter to doctor. She has been giving BENADRYL at home and applied a ice pack to face, which has helped. At the time of reporting, the event of face is swollen, eyes are swollen and rash on face was ongoing. The reporter considered the event of rash on face to be non serious. The company physician considered the events of face was swollen and eyes were swollen to be non serious.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Received vaccine on Friday. Developed hives on Sat. Went to urgent care. He was told to take BENADRYL q 6 hours for hives.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Cheilitis, Erythema, Eyelid oedema, Urticaria
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, male patient. The patient has received no other meds, no other medical diagnoses, no known allergies, used no new soap, detergent or lotion. The patient has no pets. The patient had been receiving nasal FLUMIST started which started during fall season 2012. The child had received nasal FLUMIST at the primary care doctor's office 5 days previously and the patient presented to the emergency department with facial redness, red lips, swelling of the eyelids and hives. At the time of reporting, the event of facial redness. red lips, swelling of the eyelids and hives was improving. The report was considered to be non-serious by the reporter.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash erythematous
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced RED RAISED RASH ON LEGS, ARMS AND TORSO-ANTERIOR ONLY which started on 20-Nov-2012. At the time of reporting, the event of RED RAISED RASH ON LEGS, ARMS AND TORSO-ANTERIOR ONLY was ongoing. The report was considered to be non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: (L) arm became hot and red, ice applied. Change in voice noted. Hives on chest. BENADRYL 50 mg IM given left arm, 0.5 mg. epinephrine given in (R) arm. EMS called and patient transported to hospital. Released from ER to home.
Age: 1.5
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Nasal congestion
Clinical narrative: A consumer report has been received. The report concerns a 1 year old, Female consumer, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included WHEEZING PROBLEMS. FLUMIST started on an unknown date. The patient experienced ADMINISTRATION TO AN 18 MONTH OLD which started on 29-Oct-2012 and NASAL CONGESTION. The outcome of the event of NASAL CONGESTION and ADMINISTRATION TO AN 18 MONTH OLD is unknown. The report was considered to be non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Pt reports she had allergy induced asthma. Evening after vaccination, had wheezing, cough, SOB. Called her Dr. and her placed her on steroids.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Patient states when she received the vaccine she bled at site of injection and immediately bad pain. The next day her arm was swollen, black & blue and warm to the touch. She states that the swelling has gone down, but it is still warm and very painful. She says her whole arm hurts. She has contacted her primary physician and was told it might be a hematoma, but has not yet been seen by the physician.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration, Skin warm
Clinical narrative: Patient states when she received the vaccine she bled at site of injection and immediately bad pain. The next day her arm was swollen, black & blue and warm to the touch. She states that the swelling has gone down, but it is still warm and very painful. She says her whole arm hurts. She has contacted her primary physician and was told it might be a hematoma, but has not yet been seen by the physician.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Pyrexia
Clinical narrative: A report has been received from a Physician concerning a 6 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced FEVER and BODY ACHES which started on 28-Nov-2012. The outcome of the event of FEVER and BODY ACHES is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included SPEECH AND LANGUAGE DISORDER. FLUMIST started on 10-Sep-2012. The patient experienced RASH ON HEAD AND EXTREMITIES which started on 15-Sep-2012. At the time of reporting, the event of RASH ON HEAD AND EXTREMITIES was ongoing. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Feeling abnormal, Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: Vaccine given 815 am 1/31/13 - that day child felt "not right" - sleepy; next day redness at sites 2 days later with hives on body, pain, sore, itching, (R) arm 5 x 10 cm day 4; 9 x 13 cm (L) w erythema/hot.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Skin warm, Somnolence, Urticaria
Clinical narrative: Vaccine given 815 am 1/31/13 - that day child felt "not right" - sleepy; next day redness at sites 2 days later with hives on body, pain, sore, itching, (R) arm 5 x 10 cm day 4; 9 x 13 cm (L) w erythema/hot.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Urticaria
Clinical narrative: Pt received vaccine on 1/12/13 and still has a significant welt that she feels has not really gotten any smaller since the time of vaccination. Redness & induration.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Hypoaesthesia, Immunology test normal, Injection site anaesthesia, Muscular weakness
Clinical narrative: Within 15 minutes numbness in vaccine arm and side of face on that side. Called dr after 1 hr called again after 1wk and referred to neurologist. Numbness and muscle weakness in left arm; 2-3 week numbness & weakness in arms and legs; finally in groin and abdomen. Mostly resolved at 4wks with lingering facial and abdominal numbness & occas limb weakness.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Within 15 minutes numbness in vaccine arm and side of face on that side. Called dr after 1 hr called again after 1wk and referred to neurologist. Numbness and muscle weakness in left arm; 2-3 week numbness & weakness in arms and legs; finally in groin and abdomen. Mostly resolved at 4wks with lingering facial and abdominal numbness & occas limb weakness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient described getting a case of shingles on the left side of her body from her neck down to her buttocks.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Insomnia, Irritability, Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 4 year old, Male consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 22-Oct-2012. The patient experienced FEVER and IRRITABILITY which started on 24-Oct-2012 and TROUBLE SLEEPING which started on 22-Oct-2012. At the time of reporting, the event of TROUBLE SLEEPING, FEVER and IRRITABILITY was ongoing. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Asthma, Condition aggravated, Cough, Fatigue
Clinical narrative: A report has been received from a physician concerning a three years old female patient. No medical history of the patient was reported. Concomitant medications included salbutamol, fluticasone propionate and montelukast for asthma. The patient was receiving nasal FLUMIST started on 16-Nov-2012. It was reported that the child was given FLUMIST by a nurse on 16-Nov-2012 and very shortly afterwards the child did not feel well, became very tired, weak for about 24 hours and then developed a fever followed later by a rash. For about 48 hours after she was given the FLUMIST, the child had flu like symptoms which started on 17-Nov-2012. She developed a cough, asthma conditions became worse and a runny nose with thick yellow mucous which started on 19-Nov-2012. On November 21st 2012, mother had taken her daughter to the ER of the Hospital because her asthma had flared up and she was concerned that it would not be controlled, they were seen and discharged within an hour. During the evening of November 21, the child developed a gastro type of flu and lasted until late evening November 22nd, 2012. The mother stated that she herself developed flu like symptoms on November 19th, and then had the flu though she did not receive the FLUMIST. Furthermore physician reported that gastroenteritis and cold could have been coincidental as the other children of daycare had a gastroenteritis and that the previous week was cold. FLUMIST was discontinued after one single administration on 16-Nov-2012. At the time of reporting, the child had recovered from all the reported events on an unspecified date. The reporting physician assessed all the events to be non-serious. The reporter assessed that the events of child had flu like symptoms, asthma conditions become worse/asthma flared up, developed a fever, developed a cough, daughter did not feel well, become very tired, weak for about 24 hours, later a rash and a runny nose with thick yellow mucous and developed a gastro type of flu to be causally related to the suspect drug of FLUMIST. Summary of follow-up information received by AstraZeneca/MedImmune 29-Nov-2012 from the Physician: Added reporter causality for all the events. Added stop date of suspect vaccine FLUMIST. Updated event outcome. Update dosing regimen and action taken with FLUMIST. Case was medically confirmed. Narrative updated. Corrected report 11-Dec-2012: Added the vaccine details as purchased from and vaccinated at. Added concomitant medication. Added additional reporters.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Gastroenteritis viral, Increased viscosity of nasal secretion, Influenza like illness, Malaise, Nasopharyngitis
Clinical narrative: A report has been received from a physician concerning a three years old female patient. No medical history of the patient was reported. Concomitant medications included salbutamol, fluticasone propionate and montelukast for asthma. The patient was receiving nasal FLUMIST started on 16-Nov-2012. It was reported that the child was given FLUMIST by a nurse on 16-Nov-2012 and very shortly afterwards the child did not feel well, became very tired, weak for about 24 hours and then developed a fever followed later by a rash. For about 48 hours after she was given the FLUMIST, the child had flu like symptoms which started on 17-Nov-2012. She developed a cough, asthma conditions became worse and a runny nose with thick yellow mucous which started on 19-Nov-2012. On November 21st 2012, mother had taken her daughter to the ER of the Hospital because her asthma had flared up and she was concerned that it would not be controlled, they were seen and discharged within an hour. During the evening of November 21, the child developed a gastro type of flu and lasted until late evening November 22nd, 2012. The mother stated that she herself developed flu like symptoms on November 19th, and then had the flu though she did not receive the FLUMIST. Furthermore physician reported that gastroenteritis and cold could have been coincidental as the other children of daycare had a gastroenteritis and that the previous week was cold. FLUMIST was discontinued after one single administration on 16-Nov-2012. At the time of reporting, the child had recovered from all the reported events on an unspecified date. The reporting physician assessed all the events to be non-serious. The reporter assessed that the events of child had flu like symptoms, asthma conditions become worse/asthma flared up, developed a fever, developed a cough, daughter did not feel well, become very tired, weak for about 24 hours, later a rash and a runny nose with thick yellow mucous and developed a gastro type of flu to be causally related to the suspect drug of FLUMIST. Summary of follow-up information received by AstraZeneca/MedImmune 29-Nov-2012 from the Physician: Added reporter causality for all the events. Added stop date of suspect vaccine FLUMIST. Updated event outcome. Update dosing regimen and action taken with FLUMIST. Case was medically confirmed. Narrative updated. Corrected report 11-Dec-2012: Added the vaccine details as purchased from and vaccinated at. Added concomitant medication. Added additional reporters.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: A report has been received from a physician concerning a three years old female patient. No medical history of the patient was reported. Concomitant medications included salbutamol, fluticasone propionate and montelukast for asthma. The patient was receiving nasal FLUMIST started on 16-Nov-2012. It was reported that the child was given FLUMIST by a nurse on 16-Nov-2012 and very shortly afterwards the child did not feel well, became very tired, weak for about 24 hours and then developed a fever followed later by a rash. For about 48 hours after she was given the FLUMIST, the child had flu like symptoms which started on 17-Nov-2012. She developed a cough, asthma conditions became worse and a runny nose with thick yellow mucous which started on 19-Nov-2012. On November 21st 2012, mother had taken her daughter to the ER of the Hospital because her asthma had flared up and she was concerned that it would not be controlled, they were seen and discharged within an hour. During the evening of November 21, the child developed a gastro type of flu and lasted until late evening November 22nd, 2012. The mother stated that she herself developed flu like symptoms on November 19th, and then had the flu though she did not receive the FLUMIST. Furthermore physician reported that gastroenteritis and cold could have been coincidental as the other children of daycare had a gastroenteritis and that the previous week was cold. FLUMIST was discontinued after one single administration on 16-Nov-2012. At the time of reporting, the child had recovered from all the reported events on an unspecified date. The reporting physician assessed all the events to be non-serious. The reporter assessed that the events of child had flu like symptoms, asthma conditions become worse/asthma flared up, developed a fever, developed a cough, daughter did not feel well, become very tired, weak for about 24 hours, later a rash and a runny nose with thick yellow mucous and developed a gastro type of flu to be causally related to the suspect drug of FLUMIST. Summary of follow-up information received by AstraZeneca/MedImmune 29-Nov-2012 from the Physician: Added reporter causality for all the events. Added stop date of suspect vaccine FLUMIST. Updated event outcome. Update dosing regimen and action taken with FLUMIST. Case was medically confirmed. Narrative updated. Corrected report 11-Dec-2012: Added the vaccine details as purchased from and vaccinated at. Added concomitant medication. Added additional reporters.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Breast swelling, Oedema peripheral, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 39 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 22-Oct-2012. The patient experienced ARMPIT SWOLLEN, BREAST SWOLLEN and RUNNY NOSE which started on 22-Oct-2012. The outcome of the event of ARMPIT SWOLLEN, BREAST SWOLLEN and RUNNY NOSE is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough
Clinical narrative: A consumer report has been received. The report concerns a 15 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 22-Oct-2012. The patient experienced DRY COUGH which started on 22-Oct-2012. The outcome of the event of DRY COUGH is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Headache, Malaise
Clinical narrative: A report has been received from a Health Professional concerning an Adult, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced HEADACHE and MALAISE. The outcome of the event of HEADACHE and MALAISE is unknown. The report is considered to be non-serious.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: A report has been received from a physician concerning, a 14 year old male patient. The patient's relevant history included cough and sore throat. The patient's concurrent disease and concomitant medication was not provided. The patient was received nasal FLUMIST of an unknown frequency was started on 25-Oct-2012 for an unknown indication. The physician reported that patient had flu like symptoms which was started on 26-Oct-2012. Patient also had fever and body aches which was started on 26-Oct-2012. At the time of reporting, the event of flu like symptoms was ongoing. The outcome of the events of fever and body aches was unknown. The company physician assessed the events of flu like symptoms, fever and body aches to be non serious. Summary of follow-up information received by AstraZeneca/MedImmune on 06-Aug-2012 from a HCP: Now non-serious events of fever and body aches added. Patients medical history added. Reporter's information updated. Patients height, weight and ethnic information added. Lot number added for the suspect drug.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Rhinorrhoea, Urticaria
Clinical narrative: A report was received from a physician concerning a 5 years old male patient. Concomitant medications included cetirizine hydrochloride for allergies. On 11-Oct-2012, patient received nasal FLUMIST in school and after five minutes he presented with running nose and itchy wheals all over upper body. Patient received BENADRYL. Patient received FLUMIST in 2009 and no reaction occurred. At the time of reporting, the events resolved. The reporting physician assessed the events to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 13-Nov-2012 from physician: concomitant medication with indication, new dosing line for FLUMIST added. Corrected Report 22-Nov-2012: event of itchy wheals recoded.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Nasal oedema
Clinical narrative: A report has been received from a Health Professional concerning a 16 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Oct-2012. The patient experienced HEADACHE and SWELLING IN ONE NOSTRIL which started on 23-Oct-2012. At the time of reporting, the event of HEADACHE and SWELLING IN ONE NOSTRIL was ongoing. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from a Pharmacist concerning, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 14-Nov-2012. The patient experienced POSITIVE INFLUENZA TEST which started on 19-Nov-2012. The outcome of the event of POSITIVE INFLUENZA TEST is unknown. The report was considered to be non-serious. Laboratory values are available.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Nausea, Pain
Clinical narrative: A consumer report has been received. The reporter concerns a 39 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced nausea, body aches and weakness which started on 27-Nov-2012. At the time of reporting, the event of nausea, body aches and weakness was ongoing. The report was considered to be non-serious.
Age: 5.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient was given ZOSTAVAX instead of Varicella.
Age: 5.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given ZOSTAVAX instead of Varicella.
Age: 1.54
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Allergy test, Blister, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: Rash - vesicles/pustules - 8-10 in number on the chest, back and groin.
Age: 1.54
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Full blood count, Rash, Rash pustular
Clinical narrative: Rash - vesicles/pustules - 8-10 in number on the chest, back and groin.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vertigo
Clinical narrative: Very dizzy, similar to vertigo symptoms (per patient description) x 3 wks after.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Vomiting
Clinical narrative: Vomiting daily since administration (x2 wk).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dizziness, Malaise, Pyrexia
Clinical narrative: Got really sick, weak, had to get 3 course of antibiotic after receiving FLUZONE High Dose [v. high fever, v. dizzy, coughing].
Sex: F
Vaccine: VARCEL
Symptoms: Headache
Clinical narrative: Information was received from a claims representative via a pharmacist regarding a female patient who was treated with VARIVAX (Merck), lot # 0316AE, on 21-DEC-2012. Subsequently, the patient experienced headaches. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age. On 12-FEB-2013, the patient was vaccinated with an expired MMR II (injection) (lot # 0156AA; exp. date: 01-FEB-2013 (dose and route not reported). No adverse event reported. Additional information is not expected.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Laryngeal disorder
Clinical narrative: Difficulty breathing due to largely occluded larynx on day following flu vaccine injection. Went to clinic for treatment.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: On 1/22/13 I received the flu shot - FLUZONE - extra dose for age 65. In 2 days I had a terrible headache, sore throat w/a tickle in my throat, runny nose, sinus infection, cough-hoarseness. This lasted 1 wk or more. I believe it was due to the shot & was all side effects. I very seldom have a cold and all the above I believe was due to the shot. Also, when I went to receive the shot at pharmacy the person who gave it to me never asked me what medication I was currently on, if I was allergic to anything, etc. All she asked was which arm I wanted the shot in. Isn't it amazing that as far as we are in the technical world that humans are treated like this. To the government we are just a number and I never plan on getting this shot again.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis, Throat irritation
Clinical narrative: On 1/22/13 I received the flu shot - FLUZONE - extra dose for age 65. In 2 days I had a terrible headache, sore throat w/a tickle in my throat, runny nose, sinus infection, cough-hoarseness. This lasted 1 wk or more. I believe it was due to the shot & was all side effects. I very seldom have a cold and all the above I believe was due to the shot. Also, when I went to receive the shot at pharmacy the person who gave it to me never asked me what medication I was currently on, if I was allergic to anything, etc. All she asked was which arm I wanted the shot in. Isn't it amazing that as far as we are in the technical world that humans are treated like this. To the government we are just a number and I never plan on getting this shot again.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Vaccination complication
Clinical narrative: MMR & varicella vaccines 1/14/13 rash noted face, torso, and diaper area 1/23/13. No fever - seen in office felt to be related to measles vaccine.
Age: 1.53
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 06-Nov-2012. Nurse INADVERTENTLY GAVE FLUMIST TO AN 18 MONTH OLD on 06-Nov-2012. The outcome of the event of INADVERTENTLY GAVE FLUMIST TO AN 18 MONTH OLD is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A report has been received from a health professional, concerning a 2 year old, female patient. No medical history, concurrent disease or concomitant medication was provided. On 08-Nov-2012, the patient received nasal FLUMIST. According to the reporter, it was not sure if FLUMIST went into a patient's eye. The patient squirmed, and some of the product landed on her face near her eye. It was possible that some may have gotten in her eye. At the time of reporting, the outcome of the event of FLUMIST went into a patient's eye was unknown. The report was considered to be non-serious by company physician. Corrected report 13-Dec-2012: Coding of FLUMIST went into a patient's eye was changed from accidental exposure while administering drug to drug administration error.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure
Clinical narrative: A report has been received from a health professional concerning a four year-old male patient. The patient's medical history, concomitant medications and concurrent diseases were not reported. On 15-Oct-2012 the patient received nasal FLUMIST. The dose, frequency and indication for use of the indication were not reported. On 15-Oct-2012 the patient moved his head slightly when administering second half of dose and a few drops of the medication got into his eye. At the time of reporting the action taken with the suspect drug and the outcome of the event were unknown. The company physician assessed the report to be non-serious. Corrected report 13-Dec-2012: Coding of a few drops of FLUMIST got in his eye was changed from accidental exposure while administering drug to drug administration error.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error, Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old male patient, who had been receiving Nasal FLUMIST, which was started on 09-Nov-2012. When the nurse tried to give 2nd half of dose patient got very upset and turned head and dose went into air and on his face which started on 09-Nov-2012. The outcome of the event of partial dose went into the air & on his face was unknown. The report was considered to be non-serious. Corrected report 12-Dec-2012: reporter's page edited, onset date added. Corrected report 13-Dec-2012: Coding of partial dose went into the air & on his face was changed from inappropriate dose of vaccine administered to drug administration error.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A report has been received from a physician via sales concerning a 3 year old male patient. The patient's medical history and concurrent disease were not provided. The patient's concomitant medication was not provided. The patient received nasal FLUMIST. The physician reported that a 3 year old male patient experienced severe vomiting within 48 hours that lasted one day. At the time of report, patient had recovered from the event. The reporting physician assessed the causality between the event of Severe vomiting within 48 hours/one day and the suspected vaccine FLUMIST to be related.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus
Clinical narrative: This spontaneous report as received from a 67 year old consumer refers to herself. The patient's concurrent conditions included egg allergy and codeine allergy. The patient's medical history included 2 previous rotator cuff tears. On 11-FEB-2013, the patient was vaccinated with a dose ZOSTAVAX subcutaneous (dose and lot number were not reported). No other co-suspects were reported. Concomitant therapies included NEXIUM, ZOCOR, HYDROCODONE, PAXIL, PROCARDIA and AMBIEN. The consumer reported that after getting the vaccine on 11-FEB-2013, she experienced itchy and burning in her hands, groin and the bottom on her feet and she also stated that she experienced itched from back, torso and chest down. She took 2 BENADRYL and it went away in 1 to 2 hours (also reported that she was not treated for the adverse event). The patient said that she was fine at this time. She believed that she had shingles, which had not been confirmed by a physician. Labs diagnostics studies were not performed. The patient did not sought medical attention. At the time of the report, the patient's outcome for the adverse events was unknown. The relatedness for the adverse event with ZOSTAVAX was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 73 year old female patient. On 14-FEB-2013, the patient was vaccinated with ZOSTAVAX lot # H020001, expiration date: 02-FEB-2014, 0.65 ml, subcutaneous. Concomitant therapies included NORVASC. The pharmacist reported that on 15-FEB-2013, the patient experienced injection site reaction of redness and swelling the size of a quarter. The event was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 1.82
Sex: U
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 02-Nov-2012. The nurse INADVERTENTLY ADMINISTERED A HALF-DOSE OF FLUMIST TO A 22 MONTH-OLD PATIENT which started on 02-Nov-2012. The patient recovered from the event of INADVERTENTLY ADMINISTERED A HALF-DOSE OF FLUMIST TO A 22 MONTH-OLD PATINET on 06-Nov-2012. The report was considered to be non-serious by the reporter. Corrected report on 28-Nov-2012: the vaccine was administered by the nurse, the reason was oversight. Outcome of the adverse event added.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 11-FEB-2013, the patient was vaccinated with VARIVAX (merck) injection (Lot #, dose and route were not reported) instead of ZOSTAVAX, due to a human error. No adverse effect was reported. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Ear disorder, Hyperaesthesia, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 3 year old, Male consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 14-Nov-2012. The patient experienced SENSITIVE EARS, FUSSY, FEVER 103F and RUNNY NOSE which started on 16-Nov-2012. The outcome of the event of SENSITIVE EARS, FUSSY, FEVER 103F and RUNNY NOSE is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A consumer report has been received. The report concerns a 6 year old, consumer of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. It was reported that FLUMIST was given twice in three days. The outcome of the event of FLUMIST given twice is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye pain, Irritability, Pyrexia
Clinical narrative: A report has been received from a Physician concerning a 5 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 12-Nov-2012. The patient experienced fever of 102.6 degrees F, crabby and eyes hurt which started on 12-Nov-2012. The outcome of the event of fever of 102.6 degrees F, crabby and eyes hurt is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune on 03-Dec-2012 from physician: Patient details updated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: This spontaneous report as received from a 71 years old female consumer refers on herself with hypertension and allergy to penicillin. In October 2012, the patient was vaccinated with 1 dose of ZOSTAVAX, subcutaneously (dose, anatomical location and lot number not provided). No concomitant therapy was reported. The patient stated that on 03-FEB-2013, she had shingles; however this had not been confirmed by physician. She described the pain as hives, one an inch in diameter on her left breast that had a yellow head. The patient would have appointment with her dermatologist. Lab diagnostics studies were not performed. The patient sought medical attention. The patient had not received treatment. The outcome of shingles and the pain as hives was unknown. The relatedness of shingles and the pain as hives was unknown for the therapy with ZOSTAVAX. Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 16-Nov-2012. The nurse accidentally vaccinated 14 month old with FLUMIST on 16-Nov-2012 and then saw that it is contraindicated in this age group. The nurse explained that the first dose didn't get inside the nostril but the second dose in the second nostril went in properly. The outcome of the event of accidentally vaccinated 14 month old is unknown. The report was considered to be non-serious. Corrected report 30-Nov-2012: Coding of event 'accidentally vaccinated 14 month old' corrected from Drug use in unapproved population to inappropriate age at vaccine administration, narrative updated.