chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: The initial spontaneous case was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 12th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to a 15th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 07 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site inflammation, Injection site pain, Pain, Paraesthesia
Clinical narrative: Case number PHEH2016US030248, is an initial spontaneous report received from a consumer (patient's wife) on 15 Nov 2016. This report refers to a 58-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine in the past and had no problems (unspecified details). The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618701) at a dose of 0.5 ml intramuscularly, on 15 Oct 2016. On the same day after the vaccination, the patient experienced inflammation and pain at the injection site which radiated up arm to neck on 16 Oct 2016. When he moved head in certain manner he experienced pain if he lifted arm it became numb down to thumb and with no improvement. It was reported that tingling worsened. The outcome of event tingling and numbness of arm was reported as condition deteriorated and of the events inflammation and pain at the injection site and pain was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case, was received from a pharmacist on 26-Oct-2017, concerning a male patient of unspecified age. On 05-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: left Deltoid, batch number: 179705P, expiry date: not reported). On 07-Oct-2017 after 3 days of vaccination, he had soreness in his arm. On an unspecified date, the event was improved. The reporter assessed the event as non-serious. Follow up information was received on 28-Nov-2017. Event onset date was added (07-Oct-2017). Outcome was updated from not recovered to improved. Narrative was amended accordingly.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 14th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial non-serious spontaneous case was received on 04-Oct-2017, from other health professional, concerning a 29-year-old, adult, patient of unspecified gender. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch number: 1618621, expiry date: Apr-2017, route of administration: intramuscular, anatomical location: deltoid). It was reported that, that patient was administered with the vaccine that had expired in the month of April-2017. The patient had not experienced any adverse events after administration. Revaccination with the current season was advised. The reporter assessed the events as non-serious. Follow-up received on 12-Oct-2017: The reporter stated that, the vaccine was administered intramuscularly in the deltoid muscle and confirmed that, the patient had not experienced any adverse event. Narrative amended accordingly.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 10th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that, most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route and administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 01 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: The initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 16th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction, had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 02 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 09 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patient's received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case received on 25-Oct-2017, reported by other health professional and concerns a 3 year-old male child. Patient's medical history and concomitant medications were not reported. On 24-Oct-2017, the patient received FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported, batch number: 1721301, expiry date: Jun-2018). The patient did not experienced any further adverse reactions after receiving the vaccine. The outcome of the events was not reported. The reporter assessed this case as non-serious. Non-significant case correction received on 25-Oct-2017: The narrative was corrected.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: This initial spontaneous case, was received from other health professional on 15-Oct-2017, concerning a 53-year-old adult female patient. On 02-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number XT59305 (as reported), expiry date: 17-May-2018). On 03-Oct-2017, one day after vaccination, the patient had nausea. On 04-Oct-2017, the patient recovered completely from the event. The reporter assessed the event as non-serious. Significant case correction received with IRD 15-Oct-2017: Vaccination date was changed from 12-Oct-2017 to 02-Oct-2017 in the field.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 18th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US029726, is an initial spontaneous report received from a pharmacist on 09 Nov 2016. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported, Expiry date: Jun 2016) at a dose of 0.5 ml, intramuscularly, on an unknown date. A nurse reported to the reporter that expired FLUVIRIN was administered to a patient. The nurse thought that the expiration date was Jun 2017, but it was Jun 2016. No further information was provided to the pharmacist. No adverse event was reported following this medication error (expired product administered). The pharmacist assessed the case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US025062, is a spontaneous report initially received from nurse on 26 Sep 2016. This case refers to a 53 year old female patient. Past medical history was not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) which was tolerated). Concomitant medications were not reported. The patient was vaccinated with expired FLUVIRIN (batch number: 158203, expiry date: Jun 2016) at a dose of 0.5 ml, single dose intramuscularly on 26 Sep 2016. No adverse event was reported following this medication error (expired product administered). The seriousness of event was reported as non serious by the nurse. The reported stated that, the patient was doing well. Follow up report received from a healthcare professional on 27 Dec 2016: Updated reporter information. Follow up report received from a nurse on 04 Jan 2017: Added expiry date of FLUVIRIN as Jun 2016, patient's weight and height, updated vaccination history and reporter's comment.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 05 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 06 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the event as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 11th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 17th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 31-Oct-2017, concerning a 41-year-old adult male patient. The patient had no any medical history or concomitant medications. On 31-Oct-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, batch number: 1721501, expiry date: 30-Jun-2018, route of administration: intramuscular and anatomical location: left deltoid), that underwent first temperature excursion, at a maximum temperature of 23-degree Celsius for 3 hours. It was reported that the patient had no adverse events. The reporter assessed the events as non-serious. Follow-up received on 12-Dec-2017: Added vaccination details (route of administration: intramuscular and anatomical location: left deltoid). It was reported that the patient had no adverse events.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 31-Oct-2017, concerning a 54 year-old male patient. The patient had no any medical history or concomitant medications. On 31-Oct-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, batch number: 1721501, expiry date: 30-Jun-2018, route of administration: intramuscular and anatomical location: left deltoid), that underwent first temperature excursion, at a maximum temperature of 23-degree Celsius for 3 hours. It was reported that the patient had no adverse events. The reporter assessed the events as non-serious. Follow-up received on 12-Dec-2017: Added vaccination details (route of administration: intramuscular and anatomical location: left deltoid). It was reported that the patient had no adverse events.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2017US006979, is an initial spontaneous report received from a nurse (who is also the patient) on 06 Mar 2017. Report refers to a female patient of unspecified age. Prior vaccination history included vaccination with unspecified flu vaccine (manufacturer unknown) in 1974. It was reported that about in 1983 patient developed Stevens-Johnson syndrome from a sulfa drug and it took a month to recover. Current condition and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 169305) at a dose of 0.5 ml, intramuscularly on 10 Nov 2016. After vaccination on 13 Nov 2016 (reported as 3 days after the injection was received), the patient developed pain in her left arm. It was reported that patient had declined the flu vaccine every year at work until it was mandatory and she never had the flu. It was reported that patient works in nights as nurse. The outcome of the event pain in extremity was reported as unknown. The case was assessed as non serious by the nurse and causality was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site warmth, Pain, Swelling
Clinical narrative: This non-serious initial spontaneous case, was received on 27-Sep-2017 from pharmacist, concerning a 48 year-old, adult, female patient. On 25-Sep-2017, the patient was administered with influenza vaccine (dose: 0.5 ml, batch number: (reported as 179604P), expiry date: Apr-2018, route of administration, anatomical location: not reported). On 26-Sep-2017, after vaccination, the subject experienced pain, swelling, redness but it seemed to be getting hotter at injection site. The outcome of the events was not recovered. The reporter assessed the report as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 03 out of 18 patients. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 04 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-2017 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: This initial spontaneous, was received from other non-health professional on 23-Oct-2017, concerns 55 year-old, adult female patient. The patient's current condition included abnormal blood pressure since an unspecified date. Concomitant medication included lisinopril for blood pressure and azithromycin for an unknown indication. On 23-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 179604P and expiry date: Apr-2018). It was reported that vaccine was stored below 36 degree Fahrenheit (minimum 30F for an unknown amount of time). On the same day (23-Oct-2017), one vaccine was administered to a patient. The reporter considered the events as non-serious.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Impaired driving ability, Injection site pain, Limb discomfort, Muscular weakness
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional on 21-Sep-2017, concerning a 28-year-old adult female patient. The patient's historical vaccine included unspecified flu shot (influenza vaccine) 3 times (on unspecified date). The patient had no medical history. The patient's concomitant medications included unspecified vitamins for an unknown indication. On 20-Sep-2017, at 09:29 hrs, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: expiry date: not reported). On the same day, after 5 minutes of vaccination, the patient started to feel numbness in fingers, hand, wrist and elbow. She felt a heaviness, weakness in arm and could not use both arms for driving car wheel and felt like her arm did not function. It was reported that, flu shot was more painful and patient had not experienced injection site swelling and redness. The patient did not receive any treatment for the events. It was started that, the patient got the events in the right arm. It was reported that, by the third day of vaccination the patient had no feeling of numbness. However, from then, the patient experienced small episode of localized, transient numbness, that also subsided 2 weeks post-vaccination. The patient recovered from the event numbness of upper extremities 2-weeks post vaccination. The reporter assessed the report as non-serious. Significant case correction received on 13-Oct-2017 Coding for the event feels like her arm is not functioning was changed to muscle weakness upper limb. Acute numbness in her wrists and elbows that started 5 minutes after receiving the vaccine/after 5 minutes, patient started feel numbness in fingers, then hand and wrists, up to the elbow was changed to numbness of upper extremities. Amended narrative accordingly. Follow-up report received on 26-Oct-2017: Route of administration, anatomical location was added. It was reported that, third day after vaccination the patient had no feeling of numbness. However, from then, small episode of localized, transient numbness was experienced, that also subsided 2 weeks post-vaccination.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional on 21-Sep-2017, concerning a 28-year-old adult female patient. The patient's historical vaccine included unspecified flu shot (influenza vaccine) 3 times (on unspecified date). The patient had no medical history. The patient's concomitant medications included unspecified vitamins for an unknown indication. On 20-Sep-2017, at 09:29 hrs, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: expiry date: not reported). On the same day, after 5 minutes of vaccination, the patient started to feel numbness in fingers, hand, wrist and elbow. She felt a heaviness, weakness in arm and could not use both arms for driving car wheel and felt like her arm did not function. It was reported that, flu shot was more painful and patient had not experienced injection site swelling and redness. The patient did not receive any treatment for the events. It was started that, the patient got the events in the right arm. It was reported that, by the third day of vaccination the patient had no feeling of numbness. However, from then, the patient experienced small episode of localized, transient numbness, that also subsided 2 weeks post-vaccination. The patient recovered from the event numbness of upper extremities 2-weeks post vaccination. The reporter assessed the report as non-serious. Significant case correction received on 13-Oct-2017 Coding for the event feels like her arm is not functioning was changed to muscle weakness upper limb. Acute numbness in her wrists and elbows that started 5 minutes after receiving the vaccine/after 5 minutes, patient started feel numbness in fingers, then hand and wrists, up to the elbow was changed to numbness of upper extremities. Amended narrative accordingly. Follow-up report received on 26-Oct-2017: Route of administration, anatomical location was added. It was reported that, third day after vaccination the patient had no feeling of numbness. However, from then, small episode of localized, transient numbness was experienced, that also subsided 2 weeks post-vaccination.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain upper, Hypersensitivity, Malaise, Muscle spasms
Clinical narrative: This initial spontaneous case was received on 18-Oct-2017, from other non-health professional, concerning a 21-year-old adult female patient. The patient had a history of dairy sensitivity and was not on any concomitant medications. On 21-Nov-2011, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 1100401 (as reported), anatomical location, expiry date: not reported). On the same day, after receiving the vaccine, the patient developed overall allergic reaction. The patient also experienced nausea, vomiting and cramping. She was sick for 3 days. The patient also experienced stomach issues, pain and general discomfort. On 20-Oct-2017, the patient took the FLUVIRIN vaccine again and had no problems. On 24-Nov-2011, the patient had recovered from the events allergic reaction, stomach issues, pain and general discomfort and sickness. The outcome of the other events was not reported. The reporter assessed the events as non-serious. Significant follow-up received on 27-Oct-2017: It was confirmed that, no medications were taken for the events. The patient confirmed that the allergic reaction was not due to any other factor. The patient had no problems with vaccination on 20-Oct-2017. Narrative amended accordingly. Follow up received on 18-Oct-2017 from the reporter: Added events (nausea, vomiting and cramps). Amended narrative accordingly.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: This initial spontaneous case was received on 18-Oct-2017, from other non-health professional, concerning a 21-year-old adult female patient. The patient had a history of dairy sensitivity and was not on any concomitant medications. On 21-Nov-2011, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 1100401 (as reported), anatomical location, expiry date: not reported). On the same day, after receiving the vaccine, the patient developed overall allergic reaction. The patient also experienced nausea, vomiting and cramping. She was sick for 3 days. The patient also experienced stomach issues, pain and general discomfort. On 20-Oct-2017, the patient took the FLUVIRIN vaccine again and had no problems. On 24-Nov-2011, the patient had recovered from the events allergic reaction, stomach issues, pain and general discomfort and sickness. The outcome of the other events was not reported. The reporter assessed the events as non-serious. Significant follow-up received on 27-Oct-2017: It was confirmed that, no medications were taken for the events. The patient confirmed that the allergic reaction was not due to any other factor. The patient had no problems with vaccination on 20-Oct-2017. Narrative amended accordingly. Follow up received on 18-Oct-2017 from the reporter: Added events (nausea, vomiting and cramps). Amended narrative accordingly.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from a Pharmacist on 18-Oct-2017, concerns a 14-year-old female patient. This report was 3rd out of 03 reports. The patient had no medical history and she did not receive any concomitant medications. On 16-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 1618701, and expiry date: Apr-2017). The patient received the expired product (explicitly coded as expired vaccine used) and did not experience any adverse event after the administration of the vaccine later. It was reported that, the patient was revaccinated. The reporter assessed the case as non-serious. Non-significant follow up received 30-Oct-2017: It was reported that, the patient did not experience any adverse event later and was revaccinated.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received on 18-Oct-2017, from a pharmacist, concerning a 10-year-old male. The patient had no medical history or concomitant medications. On 16-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 1618701, expiry date: Ap-2017). It was reported that, the patient was administered with expired vaccine (explicitly coded as expired vaccine used) and did not experience any adverse events later. It was reported that, the patient was revaccinated. The reporter assessed the events as non-serious. Non-significant follow up received on 30-Oct-2017: It was reported that, the patient did not experience any adverse event later and was revaccinated.
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: This initial spontaneous case, was received on 17-Oct-2017, from other non-health professional, concerning an female patient (reported as of mid-50's). The patient had no medical history or concomitant medications. On 17-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). It was reported that, when the needle was removed from the patient's arm a drop of vaccine splashed into the patient's eye (explicitly coded as exposure via eye contact). No treatment was provided and no adverse events were reported. The reporter assessed the events as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (pharmacist) on 01-Oct-2017, concerning a 61-year-old female patient. The patient's medical history included asthma (since an unspecified date). The patient's concomitant medications were not reported. On 17-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch number: 1720801, expiry date: Apr-2018, route of administration: intramuscular and anatomical location: left deltoid). The pharmacist stated that, they only had 1-inch needle and the patient had intramuscular administration with 1-inch needle, although patient stated that, she felt it was shorter needle and was given subcutaneously, which was considered as wrong device used. It was reported that, no adverse event was experienced by the patient after the administration of the vaccine. The reporter assessed the report as non-serious. Significant case correction received 01-Oct-2017: The LLT of the event (The patient believes that the vaccine was administered with a shorter needle/she suddenly had a revelation that we administered with a shorter needle/Patient stated she felt it was shorter needle [and subcutaneous, given in L Deltoid]) was changed from wrong device used to wrong injection technique and labeling was done accordingly.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Immunisation, Product storage error, Underdose
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (pharmacist) on Sep-2017, concerning a 63-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: less than 0.5 ml (as reported), batch number: 1720701, expiry date: Apr-2018, route of administration: intramuscular and anatomical location: right deltoid). The patient did not receive full dose of vaccine as the vaccine was partially frozen (explicitly considered as underdose and incorrect product storage). The reporter assessed the report as non-serious. Follow-up report received on 02-Nov-2017: The route of administration and anatomical location was added. Reporter stated that, she does know patient returned to get another flu shot. The narrative was amended accordingly.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case, was received on 27-Oct-2017, from a pharmacist concerning a 27-year-old, adult, female patient. This is second of 3 reports. On 05-Oct-2017, the patient was administered with FLUVIRIN (batch number: 179701P, dose: 0.5ml, route of administration: intramuscular and anatomical location: left deltoid). On 07-Oct-2017 after 3 days of vaccination, the patient had soreness in his arm. On 14-Oct-2017, the event was resolved. The reporter assessed the case as non-serious. Follow up information was received on 28-Nov-2017. Event onset date was added (07-Oct-2017). Outcome was updated from not recovered to resolved (14-Oct-2017). Narrative was amended accordingly.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case, was received on 26-Oct-2017, from a pharmacist concerning a male patient of unspecified age. This case refers to 03 out of 3 reports. On 05-Oct-2017, the patient was administered with FLUVIRIN (batch number: 179705P, dose: 0.5ml, route of administration; intramuscular, anatomical location: left deltoid). On 07-Oct-2017 after 3 days of vaccination, he had soreness in his arm. At the time of this report, the patient had not recovered from the event. It was reported that, the symptoms were persisting, even worsened. The reporter assessed the case as non-serious. Follow up information was received on 28-Nov-2017: The patient initials was updated. Event onset date was added (07-Oct-2017). Narrative was amended.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Dizziness, Headache, Malaise
Clinical narrative: This initial spontaneous case, was received on 26-Oct-2017, from a nurse, concerning a 53-year-old adult female patient. The patient's current conditions included type II diabetes, hypothyroidism, hyperlipidaemia, esophageal reflux and was reported as a smoker. The concomitant medications included, SYNTHROID, Aspirin, Metformin, OS-CAL, pantoprazole sodium, slow magnesium, Vitamin C, Vitamin B12, glucosamine/chondroitin, TRESIBA, NOVOLOG insulin, tramadol HCL 50, NAPROSYN. On 17-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 1721201, expiry date: Jun-2018). It was reported that, within 24 hours of vaccine administration, the patient developed headache, dizziness, decreased blood sugar (as reported). Even though, the insulin dose was reduced to half, the symptoms persisted. There was no pain, inflammation or redness at the injection site or discomfort. The patient felt unwell. The patient took ADVIL was taken for headache and got resolved. At the time of the report, the patient had not recovered from the events other than headache. The reporter assessed the events as non-serious.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pallor, Syncope
Clinical narrative: Case number PHHY2016US177827 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 648290) website on 21 Dec 2016. This report refers to 21 year old female patient. Medical history and concomitant medication was not reported. The patient previous vaccination history include (unspecified vaccine) and experienced syncope at age of 8 year. The patient was vaccinated with FLUVIRIN (batch number: 168701) intramuscular into left arm on 17 Aug 2016. On the same day, the patient experienced pallor, reports of uneasiness, feeling of syncope. She did not lose consciousness. Her blood pressure was 116/73 mmHg, BPM (beats per minute) 64 (throughout event). The patient had lie on side on floor for 10 minutes then sit upright for 5 minute. The patient was recovered after 15 minute. The outcome of the event was reported as complete recovery on an unknown date.
Age: 22.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: Case number PHHY2016US179780, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 648291) on 21 Dec 2016. This report refers to a 22 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619801) intramuscularly into left arm on 16 Aug 2016. The patient was also vaccinated with PNEUMOVAX (manufacturer unknown, batch number: C017265) intramuscularly into right arm on 16 Aug 2016. After vaccination, on 17 Aug 2016, the patient experienced rash near right arm injection site with burning sensation which was accompanied with achiness down arm. The outcome of the events was reported as unknown. The seriousness of the events was reported as non-serious and causality not reported.
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Incorrect route of drug administration, No adverse event, Product storage error
Clinical narrative: Case number PHHY2016US180652 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 649412) on 21 Dec 2016. This report refers to a 30 year old female patient. The patient had no reported medical history or current conditions. No concomitant medications were reported at the time of vaccination. The patient was vaccinated with FLUVIRIN (batch number: 1619901) administered subcutaneously and VAQTA (other manufacturer, batch number: M025773) administered intramuscularly; both vaccines administered on 12 Aug 2016. It was reported that on the same date, refrigerator temperature excursion occurred. The patient received the vaccine which experienced excursion and the manufacturer determined that vaccine was not viable based on the drop on temperature. The patient was recommended re-vaccination. No known lab data was reported. The case was reported as non-serious. No adverse event was reported following the medication error.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHHY2016US180222, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 649609) website on 21 Dec 2016. This report refers to a 23-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619901) intramuscularly in right arm on 15 Aug 2016 following refrigerator temperature excursion on 02 Aug 2016. It was determined the vaccine is not viable and CDC recommend revaccinate. No adverse event was reported following this administration error.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Limb discomfort, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Case number PHHY2016US180612, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 650306) on 21 Dec 2016. This report refers to a 20 years old female patient. Historical condition included chronic cough. Current condition included asthma. Concomitant medications included EFFEXOR, trazodone, SYMBICORT, KEFLEX and birth control (details unspecified). The patient was vaccinated with FLUVIRIN (batch number: 168704) in to right arm and PNEUMOVAX (batch number: L017265) in to left arm, both intramuscularly on 30 Aug 2016. On same day after vaccination, the patient experienced severe shoulder pain, pain was shooting down arm, pain started a few hours after administration, was not able to move shoulder that night or entire next day. On 01 Sep 2016, it was reported that, the patient was able to move arm again with mild pain, still very sore and uncomfortable. The treatment medication included Naproxen for pain as directed by pharmacist. The outcome of the events was able to move arm again with mild pain, still very sore/pain was shooting down arm and uncomfortable was reported as condition unchanged and for other events it was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Myalgia
Clinical narrative: Case number PHHY2016US180687, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 650620) on 21 Dec 2016. This report refers to a 29 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619801) intramuscularly into right arm on 29 Aug 2016. It was reported that the vaccine was administered high on the shoulder. It was reported that, on the same day after vaccination the patient experienced muscle pain and could not lift arm above the shoulder, which had been lasted for more than 3 days. It was reported that the patient was treated with ibuprofen as needed. The outcome of the events myalgia and mobility decreased was reported as condition unchanged and for other unknown. The seriousness of the events was reported as non-serious and causality not reported.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHHY2016US180302 is an initial spontaneous report received from a representative via Vaccine Adverse Event Reporting System (VAERS reference number: 651166) on 21 Dec 2016. This report refers to a 33 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1618701) into the left arm on 30 Aug 2016. Within one hour of administration, the patient developed moderate to severe arm pain and tingling sensation running down the arm. She stated that the vaccine was given too close to the shoulder. The outcome of the events was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Radiculopathy
Clinical narrative: Case number PHHY2016US177601, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 651416) website on 21 Dec 2016. This report refers to a 44 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 168705) intramuscularly into the left arm on 06 Sep 2016. On the same day after vaccination, the patient experienced left arm numbness and tingling. On an unknown date, the patient was diagnosed with nerve irritation. The patient's laboratory data reported as ED evaluation (unspecified details). The outcome of the events was reported as complete recovery on an unspecified date. The seriousness was not reported. The causality of the events were not reported.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Visual impairment
Clinical narrative: Case number PHHY2016US180645, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 653902) website on 21 Dec 2016. This report refers to a 31-years-old female patient. Past medical history was not reported. Concomitant medications included NEXPLANON for birth control. The patient was vaccinated FLUVIRIN (batch number: not reported) intramuscularly in left arm on 16 Sep 2016. On the same day after vaccination the patient experienced vision changes and dizziness. The outcome of events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.