chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US019280 is an initial spontaneous report received from a physician on 23 Sep 2014. This report refers to a 5 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. This patient under 18 years of age was inadvertently administered a dose of FLUCELVAX (batch number: not reported) intramuscularly on 22 Sep 2014. It was reported that in the prescription, seasonal influenza vaccine (manufacturer and batch number: not reported) for a child between 3 years and 18 years was mentioned, but FLUCELVAX was given instead. No adverse event was reported following the maladministration. Following an internal review on 26 Oct 2014, a significant correction was done for the information received on 23 Sep 2014: The event inappropriate age at vaccine administration was coded.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US018981, is an initial spontaneous report from a nurse received on 19 Sep 2014. This report refers to a 17-year-old female patient who received FLUCELVAC (batch number: 160233) intramuscularly on 18 Sep 2014. No adverse event reported following this maladministration (inappropriate age at vaccine administration).
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US018776 is an initial spontaneous report received  from a physician on 18 SEP 2014, with the follow-up received on 27 OCT 2014. This report refers to an 11 year old male patient. Past medical history and concomitant medications was not reported. He was vaccinated with FLUCELVAX (batch number: 017021A) at dose of 0.5 ml in the right arm, intramuscularly on 16 SEP 2014 at 15:00 PM. No adverse reaction was reported following this administration error (inappropriate age at vaccine administration).  Follow-up received from the physician on 27 OCT 2014: Updated vaccine does, site and time of vaccination.
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US018319 is an initial spontaneous report received from a nurse on 11 SEP 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. On 10 SEP 2014, he was vaccinated with FLUCELVAX 2014/2015 (batch number: 014021A) via intramuscular route. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Sex: F
Vaccine: FLUC3
Symptoms: Anxiety, Blood pressure increased, Fatigue, Muscle spasms, Pain
Clinical narrative: Case number PHEH2014US018186 is an initial spontaneous report received from a consumer on 09 SEP 2014. This report refers to a female patient whose age was not reported. She was not allergic to eggs. Her concomitant medications were not reported. Her vaccination history included influenza vaccines twice without any reaction. She had seasonal influenza vaccine (manufacturer and batch number: not reported) 5 years ago following which she had arm swelling (see related case number: PHEH2014US018187). She was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 04 SEP 2014. She stated that she had extreme  fatigue and also high blood pressure since vaccination. She reported that she was tired around 8:30 PM and woke up around 5 AM and her sleep pattern was disturbed. Her blood pressure went up 10 points after receiving FLUCELVAX. She stated that she was worried and that her blood pressure was elevated due to anxiety. Her physician asked her to stay away from flu vaccines due to the reaction occurred 5 years ago and thought she received double dosage at that time. She stated that she also got muscle spasm in her leg since receiving FLUCELVAX on 04 SEP 2014, but it has quieted down. She had pain on an unknown date and took steroid injection for treatment following which she had temporary blood pressure increase. The events outcome was unknown. The seriousness and causality were not reported.
Sex: F
Vaccine: FLUC3
Symptoms: Sleep disorder
Clinical narrative: Case number PHEH2014US018186 is an initial spontaneous report received from a consumer on 09 SEP 2014. This report refers to a female patient whose age was not reported. She was not allergic to eggs. Her concomitant medications were not reported. Her vaccination history included influenza vaccines twice without any reaction. She had seasonal influenza vaccine (manufacturer and batch number: not reported) 5 years ago following which she had arm swelling (see related case number: PHEH2014US018187). She was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 04 SEP 2014. She stated that she had extreme  fatigue and also high blood pressure since vaccination. She reported that she was tired around 8:30 PM and woke up around 5 AM and her sleep pattern was disturbed. Her blood pressure went up 10 points after receiving FLUCELVAX. She stated that she was worried and that her blood pressure was elevated due to anxiety. Her physician asked her to stay away from flu vaccines due to the reaction occurred 5 years ago and thought she received double dosage at that time. She stated that she also got muscle spasm in her leg since receiving FLUCELVAX on 04 SEP 2014, but it has quieted down. She had pain on an unknown date and took steroid injection for treatment following which she had temporary blood pressure increase. The events outcome was unknown. The seriousness and causality were not reported.
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024192 is an initial spontaneous report received from a pharmacist on 14 NOV 2014. This report refers to a 11-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014) intramuscularly on 0.5 ml on 13 NOV 2013. No adverse event was reported following the administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 14 NOV 2013. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024188 is an initial spontaneous report received from a pharmacist on 14 NOV 2013. This report refers to a 10-years-old male patient. His medical history and concomitant medications were not reported. It was reported that this patient under 16-years of age received a 0.5 ml intramuscular dose of FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: JUN 2014) on 13 NOV 2013. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 14 NOV 2013. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 8.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2013US023615 is an initial spontaneous report received from a pharmacist on 08 NOV 2013. This report refers to an 8-years-old male patient. His medical history and concomitant medications were not reported. The pharmacist reported that this patient under 18 years of age received FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly on 08 NOV 2013. No adverse event was reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 08 NOV 2013. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2013US021847 is an initial spontaneous report from pharmacist received on 17 OCT 2013. This case refers to a female patient of age less than 18 years who was vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) on 15 OCT 2013. No  other adverse event was repot following medication error (inappropriate age of vaccine administration).  Following an internal review on 18 AUG 2013, a significant correction was done for the information received on 17 OCT 2013. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "rug used in unapproved population".
Age: 60.0
Sex: M
Vaccine: FLUC3
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Case number PHEH2014US020848, is an initial spontaneous report from a consumer (also patient) received on 15 OCT 2014. This report refers to a 60-year-old male patient. Past medical history and concomitant medication was reported. He was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 14 OCT 2014. On the same day within hours after vaccination, he experienced stiff and achy neck. The stiffness and achiness had got progressive worse over 24 hour period despite treatment with Asprin  and hearing pad. The final outcome of the events was unknown. Seriousness and causality was not reported.
Age: 50.0
Sex: F
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Case number PHEH2014US020691 is an initial spontaneous report received from a nurse on 10 OCT 2014. This report refers to a 50 year old female patient. Her past medical history and concomitant medications were not reported. On 08 OCT 2014, she was vaccinated with FLUCELVAX (batch number: 017021A) intramuscularly. On 08 OCT 2014, she developed a bumpy rash which started on her back, check and then spread down her arms. It was reported that there was nothing at the injection site. The outcome of the event was not reported. The seriousness and causality of the event was not reported.
Age: 7.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PJHEH2014US019839, is an initial spontaneous report from a nurse received on 03 OCT 2014. This report refers to a 7 years old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch number: 017011A) at a dose of 0.5 ml intramuscularly on 01 OCT 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).
Sex: U
Vaccine: FLUC3
Symptoms: Incorrect product storage, Skin reaction
Clinical narrative: Case number PHEH2014US020660 is an initial spontaneous report received from a pharmacist on 10 OCT 2013. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX 2014/2015 (batch number: not reported) on 10 OCT 2014. On the same day after vaccination, patient experienced some kind of skin reaction . It was further reported that the FLUCELVAX was kept out from refrigerator (not for long time) and might have reached room temperature before administration. Final outcome, causality and seriousness were not reported.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US019841, is an initial spontaneous report from a nurse received on 02 OCT 2014. This report refers to a 13-years old female patient. Past medical history and concomitant medication were not reported. She was inadvertently vaccinated with FLUCELAX 2014/2015 (batch number: 017011A) at a dose of 0.5 ml intramuscularly on 01 OCT 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).
Sex: U
Vaccine: FLUC3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case numberPHEH2044US019855 is an initial spontaneous report from the nurse received on 01 OCT 2014. This report refers to a patient of an unknown age and gender. The patient was inadvertently vaccinated with a single dose or FLUCELVAX 2014/2015 (batch number: not reported) via subcutaneous route instead of intramuscular route on an unknown date. No adverse event reported following this medication error (inappropriate route of vaccination).
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US020024 is an initial spontaneous report received from a pharmacist on 04 OCT 2014. This report refers to a 59 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX 2014/2015 (batch number: not reported) on 04 OCT 2014. IT was reported that patient received FLUCELVAX intravenously instead of intramuscular injection. No adverse events reported after the maladministration (wrong route of administration).
Age: 0.93
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2044US020228, is an initial spontaneous report from a consumer (patient's mother) received on 06 OCT 2014. This report refers to a 10-year-old female patient. Past medical history and concomitant medication were not provided. She was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch  number: unknown) intramuscularly on 03 OCT 2014. NO adverse event was reported following the maladministration (inappropriate age at vaccine administration).
Sex: U
Vaccine: FLUC3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US020252 is an initial spontaneous report received from a pharmacist on 07 OCT 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with a FLUCELVAX 2014/2015 (batch number: not reported) via the intravenous route instead of intramuscular route on an unknown date by a trainee nurse. No adverse event was reported following this administration error (wrong route of administration). Reporter ws trying to follow up for more information.
Age: 8.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020326 an initial spontaneous report received  from a nurse on 07 OCT 2014. This report refers to a 08 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX 2014/2015 (batch number: not reported) intramuscularly at a dose of 0.5 ml on 03 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020327 an initial spontaneous report received from a nurse on 07 OCT 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX 2014/2015 (batch number: not reported) intramuscularly at a dose of 0.5 ml on 03 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020328 is an initial spontaneous report received from a nurse on 07 OCT 2014. This report refers to a 13 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLCELVAX 2014/2015 (batch number: not reported) intramuscularly at a dose of 0.5 ml in SEP 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Pediatrician was not concerned. No additional details available.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020451, is an initial spontaneous report from a nurse received on 08 OCT 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medications were not reported He was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch number: 015021A) intramuscularly on 08 OCT 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US020518, is an initial spontaneous report from a medical assistant received on 09 OCT 2014. This report refers to a 14-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2014/2015 (batch number: 012031A) intramuscularly on 01 OCT 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye swelling, Flushing, Lip swelling
Clinical narrative: Initial case received from a pharmacist, who is also the patient's daughter, on 27 January 2014. A 57-year-old female patient, with no reported medical history or concomitant medications, received a first dose of FLUZONE (lot number U3727AA) intramuscularly on 30 November 2010. The same day as vaccination, at an unspecified time, she began experiencing difficulty breathing described as "could not get air", lip swelling, eye swelling, flushed face, and possibly a rash. She did not seek any medical attention, and the patient reported that the events had recovered on an unspecified day. Additional information has been requested. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Optic neuritis
Clinical narrative: Initial case received from a hospital pharmacist on 30 January 2014. A patient, with no reported medical history or concomitant medications, received a dose of FLUZONE (lot number not reported) on an unspecified date. The reporter stated that the hospital infection control nurse reported that the patient began experienced "symptoms of optic neuritis" within a couple of days after vaccination. No additional information was reported. Documents held by sender: None.
Age: 0.62
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Electroencephalogram normal, Laboratory test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial case received on 17 March 2014 from a nurse. Upon receipt of follow-up information from the health care professional on 21 April 2014, it was confirmed that this case is a duplicate of 2014SA036023. All information will be combined in this case (2014SA034541) which will remain the case of reference; 2014SA036023 will be deleted. A baby (date of birth, age and gender not reported), with no reported medical history and no reported concomitant medication, had a seizure less than 24 hours after receiving a second dose of FLUZONE on an unspecified date. The batch number, site and route of administration were not reported. The outcome of the event was not reported. Further information will be requested from the reporter. Follow-up information was received from the healthcare professional on 21 April 2014 which confirmed that this case is a duplicate of 2014SA036023. The following combines information received on 18 March 2014 and 21 April 2014: A 7 month old female infant, received a second left thigh ("quad") injection of FLUZONE (lot number U4712AA) on 12 March 2014 at 15:30. Approximately 10 hours post-vaccination, at 01:45 on 13 March 2014, the patient experienced an afebrile seizure lasting approximately two minutes. She was admitted to the hospital, where an MRI of the brain, EEG, and unspecified laboratory testing were normal. She was discharged after one day, and the event was considered recovered. The patient had a history of amoxicillin allergy, and birth weight was reported as 3.629 kg. No illness was reported at the time of vaccination. She had one sibling. One month prior to vaccination, on 12 February 2014, the patient had received the following vaccines: a first dose of FLUZONE (lot number U4697CA); PENTACEL (lot not reported); HepB vaccine (manufacturer and lot not reported); Pneumococcal vaccine (manufacturer and lot not reported); and oral Rotavirus vaccine (manufacturer and lot not reported). She did not experience any adverse events after receiving these vaccines. Follow-up information received from the healthcare professional on 12 May 2014: The reporter's relation to patient was updated from other to vaccine provider. The dose of FLUZONE received was 0.25 ml. The patient had no pre-existing physician-diagnosed birth defects, nor medical conditions. It was reported that the patient had been hospitalized overnight to obtain MRI of brain and EEG. Patient did not have any further seizures. She never developed fever. She had no symptoms of illness. She recovered fully within a few hours after the seizure. No medications were prescribed. Documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Initial report was received from a healthcare professional on 07 October 2013. A 15-month-old male patient had received an injection of FLUZONE, lot number reported as U469CA (not a valid lot number) (route and site not reported) on 05 October 2013 at around 11:30 AM. Within a few hours on 05 October 2013, the patient developed a fever and subsequently a febrile seizure at around 7:00 PM. The patient was seen in the emergency room and dismissed without any tests needed. The patient had no previous neuro history or seizures. Outcome was not reported. Documents held by sender: None. Follow-up information received on 18 October 2013. Lot number was updated as U4697CA. Follow-up information received on 12 November 2013: The patient's name, birth weight, number of siblings (3 bros) and date of birth were provided. He had no illness at time of vaccination; no adverse event following prior vaccination; personal history of mild seasonal allergic rhinitis. The patient did not receive any other vaccination within 4 weeks prior to 05 October 2013 and no other medications. He had received his dose of FLUZONE in the right leg/thigh (0.25 mL). No relevant diagnostic tests/laboratory data were done at ER visit. The patient recovered on an unspecified date.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Eye pruritus, Hypersensitivity
Clinical narrative: Initial information received from a healthcare professional (allergist) on 04 November 2013. An 11-year-old male patient received FLUZONE, lot # U472AA (not a valid Sanofi Pasteur lot number, to be confirmed) at a pediatrician's office (date, route, site and dosage of administration were not reported). The patient's mother reported the patient experienced shortness of breath, hives, and itchy and watery eyes after vaccination. The reporter saw the patient for a consult for "allergic reaction". Treatment details were not reported. The patient has a history of egg allergy in that if he eats eggs, he vomits. Further details were not available at the time of this report. The patient outcome is unknown. Documents held by sender: None. Follow-up information received from a healthcare professional on 02 December 2013: The patient had received fifth dose of FLUZONE vaccine, lot number: U4772AA, intramuscularly in left deltoid on 05 October 2013 at 9:30 hours. The patient had laceration at right knee at the time of vaccination. He had no adverse event following prior vaccination. The patient on his right knee had cut right knee. He developed laceration at right knee (2.5 cm) with 3 mm wide and 2 mm deep. The patient referred to urgent care for suturing and supportive care. He received EMLA cream that was applied to skin around laceration with occlusive dressing at 12:00. No concomitant medications were administered. The patient complained of scratchy throat. He had frequent dry hack. He had cough 30 min after flu shot. The patient had possible anxiety induced coughing episode. The patient received Albuterol 90 mcg, 2-4 puffs inhaler, 4-6 hrs prn for cough and tight chest. He was given ORAPRED 60 mg and BENADRYL 37.5 mg.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Lacrimation increased, Throat irritation, Urticaria
Clinical narrative: Initial information received from a healthcare professional (allergist) on 04 November 2013. An 11-year-old male patient received FLUZONE, lot # U472AA (not a valid Sanofi Pasteur lot number, to be confirmed) at a pediatrician's office (date, route, site and dosage of administration were not reported). The patient's mother reported the patient experienced shortness of breath, hives, and itchy and watery eyes after vaccination. The reporter saw the patient for a consult for "allergic reaction". Treatment details were not reported. The patient has a history of egg allergy in that if he eats eggs, he vomits. Further details were not available at the time of this report. The patient outcome is unknown. Documents held by sender: None. Follow-up information received from a healthcare professional on 02 December 2013: The patient had received fifth dose of FLUZONE vaccine, lot number: U4772AA, intramuscularly in left deltoid on 05 October 2013 at 9:30 hours. The patient had laceration at right knee at the time of vaccination. He had no adverse event following prior vaccination. The patient on his right knee had cut right knee. He developed laceration at right knee (2.5 cm) with 3 mm wide and 2 mm deep. The patient referred to urgent care for suturing and supportive care. He received EMLA cream that was applied to skin around laceration with occlusive dressing at 12:00. No concomitant medications were administered. The patient complained of scratchy throat. He had frequent dry hack. He had cough 30 min after flu shot. The patient had possible anxiety induced coughing episode. The patient received Albuterol 90 mcg, 2-4 puffs inhaler, 4-6 hrs prn for cough and tight chest. He was given ORAPRED 60 mg and BENADRYL 37.5 mg.
Sex: U
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Initial report was received from another manufacturer on 14 November 2013 under reference number PUS2013US118465 who received the case from a healthcare professional. A patient (gender and age not reported) had received an injection of FLUZONE (lot number, route, site and date not reported) and 1-2 weeks later experienced a seizure. Exact date of seizure was unknown. No other information was provided. Outcome was not reported. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eyelid oedema, Headache, Hyperhidrosis, Mouth swelling
Clinical narrative: Initial report received on 24-OCT-2013 from a consumer (the patient herself): A 62-year-old female patient with a medical history of hypothyroidism treated by SYNTHROID and seasonal allergies treated with ALLEGRA with no illness at time of vaccination had received an intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number not reported) in the deltoid on 18-OCT-2013. This was the first time she had ever received a flu shot. On 18-OCT-2013, 4 hours after vaccination, the patient developed tongue oral mucus membrane, eyelid and facial swelling. She also had headache lasting 2 days, vomiting, chills and sweats, leg cramps of both lower extremities from knees to the ankles. The patient also stated she developed a rash on the heat sensor areas of her body however she stated this happens every time she has a fever. Her body temperature was reported as 99.8 (i.e. 37.6 degrees C). According to the patient, the symptoms lasted 3 hours. The patient self-medicated with OTC pain relief/fever reducer, medicine for headache and fever for 2 days. Patient did not seek physician evaluation or treatment. Patient stated symptoms have resolved (unspecified date).
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pyrexia, Rash, Swelling face, Swollen tongue
Clinical narrative: Initial report received on 24-OCT-2013 from a consumer (the patient herself): A 62-year-old female patient with a medical history of hypothyroidism treated by SYNTHROID and seasonal allergies treated with ALLEGRA with no illness at time of vaccination had received an intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number not reported) in the deltoid on 18-OCT-2013. This was the first time she had ever received a flu shot. On 18-OCT-2013, 4 hours after vaccination, the patient developed tongue oral mucus membrane, eyelid and facial swelling. She also had headache lasting 2 days, vomiting, chills and sweats, leg cramps of both lower extremities from knees to the ankles. The patient also stated she developed a rash on the heat sensor areas of her body however she stated this happens every time she has a fever. Her body temperature was reported as 99.8 (i.e. 37.6 degrees C). According to the patient, the symptoms lasted 3 hours. The patient self-medicated with OTC pain relief/fever reducer, medicine for headache and fever for 2 days. Patient did not seek physician evaluation or treatment. Patient stated symptoms have resolved (unspecified date).
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial report received on 24-OCT-2013 from a consumer (the patient herself): A 62-year-old female patient with a medical history of hypothyroidism treated by SYNTHROID and seasonal allergies treated with ALLEGRA with no illness at time of vaccination had received an intramuscular dose of FLUZONE (Sanofi Pasteur Inc., batch number not reported) in the deltoid on 18-OCT-2013. This was the first time she had ever received a flu shot. On 18-OCT-2013, 4 hours after vaccination, the patient developed tongue oral mucus membrane, eyelid and facial swelling. She also had headache lasting 2 days, vomiting, chills and sweats, leg cramps of both lower extremities from knees to the ankles. The patient also stated she developed a rash on the heat sensor areas of her body however she stated this happens every time she has a fever. Her body temperature was reported as 99.8 (i.e. 37.6 degrees C). According to the patient, the symptoms lasted 3 hours. The patient self-medicated with OTC pain relief/fever reducer, medicine for headache and fever for 2 days. Patient did not seek physician evaluation or treatment. Patient stated symptoms have resolved (unspecified date).
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Chills, Cough, Dyspnoea, Eye discharge
Clinical narrative: Initial case received from a consumer, who is also the patient, on 24 January 2014. A 48-year-old female patient, with no reported medical history or concomitant medications, received a first dose of FLUZONE (lot number UH922AB) on 20 January 2014. The patient reported she had received no prior doses of influenza vaccine. Approximately one hour post-vaccination, she began experiencing difficulty breathing "like she was holding her breath", a cough, throat swelling, and severe chills. She presented to the ER later that day, after experiencing watering eyes and "a film over her eyes". Her eyes and face were also swollen. The patient reported that the events had recovered, although her eyes "still didn't feel normal" at the time of the report on 24 January 2014. Additional information, including testing and treatment, was not reported, and has been requested. Follow-up information was received from the patient's physician on 07 March 2014, and included the emergency room report. The patient presented to the emergency room the evening of 20 January 2014 with allergic reaction, face swelling, throat swelling, and tightness. She was also noted to have mattering in her eyes and vague shortness of breath. She denied chest pain or wheezing. Medical history included an allergy to penicillin. Vital signs on presentation were as follows: temperature 98.8 degrees Fahrenheit, heart rate 101, blood pressure 117/63, respiratory rate 20, oxygen saturation 95% on room air. Height was 163 centimeters, weight 72.73 kilograms. She had no history of nicotine or alcohol use. On exam conjunctiva appeared injected bilaterally, no pharyngeal erythema, lungs clear to auscultation, respirations non-labored. She was treated with VISINE eye drops for eye irritation, and discharged home on 21 January 2014 approximately two hours after presenting to the emergency room. Final diagnosis was reported as allergic reaction and angioedema. The patient was instructed to follow-up with her primary care physician in 1-2 days if needed. The patient outcome is recovered on an unreported date. Documents held by sender: emergency room record.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Eye disorder, Eye irritation, Eye swelling, Hypersensitivity, Lacrimation increased
Clinical narrative: Initial case received from a consumer, who is also the patient, on 24 January 2014. A 48-year-old female patient, with no reported medical history or concomitant medications, received a first dose of FLUZONE (lot number UH922AB) on 20 January 2014. The patient reported she had received no prior doses of influenza vaccine. Approximately one hour post-vaccination, she began experiencing difficulty breathing "like she was holding her breath", a cough, throat swelling, and severe chills. She presented to the ER later that day, after experiencing watering eyes and "a film over her eyes". Her eyes and face were also swollen. The patient reported that the events had recovered, although her eyes "still didn't feel normal" at the time of the report on 24 January 2014. Additional information, including testing and treatment, was not reported, and has been requested. Follow-up information was received from the patient's physician on 07 March 2014, and included the emergency room report. The patient presented to the emergency room the evening of 20 January 2014 with allergic reaction, face swelling, throat swelling, and tightness. She was also noted to have mattering in her eyes and vague shortness of breath. She denied chest pain or wheezing. Medical history included an allergy to penicillin. Vital signs on presentation were as follows: temperature 98.8 degrees Fahrenheit, heart rate 101, blood pressure 117/63, respiratory rate 20, oxygen saturation 95% on room air. Height was 163 centimeters, weight 72.73 kilograms. She had no history of nicotine or alcohol use. On exam conjunctiva appeared injected bilaterally, no pharyngeal erythema, lungs clear to auscultation, respirations non-labored. She was treated with VISINE eye drops for eye irritation, and discharged home on 21 January 2014 approximately two hours after presenting to the emergency room. Final diagnosis was reported as allergic reaction and angioedema. The patient was instructed to follow-up with her primary care physician in 1-2 days if needed. The patient outcome is recovered on an unreported date. Documents held by sender: emergency room record.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swelling face, Throat tightness, Vision blurred
Clinical narrative: Initial case received from a consumer, who is also the patient, on 24 January 2014. A 48-year-old female patient, with no reported medical history or concomitant medications, received a first dose of FLUZONE (lot number UH922AB) on 20 January 2014. The patient reported she had received no prior doses of influenza vaccine. Approximately one hour post-vaccination, she began experiencing difficulty breathing "like she was holding her breath", a cough, throat swelling, and severe chills. She presented to the ER later that day, after experiencing watering eyes and "a film over her eyes". Her eyes and face were also swollen. The patient reported that the events had recovered, although her eyes "still didn't feel normal" at the time of the report on 24 January 2014. Additional information, including testing and treatment, was not reported, and has been requested. Follow-up information was received from the patient's physician on 07 March 2014, and included the emergency room report. The patient presented to the emergency room the evening of 20 January 2014 with allergic reaction, face swelling, throat swelling, and tightness. She was also noted to have mattering in her eyes and vague shortness of breath. She denied chest pain or wheezing. Medical history included an allergy to penicillin. Vital signs on presentation were as follows: temperature 98.8 degrees Fahrenheit, heart rate 101, blood pressure 117/63, respiratory rate 20, oxygen saturation 95% on room air. Height was 163 centimeters, weight 72.73 kilograms. She had no history of nicotine or alcohol use. On exam conjunctiva appeared injected bilaterally, no pharyngeal erythema, lungs clear to auscultation, respirations non-labored. She was treated with VISINE eye drops for eye irritation, and discharged home on 21 January 2014 approximately two hours after presenting to the emergency room. Final diagnosis was reported as allergic reaction and angioedema. The patient was instructed to follow-up with her primary care physician in 1-2 days if needed. The patient outcome is recovered on an unreported date. Documents held by sender: emergency room record.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral, Pharyngeal oedema, Throat irritation
Clinical narrative: Initial case received from the patient on 06 May 2014. A 62-year-old female patient had received an intramuscular dose of FLUZONE on 04 December 2013 (batch number UH893AB). The patient had a medical history of psoriasis, food allergies, and penicillin allergy. No illness was reported at time of vaccination. The patient did not receive any previous dose of flu vaccine. It was not reported whether concomitant medications were taken. On 04 December 2013, a few hours after the vaccination, the patient experienced tingling in the back of the throat, then to the tongue and lips. The lips were swollen. The patient went to the ER and had to keep clearing the throat. The patient received corrective treatment with PEPCID and IV BENADRYL in the ER and was released (no admission to the hospital). Symptoms were still present in the morning with swollen lips. No complementary investigations were reported. The patient's outcome is recovered. Additional information was received from the reporter on 06 May 2014, which noted that the patient had also experienced throat constriction. No other significant information was reported. Follow-up information was received on 04 June 2014 from a consumer who is also the patient. The 62 year-old adult female had a history of multiple allergies. The patient had an additional event of throat swelling. She was seen in the emergency room and treated with BENADRYL and PEPCID. According to the reporter, she was monitored in the ER for a few hours and then discharged to home. She reported that the next morning she continued to have some swelling and tingling of lips and throat, but it was decreased. The symptoms subsided and she had no other symptoms. Outcome was recovered. Follow-up information was received from the reporter on 23 June 2014, which confirmed the contact information for the emergency department where the patient was treated. No additional information was reported. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Initial case received from the patient on 06 May 2014. A 62-year-old female patient had received an intramuscular dose of FLUZONE on 04 December 2013 (batch number UH893AB). The patient had a medical history of psoriasis, food allergies, and penicillin allergy. No illness was reported at time of vaccination. The patient did not receive any previous dose of flu vaccine. It was not reported whether concomitant medications were taken. On 04 December 2013, a few hours after the vaccination, the patient experienced tingling in the back of the throat, then to the tongue and lips. The lips were swollen. The patient went to the ER and had to keep clearing the throat. The patient received corrective treatment with PEPCID and IV BENADRYL in the ER and was released (no admission to the hospital). Symptoms were still present in the morning with swollen lips. No complementary investigations were reported. The patient's outcome is recovered. Additional information was received from the reporter on 06 May 2014, which noted that the patient had also experienced throat constriction. No other significant information was reported. Follow-up information was received on 04 June 2014 from a consumer who is also the patient. The 62 year-old adult female had a history of multiple allergies. The patient had an additional event of throat swelling. She was seen in the emergency room and treated with BENADRYL and PEPCID. According to the reporter, she was monitored in the ER for a few hours and then discharged to home. She reported that the next morning she continued to have some swelling and tingling of lips and throat, but it was decreased. The symptoms subsided and she had no other symptoms. Outcome was recovered. Follow-up information was received from the reporter on 23 June 2014, which confirmed the contact information for the emergency department where the patient was treated. No additional information was reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received from healthcare professional on 03 JAN 2013. An elderly patient (over 65 years of age) whose gender, initials, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number, route and anatomical site of administration were not reported) on an unspecified date  It was reported that on unspecified date, after receiving FLUZONE HD, the patient developed Guillain Barre Syndrome. The corrective treatments and laboratory investigations were not reported.  At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness unilateral, Headache, Optic neuritis, Pyrexia, Visual impairment
Clinical narrative: Initial report received on 21 February 2014 from a consumer who is the daughter of the patient. This report represents one of a cluster of two patients reported by the same reporter who each experienced an adverse event following administration of FLUZONE HIGH DOSE. The events of the other patient are captured in case number 2014SA023860. An 84 year old female patient was vaccinated in September 2013 with FLUZONE HIGH DOSE (batch, route, site and exact date of administration) were not reported. The patient's concomitant medications and medical history were not reported. Later that day, the patient began experiencing headache, fever, vomiting, and vision problems. The patient had continued to have vision problems and now on 21 February 2014, the date of this report, the patient is blind in one eye. The patient was diagnosed with optic neuritis on an unreported date. Laboratory tests were not reported. The patient is being seen by her own primary care physician and will be seen by a neurologist. The reporter refused to provide physician names or contact information. No further information is available at the time of this report. Documents held by sender: None.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial report received on 21 February 2014 from a consumer who is the daughter of the patient. This report represents one of a cluster of two patients reported by the same reporter who each experienced an adverse event following administration of FLUZONE HIGH DOSE. The events of the other patient are captured in case number 2014SA023860. An 84 year old female patient was vaccinated in September 2013 with FLUZONE HIGH DOSE (batch, route, site and exact date of administration) were not reported. The patient's concomitant medications and medical history were not reported. Later that day, the patient began experiencing headache, fever, vomiting, and vision problems. The patient had continued to have vision problems and now on 21 February 2014, the date of this report, the patient is blind in one eye. The patient was diagnosed with optic neuritis on an unreported date. Laboratory tests were not reported. The patient is being seen by her own primary care physician and will be seen by a neurologist. The reporter refused to provide physician names or contact information. No further information is available at the time of this report. Documents held by sender: None.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Brachial plexopathy, Mobility decreased, Pruritus, Spinal laminectomy
Clinical narrative: Upon internal review following has been added to the case on 10 Sep 2014: The patient required ER/Doctor visit. Initial report received from a healthcare professional on 25 June 2014. A 76-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE High Dose (batch number: U4494AA, expiry: 02 April 2013, dose, dose number, route of vaccination were not reported) in the left deltoid on 26 October 2012. On an unknown date after vaccination, the patient experienced itching and developed brachial plexopathy in right arm following flu vaccination. Patient was unable to use his right arm from shoulder to wrist. It was reported that patient required ER/ doctor visit. The patient was hospitalized following vaccination on an unspecified date. As a corrective procedure, laminectomy was performed in 2013. Lab investigation details were not reported. The outcome of the event was unknown. Documents held by sender: none. Addendum: 10 September 2014 Upon second medical examination of case at time of internal review the following has been modified in this case. The field of "For Vaccine Only: Required ER/Doctor Visit was marked as Yes". Missing patient information (street address and phone number) was added. The information about ER/ Doctor visit was added in the narrative. Follow-up information was received from a healthcare professional on 17 October 2014. Reporter's relationship to patient was provided as vaccine provider. County in which patient was vaccinated. According to the reporter, they had no additional information to provide.