chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported this was a second dose of Zostavax.
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Meningitis viral
Clinical narrative: A consumer report has been received, concerning a female patient. No concomitant medication or relevant history was provided. On an unspecified date, the patient received FLUMIST QUADRIVALENT (intranasal). Two days after receiving the FLUMIST QUADRIVALENT, the patient got viral meningitis. The outcome of the event of viral meningitis/got viral meningitis 2 days after receiving FLUMIST was unknown. The company physician considered the event of viral meningitis/got viral meningitis 2 days after receiving FLUMIST as serious due to important medical event criterion. The reporter and the company physician considered that there was no causal relationship between viral meningitis/got viral meningitis 2 days after receiving FLUMIST and FLUMIST QUADRIVALENT.
Age: 52.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Meningitis viral
Clinical narrative: A spontaneous report has been received from a health professional (registered nurse), concerning a 52 year old, female patient. Relevant medical history, concurrent diseases and concomitant medications were not reported. On 01-Oct-2015, the patient received FLUMIST quadrivalent, (intranasal), 0.2 millilitres. The patient was hospitalized on 03-Oct-2015 for 11 days for viral meningitis. The outcome of the event of viral meningitis was unknown. At time of reporting the patient was back at home and back at work. The company physician assessed the event of viral meningitis to be serious due to hospitalization.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid, extending in to Shoulder with tenderness warmth and edema. Patient unable to lift arm over head.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Left deltoid, extending in to Shoulder with tenderness warmth and edema. Patient unable to lift arm over head.
Age: 12.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Abdominal pain, Fatigue, Laboratory test, Lymph node pain, Lymphadenopathy
Clinical narrative: Migraine, swollen lymph nodes in neck, clavical, and arm pit, nausea, abdominal pain, fatigue, lymphatic pain.
Age: 12.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Migraine, Nausea
Clinical narrative: Migraine, swollen lymph nodes in neck, clavical, and arm pit, nausea, abdominal pain, fatigue, lymphatic pain.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Lymphadenopathy, Migraine, Nausea, Vomiting
Clinical narrative: Migraine, nausea, within 12 hrs lymph nodes all swollen hard again like in November after first round of HPV Vaccine. Throwing up started by day 2 after vaccine....continues for a week. Lost over 4 lbs.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Weight decreased
Clinical narrative: Migraine, nausea, within 12 hrs lymph nodes all swollen hard again like in November after first round of HPV Vaccine. Throwing up started by day 2 after vaccine....continues for a week. Lost over 4 lbs.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Gait disturbance, Mobility decreased, Nervous system disorder
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female adolescent patient. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in 2015 (reported as around 6 months ago), the patient was vaccinated with GARDASIL (dose, route and site of administration, lot and expiration date were unknown). It was unspecified if this was the first, second or third shot in the GARDASIL series. On an unknown date in 2015 (reported as "shortly after" receiving the GARDASIL), the patient began to experience neurological problems, including "difficulty walking and getting around". The patient sought unspecified medical attention. These symptoms had led to a significant change in the adolescent's lifestyle, including the need to quit cheerleading. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review the events of difficulty in walking and mobility decreased were considered to be disabling. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Immediate swelling and redness, excessive bleeding upon administration of DTaP.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Oropharyngeal pain, Throat tightness
Clinical narrative: Dizziness, fatigue, lightheadedness, sensation of sore/tight throat.  HR and BP wnl for patient age, good air exchange all lung fields, OP exam benign.  Resolved after 25 minutes, tolerated sips water without difficulty.
Sex: F
Vaccine: MNQ
Symptoms: Abasia, Photosensitivity reaction, Psychomotor seizures
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) on 02 February 2016. Manufacturer Report Number: 2015310003. This case involves female (age not reported) patient who was vaccinated with a dose of Menactra (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed photosensitivity, unable to walk, psychomotor seizures. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: unable to walk, psychomotor seizures. List of documents held by sender: none. Sender's Comments: Unable to walk is unlisted but psychomotor seizures is listed with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash pruritic, Scab
Clinical narrative: I have a rash with itchy bumps that started in my scalp and has moved to my chest, back, forearms, and stomach.  The rash starts as a pink area and then turns into individual bumps that itch.   I scratch them and they scab over.   I saw my doctor on February 5th since I had been awake the night of Feb. 4, 2016 itching and scratching.  He prescribed Methylprednisolone 4 MG Dosepack and also Benadryl, and Zyrtec.   Also use Desoximetasone that I already had.  I then saw someone at a dermatolgy center on February 8 and 18th.   She believed it was related to our dogs, but I receive allergy injections that covers the dogs.   We treated our dogs and house for fleas, but no evidence of fleas was found. I am still taking the Benadryl and Zyrtec and using the prescription hydrocortisone cream and an over-the-counter one for my face and neck.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Injection site joint pain, Musculoskeletal pain
Clinical narrative: 14 days after vaccines, onset of right shoulder and right wrist joint pain of moderate-severe intensity. Noted left shoulder joint pain also but not as intense. 3 months later, wrist pain gone but right shoulder pain continues but not as intense.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray, Cough, Dysphonia, Dyspnoea, Electrocardiogram
Clinical narrative: Severe shoulder to wrist bilateral the next morning (black and blue) and throat pain and hoarseness. SOB and cough. Called nurse - no ideas, called GP - no ideas. Called VAERS from pamphlet info. Instructed to tell GP to file a form. Pains have become chronic and SOB leads to fainting spells with exertion like bending too much or walking too far.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Pain, Skin discolouration, Syncope
Clinical narrative: Severe shoulder to wrist bilateral the next morning (black and blue) and throat pain and hoarseness. SOB and cough. Called nurse - no ideas, called GP - no ideas. Called VAERS from pamphlet info. Instructed to tell GP to file a form. Pains have become chronic and SOB leads to fainting spells with exertion like bending too much or walking too far.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain, Rotator cuff syndrome
Clinical narrative: Immediately after (approximately 3 hours), more pain than usual. Next day when I woke up couldn't move shoulder. Diagnosed now as a torn rotator cuff.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: Immediately after (approximately 3 hours), more pain than usual. Next day when I woke up couldn't move shoulder. Diagnosed now as a torn rotator cuff.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased
Clinical narrative: Employee had gone for routine physical and blood work and CBC showed a low platelet count of 45. Has followed by hematologist and suspicion of reaction to flu vaccination. Reviewed CBC results annually from 3/21/2011 - 4/18/2014 and Platelets were between 186-224 range. Had received flu vaccine in the past 2010-2013 received thimerosal-free without any problem. 2014 received a regular flu vaccine on 9/23/2014, however her CBC record in 2014 was from 4/18/2014 that showed normal platelets. CBC was done prior to the flu vaccination in 2014.
Age: 0.81
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Irritability
Clinical narrative: Redness and swelling and a hard lump at site of injection.  Redness continues to spread- as of 02/24/2016 at 10:20 AM the red area is about 3.5 inches" around in the shape of a circle.  Baby is also fussier than normal.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot
Clinical narrative: During HPV school based clinic held in the cafeteria, adolescent complained of feeling dizzy and feeling hot after looking at needle when HPV injection was given. Patient lowered to the floor. Cool wash cloth applied to forehead and vital signs taken: BP 105/72 and pulse 74. Skin color good. Patient did not have breakfast and was offered juice and crackers and a bottle of cold water. Patient was assisted to sitting position and parent notified by school nurse. Patient was able to stand after 30 minutes and ambulated to the school nurse's office.
Age: 0.5
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray abnormal, Cough, Influenza, Irritability, Pneumonia
Clinical narrative: A solicited consumer report has been received. The report concerned a 5 month old female patient, height: 49.0 centimeters; weight: 5.0 kilograms. The patient's medical history included milk allergy, milk allergy and diarrhea. The patient had past medications of NAN milk powder and Aptamil milk powder. The patient had been receiving intramuscular SYNAGIS, 15.0 milligrams per kilogram, unknown frequency started on 15-Apr-2015 for prematurity and unknown influenza vaccine. The patient presented 2 episodes of pneumonia and, in both of them, the symptoms were dry cough, irritability, flu, and pulmonary secretion (described as catarrh in the chest). Due to the first episode of pneumonia, the patient was hospitalized for 8 days in order to receive unspecified treatment and to be monitored. After being discharged, she underwent inhalation with saline solution for 3 days and the events were resolved. The patient was treated with Acetylcysteine, Cloperastine Fendizoate (seki), Saline solution, Amoxicillin and Salbutamol Sulphate. SYNAGIS was continued. The patient recovered from the events of pneumonia, dry cough, irritability, flu and pulmonary secretion on an unspecified date. Assessment of the serious criteria for the report was as follows by the reporter: hospitalized. Laboratory values are available. The reporter stated that there was no reasonable possibility that the events of pneumonia, dry cough, irritability, flu, pulmonary secretion were related to SYNAGIS and influenza vaccine.    A solicited consumer report has been received via Abbvie. The report concerned a 5 month old female patient, height: 49.0 centimeters; weight: 5.0 kilograms. The patient's medical history included milk allergy, milk allergy and diarrhea. The patient had past medications of NAN milk powder and Aptamil milk powder. The patient had been receiving intramuscular SYNAGIS, 15.0 milligrams per kilogram, unknown frequency started on 15-Apr-2015 for prematurity and unknown Influenza vaccine. The patient presented 2 episodes of pneumonia and, in both of them, the symptoms were dry cough, irritability, Flu and pulmonary secretion. Due to the first episode of pneumonia, the patient was hospitalized for 8 days in order to receive unspecified treatment and to be monitored. After being discharged, she underwent inhalation with saline solution for 3 days and the events were resolved. The patient was treated with Acetylcysteine, Cloperastine Fendizoate, Saline Solution, Amoxicillin and Salbutamol Sulphate. SYNAGIS was continued. The patient recovered from the events of pneumonia, dry cough, irritability, Flu and pulmonary secretion on an unspecified date. Assessment of the serious criteria for the report was as follows by the reporter: hospitalized. Laboratory values are available. The reporter stated that there was no reasonable possibility that the events of pneumonia, dry cough, irritability, Flu, pulmonary secretion were related to SYNAGIS and Influenza vaccine.
Age: 0.5
Sex: F
Vaccine: FLUX
Symptoms: Pulmonary congestion, Secretion discharge
Clinical narrative: A solicited consumer report has been received. The report concerned a 5 month old female patient, height: 49.0 centimeters; weight: 5.0 kilograms. The patient's medical history included milk allergy, milk allergy and diarrhea. The patient had past medications of NAN milk powder and Aptamil milk powder. The patient had been receiving intramuscular SYNAGIS, 15.0 milligrams per kilogram, unknown frequency started on 15-Apr-2015 for prematurity and unknown influenza vaccine. The patient presented 2 episodes of pneumonia and, in both of them, the symptoms were dry cough, irritability, flu, and pulmonary secretion (described as catarrh in the chest). Due to the first episode of pneumonia, the patient was hospitalized for 8 days in order to receive unspecified treatment and to be monitored. After being discharged, she underwent inhalation with saline solution for 3 days and the events were resolved. The patient was treated with Acetylcysteine, Cloperastine Fendizoate (seki), Saline solution, Amoxicillin and Salbutamol Sulphate. SYNAGIS was continued. The patient recovered from the events of pneumonia, dry cough, irritability, flu and pulmonary secretion on an unspecified date. Assessment of the serious criteria for the report was as follows by the reporter: hospitalized. Laboratory values are available. The reporter stated that there was no reasonable possibility that the events of pneumonia, dry cough, irritability, flu, pulmonary secretion were related to SYNAGIS and influenza vaccine.    A solicited consumer report has been received via Abbvie. The report concerned a 5 month old female patient, height: 49.0 centimeters; weight: 5.0 kilograms. The patient's medical history included milk allergy, milk allergy and diarrhea. The patient had past medications of NAN milk powder and Aptamil milk powder. The patient had been receiving intramuscular SYNAGIS, 15.0 milligrams per kilogram, unknown frequency started on 15-Apr-2015 for prematurity and unknown Influenza vaccine. The patient presented 2 episodes of pneumonia and, in both of them, the symptoms were dry cough, irritability, Flu and pulmonary secretion. Due to the first episode of pneumonia, the patient was hospitalized for 8 days in order to receive unspecified treatment and to be monitored. After being discharged, she underwent inhalation with saline solution for 3 days and the events were resolved. The patient was treated with Acetylcysteine, Cloperastine Fendizoate, Saline Solution, Amoxicillin and Salbutamol Sulphate. SYNAGIS was continued. The patient recovered from the events of pneumonia, dry cough, irritability, Flu and pulmonary secretion on an unspecified date. Assessment of the serious criteria for the report was as follows by the reporter: hospitalized. Laboratory values are available. The reporter stated that there was no reasonable possibility that the events of pneumonia, dry cough, irritability, Flu, pulmonary secretion were related to SYNAGIS and Influenza vaccine.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: A report received from health professional via medical rep concerning a 6 year old, female patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. Patient received FLUMIST quadrivalent vaccine. The outcome of nosebleed was unknown. The reporter assessed nosebleed to be non serious. Reporter and company physician considered the nosebleed to be unrelated with FLUMIST quadrivalent.
Age: 1.8
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, Off label use
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Male patient, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (intranasal) started on an unknown date for INFLUENZA. The nurse reported that FLUMIST was inadvertently administered to a 22 month old infant male today which started on 28-Oct-2015 and also reported that FLUMIST to 22 months old infant male. The outcome of the event of ADMINISTRATION TO 22MO OLD and FLUMIST TO 22MO OLD was unknown. The report was considered to be non-serious.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Information received from an Investigator in a vaccine pregnancy registry. A 35 year old female (gravida 1 para 0) received dose 4 of BioThrax vaccine in JAN2015 (at 4 weeks 0 days estimated gestational age (EGA)). The female was determined to be pregnant in JAN2015, 10 days after vaccination. She sent a study referral (generated from active case finding efforts) in FEB2016 which indicated that she had a miscarriage in MAR2015 (5 weeks + 3 days EGA). Treatments included: oxycodone hcl / acetaminophen, promethazine and acetaminophen. No further information is expected. The subject was not eligible for entry in the registry; the Investigator forwarded the information to the vaccine manufacturer.
Sex: U
Vaccine: FLUN4
Symptoms: Labelled drug-disease interaction medication error
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, unknown for INFLUENZA. FLUMIST (intranasal) started on 21-Oct-2015 for INFLUENZA. It was reported that the administration to asthmatic patient. The outcome of the event ADMINISTERED TO ASTHMATIC PATIENT is unknown. The report was considered to be non-serious. Corrected Reported 13-Nov-2015: Relation to patient added. Reporter information added.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a female patient. No information was provided regarding the concomitant medications, concurrent diseases and medical history of the patient. The patient number eight received the FLUMIST vaccine (intranasal), 0.2 ml, dose, one time intranasally, for the prevention of the flu, date of vaccination not provided. It was unknown if the dose of 0.1 ml was given in each nostril. The office refrigerator had a temperature excursion of 1.5 degrees C for a total of 17.5 hours. The temperature would be at recommended temperature range and then dip to 1.5 degrees C, then go back to original range. FLUMSIT was continued. The outcome of the events of patient given FLUMIST vaccine after a temperature excursion of 1.5 c for 17.5 hours/temperature excursion of FLUMIST vaccine given to 14 patients and it is unknown if the dose of 0.1 ml was given in each nostril/patient number one received FLUMIST vaccine 0.2ml dose, one time intranasally was unknown. The report was considered to be non-serious by company physician.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a female subject who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown. FLUMIST (intranasal) started on an unknown date. The patient received FLUMIST when she was 4 weeks pregnant (did not know). She just found out she was pregnant. FLUMIST (intranasal) was continued. The outcome of the event of PREGNANT is 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 Pharmacist concerning a 58 years 21 weeks 1 day old. Female patient, who had been receiving Nasal FLUMIST (intranasal), 0.1 mL per nostril, with total dose of 0.2mL. FLUMIST (intranasal) started on 28-Oct-2015. The patient was 58 years old and the HCP administering the vaccine did not realize the vaccine is only approved for patients aged 2 to 49 years old. FLUMIST (intranasal) was continued. The outcome of the event of FLUMIST ADMINISTERED TO A 58 YEAR OLD PATIENT was unknown. The report was considered to be non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Contraindication to vaccination
Clinical narrative: A report has been received from a Health Professional concerning a 13 year old, male patient, who received FLUMIST. The patient's medical history included closure of aortic tunnel. Concomitant medications included acetylsalicylic acid. FLUMIST was started on 15-Oct-2015. It was reported that a 13 year old patient had received FLUMIST, while he was on aspirin therapy. The outcome of the event FLUMIST administered to child taking aspirin was unknown. The report was considered to be non-serious.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Blood glucose increased, Dizziness, Electrocardiogram, Laboratory test, Pain in extremity
Clinical narrative: Patient is here for dizziness and left arm pain-tingling, that started after a hep B shot given in same day. Patient alert and oriented times 3.  Appears pale to face.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Pallor, Paraesthesia
Clinical narrative: Patient is here for dizziness and left arm pain-tingling, that started after a hep B shot given in same day. Patient alert and oriented times 3.  Appears pale to face.
Sex: U
Vaccine: FLUN4
Symptoms: Sneezing
Clinical narrative: A report has been received from a Pharmacist concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST (intranasal) for vaccine. FLUMIST (intranasal) started on 13-Oct-2015 for vaccine. The patient experienced SNEEZED which started on 13-Oct-2015. The outcome of the event of SNEEZED is unknown. The report was considered to be non-serious.
Age: 50.0
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 female subject, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (intranasal) started on an unknown date for INFLUENZA. It was reported that the FLUMIST was administered to a 50 year old patient. Action taken with FLUMIST was unknown. The outcome of the event of ADMINISTERED TO A 50 YEAR OLD PATIENT was unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A report has been received from a Health Professional concerning a female subject, who had been receiving Nasal FLUMIST (intranasal) for INFLUENZA. FLUMIST (intranasal) started on an unknown date for INFLUENZA. The patient experienced RUNNY NOSE, SLIGHT HEADACHE and CONGESTION IN CHEST. The patient recovered from the event of RUNNY NOSE, SLIGHT HEADACHE and CONGESTION IN CHEST on an unspecified date. The report was considered to be non-serious by the company physician.
Age: 0.25
Sex: M
Vaccine: FLUN4
Symptoms: Malaise
Clinical narrative: A report has been received from a Health Professional concerning a male subject who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on 07-Nov-2015. The patient reported NOT FEELING GREAT which started on 09-Nov-2015. The outcome of the event of NOT FEELING GREAT is unknown. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN3
Symptoms: Headache, Sinus disorder
Clinical narrative: A spontaneous report had been received from a Health Professional concerning unknown number of patients of unknown gender. Lack of relevant history. No concomitant medications reported. The patients had received FLUMIST (intranasal), once/single administration started on an unknown date. The health professional reported that several people experienced severe Headache and sinus symptoms for one and half weeks after they were given the vaccine. Action taken with the FLUMIST was unknown. The outcome of the event of sinus symptoms and severe headache was unknown. The company physician assessed the event of sinus symptoms to be serious with the seriousness criteria of important medical event and the event of severe headache to be non-serious.
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a male consumer, who had been receiving nasal FLUMIST (intranasal). Concomitant medications included UNSPECIFIED). FLUMIST (INTRANASAL) started on an unknown date. The patient experienced EXPERIENCING A FEVER FOR THE PAST 36 HOURS, WHICH SPIKED. The outcome of the event of EXPERIENCING A FEVER FOR THE PAST 36 HOURS, WHICH SPIKED is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Musculoskeletal stiffness, Nasal congestion
Clinical narrative: A consumer report has been received. The report concerns a female consumer, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on 02-Nov-2015. The patient experienced NASAL CONGESTION which started on 04-Nov-2015 and STIFF NECK which started on 03-Nov-2015. The outcome of the event of STIFF NECK and NASAL CONGESTION is unknown. The reporter's description of the event (s) was as follows: see attachment. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The child turned his head so only half the dose was administered. The outcome of the event of ONLY RECEIVED HALF THE DOSE is unknown. The reporter's description of the event (s) was as follows: Unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Headache, Sinus disorder
Clinical narrative: A report has been received from a Health Professional concerning a patients of unknown gender, who had been receiving Nasal FLUMIST (intranasal), Once/Single administration for PREVENT THE FLU. FLUMIST (intranasal) started on an unknown date for PREVENT THE FLU. The patient experienced SINUS SYMPTOMS and SEVERE HEADACHE. The outcome of the event of SINUS SYMPTOMS and SEVERE HEADACHE is unknown. The reporter's description of the event (s) was as follows: unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Headache, Pyrexia
Clinical narrative: A report has been received from a Physician concerning an 11 year old, Female subject, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patient experienced low grade fever, stomach ache, headache, debilitating and extreme fatigue. The patient recovered from the event of low grade fever, stomach ache, headache, debilitating and extreme fatigue on an unspecified date. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Pain
Clinical narrative: A consumer report has been received. The report concerns a, Female consumer, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. The patient experienced the shot causes major pain for days. FLUMIST quadrivalent was continued. The outcome of the event of the shot causes major pain for days 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. FLUMIST quadrivalent started on an unknown date. The reporter stated that the patient number seven was given FLUMIST that underwent a temperature excursion and it was unknown if the dose of 0.1ml was given in each nostril. The outcome of the event of patient number seven given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
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 Millilitres. FLUMIST quadrivalent, (intranasal) startedon an unknown date. It was reported that the patient had been given a few doses of FLUMIST this season from the frozen supply. The outcome of the event of GIVING FLUMIST that had been frozen 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 male patient who had been receiving FLUMIST quadrivalent (intranasal) 0.2 milliliters, once/single administration. FLUMIST quadrivalent started on an unknown date. It was reported that patient number eleven received the FLUMIST, 0.2ml dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1ml was given in each nostril. The office refrigerator had a temperature excursion of 1.5 degrees C for a total of 17.5 hours. The temperature would be at recommended temperature range and then dip to 1.5 degrees C, then go back to original range. FLUMIST quadrivalent was continued. The outcome of the event of patient number eleven given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril 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, Female 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 patient number thirteen given FLUMIST that underwent a temperature excursion and 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 thirteen given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril 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 mL (0.1 mL in each nostril), once/single administration. FLUMIST quadrivalent started on an unknown date. The patient experienced patient number thirteen given FLUMIST that underwent a temperature excursion and 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 thirteen given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza like illness, Upper respiratory tract infection
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patient experienced flu-like syndrome and persistent upper respiratory infection symptoms. The outcome of the event of flu-like syndrome and persistent upper respiratory infection symptoms is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST quadrivalent started on an unknown date. The reporter was medical assistant reporting a temperature excursion of FLUMIST that had been given to 14 patients. Reporter reported that patient number nine received the FLUMIST, 0.2ml dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1ml was given in each nostril. Reporter reported that the patient was a female. The reporter was not comfortable giving patient name, address, contact number, height, weight, race, relevant medical history or concomitant medications due for fear of HIPPA violations. Reporter stated that patient safety may contact the HCP office for additional information if needed. The office refrigerator had a temperature excursion of 1.5 degrees C for a total of 17.5 hours. The temperature would be at recommended temperature range and then dip to 1.5 degrees C, then go back to original range. FLUMIST quadrivalent was continued. The outcome of the events of patient number nine given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril were unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender and age, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres. FLUMIST quadrivalent, (intranasal) started on an unknown date. The patient experienced there was possibly an unknown number of consumers who received the FLUMIST quadrivalent during a temperature excursion for the vaccine. The outcome of the event of there was possibly an unknown number of consumers who received the FLUMIST quadrivalent during a temperature excursion for the vaccine was unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female 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 patient number six given FLUMIST that underwent a temperature excursion and it was unknown if the dose of 0.1ml was given in each nostril. FLUMIST quadrivalent was continued. The outcome of the events of patient number six given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril is unknown. The report was considered to be non-serious. Corrected report on 02-Nov-2015: Event coding updated. Narrative edited. Case was suppressed.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, Height: 63.0 inches; weight: 165.0 pounds, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST quadrivalent started on 28-Sep-2015. It was reported that patient was pregnant. FLUMIST quadrivalent was continued. The outcome of the event of pregnant is unknown. The report was considered to be non-serious. Correct reported 13-Nov-2015: Relation to patient added. Reporter information added.
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning a female patient, who had been receiving FLUMIST quadrivalent (intranasal) 0.2mL, once/single administration, 0.1 mL in each nostril. FLUMIST quadrivalent started on an unknown date. HCP reported first half dose of FLUMIST did not take well as some vaccine was reported to had run out of nose. Second half dose administered with no issue. FLUMIST quadrivalent was continued. The outcome of the event of first half dose of FLUMIST was reported to have run out of the nose was unknown. The report was considered to be non-serious by company physician.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a female patient, who received FLUMIST quadrivalent, (intranasal), 0.2 Millilitres, Once/Single administration. FLUMIST quadrivalent, (intranasal) started on an unknown date. Patient reported that patient number three received the FLUMIST vaccine, 0.2 ml dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1 ml was given in each nostril. Caller reported that the patient was a female. The caller was not comfortable given patient name, address, contact number, height, weight, relevant medical history or concomitant medications due for fear of HIPAA violations. Caller stated that patient safety may contact the HCP office for additional information if needed. The office refrigerator had a temperature excursion of 1.5 degrees C for a total of 17.5 hours. The temperature would be at recommended temperature range and then dip to 1.5 degrees C, then go back to original range. FLUMIST quadrivalent, (intranasal) was continued. The outcome of the event of patient number four 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: 51.0
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 51 year old, female patient, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, and once/single administration. FLUMIST quadrivalent started on 16-Oct-2015. The reporter stated that the patient was administered FLUMIST quadrivalent 0.2ml today which started on 16-Oct-2015. FLUMIST quadrivalent was discontinued on 16-Oct-2015. The patient recovered from administered FLUMIST to 51 year old consumer on 16-Oct-2015. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report had been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST quadrivalent started on an unknown date. It was reported that there could have been consumers involved in receiving FLUMIST quadrivalent that was involved in a temperature excursion of 57.4 degrees Fahrenheit in the refrigerator for 203.83 cumulative hours. The outcome of the event of there could have been consumers involved in receiving the FLUMIST quadrivalent that was involved in a temperature excursion of 57.4 degrees Fahrenheit in the refrigerator for 203.83 cumulative hours is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a female patient, who had received FLUMIST quadrivalent (intranasal), 0.1 mL in each nostril, once/single administration. FLUMIST quadrivalent started on an unknown date. The patient experienced patient number five given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1mL was given in each nostril. FLUMIST quadrivalent was continued. The outcome of the event of patient number five given FLUMSIT 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 by company physician.
Sex: U
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: A report has been received from a Health Professional concerning multiple patients of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patients experienced sick. The outcome of the event of sick is unknown. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
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, unknown. FLUMIST quadrivalent starting during Oct-2015. The patient experienced possible use of FLUMIST after a temperature excursion to 27F. The outcome of the event of possible use of FLUMIST after a temperature excursion to 27F is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Headache, Sinus disorder
Clinical narrative: The report had been received from a health professional. The report concern a patient of unknown age and gender. Concomitant medications, concurrent diseases and medical history were not reported. The patient was receiving FLUMIST (intranasal). The patient experienced severe headaches and sinus symptoms. The outcomes of the events of severe headaches and sinus symptoms were unknown. The events were considered to be non-serious by the company physician.
Age: 20.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Injection site pruritus, Injection site reaction, Petechiae, Pruritus
Clinical narrative: Petechial rash and itching initially around site of injection, and then spread to both arms, and now is present on arms, lower back, and abdomen.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site became hot and red.  Similar to the look of an infection.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a female patient, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, once/single administration. FLUMIST quadrivalent started on an unknown date. It was reported temperature excursion of FLUMIST that had been given to 14 patients. The patient number three received the FLUMIST, 0.2ml dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1ml was given in each nostril. The office refrigerator had a temperature excursion of 1.5 degrees C for a total of 17.5 hours. The temperature would be at recommended temperature range and then dip to 1.5 degrees C, then go back to original range. FLUMIST quadrivalent was continued. The outcome of the event of patient number three 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: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Rash
Clinical narrative: A report has been received from a Pharmacist (mother of the patient) concerning a 7 year old, Male subject, who had been receiving FLUMIST (intranasal). FLUMIST was administered on 02-Nov-2015. The patient got large raised bumps on legs and hips which started on 03-Nov-2015. At the time of reporting, the event of large raised bumps on legs and hips was ongoing. The report was considered to be non-serious by the reporter. The reporter considered that there was no causal relationship between large raised bumps on legs and hips and FLUMIST and the company physician agreed.
Age: 39.0
Sex: F
Vaccine: FLUN4
Symptoms: Epistaxis, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: A report had been received from a consumer concerning a female patient. Patient had allergies to ibuprofen where she got blood blisters on her legs and mouth, allergies to AUGMENTIN where she got a rash. Patient received nasal FLUMIST (intranasal), 0.2 millilitres, single administration for flu prevention on 30-Sep-2015. Patient reported that she got nosebleed, sore throat, and general stuffiness like a head cold for three days and then it stopped. Patient stated that the nosebleed never happened to her before and this was the first time. The patient recovered from sore throat, general stuffiness like a head cold and nosebleed on an unspecified date. The company physician assessed nosebleed, sore throat and general stuffiness like a head cold to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a female patient, who had been receiving Nasal FLUMIST Quadrivalent., 0.1 ml in each nostril. Once/Single administration. FLUMIST Quadrivalent started on an unknown date. The patient number two given FLUMIST vaccine that underwent a temperature excursion and it was unknown if the dose of 0.1 ml was given in each nostril. FLUMIST Quadrivalent was continued. The outcome of the event of patient number two given FLUMIST vaccine that underwent a temperature excursion and it is unknown if the dose of 0.1 ml was given in each nostril was unknown. The report was considered to be non-serious by company physician.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Pt stated was nauseated and had myalgias and headache, but no localized reaction. Symptoms resolved after 10 days duration.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Neuritis, Pallor
Clinical narrative: Client's mother reported at 2:00 am 2-19-16 client woke up reporting pain in Lt deltoid area, numbness from shoulder to fingers on Lt arm. Client was also pale. Client taken to ER. Advised to ice area and not lift. Mother reports after 24 hrs client had occasional numbness in Lt arm 32 hrs client had full recovery denied tenderness or soreness.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood count abnormal, Catheter site infection, Chemotherapy, Myelodysplastic syndrome
Clinical narrative: Family believes since his PCV13 given his blood count decreased.
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning, a male subject, who had been receiving Nasal FLUMIST (intranasal), 0.1 Millilitres, Unknown FLUMIST (intranasal) started on 28-Oct-2015. Patient was administered only half the FLUMIST dose 0.1mL) because child was uncooperative and so the second dose in the second nostril was not even attempted to be administered. The outcome of the event of WRONG DOSE GIVEN was unknown. The reporter's description of the event (s) was as follows: has received Flu vaccine (IM) previously. The report was considered to be non-serious. The reporter considered that there was no causal relationship between WRONG DOSE GIVEN and FLUMIST.