chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Pharmacist concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. It was reported that Pharmacist's colleague accidentally administered both doses into a single nostril in 4 children approximately 2 weeks ago. The outcome of the event of accidentally administered both doses into a single nostril in 4 children is unknown. The report was considered to be non-serious.
Age: 29.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 29 year old patient of unknown gender, who on 18-FEB-2013, was vaccinated with VARIVAX (merck) (lot # 1101z exp date: 25-AUG-2012) dose 1, 0.5 ml, subcutaneous. No concomitant medications were reported. The Pharmacist states that there was no adverse effects. Additional information has been requested.
Age: 1.92
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included ACCIDENTAL POISONING BY SECOND HAND SMOKE. Concomitant Drug(s) Not Used. FLUMIST started on 09-Nov-2012. FLUMIST was GIVEN TO 23 MONTH OLD on 09-Nov-2012. The patient did not experience any adverse event. The outcome of the event of FLUMIST GIVEN TO 23 MONTH OLD is unknown. The report was considered to be non-serious by company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 19-Nov-2012 from Health Professional: Disease, information regarding concomitant medications, occupation of reporter (Administered by) added, narrative updated. Corrected report 30-Nov-2012: Action taken of FLUMIST corrected from Unknown to Not applicable.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 29-Oct-2012. The patient experienced fever for 3 days after receiving FLUMIST which started on 30-Oct-2012. The outcome of the event of fever for 3 days after receiving FLUMIST is unknown. The report was considered to be non-serious by the reporting health professional.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot not reported). The pharmacist reported that a nurse might have administered expired PNEUMOVAX 23. No adverse event reported. The outcome of the events was unknown. The reporter considered events to be not related to PNEUMOVAX 23. Additional information is not expected.
Sex: U
Vaccine: FLUN3
Symptoms: Lacrimation increased
Clinical narrative: A report has been received from a Health Professional concerning several patients of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started during 2011. The patient experienced EYE TEARING. The outcome of the event of EYE TEARING is unknown. The report was considered to be non-serious by the company physician.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza A virus test positive, Influenza B virus test, Influenza like illness, Pyrexia
Clinical narrative: A report has been received from a health professional concerning a 3 year old male patient. The patient was receiving nasal FLUMIST started on 09-Nov-2012 and 13-Nov-2012. It was reported that the patient had flu like symptoms, fever of 103 F and tested positive for influenza A which started on 13-Nov-2012. Action taken with FLUMIST was unknown. The outcome of the event of flu like symptoms, fever of 103 F and tested positive for influenza A is unknown. Company physician reporter assessed the events flu like symptoms, fever of 103 F and tested positive for influenza A to be non-serious.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Erythema, Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 61 year old female patient with no known drug allergies. On 14-FEB-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) subcutaneously in the back of left arm. The pharmacist reported that on 16-FEB-2013, "36 hours post vaccination", the patient developed adverse event. The patient complained of redness at the injection site of left arm. The redness spread across the arm, around the arm and under the left arm. The arm was so sore that patient could not lift her seat belt to put it on. The patient did not receive treatment for the adverse event. The patient's symptoms were subsiding. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician concerning a 64 year old male patient who on 16-JAN-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H014196, Exp 29-MAR-2014) (Dose not provided). The physician stated that in approximately 2013 the patient experienced redness and swelling of his arm at the injection site. The patient was evaluated at an unspecified emergency room on 18-JAN-2013 and sent home. The patient was treated with an unspecified antibiotic, TYLENOL and cold compresses. The outcome of redness and swelling of his arm at the injection site was reported as recovering. The relatedness of PNEUMOVAX 23 and the events mentioned above was not provided. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a physician concerning an 85 year old male patient who on 31-JAN-2013 was vaccinated with a dose of PNEUMOVAX 23 (lot # H014196, Exp 29-MAR-2014) (Dose not provided). The physician stated that in approximately 2013 the patient experienced swelling of her arm at the injection site after receiving PNEUMOVAX 23. The patient was seen back in the physician's office on 04-FEB-2013 and was noted to have a mild local reaction. The outcome of swelling of her arm at the injection site and mild local reaction was reported as recovering. The relatedness of PNEUMOVAX and the events mentioned above was not provided. Additional information has been requested.
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A report has been received from a Physician concerning a Child, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced BLOODY NOSE which started on 03-Sep-2012. The reporter explained the child was worked up prior to receiving FLUMIST and the nose bleed occurred prior to the child getting FLUMIST. The outcome of the event of BLOODY NOSE is unknown. The report was considered to be non-serious by the reporter. Summary of follow up of information received by AstraZeneca/MedImmune 21-Sep-2012: The case become non valid as the event of bloody nose occurred prior to receiving FLUMIST.
Sex: U
Vaccine: FLUN3
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: A report has been received from the Center of Disease Control (as a reporting regulatory authority), concerning a child of unknown age. The patient's concurrent disease included egg allergy. No concomitant drugs were reported. On an unknown date, the patient started to receive nasal FLUMIST. It was reported that the patient experienced anaphylactic allergic reaction. At the time of reporting, the outcome of the event of anaphylactic allergic reaction was unknown. According to the reporter, the assessment of the serious criteria for the report was as follows: important medical event.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced inadvertently gave FLUMIST to a patient with asthma. The outcome of the event of inadvertently gave FLUMIST to a patient with asthma is unknown. The report was considered to be non-serious.
Age: 0.77
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 9 month old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST was started on an unknown date. The patient experienced inadvertently gave FLUMIST to a 9 month old which started on 10-Oct-2012. Pediatric office inadvertently gave FLUMIST to a nine month old patient on 10-Oct-2012. Patient experienced no symptoms at the time of administration, and no symptoms were reported at the time of reporting either. The patient recovered from the event of inadvertently gave FLUMIST to a 9 month old on an unspecified date. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Nov-2012. The patient experienced inadvertently gave patient with asthma FLUMIST. The outcome of the event of inadvertently gave patient with asthma FLUMIST is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter reported that they inadvertently gave FLUMIST to patients with asthma. The outcome of the event of INADVERTENTLY GAVE PATIENT WITH ASTHMA FLUMIST is unknown. The report was considered to be non-serious.
Age: 0.6
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 month 24 days old patient (gender unspecified). In approximately July 2012, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (manufacturer unspecified, but VAQTA could not be ruled out) at 7 months 24 days of age. Lot # and administration route were unspecified. On 12-FEB-2013, the physician administered a dose of VAQTA (25U/0.5ml injection) for vaccination to the patient (patient was noted as being 1 year 2 months of age at the time of the report). The physician and office associated with the case was not the office or physician that administered the Hepatitis A vaccine (manufacturer unspecified) to the patient at 7 months 24 days (name of office or physician was unspecified). No adverse event reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 04-Dec-2012. The patient experienced RECEIVED EXPIRED FLUMIST which started on 04-Dec-2012. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Heath Professional concerning, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Dec-2012. The patient experienced A FULL DOSE OF FLUMIST WAS ADMINISTERED TO ONE NOSTRIL which started on 05-Dec-2012. The outcome of the event of A FULL DOSE OF FLUMIST WAS ADMINISTERED TO ONE NOSTRIL is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a registered nurse concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 04-Dec-2012. The nurse reported that they gave patient a dose of FLUMIST on Dec 4, 2012, the dose of FLUMIST expired on Dec 3, 2012. RN reported that patient had not reported any adverse effects. The outcome of the event of gave patient FLUMIST on 04-DEC-2012 and the FLUMIST dose expired on 03-DEC-2012 is unknown. The report was considered to be non-serious.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial information has been received from a consumer's parent concerning her daughter, a 18 year old female with an unspecified pertinent medical history or drug reactions/allergies. on 16-FEB-2013 the patient was vaccinated with an expired GARDASIL (Lot number 1167Z expiration date 08-DEC-2012) as prophylaxis (dose, route were not reported). No co-suspect were reported. No concomitant medication were reported. Upon pharmacy contacted the patient to stated that she needed to return as the vaccine received as expired. No adverse experience reported. No treatment information was reported. Laboratory studies were not reported. The patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving FLUMIST. FLUMIST started on 06-Dec-2012. The patient experienced INADVERTENTLY GAVE EXPIRED FLUMIST TO PATIENT which started on 06-Dec-2012. The outcome of the event of INADVERTENTLY GAVE EXPIRED FLUMIST TO PATIENT is unknown. Inadvertently gave expired FLUMIST to three patients. The report was considered to be non-serious.
Age: 1.3
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 29-Nov-2012. The patient experienced INADVERTENTLY GAVE FLUMIST TO A 16M ONTH OLD which started on 29-Nov-2012. The outcome of the event of INADVERTENTLY GAVE FLUMIST TO A 16 MONTH OLD is unknown. The report was considered to be non-serious.
Age: 1.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Physician concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced nurse gave FLUMIST to 13 month old child which started on 29-Nov-2012. The outcome of the event of nurse gave FLUMIST to 13 month old child is unknown. The report was considered to be non-serious by the reporter.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Nov-2012. The reporter reported that they inadvertently gave FLUMIST to patients with asthma. The outcome of the event of INADVERTENTLY GAVE PATIENT WITH ASTHMA FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter reported that inadvertently gave FLUMIST to patient with asthma. The outcome of the event of inadvertently gave FLUMIST to patient with asthma is unknown. The reporter was considered to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced INADVERTENT ADMINISTRATION OF FLUMIST TO A 12 MONTH OLD which started on 14-Sep-2012. The outcome of the event of INADVERTENT ADMINISTRATION OF FLUMIST TO A 12 MONTH OLD is unknown. The report was considered to be non-serious by the reporting health professional.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event, Underdose
Clinical narrative: A report has been received from registered nurse concerning a 3 year old, male patient. The patient's medical history and concomitant medications were not reported. Nurse reports that she forgot to take clip off FLUMIST syringe and only administered 1/2 of dose to two children, who are her grandchildren, administered 2 weeks ago. No symptoms to report. This case referred to the youngest. The patient experienced administered half a dose which started on 21-Sep-2012. The nurse said that the patient was fine and had no late occurring adverse events. The report was considered to be non-serious. Summary of follow-up information received 17-Oct-2012: outcome changed to recovered, reporter's phone number added. Corrected report 06-Dec-2012: Coding of event 'administered half a dose' changed from Drug administration error to Vaccine underdose, narrative updated.
Age: 1.85
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from registered nurse, concerning 22 month old, female patient. No concomitant medication and medical history. Caller states that FLUMIST was inadvertently administered to a 22 month old. No adverse reaction has occurred. The outcome was unknown. The report was considered to be non-serious by the reporting health professional. Follow-up of insignificant information received AstraZeneca/MedImmune on 08-Oct-2012 from health professional: patient's date of birth updated.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Underdose
Clinical narrative: A report has been received from registered nurse, concerning a 3 year old, female patient. The patient's medical history and concomitant medications were not reported. On 26-Sep-2012, the patient received FLUMIST to one nostril, half dose. The outcome of the event of half dose of FLUMIST administered was unknown. The report was considered to be non-serious. Corrected report 06-Dec-2012: Coding of event 'half dose of FLUMIST administered' changed from inappropriate dose of vaccine administered to Vaccine underdose, narrative updated, reporter details corrected.
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a Child, patient of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter reported that children under the age of 8 received a second dose of FLUMIST and should not have. The outcome of the event of children under 8 years old received a second dose of FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old. Female subject, who had been receiving FLUMIST, 0.2 millilitres. Once/Single administration. FLUMIST was administered on 11-Nov-2012. The patient received the full dose in one nostril on 11-Nov-2012. FLUMIST was administered erroneously once, on 11-Nov-2012. The outcome of the event of full dose in one nostril is unknown. The report was considered to be non-serious according to the reporter. Corrected report 03-Dec-2012: Coding of event 'full dose in one nostril' changed from Medication error to Drug administration error, narrative updated.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A consumer report has been received. The report concerns a 2 year old, Male consumer, who had been receiving FLUMIST. FLUMIST started on 08-Nov-2012. The child was administered FLUMIST twice, once at clinic with his mom on 15-Nov-2012 and other at doctors office with his dad on 08-Nov-2012 which started on 15-Nov-2012. The outcome of the event of FLUMSIT GIVEN TWICE is unknown. The report was considered to be non-serious. Corrected report 30-Nov-2012: Coding of event 'FLUMIST given twice' changed from Intentional drug misuse to Extra dose administered, narrative updated.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: A consumer report has been received. The report concerned a 4 month old, male consumer. On 15-Nov-2012 the patient started receiving nasal FLUMIST. The patient experienced fever and sore throat which started on 16-Nov-2012. Consumer reported that the patient was not sitting upright when he received his dose of FLUMIST. The action taken of FLUMIST was not applicable. The outcome of the event of fever and sore throat was unknown. The report was considered to be non-serious by the reporter.
Age: 1.6
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 19 months old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated that they accidentally gave FLUMIST to a 19 month old patient on 17-Oct-2012 and the patient had not experienced any adverse events. The outcome of the event of ACCIDENTALLY GAVE FLUMIST TO 19 MONTH-OLD was unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A consumer report has been received. The report concerns a 4 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 08-Nov-2012. The two children was administered with FLUMIST twice, once at a clinic with mom on 15-Nov-2012 and the other the doctor office with dad on 08-Nov-2012 which started on 15-Nov-2012. The outcome of the event of RECEIVED FLUMIST TWICE is unknown. The report was considered to be non-serious. Corrected report 30-Nov-2012: Coding of event 'received FLUMIST twice' changed from Intentional drug misuse to Extra dose administered, narrative updated.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: A consumer report has been received concerning a 14 year old female patient. The patient's medical history and concomitant medications were not reported. The patient's sister received nasal FLUMIST for unknown indication on 05-Nov-2012 and patient developed symptoms. The patient's mother reported that patient had secondary transmission 3-4 days after her sister received FLUMIST on 05-Nov-2012. The patient developed symptoms of fever, sore throat, swollen tonsils, cough, chills, and congestion. The outcome of reported events was unknown. The company physician assessed the event to be non-serious.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Tonsillar hypertrophy
Clinical narrative: A consumer report has been received concerning a 14 year old female patient. The patient's medical history and concomitant medications were not reported. The patient's sister received nasal FLUMIST for unknown indication on 05-Nov-2012 and patient developed symptoms. The patient's mother reported that patient had secondary transmission 3-4 days after her sister received FLUMIST on 05-Nov-2012. The patient developed symptoms of fever, sore throat, swollen tonsils, cough, chills, and congestion. The outcome of reported events was unknown. The company physician assessed the event to be non-serious.
Age: 1.67
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced ADMINISTRATION TO A 20 MONTH OLD which started on 15-Nov-2012. The outcome of the event of ADMINISTRATION TO A 20 MONTH OLD is unknown. The report was considered to be non-serious. Corrected report 29-Nov-2012: Key ingredient of FLUMIST corrected from influenza virus vaccine polyvalent to FLUMIST, coding of event 'administration to a 20 month old' corrected from intentional drug misuse to inappropriate age at vaccine administration, narrative updated.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A report has been received from a Physician concerning an 8 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 09-Nov-2012. The patient experienced Mild RUNNY NOSE. The patient recovered from the event of RUNNY NOSE on an unspecified date. The report was considered to be non-serious. The reported physician causality between the event runny nose with the FLUMIST to be yes. Summary of follow-up information received on 30-Nov-2012 from Physician: Reported causality added. Outcome of event runny nose changed from unknown to Recovered and intensity added for the same event. Vaccination history added. Corrected report on 07-Dec-2012: New reporter added. Patient initial added.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A report has been received from a Physician concerning a 6 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced mild vomiting. The patient recovered from the event of mild vomiting on an unspecified date. The report was considered to be non-serious. Corrected report 16-Nov-201: Key ingredient of FLUMIST corrected.
Age: 1.77
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 11-Sep-2012. The patient experienced FLUMIST ADMINISTERED TO 22 MONTH-OLD which started on 11-Sep-2012. The outcome of event of FLUMIST ADMINISTERED TO 22 MONTH-OLD is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 23-Oct-2012: reporter page, administration date, event onset date were corrected, manufacturer name added.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A report has been received from a Physician concerning a 6 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 09-Nov-2012. The patient experienced RUNNY NOSE. The patient recovered from the event of RUNNY NOSE on an unspecified date. The report was considered to be non-serious. The reported physician causality between the event of runny nose with the FLUMIST to be yes. Summary of follow-up information received by AstraZeneca on 12-Nov-2012 from Physician: Reported causality added. Outcome of event runny nose changed from unknown to Recovered. Corrected report: Vaccine type added.
Age: 0.25
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: A consumer report has been received. The report concerns a 5 year old, female consumer, who had been receiving FLUMIST. FLUMIST started on 15-Nov-2012. The patient experienced STOMACH PAINS, LOOSE STOOLS, NAUSEA, VOMITING and TIRED which started on 16-Nov-2012. The outcome of the event of STOMACH PAINS, LOOSE STOOLS, NAUSEA and TIRED is unknown. The report was considered to be non-serious by company physician.
Age: 0.5
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration
Clinical narrative: A report has been received from a Health Professional concerning a 6 month old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. It was reported that patient received FLUMIST BOOSTER 17 DAYS APART which started on 17-Sep-2012. The outcome of the event of FLUMIST BOOSTER DOSES 17 DAYS APART is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by MedImmune on 19-Oct-2012 Physician: No new information to add. Corrected report. New reporter were added. Corrected report 06-Dec-3012. The coding of FLUMIST booster doses 17 days apart was changed from drug administration error to inappropriate schedule of vaccine administered.
Sex: U
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning a child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. It was reported that Pharmacist's colleague accidentally administered both doses into a single nostril in 4 children approximately 2 weeks ago. The outcome of the event of ACCIDENTALLY ADMINISTERED BOTH DOSES INTO A SINGLE NOSTRIL IN 4 CHILDREN is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A report has been received from a Pharmacist concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. Pharmacist accidently administered both doses into a single nostril in 4 children approximately 2 weeks ago. The outcome of the event of ACCIDENTLY ADMINISTERED BOTH DOSES INTO A SINGLE NOSTRIL IN 4 CHILDREN is unknown. The report was considered to be non-serious.
Age: 1.55
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Rash generalised, Urticaria
Clinical narrative: Vaccines administered on 2-19-13 at 1130AM, Pt developed rash on 2-19-13 at 630 pm. Rash started on trunk and groin and began spreading. Saw pt in office 2-20-13 at 8 am. Widespread hives to trunk, inguinal area, scalp line, legs, back Pt was given BENADRYL in office. Pt was Rx BENADRYL, Prednisone, Ranitidine, EPIPEN. No SOB or difficulty breathing. Pt sent home. Called at 3pm to check on pt. mom reports rash has improved, no trouble breathing.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: REPORTED SOME RASH AND ITCHING ON RIGHT SIDE OF FACE NEAR THE EAR. DR. PRESCRIBED USE OF TRIAMCINOLONE THIS DID NOT HELP AND RASH AND ITCHING SPREAD TO OTHER AREAS OF BODY. SAW DR AGAIN ON 10/17/2012 AND STARTED USE OF POLYSPORIN AND SET UP REFERAL TO DERMATOLOGIST. CONDITION CONT'D TO WORSEN.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Arm/injection site throbbing, slightly swollen, dull/aching.
Age: 13.0
Sex: U
Vaccine: PPV
Symptoms: Meningitis pneumococcal, Vaccination failure
Clinical narrative: This literature marketed report as received from author refers to a 13 year old patient of unknown gender with sickle cell anemia. A single sickle cell center started a pilot screening program of antibody response to pneumococcal vaccination in patients with sickle cell disease (SCD). Patients were chosen for screening based on frequency of hospitalization and acute chest syndrome. Medical records of 5 patients less than 19 years old were reviewed to date for infections, pneumococcal vaccination, and response to pneumococcal vaccines. As a result 5 patients reviewed had different genotypes of SCD (2HbSS, 2 HbSC, and 1 Hemoglobin S-beta-thalassemia). Within this cohort, 1/5 (20 percent) had an adequate response to pneumococcal vaccination, defined as greater than 70 percent of serotype-specific pneumococcal IgG antibodies to 23 serotypes with serum levels of at least 1.3microgram/milliliter. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)(lot number, expiry date, route and dose were not reported). On an unknown date, the 13 year old patient developed streptococcus pneumonia meningitis despite vaccination (medically significant). The outcome of the event was unknown. The author considered the events as related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown). All 5 patients had received adequate vaccination with both polysaccharide and conjugate pneumococcal vaccines. The author concluded that the prevalence of sickle cell patients with low pneumococcal titers was unknown. Patients with SCD who had inadequate response to vaccination were at increased risk for invasive pneumococcal disease and could benefit from early, routine screening. If confirmed, poor response to pneumococcal vaccination may provide a rationale for continuing sickle cell patients on lifetime penicillin prophylaxis. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Throat tightness
Clinical narrative: C/O "throat closing and itching" after flu vaccine (12:15 p.m.). BENADRYL 50mg. IM administered at 1230 p.m. (approx.). To hospital via 911 (1245 arrival of ambulance).
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Acne, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: This is a spontaneous report from the non-clinical study program Pfizer line for healthcare professionals for a contactable consumer. This 33 year old female consumer received PREVNAR 13 on 13Feb2013 single dose. Relevant medical history included Crohn's disease since an unknown date in 2003. Relevant concomitant medication included ENTOCORT EC since an unknown duration at a dose of 6 mg daily for Crohn's disease. The consumer mentioned that she started to experience red giant painful wart (which she mentioned was on her upper right arm at the site of injection and further elaborated as a hard painful pimple which was not warm) on 13Feb2013 after PREVNAR 13 injection. Relevant laboratory data was none. The consumer mentioned that on 13Feb2013 she had washed the area with soap and applied BENADRYL (dose and frequency unknown) as therapeutic measures in response to the event. The consumer had not recovered from the event at the time of report.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Skin papilloma
Clinical narrative: This is a spontaneous report from the non-clinical study program Pfizer line for healthcare professionals for a contactable consumer. This 33 year old female consumer received PREVNAR 13 on 13Feb2013 single dose. Relevant medical history included Crohn's disease since an unknown date in 2003. Relevant concomitant medication included ENTOCORT EC since an unknown duration at a dose of 6 mg daily for Crohn's disease. The consumer mentioned that she started to experience red giant painful wart (which she mentioned was on her upper right arm at the site of injection and further elaborated as a hard painful pimple which was not warm) on 13Feb2013 after PREVNAR 13 injection. Relevant laboratory data was none. The consumer mentioned that on 13Feb2013 she had washed the area with soap and applied BENADRYL (dose and frequency unknown) as therapeutic measures in response to the event. The consumer had not recovered from the event at the time of report.
Age: 0.3
Sex: U
Vaccine: PNC13
Symptoms: Fontanelle bulging, Irritability, Pyrexia, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable physician from Pfizer Medical Information. A 4-month-old patient received PREVNAR 13 via an unspecified route of administration on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date 24 hours after vaccination, the patient experienced irritability, fever, and bulged fontanelle. As a result, the patient was taken to the emergency room for evaluation. The physician suggested a lumbar puncture; however, the patient's family refused. The patient subsequently left the emergency room. Evaluation confirmed that the events were a vaccine reaction. The outcomes of the events, irritability, fever, and bulged fontanelle, were recovering.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Angiogram, Antinuclear antibody, Blood thyroid stimulating hormone, Cognitive disorder, Cytomegalovirus test
Clinical narrative: MENACTRA & FLUZONE vaccines given 10/22/2012 symptoms reported 11/13/2012. C/O fatigue, vertigo, headaches, cognitive and sensory deficits, photophobia.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Drug screen, Fatigue, Headache, Lumbar puncture, Metabolic function test
Clinical narrative: MENACTRA & FLUZONE vaccines given 10/22/2012 symptoms reported 11/13/2012. C/O fatigue, vertigo, headaches, cognitive and sensory deficits, photophobia.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Mononucleosis heterophile test, Nuclear magnetic resonance imaging brain, Photophobia, Sensory loss, Vertigo
Clinical narrative: MENACTRA & FLUZONE vaccines given 10/22/2012 symptoms reported 11/13/2012. C/O fatigue, vertigo, headaches, cognitive and sensory deficits, photophobia.
Age: 35.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Axillary pain, Chills, Nausea, Pain, Pyrexia
Clinical narrative: RASH, PAIN IN ARMPIT, NAUSEA, PATIENT REPORTED FEVER/CHILLS, AND BODY ACHES. PATIENT HAD TEMP OF 99.0 AT ARRIVAL IN CLINIC.
Age: 35.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Rash
Clinical narrative: RASH, PAIN IN ARMPIT, NAUSEA, PATIENT REPORTED FEVER/CHILLS, AND BODY ACHES. PATIENT HAD TEMP OF 99.0 AT ARRIVAL IN CLINIC.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient stated swelling and redness at site of injection with pain.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Childhood disintegrative disorder, Hemiparesis, Tremor
Clinical narrative: Pt reported to stop walking right after 12 month vaccines, now with tremor and right sided weakness.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Anxiety, Dyspnoea, Emotional distress, Hypersensitivity
Clinical narrative: Pt. help to floor; supine with feet elevated. O2 applied using facial mask at 15 liters/minute. Pt. given juice to drink. After about 10 minutes, Pt. felt better. Pt. helped to sit up and then to chair. At 6:45pm, Pt. given Zyrtec 1 tab po. Pt. observed until 7:00pm at which time she requested to be released as she felt much better. Pt. dismissed. Pt. was seen the next day (1/30/13) at ER. The following is from the adjusters notes: DOS 1/30/13; Dr of E.R. HX: Clmt C/O rash to upper chest & face after receiving Hep A/B vaccine. She was given Zyrtec prior to arival. C/O mild SOB. Exam: Clmt's BMI: 32.5. She is anxious & in distress. Exam of all systems WNL. DX: Allergic reaction. (Likely IgE mediated reaction considering timing of symptoms). Plan: Clmt given Benadryl, Pepcid and Solu-Medrol and observed for several hrs w/resolution of symptoms. Clmt dischrgd in good condition & asked to F/U w/her PCP. Dr listed other possible considerations: anaphylaxis and anxiety.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Continuous, low-level muscle pain in upper left shoulder and left forearm (vaccination site).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site cellulitis, Tenderness
Clinical narrative: Mild, localized, superficial, cellulitis around the administration site in the thigh. Mild tenderness and no systemic symptoms.  Was given antibiotics (Cefadroxil) for two days with complete resolution.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Pts bottom lip swelled up approximately 10 minutes after she recieved the singles vaccination. Vitals @ 1319 were B/P- 132/62, HR 63, SpO2 99%, and respirations 14. She was also given a 25mg Benadryl at this time.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Cold sweat, Dizziness, Erythema
Clinical narrative: L arm with redness in AM. Then in PM all joints hurt, dizzy, cold and hot sweats. ON 2/14/13 big red blothes on L arm below injection site,neck stiff, weakness. On 2/14/13 AM. Face flushed, whole body rash, itching, heart racing, headache. To clinic and given Prednisone by Dr. of Clinic.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Headache, Hyperhidrosis, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: L arm with redness in AM. Then in PM all joints hurt, dizzy, cold and hot sweats. ON 2/14/13 big red blothes on L arm below injection site,neck stiff, weakness. On 2/14/13 AM. Face flushed, whole body rash, itching, heart racing, headache. To clinic and given Prednisone by Dr. of Clinic.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations, Pruritus, Rash generalised, Rash macular
Clinical narrative: L arm with redness in AM. Then in PM all joints hurt, dizzy, cold and hot sweats. ON 2/14/13 big red blothes on L arm below injection site,neck stiff, weakness. On 2/14/13 AM. Face flushed, whole body rash, itching, heart racing, headache. To clinic and given Prednisone by Dr. of Clinic.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Aphagia, Asthenia, Mobility decreased, Nausea
Clinical narrative: Fever and swollen arm that I could not move. Took 480 mg of Tylenol, but fever persisted until Wednesday p.m. I could not move my arm and had to miss work. Fever made me nauseous, and I could not eat. Became very weak.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Fever and swollen arm that I could not move. Took 480 mg of Tylenol, but fever persisted until Wednesday p.m. I could not move my arm and had to miss work. Fever made me nauseous, and I could not eat. Became very weak.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Shingles outbreak in dermatome that correlates with where vaccine administered; was given in left deltoid; broke out in left shoulder and pectoral area.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever, swollen lymph node two days after vaccination.  All but lymph node had recovered by the end of the month. Lymph node ceased swelling shortly after. Patient fully recovered.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Anxiety, Chest discomfort, Discomfort, Dyspnoea, Injection site pain
Clinical narrative: Pain at injection site 6-7/10, Chest tightness, unable to take a deep breath, anxiety. Regular respirations, HRR at 74, Pulse Ox 99%, Lungs CTA, throat without swelling.  Patient able to speak and maintain conversation with provider.  Symptoms improved by 11:05 AM; discomfort at 2-3/10.  Symptoms resolved by 11:10 AM. Patient up and walking, in no apparent distress by 11:15 AM. No medication administered but I did give patient a prescription for Albuterol inhaler to take to the pharmacy; history of asthma but had no inhaler at home.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local swelling, Mastication disorder, Mumps antibody test negative, Polymerase chain reaction, Pyrexia
Clinical narrative: Mom noticed child had unilateral swelling on left side of neck.  Child c/o not being able to chew on that side of his mouth.  Fever of 100.2.  He was taken to doctor and referred to Emergency room.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased, Pain
Clinical narrative: Pneumonia shot in right upper arm reaction--Severe swelling (2 times normal) of upper arm from elbow over top into shoulder with redness and radiating heat. By 9:00 PM unable to move arm even slightly without severe pain, 9 on a scale of 1-10 with 10 being worse.  Pain, redness, swelling, heat lasted through 2/17/2013. Suffered from systemic moderate body aches for a full day on 2/16/2013.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Rash erythematous, Rash pruritic, Vaccination site swelling
Clinical narrative: VERY itchy red bumps mainly on chest and a few on arms.   There is a large red circle and some swelling around the vaccination site.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis, Syncope
Clinical narrative: This spontaneous report as received from internet referred to a female student (patient) of unknown age. On an unknown date the patient was vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were unspecified). Patient said she collapsed and was left paralysed for six hours after being injected. "I couldn't move at all. There were girls dropping like flies, basically". Patient also said she had been vaccinated in the past (Lot#, dose/frequency, route and duration were unspecified) but her reaction to GARDASIL was different. At the time of reporting the outcome and relationship were unknown. But "authorities believed the reactions were likely to be related to having an injection not the vaccine itself." Upon internal review, paralysed was considered as other medical significant event. This is one of several reports that received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: This spontaneous report as received from internet referred to unspecified number of female patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were unspecified). Then on an unknown date the patients experienced paralysis (more reports of paralysis in girls who have gotten the poorly tested HPV vaccine). At the time of reporting the outcome of relationship were unknown. Upon internal review, paralysis was considered as other medical significant event. This is one of several reports that received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Diplegia, Dysstasia, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: This spontaneous report as received from internet referred to a female patient of unknown age. On an unknown date the patient was vaccinated with her first booster shot of GARDASIL (Lot#, dose/frequency, route and duration were unspecified) on May 2. A family friend of the patient said that, "Her legs are paralyzed, her arms are affected. She is very weak in her arms," "She has to use a walker. Even with that, she can't get to the bathroom. She can't stand up at all." Patient had been determined by her doctor to have Guillain-Barre syndrome, an acute, autoimmune condition that could lead to paralysis. At the time of reporting, outcome and relationship were unknown. Upon internal review, Guillain-Barre syndrome was considered as other medical significant event. This is one of several reports that received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Walking aid user
Clinical narrative: This spontaneous report as received from internet referred to a female patient of unknown age. On an unknown date the patient was vaccinated with her first booster shot of GARDASIL (Lot#, dose/frequency, route and duration were unspecified) on May 2. A family friend of the patient said that, "Her legs are paralyzed, her arms are affected. She is very weak in her arms," "She has to use a walker. Even with that, she can't get to the bathroom. She can't stand up at all." Patient had been determined by her doctor to have Guillain-Barre syndrome, an acute, autoimmune condition that could lead to paralysis. At the time of reporting, outcome and relationship were unknown. Upon internal review, Guillain-Barre syndrome was considered as other medical significant event. This is one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from internet referred to three patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were unspecified). Then on an unknown date the patients died (three deaths have been reported along with more reports of paralysis in girls who had gotten the poorly tested HPV vaccine). The date and cause of death were not reported. It was unknown whether autopsy was done. This is one of several reports that received from the same source. Additional information has been requested.