chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 61-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 07-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804083 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 67.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 67-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 06-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804077 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 65-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 05-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201803871 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Info Number (SEQ18-04086) was updated in the additional information tab. No changes were made in the narrative.
Age: 76.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 25-Sep-2018, concerns a 76-year-old, elderly male patient. The patient's medical history and concomitant medications were not reported. On 24-Sep-2018, the suspect vaccine was left in the cooler that reached the temperature of 34.4 F, which was out of the recommended temperature range for 45 minutes. The average of the incident was about 35.4 F for a period for 35 minutes (explicitly coded as incorrect product storage). On 24-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252657 and expiry date: 31-May-2019) that underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse events after administration. The reporter assessed this case as non-serious. Follow-up report received from the reporter on 25-Oct-2018: The reporter confirmed the date of temperature excursion and vaccine administration (24-Sep-2018). The narrative was amended accordingly.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse), on 12-Oct-2018, concerns a 35-year-old, adult female pregnant patient. On 10-Oct-2018, the pregnant patient was administered an expired suspect vaccine FLUCELVAX QIVc [batch number: 195215, expiry date: 30-Apr-2018, dose, route of administration and anatomical location: not reported]. At the time of this report, no adverse events were reported. This case was linked to case 201804438 due to the same reporter.
Age: 79.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 79-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9 (explicitly coded as incorrect product storage). On 07-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804088 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 25-Sep-2018, concerning a 65-year-old, elderly, female patient. On 24-Sep-2018, suspect vaccine, FLUCELVAX QIVc was left in the cooler and the temperature reached 34.4-degree F. The average of the incident was about 35.4-degree F for a period for 45 minutes. This was the first-time excursion. On 25-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252657 and expiry date: 31-May-2019) which underwent temperature excursion. The patients had not experience any adverse event after the vaccination. The reporter assessed the case as non-serious. This case was linked to case number: 201804054 due to same reporter. Follow-up report received from the reporter on 25-Oct-2018: The reporter confirmed that the vaccine was administered on 25-Sep-2018 and temperature excursion also occurred on 24-Sep-2018. The narrative was amended accordingly.
Age: 72.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 72-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 06-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804081 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 62-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 08-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804084 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Chest pain, Eructation, Feeling abnormal, Gastrooesophageal reflux disease
Clinical narrative: Muscle aches, chest tightness and soreness since afternoon after immunization. Here to office with wife with reports of not feeling well since getting Tdap. States has tightness in chest duration one week. No cough or SOB. No increase in symptoms with activity, states "gets better" with activity. States "I feel bad". No change in GERD symptoms, belching unchanged. No fever or sweaty spells. No palpitations or episodes of atrial fib. The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, past family history, past social history, past surgical history and problem list.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise, Myalgia
Clinical narrative: Muscle aches, chest tightness and soreness since afternoon after immunization. Here to office with wife with reports of not feeling well since getting Tdap. States has tightness in chest duration one week. No cough or SOB. No increase in symptoms with activity, states "gets better" with activity. States "I feel bad". No change in GERD symptoms, belching unchanged. No fever or sweaty spells. No palpitations or episodes of atrial fib. The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, past family history, past social history, past surgical history and problem list.
Age: 28.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 28-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 15-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804112 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: The info number (SEQ18-02667) was added in additional information tab. No new information was received. Hence, no changes were done in the narrative.
Age: 28.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 28-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 14-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after vaccination. The reporter assessed the case as non-serious. This case 201804107 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Dehydration, Headache, Nausea
Clinical narrative: Father reported that patient developed massive headache, nausea, and couldn't keep eyes open while in car leaving our office. They drove straight to emergency room. ER told father that patient was dehydrated and father said patient received, "a couple bags of fluid." They monitored patient and sent home. I followed up with father the following day and patient resting at home doing well. Father stated ER and father both thought unrelated to vaccine.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysgeusia
Clinical narrative: This spontaneous case, initially received on 11-Oct-2018, reported by other healthcare professional (nurse) concerns a 54-year-old adult, female patient. The patient's historical vaccine included influenza vaccine (for 25 years). The patient had no historical conditions. On 11-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252659 and expiry date: 31-May-2019]. On the same day, after vaccination, the patient experienced a metallic taste in her mouth. The patient was advised to go to the emergency room (ER) if symptoms worsened. The event did not require hospitalization. The patient did not take any treatment measures associated with the event. The patient was already fine in the afternoon of the day (recovered). It was reported that, the patient has had flu shots for 25 years and this had never happened before. The reporter assessed this case as non-serious. Follow-up received from other health professional (nurse) on 09-Nov-2018: The outcome of the event was changed from 'not reported' to 'recovered' in the event tab. the narrative was amended accordingly.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Peripheral swelling
Clinical narrative: Upper arm pain and shivering.
Sex: M
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: This non-serious spontaneous case, initially received on 18-Sep-2018, from a pharmacist, concerning an adult, male patient of an unspecified age. On an unspecified date (reported as last year), the patient was administered FLUCELVAX QIVc (dose, route of administration, anatomical site, batch number and expiry date: not reported). On an unspecified date, after vaccination, the patient experienced a little pain but did not get any swelling. At the time of this report, the outcome of the event was not reported. This case 201803897 was cross-linked to the case: 201803895 (same patient). Non-significant follow-up received on 01-Oct-2018: The information regarding vaccination date of the suspect product and start date of the event 'a little pain' was not available. No amendments were done in the narrative.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysgeusia, Dysphagia, Feeling abnormal, Feeling hot, Pharyngeal hypoaesthesia
Clinical narrative: This spontaneous case, initially received from other non-health professional on 17-Sep-2018, concerns a 61-year-old, adult female patient. The patient's medical history included lump in throat and difficulty to swallow when she had allergic reaction to eggs (unspecified date). It was reported that, later the patient had no issues while eating eggs and with other vaccines. On 17-Sep-2018, at 2:00 pm, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252380 and expiry date: 31-May-2019]. On the same day, right after vaccination, the patient felt warmth in her neck and face. About 20 minutes after vaccination, the patient felt strange and, on the way back to home, felt throat tightness and the road before her was jumping around. The patient also had a metallic taste in the mouth and the throat was numb, like someone had sprayed antiseptic spray. The patient stated that some of these symptoms had diminished, but felt there was a lump in her throat and it was hard to swallow. At the time of this report, symptoms reduced but the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Sensation of foreign body, Throat tightness
Clinical narrative: This spontaneous case, initially received from other non-health professional on 17-Sep-2018, concerns a 61-year-old, adult female patient. The patient's medical history included lump in throat and difficulty to swallow when she had allergic reaction to eggs (unspecified date). It was reported that, later the patient had no issues while eating eggs and with other vaccines. On 17-Sep-2018, at 2:00 pm, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252380 and expiry date: 31-May-2019]. On the same day, right after vaccination, the patient felt warmth in her neck and face. About 20 minutes after vaccination, the patient felt strange and, on the way back to home, felt throat tightness and the road before her was jumping around. The patient also had a metallic taste in the mouth and the throat was numb, like someone had sprayed antiseptic spray. The patient stated that some of these symptoms had diminished, but felt there was a lump in her throat and it was hard to swallow. At the time of this report, symptoms reduced but the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 61-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 18-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804115 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up report received from reporter on 14-Nov-2018: The med info number (SEQ18-04086) was updated. No new information was received. Hence, no changes were done in the narrative.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Musculoskeletal chest pain, Pyrexia
Clinical narrative: Chest wall pain left side severe rib pain immediately after vaccination with fever for 3 days.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 63-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 08-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804085 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist), on 12-Oct-2018, concerns a 47-year-old, adult male patient. On 12-Oct-2018, the patient received expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195245 and expiry date: 30-Jun-2018]. No adverse events were reported by the patient after the vaccination. The reporter assessed the case as non-serious. This case '201804448' was linked to '201804445' due to same reporter. Follow up received from the pharmacist on 31-Oct-2018: Updated patient's date of birth and age (47 years) was added in the patient's tab. Added batch number (195245) in the product tab. The narrative was amended accordingly.
Age: 81.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning an 81-year-old, elderly, patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 12-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This cases (201804096) was cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Med info number (SEQ18-04086) was added in the additional information tab. No changes were made to the narrative.
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 29-Jun-2018 by Seqirus from VAERS (VAERS ID: 735942), concerns a male child of unspecified age. On an unspecified date in 2017 (reported as last year's flu shot), the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2017, after vaccination, the patient developed mild reaction at the injection site, which included redness, swelling and warm to touch. At the time of this report, the outcome of the events was unknown. This case was linked to case 201802716 due to same patient.
Age: 1.42
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 11 cm x 17 cm erythematous, pruritic patch on leg surrounding injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain, Erythema, Eye swelling, Swelling face, Wheezing
Clinical narrative: 30 minutes after immunization given, pt returned with swelling of face/eyes but not lips, erythema of face. Had abdominal pain but no vomiting/diarrhea. Had wheezing on exam. Gave EPIPEN Jr (0.15mg) IM, albuterol nebulizer treatment inhaled, EMT's called and arrived in minutes and assumed care. Taken to ED.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 63-year-old, adult patient of unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 10-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804087 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 05-Oct-2018, concerns a female patient of an unspecified age. On an unspecified date, the patient was administered FLUCELVAX QIVc (dose, route of administration, anatomical location, batch number and expiry date: not reported). It was reported that, during the vaccination the syringe leaked and the vaccine ran down the patient's arm, so partial dose was administered. The reporter did not complain about the product and said it was a user error. At the time of this report, no adverse event was reported.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional on 20-Sep-2018, concerns a 29-year-old adult pregnant patient. The patient's historical drug included penicillin (taken prior pregnancy) for an unknown indication. The patient's maternal medical history included hypertension. This was the second pregnancy of the patient. The concomitant medications included aspirin, COLACE, Vit B6, REGLAN, ZOFRAN and Prenatal vitamins for unknown indications. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 34.3F for 58 minutes for the first time. It was reported that, patient was 6 weeks and 5 days on her first appointment and the patient's last menstrual period date (LMP) was on 23-May-2018 (reported as unsure). On 20-Sep-2018, at gestational age of 23-weeks (second trimester of pregnancy) the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252656 and expiry date: 31-May-2019) which underwent a temperature excursion. At the time of this report, the patient and foetus had no adverse events. The patient's estimated date of delivery was reported as 11-Jan-2019. The reporter assessed this case as non-serious. Follow-up received from other health professional on 29-Oct-2018: It was reported that, the patient was 6 weeks and 5 days on her first appointment and last menstrual period date (LMP) was on 23-May-2018 (reported as unsure). The patient's week of exposure was 23 weeks (second trimester of pregnancy) was updated in the patient tab. The narrative was amended accordingly.
Age: 65.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 07-Sep-2018, reported by a pharmacist and concerns a 65-year-old, elderly, male patient. On 07-Sep-2018, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195124, expiry date: 30-Apr-2018, route of administration and anatomical location: not reported). On the same day, the patient also received the non-company suspect ZOSTAVAX (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient was observed for 10 minutes and did not experience any adverse events. This case '201803759' was linked to 201803758, reported by the same reporter. The reporter assessed the case as non-serious.
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This initial spontaneous case was received on 05-Dec-2017, from physician and concerns a 2-year-old child patient of unspecified gender. On an unspecified date (reported as 2 months ago), the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location, batch number, expiry date: not reported). It was reported that, 2-year-old child was administered with vaccine. Reporter stated that, after the administration of vaccine, the patient did not experience any adverse reaction. The reporter assessed this case as non-serious.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 04-Sep-2018, concerns a 24-year-old, adult, male patient. The patient's concomitant medications included fluticasone and azelastine for unknown indications. It was reported that, the FLUCELVAX QIV vaccine underwent temperature excursion (52 Fahrenheit) for 2 hours. On 04-Sep-2018, the patient was administered FLUCELVAX QIV [dose: 1 DF (reported as full dose), batch number: 252381, expiry date: 31-May-2019, route of administration and anatomical location: not reported] that underwent temperature excursion. The Seqirus confirmed that, batch number (252381) was a valid FLUCELVAX NH1819 QIV PFS LL 10X1 batch number. No adverse event was reported. The reporter assessed the case as non-serious. Update received on 07-Sep-2018: Non-significant case correction (IRD: 04-Sep-2018): The Seqirus confirmed that, batch number (252381) was a valid FLUCELVAX NH1819 QIV PFS LL 10X1 batch number. Hence, batch number (252381) of the suspect product was added in the product tab and the narrative was amended accordingly.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Induration, Pruritus, Swelling
Clinical narrative: This is a spontaneous case, initially received on 03-Oct-2018, reported by other health professional (pharmacist), concerning a 56-year-old, adult, female patient. The patient's current condition included hyperlipidaemia and hypertension (reported as medical history). The patient didn't receive any concomitant medications. On 03-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid batch number: 252668 and expiry date: 30-Jun-2019). On the same day, within few minutes, the patient experienced swelling of area and developed a hardened area (reported as goose egg), with no bleeding and bruising. It was reported that, the patient had some itchiness. The patient did not receive any treatment medications at the time of the report. At the time of the report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Follow up report received on 05-Nov-2018: The expiry date of the product was confirmed as 30-Jun-2019. Hence, the expiry date (30-Jun-2019) was updated in the product tab and the event 'expired product used' was deleted from the event tab. The narrative and case comment were amended accordingly.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous case, initially received from a pharmacist on 29-Aug-2018, concerning a 45-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 25-Aug-2018, the patient received FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported]. On the same day after vaccination, the patient felt it circulating around other muscles in her arm. The pharmacist who gave her injection, said it was the right dose and in the right place. On the same day, the patient had recovered from the event. The reporter assessed this case as non-serious. Update received on 20-Sep-2018: Non-significant case correction received with IRD: 29-Aug-2018: The first sentence of the case comment was modified from 'A 45-year-old, female patient felt abnormal on the same day after receiving the suspect vaccine FLUCELVAX QIVc' to 'A 45-year-old, female patient felt abnormal as the vaccine is circulating around the muscles in her arm on the same day after receiving the suspect vaccine FLUCELVAX QIVc'. Non-significant follow-up report received from pharmacist on 10-Oct-2018: The reporter confirmed the start date of the suspect product as 25-Aug-2018. No new information received.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain in extremity, Wrong technique in product usage process
Clinical narrative: This initial non-serious spontaneous case, received on 06-Dec-2017 reported by a pharmacist and concerns a female patient of unspecified age. The patient's historical condition included stroke recently. The patient's concomitant medications included NORCO for pain, LIPITOR for cholesterol, ZESTRIL for blood pressure, EFFEXOR and BUSPAR for anxiety, Aspirin. On 03-Nov-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195215, expiry date: 30-Apr-2018). It was reported that, the pharmacist administered the vaccine by raising the arm higher than normal, possibly injected into the joint. As the pain continued, the patient visited ER where she was given a pain shot. On an unspecified date, after vaccination the patient had pain in her arm and numb sometimes. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the causality for the events (injection site pain and numbness of upper arm) as related to the suspect vaccine.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 03-Oct-2018, concerning a 41-year-old, adult female patient. The patient's historical condition included migraines, hemochromatosis, mast cell activation disease, endometriosis, postural orthostatic hypertension. The patient did not administer any concomitant medications. On 01-Oct-2018 (reported as night prior to vaccination), the vaccine was left in a freezer overnight and it had frozen. On 02-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) which had been frozen. On the same day, after the vaccine administration, the patient experienced pain and soreness on the injection site. The patient did not take any treatment measures associated with the event. On 02-Oct-2018, the patient had recovered from the event pain on the injection. On an unspecified date, the patient was recovering from the event soreness on the injection site. The reporter assessed this case as non-serious. Follow up received from other non-health professional (consumer) on 01-Nov-2018: It was reported that the patient's soreness had subsided. Hence, the outcome of the event soreness on the injection site was updated from not-recovered to recovering. The reporter was unable to obtain the lot number and expiry date. Upon internal review, it was realised that the batch number and expiry date was captured in the narrative, though not provided in the source document. Hence the batch number and expiry date was removed from the product tab. The narrative was amended accordingly.
Age: 7.0
Sex: M
Vaccine: FLU4, FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health care professional (medical assistant) on 02-Oct-2018, concerns a 7-year-old, child male patient. The patient's historical condition included recurrent strep throat and sensory neural hearing loss. The patient did not administer any concomitant medications. On 02-Oct-2018, at 9:35 AM, the patient was administered non-company co-suspect vaccine FLUARIX [dose: 0.5 ml, route of administration: intramuscular, batch no: 9455T, expiry date: 30-Jun-2019 and anatomical location: not reported] and on the same day at 11:35 AM, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, batch no: 252664, expiry date: 30-Jun-2019 and anatomical location: not reported]. No adverse events were reported after the vaccine administration. The reporter assessed the case as non-serious. Update received on 02-Nov-2018: Non-significant case correct (IRD: 02-Oct-2018): The sentence in the case comment was corrected from 'A 7 -year-old, male patient, was administered suspect' to 'A 7-year-old, male patient, was administered suspect'.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 57-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 08-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804086 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site coldness
Clinical narrative: Redness measured 2.5 x 1.75 in diameter. No fever-No itching. No warmness. Site cool/dry to touch.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient states he has a red dot where he received the immunization and itching still.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 03-Oct-2018 from other health professional (nurse), concerns a 59-year-old, adult female patient. On 03-Oct-2018, the patient was administered expired FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195126, expiry date: 30-Apr-2018) (explicitly coded as expired vaccine used).  At the time of this report, the patient had not experienced any adverse event. The reporter assessed this case as non-serious. This case 201804266 was cross-linked to case 201804267 due to the same reporter. Follow up received from other health professional (nurse) on 30-Oct-2018: The patient's age (59 years) was added. The reporter confirmed that, the patient had not experienced any adverse event. The narrative and case comment were amended accordingly.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Presyncope, Tinnitus, Tremor, Tunnel vision
Clinical narrative: This spontaneous case, initially received from the other health professional on 05-Dec-2017, concerns a 36-year-old adult male patient. The patient's concomitant medication included long and short acting benzodiazepine for an unknown indication. On 30-Nov-2017, the patent was administered with FLUCELVAX QIV (dose 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195233, expiry date: 31-May-2018). On the same day immediately after vaccination, the patient experienced a vasovagal response with tunnel vision, ringing sound in his ears and shaking hands. It was reported that, he did not take any food and had been provided with nutritional bar and water. Later, he sat for 30 minutes and then walked store for 20 minutes. At the time of this report, he completely recovered (before leaving store) from the event and symptoms (tunnel vision, ringing sound in his ears and shaking hands). The reporter assessed the reporter as non-serious. Follow-up received with IRD 05-Jan-2018: No further information available and considered the case lost to follow-up.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting starting 6 hours after vaccine (PENTACEL) then fever (103). pt had rectal supp of TYLENOL during nt and given 3/4 tsp MOTRIN in office.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Hypoaesthesia, Injection site rash, Muscular weakness, Pain in extremity
Clinical narrative: Rash at both sites that spread to the whole body which lasted for 2 days. She also stated that she experienced prickly head sensation on the back of her head. Her wrists, elbows and fingers started hurting. She also felt sensation of numbness on both lower limbs and some degree of weakness.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Paraesthesia, Rash generalised
Clinical narrative: Rash at both sites that spread to the whole body which lasted for 2 days. She also stated that she experienced prickly head sensation on the back of her head. Her wrists, elbows and fingers started hurting. She also felt sensation of numbness on both lower limbs and some degree of weakness.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Rash at injection site, right and left upper thigh, 9 days after vaccine admin. date; rash spread to stomach and face. Seen and treated for urticaria and vaccine reaction, received 5 ml BENADRYL q 4 hours prn and ORAPRED 15/5 3.5 ml po bid.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Pyrexia
Clinical narrative: Fever, headache, chills, some redness on injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Peripheral swelling, Pyrexia
Clinical narrative: Fever, big redness and swelling on the arm, itching at the injection site.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Feeling abnormal, Paraesthesia oral, Pruritus, Skin warm
Clinical narrative: This spontaneous case, initially received on 05-Oct-2018, from other non-health professional (consumer), concerns a 53-year-old, adult, female patient. It was reported that the patient never had a reaction to flu shots in past. The patient's historical drug included medroxyprogesterone a five-day course which stopped on 03-Oct-2018 (Wednesday as reported). The patient was allergic to sulfa and penicillin. The patient's concomitant medications included SYNTHROID, KLOR-CON m20, propranolol (extended release), fluoxetine HCL, Triamterene/HCTZ and multivitamins for unknown indications. On 05-Oct-2018, at 08:35 am, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252227 and expiry date: 31-May-2019]. The Seqirus Quality Assurance (QA) have confirmed that the batch number as 252227. On the same day, half and hour after vaccination, the patient reported that, her arm started to get red and itchy and the patient felt a little weird, hot skin and tingling in lips. No treatment was received. On the same day, the patient had recovered from the events. The reporter assessed the case as non-serious. Follow-up received from the reporter on 09-Nov-2018: The outcome of the events- skin warm, weird feeling, tingling lips and itchy was updated to recovered. The stop date (05-Oct-2018) was added. The narrative was amended accordingly. Significant case amendment (05-Oct-2018): The Seqirus Quality Assurance (QA) have confirmed that the reported batch number as 252227. Hence, the batch number was added in the product tab. The narrative was amended accordingly.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This is a spontaneous case, initially received on 05-Oct-2018, reported by other health professional (nurse), concerning a 40-year-old, adult, female patient. The patient had no medical history and concomitant medications. On 05-Oct-2018 at 10 am, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: gluteus muscle, batch number and expiry date: not reported) at inappropriate site. On the same day, after vaccination, the patient developed large hive, itching and redness. It was reported that, the patient was not hospitalized, and the patient did not require any treatment for the events. The same day (05-Oct-2018), the patient had recovered from the event hive. At the time of this report, the outcome of the events itching and redness was not reported. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received on 04-Oct-2018, reported by other healthcare professional (nurse), concerns a female patient of unspecified age. On an unspecified date, the patient was administered expired FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. At the time of this report, no adverse events were reported. As the reporter did not provide consent to follow up, hence this case is considered as lost to follow up.
Age: 1.17
Sex: M
Vaccine: FLUC4
Symptoms: Crying, Discomfort, Injection site swelling
Clinical narrative: This spontaneous case, initially received (combinedly processed with follow-up received on 11-Oct-2018) from other non-health professional (consumer) on 05-Oct-2018, concerning a 14-month-old, male infant patient. The patient had no medical history and concomitant medications. On 04-Oct-2018, the patient (under 4 years age) administered FLUCELVAX QIVc [dose: 0.5 ml, batch number, 252657, expiry date: 31-May-2019, route of administration, anatomical location: not reported]. On the same day, after vaccination, the patient was uncomfortable overnight, crying and the injection site was swollen. No treatment was received. At the time of this report, the outcome of the events (discomfort, crying and injection site swelling) was not reported. The reporter assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from the other health professional (nurse) on 03-Oct-2018, concerns a 50-year-old, adult female patient. On 03-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195126 and expiry date: 30-Apr-2018]. At the time of this report, the patient had not experienced any adverse event. The reporter assessed the case as non-serious. This case 201804267 was linked to 201804266 reported by the same reporter. Follow up received from other health professional (nurse) on 30-Oct-2018: The patient's age (50 years) was added. The reporter confirmed that, the patient had not experienced any adverse event. The narrative and case comment were amended accordingly.