chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: U
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: A report has been received from a Pharmacist concerning a 7 year old patient of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. Child has been vaccinated against the flu in the past. Administration followed appropriate procedure as described where half the dose was administered into one nostril and then the 2nd half after divider was removed was administered into the 2nd nostril. After it was administered into the 2nd nostril, dripping out of the nose occurred (a stream). The outcome of the event of leakage of vaccine out of one nostril was unknown. The reporter's description of the event(s) was as follows: Not on any other medications. The report was considered to be non-serious.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a Health Professional concerning an 9 year old, female subject, who had been receiving Nasal FLUMIST Quadrivalent, 0.2 milliliters. FLUMIST Quadrivalent started on 27-OCT-2015. On 28-OCT-2015 the patient tested positive for the flu, less than 24 hours after receiving FLUMIST. The outcome of the event of positive test for flu is unknown. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: A report has been received from a Pharmacist concerning a patient of unknown gender, who received nasal FLUMIST Quadrivalent, 0.2 milliliters. Pharmacist administering the vaccines had noticed that when administering the first half of the dose to a patient, there has been dribbling of liquid out of the nostril of the patient, but upon delivery the second half of the vaccine dose to the patient in the other nostril, there has been less dribbling of liquid after administration. It was unknown whether the patients were receiving the full dose of vaccine. Also reported product quality complaint. Action taken with FLUMIST Quadrivalent was unknown. The outcome of when administering first half of dose to patient there has been dribbling of liquid out of nostril of patient, but upon delivering second half of vaccine dose in other nostril there has been less dribbling of liquid after administration, unknown whether the patients are receiving the full dose of vaccine and product quality complaint was unknown. The report was considered to be non-serious by company physician.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, female subject, who received Nasal FLUMIST Quadrivalent, 0.2 milliliters, on 22-OCT-2015 then approximately 6 days later on October 28, 2015, they each received another single dose of FLUMIST at the clinic. FLUMIST Quadrivalent  started on an unknown date. The outcome of the event of patient received 2 single doses of FLUMIST almost one week apart is unknown. The report was considered to be non-serious by company physician.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, female subject, who had been receiving FLUMIST Quadrivalent, 0.2 milliliters. FLUMIST Quadrivalent started on 22-OCT-2015. The patient received a second dose of FLUMIST a week later on 28-OCT-2015. FLUMIST Quadrivalent was continued. The outcome of the event of patient received 2 single doses of FLUMIST also one week apart is unknown. The report was considered to be non-serious by the company physician.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Pharmacist concerning a female subject, who had been receiving Nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The patient experienced expired FLUMIST Quadrivalent. The outcome of the event of expired FLUMIST Quadrivalent administered was unknown. The report was considered to be non-serious. Summary of insignificant follow-up information received by AstraZeneca/Medimmune on 15-JAN-2015 from pharmacist. No new information to add. Corrected report 21-OCT-2015. Key ingredient updated.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving Nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that patient was administered an expired FLUMIST which started on 30-DEC-2014. The outcome of the event of expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious. Corrected report 21-OCT-2015: Key ingredient updated.
Age: 63.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a pharmacist concerning a 63 year old, female subject, who had been receiving QLAIV (intranasal), one dose was administered. FLUMIST Quadrivalent started on 04-Nov-2014. The outcome of the event of wrongful administration is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between wrongful administration and QLAIV. Company physician assessed the causality between event wrongful administration to be unrelated to the suspect drug QLAIV. Corrected report 21-Oct-2015: Key ingredient corrected. Initial unit corrected.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a pharmacist concerning an 8 year old male subject, who had been receiving FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on 17-Nov-2014. It was reported that stopper came off or wasn't on the FLUMIST Quadrivalent and it went all in one nostril which started on 17-Nov-2014. The outcome of the event of stopper came off or wasn't on the FLUMIST Quadrivalent and it went all in one nostril is unknown. The report was considered to be non-serious. Corrected report 20-Oct-2015: Key ingredient updated. Initial unit updated.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Sneezing
Clinical narrative: A report has been received from a pharmacist concerning a 3 year old, male subject who had been receiving FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on 03-Sep-2014. The patient experienced sneezing which started on 03-Sep-2014. The outcome of the event of sneezing is unknown. The report was considered to be non-serious by reporter. Corrected report 21-Oct-2015: Key ingredient updated.
Age: 0.7
Sex: M
Vaccine: FLUN4
Symptoms: Injection site reaction, Local reaction
Clinical narrative: A report received from a health professional concerning a 7 month old male patient. The patient medical history and concomitant medication were not provided. The patient had received nasal influenza vaccine started on an unknown date and intramuscular SYNAGIS started on an unknown date. It was informed that the patient had a local site reaction  to influenza vaccine on 23-NOV-2015. The patient also had a SYNAGIS injection one week prior. Action taken with influenza vaccine and SYNAGIS was unknown. The outcome of the event of local site reaction to flue shot was unknown. The company physician assessed the event locate site reaction to flu shot (unspecified) to be non-serious.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 5 year old, Male consumer, Weight 40.0 Pounds, who had been receiving FLUMIST quadrivalent (intranasal), 1. FLUMIST quadrivalent (intranasal) started on 25-Nov-2015. It was reported that, on 26-Nov-2015 the patient had fever 100 F. The outcome of the event of Fever 100 F is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced sneezing and runny nose. The outcome of the event of sneezing and runny nose is unknown. The report was considered to be non-serious by the company physician.
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion
Clinical narrative: A report has been received from a Health Professional concerning a male patient, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced possible inadvertent exposure to eye which started on 13-Nov-2015 and stuffy nose. The outcome of the event of possible inadvertent exposure to eye and stuffy nose was unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Malaise, Product quality issue, Rhinorrhoea
Clinical narrative: A report has been received from consumer. The report concerns a male patient, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. It was reported that the patient experienced quite sick which started on 09-Nov-2015, slight runny nose which started on 08-Nov-2015 and product quality issue. The outcome of the event of slight runny nose, quite sick and product quality issue was unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A consumer report has been received concerning a female patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. Participant in research said that, after taking FLUMIST (intranasal) during Sep-2015, she contracted influenza. She believed FLUMIST was the cause. The patient recovered from influenza during Sep-2014. The report was considered to be non-serious. Participant in research said that, after taking FLUMIST, she contracted influenza. She believed FLUMIST was the cause.
Sex: M
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on an unknown date. The patient experienced patient pulled back some and a little bit of FLUMIST got into his right. The patient recovered from the event of patient pulled back some and a little bit of FLUMIST got into his right on an unspecified date. Assessment of the serious criteria for the report was as follows: important medical event.
Age: 1.6
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 patient of unknown gender, who received FLUMIST (intranasal). FLUMIST (intranasal) was started on an unknown date. The parent of an 18 month child who was given FLUMIST, want to know of any side effects that she should watch for after he child was given the FLUMIST. The outcome of the event of administration of FLUMIST to a child younger than 2 years of age was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Product use issue
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal), unknown MMR vaccine and unknown VARIVAX vaccine. FLUMIST quadrivalent (intranasal) started on 13-Nov-2015, MMR started on 04-Dec-2014 and VARIVAX started on an unknown date. Nurse reported that patient received a dose of MMR  FLUMIST and VARIVAX less than 4 weeks apart from another live vaccine called FLUMIST quadrivalent. The outcome of the event of FLUMIST quadrivalent administered with MMR and VARIVAX is unknown. The report was considered to be non-serious. Corrected report on 25-Nov-2015: Key ingredient updated.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A spontaneous report had been received from health professional concerning a 5 year old, male patient. No information was provided regarding medical history and concomitant medications and concurrent disease of the patient. Five year old patient was administered the full dose of FLUMIST, (intranasal) (0.2 ml) in one nostril by the clinic nurse. Incorrect administration. The outcome of the incorrect administration was unknown. The company physician considered the incorrect administration to be non-serious. The reporter considered that there was no causal relationship between incorrect administration and FLUMIST and company physician agreed with the reporter's assessment of causality.
Sex: U
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from pharmacist concerning a patient of unknown gender. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Pharmacist inadvertently administered 2 doses (0.2mL) of a FLUMIST (intranasal) into one nostril of an adult patient on 10-Nov-2015 in the evening. FLUMIST was administered in a pharmacy setting. Pharmacist who administered FLUMIST told that they had problems with the divider of the device and thus full syringe was inadvertently administered in one nostril. Patient did not experience any adverse effects following the administration. Reporter was not the same pharmacist who administered the FLUMIST. It was reported that there was no product complaint in place, the pharmacist who administered the dose was new to that product and was unsure of its administration process. The product itself was fine, no defect, no PQC. Pharmacist was not aware. The outcome of the event of single nostril administration was unknown. The reporter assessed the event of single nostril administration to be non serious.
Age: 2.1
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A spontaneous report has been received from a physician concerning a 2 years 8 weeks old, male patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. Patient administered the full dose of FLUMIST (intranasal) in one nostril (0.2mL) by clinic nurse. The outcome of incorrect administration was unknown. The reporter considered the incorrect administration to be non serious. The reporter and company physician considered that there was no causal relationship between incorrect administration and FLUMIST.
Age: 1.4
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional. It was reported that a 17 month old child inadvertently administered FLUMIST (intranasal). It was quickly realized and only half the dose was administered (0.1 mL). The outcome of the event of inadvertent administration to a 17 month old is unknown. The reporter's description of the event(s) was as follows: Child has history of asthma. He received the IM injection last year. Father is an infection control practitioner. Mother is a nurse. There was concern as well re: mother as she is pregnant and they were worried about viral shedding. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza like illness, Oropharyngeal pain
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender and age. The patient's medical history included sore throat. Concomitant medications were not reported. It was reported that the patient was given a once/single dose of FLUMIST Quadrivalent on 29-Sep-2015. The patient had a sore throat and the physician thought it would be okay for the patient to get a dose of FLUMIST. Mother had returned with the patient who had flu like symptoms experienced on 30-Sep-2015. Action taken with FLUMIST Quadrivalent was none. The outcome of the event of flu like symptoms was unknown. The report was considered to be non-serious by the company physician.
Sex: M
Vaccine: FLUN4
Symptoms: Overdose
Clinical narrative: A spontaneous report has been received from Physician concerning a male patient. Patient relevant history and concurrent diseases were not provided. Patient had been receiving FLUMIST quadrivalent (intranasal), started on an unknown date. Doctor explained patient thought the first dose was expired, then later found out it was not expired- after administering the second dose which was considered as overdose. Action taken with FLUMIST quadrivalent was unknown. The outcome of the event overdose was unknown. The reporter assessed the event overdose to be non serious.
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: A spontaneous report has been received from a health professional concerned a female patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. The patient had been receiving FLUMIST Quadrivalent (intranasal) started on an unknown date. Doctor explained she thought the first dose was expired, then later found it was not expired after administering the second dose. The action taken of the FLUMIST Quadrivalent was unknown. The outcome of the event of overdose was unknown. The company physician assessed the event of thrush to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Off label use, Product use issue
Clinical narrative: A report has been received from a Health Professional concerning a male patient, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent, (intranasal) started on an unknown date. The patient stated two doses 4 days apart (off-label use). FLUMIST quadrivalent was continued. The outcome of the event of off label use and 2 doses 4 days apart was unknown. The report was considered to be non-serious.
Age: 58.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a female subject of 58 years, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 mL. FLUMIST Quadrivalent started on 28-Sep-2015. FLUMIST was administered to 3 women on Sept. 28, 2015 who are over the age of 49 years. Ages are 57, 58 and 61. FLUMIST Quadrivalent was discontinued on 28-Sep-2015. The outcome of the event of over 49 years of age is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on an unknown date. It was reported that a temperature excursion of FLUMIST vaccine that had been given to 14 patients and patient number twelve received the FLUMIST vaccine, 0.2mol dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1ml was given in each nostril. FLUMIST Quadrivalent was continued. The outcome of the event of patient number twelve given FLUMIST vaccine that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril was unknown. The report was considered to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Body temperature increased, Eyelid oedema, Rhinorrhoea, Sneezing
Clinical narrative: A report has been received from a pharmacist concerning a 2 years 2 weeks 4 days old female patient, height: 35.0 inches; weight: 25.0 pounds. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient received FLUMIST Quadrivalent (intranasal), 0.2 milliliters, years for guidelines practice, started on an unknown date. The PSS reported 2 days after the FLUMIST, 27-Sep-2015, her daughter had a runny nose, puffy eyes, sneezing, and a temperature of 99.3. FLUMIST Quadrivalent was continued. The patient recovered from the event of sneezing, temperature 99.3, runny nose and puffy eyes on 28-Sep-2015. The report was considered to be non-serious by company physician.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered, Product quality issue
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, female patient, who had been receiving FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on an unknown date. It was reported that the patient received an expired dose of FLUMIST from Jan2015. And also reported product quality issue. The outcome of the event of received an expired dose and product quality issue was unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Product quality issue
Clinical narrative: A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on 25-Sep-2015. Pharmacist reported that the consumer felt the FLUMIST Quadrivalent only went in 1 nostril despite the fact that the pharmacist administered the FLUMIST correctly in both nostrils product quality complaint was reported. FLUMIST Quadrivalent was discontinued on 25-Sep-2015. The outcome of the event of full dose in one nostril and product quality complaint is unknown. The report was considered to be non-serious.
Age: 1.0
Sex: M
Vaccine: FLUN4
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 FLUMIST quadrivalent, (intranasal), 0.2 Millilitres. The patient's concurrent disease(s) included thyroid, diabetes mellitus and high blood pressure. Family history included Eczema, FLUMIST quadrivalent (intranasal) started on 24-Sep-2015. The patient who was 1 year old was administered FLUMIST on 24-Sep-2015. No wheezing. The outcome of the event of administered to 1 year old and was administered FLUMIST, is 1 year old is unknown. The reporter's description of the event(s) was as follows: No known medical problems. Family history of eczema, DM, HTN, thyroid. The report was considered to be non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal discomfort, Abdominal pain upper, Bacterial infection, Bone density decreased, Burn oesophageal
Clinical narrative: A spontaneous report received from consumer. The report concerns a 13 years 21 weeks 1 day old, male patient, (height : 68.0 inches, weight: 140.0 pounds). The patient's relevant history included hospitalization. The patient's concurrent diseases included arm swelling after flu shot. Concomitant medications included salbutamol for respiratory wheeze and fluticasone propionate for inflammation in lungs post infection. Patient received FLUMIST (intranasal) 0.2 ml in 2012, 2013, and 2014. Also prescribed oral PRILOSEC Rx capsule unknown dose and frequency, started 18-Jan-2015. Unknown stop but he took the PRILOSEC Rx for about 3-4 months. The reporter thought patient may have taken Omeprazole Rx  for about 1 month sometime after 18-Jan-2015 for stomach pain. He also took Omeprazole OTC for 2-3 months sometime after taking PRILOSEC Rx. The reporter stated the patient may have switched from PRILOSEC Rx to Omeprazole Rx to Omeprazole OTC based on availability. Specified dates are not known. It was reported that patient used PRILOSEC Rx for long term and FLUMIST QUADRIVALENT did not work still got influenza B, hospitalized 5-Jan-2015 to 18-Jan-2015 ICU and was intubated on 07-Jan-2015 and had bad stomach issues after intubation, was throwing up and gagging on tube, after extubation anything he would eat would throw up it was painful to eat, swallow, or drink, had stomach pain. ZANTAC was not working was still having stomach pain after discharge from hospital. Esophagus was burning had reflux and stomach was burning, septic with low blood pressure, pneumonia, blood clot and attributes to a cast that was placed after x ray showed bilateral tibia fracture but left leg fracture was worse and was casted, leg cast placed for fracture 12-Aug-2015, weight loss 20 lb with continued complications with stress fractures and residual complications from being sick from the flu. Complaining of leg pain and was walking around on stress fractures and this was treated with shin splints. The reporter assumed that the patient had loss of bone density. The outcome of influenza B/flu, septic, stomach issues, throwing up, stomach pain, esophagus was burning/stomach was burning, pneumonia, blood clot in leg, weight loss, complaining of leg pain, gagging, painful to eat, swallow and drink, reflux, stress fractures, sick, flu, bilateral tibia fracture, loss of bone density, long term use PRILOSEC Rx and FLUMIST QUADRIVALENT did not work was unknown. The event loss of bone density was identified by the company physician from the source documents and added as adverse event and considered it serious due to the important medical event. The company physician assessed the septic, stress fractures and bilateral tibia fracture to be serious due to important medical event. The company physician assessed the FLUMIST QUADRIVALENT did not work, influenza B/flu to be serious due to hospitalization and rest all events were assessed as non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Cast application, Dyspepsia, Endotracheal intubation, Endotracheal intubation complication, Gastrooesophageal reflux disease
Clinical narrative: A spontaneous report received from consumer. The report concerns a 13 years 21 weeks 1 day old, male patient, (height : 68.0 inches, weight: 140.0 pounds). The patient's relevant history included hospitalization. The patient's concurrent diseases included arm swelling after flu shot. Concomitant medications included salbutamol for respiratory wheeze and fluticasone propionate for inflammation in lungs post infection. Patient received FLUMIST (intranasal) 0.2 ml in 2012, 2013, and 2014. Also prescribed oral PRILOSEC Rx capsule unknown dose and frequency, started 18-Jan-2015. Unknown stop but he took the PRILOSEC Rx for about 3-4 months. The reporter thought patient may have taken Omeprazole Rx  for about 1 month sometime after 18-Jan-2015 for stomach pain. He also took Omeprazole OTC for 2-3 months sometime after taking PRILOSEC Rx. The reporter stated the patient may have switched from PRILOSEC Rx to Omeprazole Rx to Omeprazole OTC based on availability. Specified dates are not known. It was reported that patient used PRILOSEC Rx for long term and FLUMIST QUADRIVALENT did not work still got influenza B, hospitalized 5-Jan-2015 to 18-Jan-2015 ICU and was intubated on 07-Jan-2015 and had bad stomach issues after intubation, was throwing up and gagging on tube, after extubation anything he would eat would throw up it was painful to eat, swallow, or drink, had stomach pain. ZANTAC was not working was still having stomach pain after discharge from hospital. Esophagus was burning had reflux and stomach was burning, septic with low blood pressure, pneumonia, blood clot and attributes to a cast that was placed after x ray showed bilateral tibia fracture but left leg fracture was worse and was casted, leg cast placed for fracture 12-Aug-2015, weight loss 20 lb with continued complications with stress fractures and residual complications from being sick from the flu. Complaining of leg pain and was walking around on stress fractures and this was treated with shin splints. The reporter assumed that the patient had loss of bone density. The outcome of influenza B/flu, septic, stomach issues, throwing up, stomach pain, esophagus was burning/stomach was burning, pneumonia, blood clot in leg, weight loss, complaining of leg pain, gagging, painful to eat, swallow and drink, reflux, stress fractures, sick, flu, bilateral tibia fracture, loss of bone density, long term use PRILOSEC Rx and FLUMIST QUADRIVALENT did not work was unknown. The event loss of bone density was identified by the company physician from the source documents and added as adverse event and considered it serious due to the important medical event. The company physician assessed the septic, stress fractures and bilateral tibia fracture to be serious due to important medical event. The company physician assessed the FLUMIST QUADRIVALENT did not work, influenza B/flu to be serious due to hospitalization and rest all events were assessed as non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Hypotension, Influenza, Intensive care, Lower limb fracture, Medial tibial stress syndrome
Clinical narrative: A spontaneous report received from consumer. The report concerns a 13 years 21 weeks 1 day old, male patient, (height : 68.0 inches, weight: 140.0 pounds). The patient's relevant history included hospitalization. The patient's concurrent diseases included arm swelling after flu shot. Concomitant medications included salbutamol for respiratory wheeze and fluticasone propionate for inflammation in lungs post infection. Patient received FLUMIST (intranasal) 0.2 ml in 2012, 2013, and 2014. Also prescribed oral PRILOSEC Rx capsule unknown dose and frequency, started 18-Jan-2015. Unknown stop but he took the PRILOSEC Rx for about 3-4 months. The reporter thought patient may have taken Omeprazole Rx  for about 1 month sometime after 18-Jan-2015 for stomach pain. He also took Omeprazole OTC for 2-3 months sometime after taking PRILOSEC Rx. The reporter stated the patient may have switched from PRILOSEC Rx to Omeprazole Rx to Omeprazole OTC based on availability. Specified dates are not known. It was reported that patient used PRILOSEC Rx for long term and FLUMIST QUADRIVALENT did not work still got influenza B, hospitalized 5-Jan-2015 to 18-Jan-2015 ICU and was intubated on 07-Jan-2015 and had bad stomach issues after intubation, was throwing up and gagging on tube, after extubation anything he would eat would throw up it was painful to eat, swallow, or drink, had stomach pain. ZANTAC was not working was still having stomach pain after discharge from hospital. Esophagus was burning had reflux and stomach was burning, septic with low blood pressure, pneumonia, blood clot and attributes to a cast that was placed after x ray showed bilateral tibia fracture but left leg fracture was worse and was casted, leg cast placed for fracture 12-Aug-2015, weight loss 20 lb with continued complications with stress fractures and residual complications from being sick from the flu. Complaining of leg pain and was walking around on stress fractures and this was treated with shin splints. The reporter assumed that the patient had loss of bone density. The outcome of influenza B/flu, septic, stomach issues, throwing up, stomach pain, esophagus was burning/stomach was burning, pneumonia, blood clot in leg, weight loss, complaining of leg pain, gagging, painful to eat, swallow and drink, reflux, stress fractures, sick, flu, bilateral tibia fracture, loss of bone density, long term use PRILOSEC Rx and FLUMIST QUADRIVALENT did not work was unknown. The event loss of bone density was identified by the company physician from the source documents and added as adverse event and considered it serious due to the important medical event. The company physician assessed the septic, stress fractures and bilateral tibia fracture to be serious due to important medical event. The company physician assessed the FLUMIST QUADRIVALENT did not work, influenza B/flu to be serious due to hospitalization and rest all events were assessed as non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Odynophagia, Pain in extremity, Peripheral swelling, Pneumonia, Retching
Clinical narrative: A spontaneous report received from consumer. The report concerns a 13 years 21 weeks 1 day old, male patient, (height : 68.0 inches, weight: 140.0 pounds). The patient's relevant history included hospitalization. The patient's concurrent diseases included arm swelling after flu shot. Concomitant medications included salbutamol for respiratory wheeze and fluticasone propionate for inflammation in lungs post infection. Patient received FLUMIST (intranasal) 0.2 ml in 2012, 2013, and 2014. Also prescribed oral PRILOSEC Rx capsule unknown dose and frequency, started 18-Jan-2015. Unknown stop but he took the PRILOSEC Rx for about 3-4 months. The reporter thought patient may have taken Omeprazole Rx  for about 1 month sometime after 18-Jan-2015 for stomach pain. He also took Omeprazole OTC for 2-3 months sometime after taking PRILOSEC Rx. The reporter stated the patient may have switched from PRILOSEC Rx to Omeprazole Rx to Omeprazole OTC based on availability. Specified dates are not known. It was reported that patient used PRILOSEC Rx for long term and FLUMIST QUADRIVALENT did not work still got influenza B, hospitalized 5-Jan-2015 to 18-Jan-2015 ICU and was intubated on 07-Jan-2015 and had bad stomach issues after intubation, was throwing up and gagging on tube, after extubation anything he would eat would throw up it was painful to eat, swallow, or drink, had stomach pain. ZANTAC was not working was still having stomach pain after discharge from hospital. Esophagus was burning had reflux and stomach was burning, septic with low blood pressure, pneumonia, blood clot and attributes to a cast that was placed after x ray showed bilateral tibia fracture but left leg fracture was worse and was casted, leg cast placed for fracture 12-Aug-2015, weight loss 20 lb with continued complications with stress fractures and residual complications from being sick from the flu. Complaining of leg pain and was walking around on stress fractures and this was treated with shin splints. The reporter assumed that the patient had loss of bone density. The outcome of influenza B/flu, septic, stomach issues, throwing up, stomach pain, esophagus was burning/stomach was burning, pneumonia, blood clot in leg, weight loss, complaining of leg pain, gagging, painful to eat, swallow and drink, reflux, stress fractures, sick, flu, bilateral tibia fracture, loss of bone density, long term use PRILOSEC Rx and FLUMIST QUADRIVALENT did not work was unknown. The event loss of bone density was identified by the company physician from the source documents and added as adverse event and considered it serious due to the important medical event. The company physician assessed the septic, stress fractures and bilateral tibia fracture to be serious due to important medical event. The company physician assessed the FLUMIST QUADRIVALENT did not work, influenza B/flu to be serious due to hospitalization and rest all events were assessed as non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Septic shock, Stress fracture, Thrombosis, Tibia fracture, Vomiting
Clinical narrative: A spontaneous report received from consumer. The report concerns a 13 years 21 weeks 1 day old, male patient, (height : 68.0 inches, weight: 140.0 pounds). The patient's relevant history included hospitalization. The patient's concurrent diseases included arm swelling after flu shot. Concomitant medications included salbutamol for respiratory wheeze and fluticasone propionate for inflammation in lungs post infection. Patient received FLUMIST (intranasal) 0.2 ml in 2012, 2013, and 2014. Also prescribed oral PRILOSEC Rx capsule unknown dose and frequency, started 18-Jan-2015. Unknown stop but he took the PRILOSEC Rx for about 3-4 months. The reporter thought patient may have taken Omeprazole Rx  for about 1 month sometime after 18-Jan-2015 for stomach pain. He also took Omeprazole OTC for 2-3 months sometime after taking PRILOSEC Rx. The reporter stated the patient may have switched from PRILOSEC Rx to Omeprazole Rx to Omeprazole OTC based on availability. Specified dates are not known. It was reported that patient used PRILOSEC Rx for long term and FLUMIST QUADRIVALENT did not work still got influenza B, hospitalized 5-Jan-2015 to 18-Jan-2015 ICU and was intubated on 07-Jan-2015 and had bad stomach issues after intubation, was throwing up and gagging on tube, after extubation anything he would eat would throw up it was painful to eat, swallow, or drink, had stomach pain. ZANTAC was not working was still having stomach pain after discharge from hospital. Esophagus was burning had reflux and stomach was burning, septic with low blood pressure, pneumonia, blood clot and attributes to a cast that was placed after x ray showed bilateral tibia fracture but left leg fracture was worse and was casted, leg cast placed for fracture 12-Aug-2015, weight loss 20 lb with continued complications with stress fractures and residual complications from being sick from the flu. Complaining of leg pain and was walking around on stress fractures and this was treated with shin splints. The reporter assumed that the patient had loss of bone density. The outcome of influenza B/flu, septic, stomach issues, throwing up, stomach pain, esophagus was burning/stomach was burning, pneumonia, blood clot in leg, weight loss, complaining of leg pain, gagging, painful to eat, swallow and drink, reflux, stress fractures, sick, flu, bilateral tibia fracture, loss of bone density, long term use PRILOSEC Rx and FLUMIST QUADRIVALENT did not work was unknown. The event loss of bone density was identified by the company physician from the source documents and added as adverse event and considered it serious due to the important medical event. The company physician assessed the septic, stress fractures and bilateral tibia fracture to be serious due to important medical event. The company physician assessed the FLUMIST QUADRIVALENT did not work, influenza B/flu to be serious due to hospitalization and rest all events were assessed as non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Weight decreased, X-ray limb abnormal
Clinical narrative: A spontaneous report received from consumer. The report concerns a 13 years 21 weeks 1 day old, male patient, (height : 68.0 inches, weight: 140.0 pounds). The patient's relevant history included hospitalization. The patient's concurrent diseases included arm swelling after flu shot. Concomitant medications included salbutamol for respiratory wheeze and fluticasone propionate for inflammation in lungs post infection. Patient received FLUMIST (intranasal) 0.2 ml in 2012, 2013, and 2014. Also prescribed oral PRILOSEC Rx capsule unknown dose and frequency, started 18-Jan-2015. Unknown stop but he took the PRILOSEC Rx for about 3-4 months. The reporter thought patient may have taken Omeprazole Rx  for about 1 month sometime after 18-Jan-2015 for stomach pain. He also took Omeprazole OTC for 2-3 months sometime after taking PRILOSEC Rx. The reporter stated the patient may have switched from PRILOSEC Rx to Omeprazole Rx to Omeprazole OTC based on availability. Specified dates are not known. It was reported that patient used PRILOSEC Rx for long term and FLUMIST QUADRIVALENT did not work still got influenza B, hospitalized 5-Jan-2015 to 18-Jan-2015 ICU and was intubated on 07-Jan-2015 and had bad stomach issues after intubation, was throwing up and gagging on tube, after extubation anything he would eat would throw up it was painful to eat, swallow, or drink, had stomach pain. ZANTAC was not working was still having stomach pain after discharge from hospital. Esophagus was burning had reflux and stomach was burning, septic with low blood pressure, pneumonia, blood clot and attributes to a cast that was placed after x ray showed bilateral tibia fracture but left leg fracture was worse and was casted, leg cast placed for fracture 12-Aug-2015, weight loss 20 lb with continued complications with stress fractures and residual complications from being sick from the flu. Complaining of leg pain and was walking around on stress fractures and this was treated with shin splints. The reporter assumed that the patient had loss of bone density. The outcome of influenza B/flu, septic, stomach issues, throwing up, stomach pain, esophagus was burning/stomach was burning, pneumonia, blood clot in leg, weight loss, complaining of leg pain, gagging, painful to eat, swallow and drink, reflux, stress fractures, sick, flu, bilateral tibia fracture, loss of bone density, long term use PRILOSEC Rx and FLUMIST QUADRIVALENT did not work was unknown. The event loss of bone density was identified by the company physician from the source documents and added as adverse event and considered it serious due to the important medical event. The company physician assessed the septic, stress fractures and bilateral tibia fracture to be serious due to important medical event. The company physician assessed the FLUMIST QUADRIVALENT did not work, influenza B/flu to be serious due to hospitalization and rest all events were assessed as non-serious.
Age: 1.4
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Constipation, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 1 year old, Female consumer, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent (intranasal) started during Sep-2015. The mother of patient reported that her a 17 month old girl received the FLUMIST quadrivalent from her HCP she also reported that since she received the FLUMIST quadrivalent her daughter has had a runny nose, and congestion and stomach cramping, and constipation. The outcome of stomach cramping, runny nose, constipation, congestion and 17 month old girl who received the FLUMIST quadrivalent (inadvertent administration) is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect route of drug administration
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender. No relevant history or concomitant medication was provided. The patient had been receiving unknown FLUMIST quadrivalent (intranasal), 0.2 millilitres, unknown starting on 16-Sep-2015. It was reported that a consumer in the doctor's office may or may not have been injected with the FLUMIST quadrivalent vaccine which started on 16-Sep-2015. The outcome of the event of a consumer in the doctor's office may or may not have been injected with the FLUMIST quadrivalent vaccine was unknown. The report was considered to be non-serious by company physician.
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus, Urticaria
Clinical narrative: A spontaneous report has been received from consumer. The report concerns a male patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient received FLUMIST Quadrivalent (intranasal), in during 2014. The mother of the patient reported that her son got the vaccine from his doctor's office at 10 am and they were out and about with errands after that her son started itching. She lifted his shirt and saw that he had hives all over his trunk, upper thighs and buttocks and an hour and a half to 2 hours after he received the vaccine. The patient recovered from itching and hives all over trunk, upper thighs and buttocks on an unspecified date. The report was considered to be non-serious by company physician.
Age: 0.55
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a 7 month old, male subject, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on 11-Dec-2014. A registered nurse with the county health department called the information center to find out any information available about what happens if a 6 month old receives a FLUMIST vaccine approved for ages 2 years and up. Registered nurse stated that it was discovered through an audit that a 6 month old erroneously received a FLUMIST vaccine on 11DEC2014. Registered nurse was unaware of any events resulting from this medication error. Registered nurse stated she already reported this event through the Vaccine Adverse Event Reporting System, but did not have a confirmation number yet. The outcome of the event of 6 month old received the FLUMIST vaccine is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 28-Aug-2015 from health professional via spontaneous source: Reporter details updated. Start date of event updated. Narrative updated.
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: A consumer report has been received. The report concerns a female consumer, who had been receiving FLUMIST (intranasal), unknown. Concomitant medications included ranitidine hydrochloride, iron and minerals NOS+vitamins NOS. FLUMIST started on 16-Dec-2003. The patient experienced no adverse event. FLUMIST was discontinued on 16-Dec-2003. The outcome of the event of no adverse event is unknown. The report was considered to be non-serious. Corrected report 30-Nov-2015: Event updated to no adverse event.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Malaise, Nasal congestion
Clinical narrative: A consumer report has been received. The report concerns a 38 year old, female consumer, height: 63.0 inches; weight: 130.0 pounds, who had been receiving FLUMIST Quadrivalent (intranasal) 0.2 milliliters, once/single administration. Concomitant medications included ethinylestradiol, levonorgestrel for birth control. FLUMIST Quadrivalent started on an unknown date. The patient experienced headache which started on 11-Oct-2015, nasal congestion and malaise. The outcome of the event of headache, nasal congestion and malaise was unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Medication error, No adverse event
Clinical narrative: Information regarding FLUMIST (2003-2004 formula) (intranasal) was received from a consumer regarding a female patient who received FLUMIST while nursing. The patient received a dose on 13-Dec-2003. The patient had no medical history. Product was administered on 13-Dec-2003. Dose regimen was 1 dose. Concomitant therapy included MICRONOR. The reporter stated the question "Why did my doctor tell me it was OK to received FLUMIST even though I am nursing?". As of 15-Dec-2003, no adverse events had occurred in the patient or her 5-month-old son whom she was nursing. No additional information was available at the date of this report. Corrected report 30-Nov-2015: Associated case ID added.
Sex: U
Vaccine: FLUN3
Symptoms: Intentional product misuse
Clinical narrative: A report has been received from a physician via Merck concerning a patient of unknown gender, who had been receiving FLUMIST (intranasal), dose unknown. Concomitant medications included varicella virus vaccine, live. FLUMIST started on an unknown date. The physician reported that VARIVAX was administered to the patient within less than 4 weeks from FLUMIST spray. The outcome of VARIVAX was administered within less than 4 weeks from FLUMIST spray was unknown. The reporter's description of the event(s) was as follows: Please see the attached document. The report was considered to be non-serious.
Age: 31.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 31 year old, female patient, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. It is reported that the FLUMIST Quadrivalent administered to pregnant patient. The outcome of the event of administered to pregnant patient was unknown. The report was considered to be non-serious.
Age: 1.48
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, Intentional product misuse
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, male subject, height: 32.0 inches; weight: 21.6 pounds, who had been receiving FLUMIST Quadrivalent (intranasal), 0.1 ml in each nostril/one time administration. FLUMIST Quadrivalent started on 12-Oct-2015. Patient stated that on 12-Oct-2015, an 18 months old child was administered FLUMIST, 0.1 ml in each nostril/one time administration, intranasally by an inexperienced nurse who did not read the indications. The outcome of the event of 18 month old child was administered FLUMIST was unknown and the outcome of the event of intentional product misuse was unknown. The reporter's description of the event(s) was as follows: allergy to amoxicillin (rash). The report was considered to be non-serious.