chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a patient born on 06-Jan-1996, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced administration of only a half dose of FLUMIST in one nostril. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A  report has been received from a Pharmacist concerning a 10 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient received only a half dose FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious by the reporter.
Age: 50.0
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 50 year old, female subject, who had been receiving FLUMIST. The patient's medical history included allergic reactions to eating eggs or to a component of influenza vaccine. FLUMIST started on 22-Nov-2013. The patient experienced gave FLUMIST to a 50 year old patient which started on 22-Nov-2013. The outcome of the event of gave FLUMIST to a 50 year old patient is unknown. The report was considered to be non-serious by the reporter. Follow-up insignificant information received  on 26-Nov-2013 from a Health Professional. Relevant history added.
Age: 54.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 54 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 22-Nov-2013. They accidentally gave FLUMIST to a 54 year old patient on 22-Nov-2013. The outcome of the event of accidentally gave FLUMIST to a 54 year old patient is unknown. The report was considered to be non-serious.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning an 8 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Reporter mentioned that patient was received multiple flu vaccines/we have a FLUMIST on 20-Nov-2013 to a child who received a dose on 06-Sep-2013 patient was inadvertently given FLUMIST twice. The outcome of the event of received multiple flu vaccines/we gave FLUMIST on Nov-20-2013 to a child who received a dose on Sept 6, 2013/patient was inadvertently given FLUMIST twice is unknown. The report was considered to be non-serious. Summary of significant follow-up information received on 03-Dec-2013 from a health professional. Product lot number and expiry date added. Event start date added. Patient details added.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Pharmacist concerning a 3 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The child received two doses of FLUMIST one month apart which started on 04-Nov-2013. The outcome of the event of received 2 doses of FLUMIST is unknown. The report was considered to be non-serous by the reporter.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from Health Professional concerning a patient of unknown gender. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving nasal FLUMIST started on an unknown date. The reporter stated that three patients received FLUMIST and then got the flu. The outcome of event of flu was unknown. The reporter considered the event of the flu to be non-serious.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: No adverse event, Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 13 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The Pharmacist reported that the patient received only a half dose FLUMIST in one nostril at one of the facilities mobile clinics. No adverse reactions reported. The outcome of the event of administration of only a half dose of FLUMIST in one is unknown. The report was considered to be non-serious.
Age: 22.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 22 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient experienced administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious by the reporter.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 38 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient experienced administration of only a half dose of FLUMIST in one nostril, which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious by the reporter.
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 13 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient experienced administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 6 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient was administered only a half dose of FLUMIST in one nostril started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The medical assistant reported that they inadvertently administered expired FLUMIST to a patient on 27-Nov-2013. The outcome of the event of administration of expired dose/we inadvertently administered expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 05-Dec-2013. The reporter stated that the patient was inadvertently administered expired FLUMIST to four patients which started on 05-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST to four patients is unknown. The report was considered to be non-serious.
Age: 54.0
Sex: F
Vaccine: FLUN4
Symptoms: Accidental exposure to product, Headache, Nasal congestion, Respiratory tract congestion, Sinus headache
Clinical narrative: A report has been received from a Health Professional concerning a 54 year old, female subject, who had been receiving FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included asthma. Concomitant medications included Paracetamol, Hormone Replacement Therapy and Cetirizine Hydrochloride for allergies. FLUMIST started on 07-Oct-2013. It was reported that consumer had administered vaccine during flu clinics and individual appointments but had not received FLUMIST but had been administering FLUMIST. The consumer experienced nasal congestion, congestion and headaches, sinus pain which started on 19-Oct-2013. At the time of reporting, the event of nasal congestion/congestion and headaches/sinus pain was ongoing and the outcome of the event of administered vaccine during flu clinics and individual appointments/have not received FLUMIST but have been administered FLUMIST is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a physician concerning patient of unknown gender. No information regarding relevant medical history, concomitant disease, or concomitant medication was provided. It was reported that after receiving FLUMIST Quadrivalent last week the patient developed flu symptoms. The outcome of the event of patient develops flu symptoms after receiving FLUMIST was unknown. The reporter assessed the event of develops flu symptoms after receiving FLUMIST to be non-serious.
Age: 43.0
Sex: F
Vaccine: FLUN4
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: A report has been received from a Health Professional concerning a 43 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced headache, joint pain, and body aches which started on 14-Oct-2013. The outcome of the event of headache, joint pain and body aches is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza like illness, Irritability, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: A report had been received from a health professional concerning a 2 year old female patient. The medical history and the concomitant medications were not reported. The patient received FLUMIST quadrivalent (intranasal) on an unknown date. The reporter stated that the patient had flu like symptoms after receiving FLUMIST quadrivalent. The symptoms included wheezing, runny nose, irritability, body aches, and fever of 101.7 while taking ibuprofen. The patient received FLUMIST on 18-Oct-2013 and symptoms started on 20-Oct-2013. The physician of the patient was aware, but reporter did not have physician information. The outcome of the event of patient had flu like symptoms after receiving FLUMIST quadrivalent, wheezing, runny nose, irritability, body aches and fever of 101.7 is unknown.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Wheezing
Clinical narrative: A report had been received from a health professional concerning a 2 year old female patient. The medical history and the concomitant medications were not reported. The patient received FLUMIST quadrivalent (intranasal) on an unknown date. The reporter stated that the patient had flu like symptoms after receiving FLUMIST quadrivalent. The symptoms included wheezing, runny nose, irritability, body aches, and fever of 101.7 while taking ibuprofen. The patient received FLUMIST on 18-Oct-2013 and symptoms started on 20-Oct-2013. The physician of the patient was aware, but reporter did not have physician information. The outcome of the event of patient had flu like symptoms after receiving FLUMIST quadrivalent, wheezing, runny nose, irritability, body aches and fever of 101.7 is unknown.
Age: 21.0
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered, Oropharyngeal pain
Clinical narrative: A consumer report has been received. The report concerns a 21 year old, female consumer, who had been receiving FLUMIST quadrivalent (intranasal), half dose. FLUMIST quadrivalent (intranasal) started on an unknown date. The patient experienced pharmacist forgot to take the clip off and she only received 1/2 the dose in one nostril and sore throat. The outcome of the event of pharmacist forgot to take the clip off and she only received 1/2 the dose in one nostril and sore throat is unknown. The report was considered to be non-serious. Corrected report: 31-Oct-2013: Have you reported this AE previously field ticked.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Vaccination error
Clinical narrative: A report has been received from a physician concerning a 4 year old, female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 18-Oct-2013. The patient received first half of vaccine on 18-Oct-2013 but moved their head for second half and vaccine sprayed into her eye and did not go into nostril. The outcome of the event of vaccine sprayed into her eye is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a child, subject of unknown gender, who had been received FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started during Oct-2013. The patient experienced fever which started on 18-Oct-2013. The outcome of the event of fever is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a physician concerning female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient was administered FLUMIST twice in one day. The outcome of the event of administered FLUMIST twice in one day is unknown. The report was considered to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a Health Professional via MedImmune representative concerning a 5 year old female patient. The relevant history and concomitant drugs of patient were not reported. Patient was a healthy child-no medical issues. The patient had been receiving FLUMIST quadrivalent (intranasal) started on 23-Oct-2013. MedImmune representative stated that 3 patients contracted the flu after being vaccinated with FLUMIST. The patient was diagnosed with flu after vaccination with FLUMIST which started on 18-Nov-2013. She was treated with TAMIFLU. The outcome of the event of flu diagnosis after vaccination was unknown. The reporter considered the event of flu diagnosis after vaccination with FLUMIST to be non-serious.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Angioedema and eyes were red and watery. Diphenhydramine 50 mg once, diphenhydramine 25 mg HS.
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Blister, Incisional drainage, Local swelling
Clinical narrative: Case number PHHY2013US110820 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496864) website on 04 Oct 2013, with the follow-up received from Quality Assurance Department (reference number: 257014) on 17 Feb 2014. This report refers to 12-year-old male patient. His medical history and concomitant medication was not reported. On 01 Jul 2013 he was vaccinated with MENVEO (batch number: A12009 and expiry date: Feb 2014) intramuscularly and VARIVAX (other manufacturer, batch number: J001181) subcutaneously in the left arm; HAVRIX (other manufacturer, batch number: AHAVB520AA) and BOOSTRIX (other manufacturer, batch number: AC52B091FA) intramuscularly in the right arm. On 02 Jul 2013, he experienced swollen arm. He also experienced blisters in the arm. It was reported that his arm was drained. He visited the emergency room on 03 Jul 2013. He was prescribed BACTRIM and BENADRYL. The reporter suspected a possibility of cellulitis or allergic reaction. The outcome was reported as completely recovered on an unspecified date. The seriousness and causality was not reported. No additional information was available. Based on the investigation performed, QA department stated that, the MENVEO vaccine (batch number: A12009) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 257014) on 17 Feb 2014: Updated batch review report.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose decreased, Condition aggravated, Hypoglycaemia
Clinical narrative: Case number PHHY2013US147127 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 512672) website on 16 Dec 2013 with the follow-up received from management on 20 Feb 2014. This report refers to an 88-year-female patient. Her concurrent conditions included insulin dependent diabetes mellitus (IDDM) and no known drug allergies (NKDA). Concomitant medications included LANTUS 40 units daily. She was vaccinated with FLUVIRIN (batch number 1308101) into left arm on 24 Oct 2013. Within 2 hours of the vaccine, the patient had an incident of hypoglycemia with a sugar as low as 40 mg/dl. She felt weak when it happened. Emergency was called paramedics came and treated her and brought her blood sugar back up. She did not have to go to the hospital but was taken to her health care professional later that day. She was well now with stable blood sugars. The patient's daughter was unsure if the patient took the insulin dose twice since she was unsure how to use the insulin pen. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported. Follow-up received from management on 20 Feb 2014: Upon follow-up, the reported batch number (1308101) was confirmed as FLUVIRIN. Hence suspect product was recoded from seasonal influenza vaccine INN to FLUVIRIN.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Extremity contracture, Fall, Gaze palsy, Headache, Somnolence
Clinical narrative: Case number PHHY2014US012634 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 513400) website on 03 Feb 2014, with the follow-up received from Quality Assurance Department (QA reference number: 279310) on 14 Feb 2014. This report refers to an 11-year-old male patient. His concurrent condition included asthma. Concomitant medications included SINGULAIR, PROVENTIL HFA and Albuterol. He was vaccinated with MENVEO (batch number: M13012 and expiry date: Sep 2014) intramuscularly in the left arm on 16 Nov 2013. On the same day, he was also vaccinated with FLUZONE (other manufacturer, batch number: UH899AC) intramuscularly in the right arm. On the same day, post vaccinations, he told his grandmother that he just wanted to go to sleep then he fell to the ground. His eyes began to roll up into the back of his head and his limbs began to contract. He came to about a minute later and complained about a headache. Reporter spoke to him, asked him questions and he responded correctly but, he complained of headaches. Emergency department arrived and took him to hospital. Outcome of the events was reported as recovered. Seriousness and causality of the events were not reported. Based on the investigation performed, QA department stated that, the MENVEO vaccine (batch number: M13012) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 279310) on 14 Feb 2014: Updated batch review report.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Skin test, Skin test positive
Clinical narrative: This medically confirmed literature report (initial receipt 11-Feb-2014) concerns a four year old male patient who had a medical history of perioral rash with ingestion of meringue icing and a food reaction (watery mouth, abdominal pain, weakness) after the ingestion of gummy candies, gummy vitamins and marshmallows. The parents were avoiding giving the patient unbaked egg due to the perioral rash which had occurred in the past. The patient had received the influenza vaccine in the past without any issues. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). Within 15 minutes of receiving the immunisation, he developed diffuse hives, watery eyes, sneezing and vomiting which was diagnosed as anaphylaxis. The patient was evaluated for egg allergy and gelatin IgE-sensitisation. A skin prick test showed a wheal of 4mm and a flare of 21mm with commercial egg extract, and a wheal of 13mm and flare of 33mm with fresh gelatin. A serum test showed a IgE level of 4.76 KIU/L for egg white and 0.39 kIU/L for bovine gelatin. The family declined further testing. The patient was recommended to avoid all foods with unbaked egg and gelatin and was prescribed an epinephrine auto-injector, provided with an emergency action plan and reviewed the management of food allergies. Outcome was not reported.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Blood immunoglobulin E decreased, Food allergy, Lacrimation increased, Skin test positive
Clinical narrative: This medically confirmed literature report (initial receipt 11-Feb-2014) concerns a four year old male patient who had a medical history of perioral rash with ingestion of meringue icing and a food reaction (watery mouth, abdominal pain, weakness) after the ingestion of gummy candies, gummy vitamins and marshmallows. The parents were avoiding giving the patient unbaked egg due to the perioral rash which had occurred in the past. The patient had received the influenza vaccine in the past without any issues. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). Within 15 minutes of receiving the immunisation, he developed diffuse hives, watery eyes, sneezing and vomiting which was diagnosed as anaphylaxis. The patient was evaluated for egg allergy and gelatin IgE-sensitisation. A skin prick test showed a wheal of 4mm and a flare of 21mm with commercial egg extract, and a wheal of 13mm and flare of 33mm with fresh gelatin. A serum test showed a IgE level of 4.76 KIU/L for egg white and 0.39 kIU/L for bovine gelatin. The family declined further testing. The patient was recommended to avoid all foods with unbaked egg and gelatin and was prescribed an epinephrine auto-injector, provided with an emergency action plan and reviewed the management of food allergies. Outcome was not reported.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Sneezing, Urticaria, Vomiting
Clinical narrative: This medically confirmed literature report (initial receipt 11-Feb-2014) concerns a four year old male patient who had a medical history of perioral rash with ingestion of meringue icing and a food reaction (watery mouth, abdominal pain, weakness) after the ingestion of gummy candies, gummy vitamins and marshmallows. The parents were avoiding giving the patient unbaked egg due to the perioral rash which had occurred in the past. The patient had received the influenza vaccine in the past without any issues. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). Within 15 minutes of receiving the immunisation, he developed diffuse hives, watery eyes, sneezing and vomiting which was diagnosed as anaphylaxis. The patient was evaluated for egg allergy and gelatin IgE-sensitisation. A skin prick test showed a wheal of 4mm and a flare of 21mm with commercial egg extract, and a wheal of 13mm and flare of 33mm with fresh gelatin. A serum test showed a IgE level of 4.76 KIU/L for egg white and 0.39 kIU/L for bovine gelatin. The family declined further testing. The patient was recommended to avoid all foods with unbaked egg and gelatin and was prescribed an epinephrine auto-injector, provided with an emergency action plan and reviewed the management of food allergies. Outcome was not reported.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Lacrimation increased, Serology test, Skin test, Skin test positive
Clinical narrative: This medically confirmed literature report (initial receipt 11-Feb-2014) concerns a four year old male patient who had a medical history of perioral rash with ingestion of meringue icing and a food reaction (watery mouth, abdominal pain, weakness) after the ingestion of gummy candies, gummy vitamins and marshmallows. The parents were avoiding giving the patient unbaked egg due to the perioral rash which had occurred in the past. The patient had received the influenza vaccine in the past without any issues. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). Within 15 minutes of receiving the immunisation, he developed diffuse hives, watery eyes, sneezing and vomiting which was diagnosed as anaphylaxis. The patient was evaluated for egg allergy and gelatin IgE-sensitisation. A skin prick test showed a wheal of 4mm and a flare of 21mm with commercial egg extract, and a wheal of 13mm and flare of 33mm with fresh gelatin. A serum test showed a IgE level of 4.76 KIU/L for egg white and 0.39 kIU/L for bovine gelatin. The family declined further testing. The patient was recommended to avoid all foods with unbaked egg and gelatin and was prescribed an epinephrine auto-injector, provided with an emergency action plan and reviewed the management of food allergies. Outcome was not reported.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Food allergy, Lacrimation increased, Sneezing, Urticaria
Clinical narrative: This medically confirmed literature report (initial receipt 11-Feb-2014) concerns a four year old male patient who had a medical history of perioral rash with ingestion of meringue icing and a food reaction (watery mouth, abdominal pain, weakness) after the ingestion of gummy candies, gummy vitamins and marshmallows. The parents were avoiding giving the patient unbaked egg due to the perioral rash which had occurred in the past. The patient had received the influenza vaccine in the past without any issues. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). Within 15 minutes of receiving the immunisation, he developed diffuse hives, watery eyes, sneezing and vomiting which was diagnosed as anaphylaxis. The patient was evaluated for egg allergy and gelatin IgE-sensitisation. A skin prick test showed a wheal of 4mm and a flare of 21mm with commercial egg extract, and a wheal of 13mm and flare of 33mm with fresh gelatin. A serum test showed a IgE level of 4.76 KIU/L for egg white and 0.39 kIU/L for bovine gelatin. The family declined further testing. The patient was recommended to avoid all foods with unbaked egg and gelatin and was prescribed an epinephrine auto-injector, provided with an emergency action plan and reviewed the management of food allergies. Outcome was not reported.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: This medically confirmed literature report (initial receipt 11-Feb-2014) concerns a four year old male patient who had a medical history of perioral rash with ingestion of meringue icing and a food reaction (watery mouth, abdominal pain, weakness) after the ingestion of gummy candies, gummy vitamins and marshmallows. The parents were avoiding giving the patient unbaked egg due to the perioral rash which had occurred in the past. The patient had received the influenza vaccine in the past without any issues. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). Within 15 minutes of receiving the immunisation, he developed diffuse hives, watery eyes, sneezing and vomiting which was diagnosed as anaphylaxis. The patient was evaluated for egg allergy and gelatin IgE-sensitisation. A skin prick test showed a wheal of 4mm and a flare of 21mm with commercial egg extract, and a wheal of 13mm and flare of 33mm with fresh gelatin. A serum test showed a IgE level of 4.76 KIU/L for egg white and 0.39 kIU/L for bovine gelatin. The family declined further testing. The patient was recommended to avoid all foods with unbaked egg and gelatin and was prescribed an epinephrine auto-injector, provided with an emergency action plan and reviewed the management of food allergies. Outcome was not reported.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Psoriasis, Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female with diabetes. In September 2013 the patient was vaccinated with a dose of ZOSTAVAX (manufacturer unknown) (lot#, expiration date, dose, indication, route not reported). Other suspect therapies included insulin (dose, frequency, route, indication not reported) and a dose of influenza virus vaccine (manufacturer unknown) (lot#, expiration date, dose, indication, route not reported) on 13-AUG-2013. Concomitant therapies included MOTRIN as needed and lisinopril (manufacturer unknown). On an unknown date in September 2013, 2 days after vaccination, the patient started with bumps on arm that spread all over. No lab diagnostics tests. The patient reported the event to the doctor. There was no illness at the time of the vaccination. The patient was on insulin, and dermatologist said it was psoriasis, the physician thought it was from insulin, the insulin type was switched. The outcome of the event was reported still present but better now. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Psoriasis, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female with diabetes. In September 2013 the patient was vaccinated with a dose of ZOSTAVAX (manufacturer unknown) (lot#, expiration date, dose, indication, route not reported). Other suspect therapies included insulin (dose, frequency, route, indication not reported) and a dose of influenza virus vaccine (manufacturer unknown) (lot#, expiration date, dose, indication, route not reported) on 13-AUG-2013. Concomitant therapies included MOTRIN as needed and lisinopril (manufacturer unknown). On an unknown date in September 2013, 2 days after vaccination, the patient started with bumps on arm that spread all over. No lab diagnostics tests. The patient reported the event to the doctor. There was no illness at the time of the vaccination. The patient was on insulin, and dermatologist said it was psoriasis, the physician thought it was from insulin, the insulin type was switched. The outcome of the event was reported still present but better now. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This medically confirmed report (initial receipt 12-Feb-2014) concerns a 15 year old male patient who had no pertinent medical history, no concomitant medications and no drug reactions/allergies. On the 06-Feb-2014, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not provided) and concomitantly received GARDASIL (batch number J012212). On the 06-Feb-2014, after receiving a first dose of GARDASIL and the unspecified flu vaccine, the patient fainted and developed tonic clonic movements. The patient sought medical attention. The patient was treated with ice packs and alcohol smelling capsules. Outcome was reported as recovered on the 06-Feb-2014.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Aphagia, Aphthous stomatitis, Biopsy, Blood test, Culture
Clinical narrative: This consumer report (initial receipt 11-Feb-2014) concerns a 61 year old female patient who had a healthy immune system and no history of cold sores. On an unspecified date in Jan-2013, the patient received a flu vaccine (manufacturer and batch number not reported). Within the same week, the patient also received a pertussis vaccination (manufacturer and batch number not reported) and ZOSTAVAX injection (batch number not reported) as a single dose. On an unspecified date, a few weeks after receiving the ZOSTAVAX vaccine, the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. The fever worsened and the patient developed symptoms of a urinary tract infection (UTI) but no UTI was confirmed. The patient developed severe discomfort in her throat which included difficulty in swallowing. She visited a walk-in clinic where she was prescribed levofloxacin. She later sought medical attention from her PCP (primary care physician). At this time, she also developed a white tongue and canker sores in her mouth and was unable to eat or drink. The patient was referred to an Infection Disease Specialist. On the 04-Feb-2014, the patient went to the Emergency Room of a hospital and was admitted. An endoscopy was performed and was diagnosed with herpes virus blisters in the throat. Treatment included acyclovir by intravenous administration and sucralfate to coat the ulcerations. Other treatments included vancomycin and sulfamethoxazole/trimethoprim. Laboratory studies included blood and urine tests, endoscopy, cultures and biopsies. The patient was discharged on the 09-Feb-2014 and was able to eat and drink lightly but was still uncomfortable. Outcome was reported as recovering.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Dysphagia, Endoscopy, Fluid intake reduced, Headache, Herpes virus infection
Clinical narrative: This consumer report (initial receipt 11-Feb-2014) concerns a 61 year old female patient who had a healthy immune system and no history of cold sores. On an unspecified date in Jan-2013, the patient received a flu vaccine (manufacturer and batch number not reported). Within the same week, the patient also received a pertussis vaccination (manufacturer and batch number not reported) and ZOSTAVAX injection (batch number not reported) as a single dose. On an unspecified date, a few weeks after receiving the ZOSTAVAX vaccine, the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. The fever worsened and the patient developed symptoms of a urinary tract infection (UTI) but no UTI was confirmed. The patient developed severe discomfort in her throat which included difficulty in swallowing. She visited a walk-in clinic where she was prescribed levofloxacin. She later sought medical attention from her PCP (primary care physician). At this time, she also developed a white tongue and canker sores in her mouth and was unable to eat or drink. The patient was referred to an Infection Disease Specialist. On the 04-Feb-2014, the patient went to the Emergency Room of a hospital and was admitted. An endoscopy was performed and was diagnosed with herpes virus blisters in the throat. Treatment included acyclovir by intravenous administration and sucralfate to coat the ulcerations. Other treatments included vancomycin and sulfamethoxazole/trimethoprim. Laboratory studies included blood and urine tests, endoscopy, cultures and biopsies. The patient was discharged on the 09-Feb-2014 and was able to eat and drink lightly but was still uncomfortable. Outcome was reported as recovering.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Oropharyngeal blistering, Oropharyngeal discomfort, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This consumer report (initial receipt 11-Feb-2014) concerns a 61 year old female patient who had a healthy immune system and no history of cold sores. On an unspecified date in Jan-2013, the patient received a flu vaccine (manufacturer and batch number not reported). Within the same week, the patient also received a pertussis vaccination (manufacturer and batch number not reported) and ZOSTAVAX injection (batch number not reported) as a single dose. On an unspecified date, a few weeks after receiving the ZOSTAVAX vaccine, the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. The fever worsened and the patient developed symptoms of a urinary tract infection (UTI) but no UTI was confirmed. The patient developed severe discomfort in her throat which included difficulty in swallowing. She visited a walk-in clinic where she was prescribed levofloxacin. She later sought medical attention from her PCP (primary care physician). At this time, she also developed a white tongue and canker sores in her mouth and was unable to eat or drink. The patient was referred to an Infection Disease Specialist. On the 04-Feb-2014, the patient went to the Emergency Room of a hospital and was admitted. An endoscopy was performed and was diagnosed with herpes virus blisters in the throat. Treatment included acyclovir by intravenous administration and sucralfate to coat the ulcerations. Other treatments included vancomycin and sulfamethoxazole/trimethoprim. Laboratory studies included blood and urine tests, endoscopy, cultures and biopsies. The patient was discharged on the 09-Feb-2014 and was able to eat and drink lightly but was still uncomfortable. Outcome was reported as recovering.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Tongue discolouration, Urinary tract infection, Urine analysis
Clinical narrative: This consumer report (initial receipt 11-Feb-2014) concerns a 61 year old female patient who had a healthy immune system and no history of cold sores. On an unspecified date in Jan-2013, the patient received a flu vaccine (manufacturer and batch number not reported). Within the same week, the patient also received a pertussis vaccination (manufacturer and batch number not reported) and ZOSTAVAX injection (batch number not reported) as a single dose. On an unspecified date, a few weeks after receiving the ZOSTAVAX vaccine, the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. The fever worsened and the patient developed symptoms of a urinary tract infection (UTI) but no UTI was confirmed. The patient developed severe discomfort in her throat which included difficulty in swallowing. She visited a walk-in clinic where she was prescribed levofloxacin. She later sought medical attention from her PCP (primary care physician). At this time, she also developed a white tongue and canker sores in her mouth and was unable to eat or drink. The patient was referred to an Infection Disease Specialist. On the 04-Feb-2014, the patient went to the Emergency Room of a hospital and was admitted. An endoscopy was performed and was diagnosed with herpes virus blisters in the throat. Treatment included acyclovir by intravenous administration and sucralfate to coat the ulcerations. Other treatments included vancomycin and sulfamethoxazole/trimethoprim. Laboratory studies included blood and urine tests, endoscopy, cultures and biopsies. The patient was discharged on the 09-Feb-2014 and was able to eat and drink lightly but was still uncomfortable. Outcome was reported as recovering.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Aphagia, Aphthous stomatitis, Biopsy, Blister, Blood test
Clinical narrative: This consumer report (initial receipt 11-Feb-2014) concerns a 61 year old female patient who had a healthy immune system and no history of cold sores. On an unspecified date in Jan-2013, the patient received a flu vaccine (manufacturer and batch number not reported). Within the same week, the patient also received a pertussis vaccination (manufacturer and batch number not reported) and ZOSTAVAX injection (batch number not reported) as a single dose. On an unspecified date, a few weeks after receiving the ZOSTAVAX vaccine, the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. The fever worsened and the patient developed symptoms of a urinary tract infection (UTI) but no UTI was confirmed. The patient developed severe discomfort in her throat which included difficulty in swallowing. She visited a walk-in clinic where she was prescribed levofloxacin. She later sought medical attention from her PCP (primary care physician). At this time, she also developed a white tongue and canker sores in her mouth and was unable to eat or drink. The patient was referred to an Infection Disease Specialist. On the 04-Feb-2014, the patient went to the Emergency Room of a hospital and was admitted. An endoscopy was performed and was diagnosed with herpes virus blisters in the throat. Treatment included acyclovir by intravenous administration and sucralfate to coat the ulcerations. Other treatments included vancomycin and sulfamethoxazole/trimethoprim. Laboratory studies included blood and urine tests, endoscopy, cultures and biopsies. The patient was discharged on the 09-Feb-2014 and was able to eat and drink lightly but was still uncomfortable. Outcome was reported as recovering.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Culture, Dysphagia, Endoscopy, Headache, Herpes virus infection
Clinical narrative: This consumer report (initial receipt 11-Feb-2014) concerns a 61 year old female patient who had a healthy immune system and no history of cold sores. On an unspecified date in Jan-2013, the patient received a flu vaccine (manufacturer and batch number not reported). Within the same week, the patient also received a pertussis vaccination (manufacturer and batch number not reported) and ZOSTAVAX injection (batch number not reported) as a single dose. On an unspecified date, a few weeks after receiving the ZOSTAVAX vaccine, the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. The fever worsened and the patient developed symptoms of a urinary tract infection (UTI) but no UTI was confirmed. The patient developed severe discomfort in her throat which included difficulty in swallowing. She visited a walk-in clinic where she was prescribed levofloxacin. She later sought medical attention from her PCP (primary care physician). At this time, she also developed a white tongue and canker sores in her mouth and was unable to eat or drink. The patient was referred to an Infection Disease Specialist. On the 04-Feb-2014, the patient went to the Emergency Room of a hospital and was admitted. An endoscopy was performed and was diagnosed with herpes virus blisters in the throat. Treatment included acyclovir by intravenous administration and sucralfate to coat the ulcerations. Other treatments included vancomycin and sulfamethoxazole/trimethoprim. Laboratory studies included blood and urine tests, endoscopy, cultures and biopsies. The patient was discharged on the 09-Feb-2014 and was able to eat and drink lightly but was still uncomfortable. Outcome was reported as recovering.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Mouth ulceration, Oropharyngeal discomfort, Pain, Pyrexia, Tongue discolouration
Clinical narrative: This consumer report (initial receipt 11-Feb-2014) concerns a 61 year old female patient who had a healthy immune system and no history of cold sores. On an unspecified date in Jan-2013, the patient received a flu vaccine (manufacturer and batch number not reported). Within the same week, the patient also received a pertussis vaccination (manufacturer and batch number not reported) and ZOSTAVAX injection (batch number not reported) as a single dose. On an unspecified date, a few weeks after receiving the ZOSTAVAX vaccine, the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. The fever worsened and the patient developed symptoms of a urinary tract infection (UTI) but no UTI was confirmed. The patient developed severe discomfort in her throat which included difficulty in swallowing. She visited a walk-in clinic where she was prescribed levofloxacin. She later sought medical attention from her PCP (primary care physician). At this time, she also developed a white tongue and canker sores in her mouth and was unable to eat or drink. The patient was referred to an Infection Disease Specialist. On the 04-Feb-2014, the patient went to the Emergency Room of a hospital and was admitted. An endoscopy was performed and was diagnosed with herpes virus blisters in the throat. Treatment included acyclovir by intravenous administration and sucralfate to coat the ulcerations. Other treatments included vancomycin and sulfamethoxazole/trimethoprim. Laboratory studies included blood and urine tests, endoscopy, cultures and biopsies. The patient was discharged on the 09-Feb-2014 and was able to eat and drink lightly but was still uncomfortable. Outcome was reported as recovering.
Age: 61.0
Sex: F
Vaccine: FLU3, PER, VARZOS, FLUX, PER, VARZOS
Symptoms: Urinary tract infection, Urine analysis
Clinical narrative: This consumer report (initial receipt 11-Feb-2014) concerns a 61 year old female patient who had a healthy immune system and no history of cold sores. On an unspecified date in Jan-2013, the patient received a flu vaccine (manufacturer and batch number not reported). Within the same week, the patient also received a pertussis vaccination (manufacturer and batch number not reported) and ZOSTAVAX injection (batch number not reported) as a single dose. On an unspecified date, a few weeks after receiving the ZOSTAVAX vaccine, the patient developed body aches and a low-grade fever. The body aches were accompanied by a constant dull headache. The fever worsened and the patient developed symptoms of a urinary tract infection (UTI) but no UTI was confirmed. The patient developed severe discomfort in her throat which included difficulty in swallowing. She visited a walk-in clinic where she was prescribed levofloxacin. She later sought medical attention from her PCP (primary care physician). At this time, she also developed a white tongue and canker sores in her mouth and was unable to eat or drink. The patient was referred to an Infection Disease Specialist. On the 04-Feb-2014, the patient went to the Emergency Room of a hospital and was admitted. An endoscopy was performed and was diagnosed with herpes virus blisters in the throat. Treatment included acyclovir by intravenous administration and sucralfate to coat the ulcerations. Other treatments included vancomycin and sulfamethoxazole/trimethoprim. Laboratory studies included blood and urine tests, endoscopy, cultures and biopsies. The patient was discharged on the 09-Feb-2014 and was able to eat and drink lightly but was still uncomfortable. Outcome was reported as recovering.
Age: 55.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 55 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. Concomitant medications included Glucosamine and Vitamins NOS. FLUMIST QUADRIVALENT started on 01-Oct-2013. Medical assistant reported that they inadvertently gave FLUMIST QUADRIVALENT to a 55 year old patient which started on 01-Oct-2013. The outcome of the event of inadvertently gave FLUMIST QUADRIVALENT to a 55 year old patient is unknown. The report was considered to be non-serious.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Bone pain
Clinical narrative: Bone in my thumb is painful like when I had bone edema from Parsonage Turner Syndrome years ago following a flu shot. The syndrome can be caused by viruses and apparently has relation to Guillain Barre. The earlier incident was significant. This time it is not (yet?)
Age: 62.0
Sex: F
Vaccine: TTOX
Symptoms: Petechiae
Clinical narrative: Petechial rash developed on right hand/wrist.
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a patient, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. It was reported that they inadvertently a dose of FLUMIST QUADRIVALENT into one nostril instead of dividing it. The outcome of the event of inadvertently a dose of FLUMIST QUADRIVALENT into one nostril instead of dividing it is unknown. The report was considered to be non-serious.