chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Anaphylaxis reaction; This is a spontaneous case from, initially received from other health professional via agency [reference number: SEQ19-03449] on 27-Sep-2019, concerning a 35-year-old, female patient.   The patient's relevant medical history and concomitant medications were not reported.  On 27-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: intramuscularly, anatomical location: deltoid, batch number: P100118564 and expiration date: 30-Jun-2020] for influenza prophylaxis.   On the same day, after vaccination, the patient experienced shortness of breath. It was reported that the patient had anaphylaxis reaction and that the paramedics were called and took the patient to hospital. The patient was treated with multiple doses of Benadryl (diphenhydramine hydrochloride) and another shot of epinephrine. Later that night, the patient was discharged home.  The outcome of the event anaphylaxis reaction was recovered on 27-Sep-2019.  The case was assessed as serious and causality was not provided.   The reporter did not provide causality assessment.  This case is linked to case ID 201904847 (same reporter).  Follow up received from other health professional on 03-Oct-2019: Treatment medications, Benadryl and epinephrine, were added. Hospitalisation stop date was provided. Event outcome and stop date was provided. Hospitalisation removed as seriousness criteria. Narrative was amended accordingly.; Sender's Comments: The patient experienced anaphylactic reaction after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as possible related.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Rash (and hives) on left side of face; (Rash and) hives on left side of face; This is a spontaneous case from initially received from agency (case ID: SEQ19-03449) by other healthcare professional on 27-Sep-2019, concerning a 44-year-old, female patient.    On 27-Sep-2019, the patient was administered Afluria Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscularly, anatomical location: deltoid, batch number: P100118564, expiration date: 30-Jun-2020) for influenza prophylaxis.   On the same day as vaccination, the patient experienced a rash and hives on left side of face. The patient used a cold compress as a treatment.   The outcome for the both events was not recovered.   The reporter did not provide seriousness and causality assessment.  All events were assessed as related per company; Sender's Comments: All events were assessed as related per company.
Sex: U
Vaccine: FLUA3
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Some of the vaccine sprayed out; Vaccine sprayed out on skin; Vaccine sprayed out on skin; This is a spontaneous case, initially received from pharmacist via Agency (reference number: SEQ19-03446) on 27-Sep-2019, concerning a patient of an unspecified age and gender.   The patient's relevant medical history, drug reactions or allergies and concomitant medications were not reported.  On 27-Sep-2019, the patient was administered with administered Fluad vaccine [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 mL, route of administration. intramuscular, anatomical location: deltoid, batch number and expiration date: not reported] for influenza prophylaxis. As reported, during vaccine administration, some of the vaccine sprayed out on the reporter and the patient (explicitly coded as incomplete dose administered', exposure via skin contact' and accidental exposure to product').   The reporter assessed the case as non-serious but did not provide causality assessment.  Significant case amendment (27-Sep-2019): Accidental exposure to product and Exposure via skin contact added as events. Narrative amended accordingly.  Non-significant follow-up reported by other health professional from Agency  [reference number: SEQ19-07076] on 27-Dec-2019: Additional reference number added. No changes in narrative.; Sender's Comments: The patient was administered incomplete dose of Fluad (TIV). Reportedly, during vaccine administration, some of the vaccine sprayed out on the reporter and the patient's skin which was coded as accidental exposure to product and exposure via skin contact. It was not reported whether the patient experienced any adverse event. All three events are assessed as not related per company's conventions.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: She developed large (bulls eye red) area 2 1\2 inches (wide red itchy and) sore on first day, second day the area was larger.; She developed large bulls eye red area 2 1\2 inches wide red (itchy and sore) on first day, second day the area was larger.; She developed large (bulls eye red) area 2 1\2 inches wide (red) itchy (and sore) on first day, second day the area was larger.; This is spontaneous case reported by other health care professional to agency (reference number: SEQ19-03457) and initially received on 30-Sep-2019, concerning a 7-year-old female patient.  The patient's current condition included allergy. The patient's concomitant medication included allergy shots (as reported).  On 28-Sep-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: right upper arm, batch number: 261204 and expiration date: 26-Jun-2020] for influenza prophylaxis.   On the same day, the patient developed large bulls eye red area two and a half inches wide red itchy and sore. On the second day, the area was larger. On an unspecified date, the patient started corrective treatment with Motrin (ibuprofen).  The outcome of the events was not reported.  The case was assessed as non-serious. The reporter did not provide causality assessment to Flucelvax QIV.; Sender's Comments: The patient experienced pain of skin, erythema and pruritus after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. Medical history of allergy may have contributed to development of the event. Causality was confounded by therapy with concomitant medication allergy shots (as reported). Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Mouth swelling
Clinical narrative: A half an hour after getting the shot, her mouth (and lip) started to swell; A half an hour after getting the shot, her (mouth and) lip started to swell.; This is a spontaneous case from the reported by other non-health professional (consumer) to agency (reference number: SEQ19-03428) and initially received on 27-Sep-2019, concerning a 33-year-old, female patient.     The patient's current conditions included: hypertension, chronic intractable migraines, brain cancer and allergy to suvorexant. The patient's concomitant medications included: metoprolol, Depakote (valproate semisodium), gabapentin, Paxil (piroxicam), memantine, ranitidine, Zyrtec (cetirizine hydrochloride), vitamin D and Emgality (galcanezumab) all for unknown indication and magnesium as supplement.  On 26-Sep-2019 (at 14:00), the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: left upper arm, batch number reported as B100118555 (Seqirus batch number: P100118555), route of administration and expiration date: not provided) for influenza prophylaxis.  On the same day, half an hour after vaccination, the patient developed mouth and lip swelling. The patient was advised to take Benadryl (diphenhydramine hydrochloride) as a treatment. When the patient's symptoms did not improve,  the patient went to the emergency room, received intravenously solumedrol and got a prescription for prednisone.   On 27-Sep-2019 (at 12:30), the patient recovered from both events.   The case was assessed as serious. The reporter did not provide causality assessment to Afluria Quadrivalent.  Follow up received on 09-Oct-2019: Reporter provided current medical conditions and concomitant medications for the patient. Narrative was amended accordingly.; Sender's Comments: A 33-year-old female patient has experienced mouth swelling and lip swelling half an hour after vaccination with Afluria Quadrivalent. Chronology seems highly suggestive. The patient's historical vaccines included flu shots (without any reaction). Medical history of brain cancer and allergy to suvorexant may have contributed to development of the events. Causality was also confounded by therapy with multiple concomitant drugs.  Considering all the above mentioned, causal role of the suspect product is assessed as possibly related.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: 5 ml dose administered insted of 0.5 ml; Arm was sore for 2-3 days; This is a spontaneous case, initially received from pharmacist via Agency (reference number: SEQ19-03332) on 26 -Sep-2019, concerning a 56-year-old male patient.   The patient's relevant medical history included artificial knee joint on Dec-2017.   The patient's concomitant medications included Celebrex azitamide (celecoxib) for an unknown indication.  On 26-Sep-2019, pharmacist thought that the vaccine was diluted version.  On 26-Sep-2019, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 259815 and expiration date: Jun-2020] (explicitly coded as 'Accidental overdose') for influenza prophylaxis instead of 0.5 ml.  On an unknown date in 2019, after vaccination, the patient's arm was sore for 2-3 days and resolved after third day.  The case was assessed as non-serious and the reporter did not provide causality assessment.  Follow-up received from other health professional on 08-Oct-2019: Special case with no adverse event removed from general tab. It was confirmed that patient received Flucelvax Quadrivalent vaccine. The outcome of the event of accidental overdose was changed from not reported to resolved. Event of painful arm was added. Narrative was amended accordingly.  Follow-up received from other health professional on 30-Oct-2019 via Agency (reference number: SEQ19-04918) : The outcome of the event painful arm was changed from not resolved to resolved. Narrative was amended accordingly.; Sender's Comments: Reportedly, accidental overdose occurred with the suspect product Flucelvax (QIV). The patient experienced pain in extremity, on an unspecified day after vaccination. Chronology needs more clarification. For the event pain in extremity, causal role of the suspect product is assessed as possibly related. Accidental overdose is assessed as not related per company conventions.
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain in extremity, Sleep disorder
Clinical narrative: Soreness in arm; Numbnsess in finger tips; This is spontaneous case reported by pharmacist to Agency (reference number: SEQ19-03548) and initially received on 30-Sep-2019, concerning a male patient of unknown age.  The patient's relevant medical history and concomitant medications were not provided.  On 02-Sep-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 261203, expiry date: Jun-2020, dose: 0.5 ml, route of administration and anatomical location: not reported] for influenza prophylaxis.  On 02-Sep-2019 the patient experienced soreness in arm. The event lasted for two weeks and the patient could not sleep on that arm of injection.  On unspecified date in Sep-2019  patient developed numbness in finger tips.   The outcome of the event soreness in arm and numbness in finger tips was not recovered.  The reporter did not provide seriousness and causality assessment.; Reporter's Comments: The patient developed pain in extremity and hypoaesthesia after administration of the suspect product, Flucelvax QIV. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect vaccine is assessed as possibly related.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on neck and arms; This is a spontaneous case initially received from Med Communications (case ID: SEQ19-03486) by pharmacist on 30-Sep-2019 and follow up received on 01-Oct-2019 (being processed together), concerning a 28-year-old, male patient.     The patient's current medical condition included penicillin allergy.   On 25-Sep-2019, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: right deltoid, route of administration: intramuscularly, batch number: P100116850, expiration date: 30-Jun-2020) for influenza prophylaxis.  On the same day, after the vaccination, the patient developed hives on neck and arms.  On 26-Sep-2019 in the evening, the patient came back to pharmacy with hives on neck and arms.   On 28-Sep-2019, the patient was seen at urgent care and came to pharmacy with prescription for hives.   At the time of report, the outcome for the event was not reported.  The reporter assessed the case as non-serious. The reporter did not provide causality assessment.  Event's causality was assessed as related to the suspect product per company.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
Sex: M
Vaccine: FLUC4
Symptoms: Discomfort, Limb injury, Musculoskeletal pain, Poor quality sleep
Clinical narrative: (Severe shoulder pain/injury which has been) keeping awake a little at night as well due to uncomfortable sleeping positions; Severe shoulder pain/(injury) following the administration of flu shot; Severe shoulder (pain/)injury following the administration of flu shot; This is a spontaneous case reported by other non-health professional to Agency (reference number: SEQ19-03477) and initially received on 30-Sep-2019, concerning a male patient of unknown age.    The patient's medical history and concomitant medications were not provided.  On 26-Sep-2019, the patient was administered Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, anatomical location, route of administration, batch number and expiration date: not provided) for influenza prophylaxis.  On an unspecified date in Sep-2019, at unknown time after vaccination, the patient experienced severe shoulder pain/injury. The pain has been keeping him awake a little at night as well due to uncomfortable sleeping positions.     The outcome for the both events was reported as unknown.  The case was assessed as non-serious. The reporter did not provide causality assessment to Flucelvax QIV.; Sender's Comments: The patient experienced insomnia, musculoskeletal pain and shoulder injury related to vaccine administration after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related for all events.
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Rash on face two days after the injection; This is a spontaneous case from reported by other health professional to agency (reference number: SEQ19-03544) and initially received on 30-Sep-2019, concerning a 67-year-old, female patient.     The patient's current medical conditions included hypertension and osteoporosis.   The patient's concomitant medications included beta blockers and osteoporosis medication (as reported).    On 26-Sep-2019, the patient was administered Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscularly, batch number: 261199, expiration date: Jun-2020) for prevention of influenza.  On 28-Sep-2019, two days after the vaccination, the patient developed a rash on her face. Rash began to fade and turned to a pink colour.   On an unspecified date in 2019, the patient recovered from the event of rash on face.   The case was assessed as non-serious and the reporter did not provide causality assessment to Flucelvax QIV.  Follow up was received from other health professional on 14-Nov-2019: Start date for the event was confirmed as 28-Sep-2019 and the outcome was changed from resolving to resolved. Narrative was amended accordingly.  Company comment: The event is considered as related to Flucelvax QIV.; Sender's Comments: The event is considered as related to Flucelvax QIV.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Fatigue, Pain
Clinical narrative: Feeling achey; Feeling tired; This is a spontaneous case, initially received from other non-health professional via Agency (reference number: SEQ19-03665) on 01-Oct-2019, concerning a 76-year-old, female patient.   The patient's relevant medical history, drug reactions or allergies were not reported.  The patient's concomitant medications included amlodipine, latanoprost and escitalopram.  On 23-Sep-2019, the patient was administered with administered Fluad vaccine [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, batch number: 260668, expiration date: 30-Apr-2020, dose, route of administration and anatomical location: not reported] for influenza prophylaxis.   On 25-Sep-2019, the patient started feeling achey and tired.  On an unspecified date, the patient stated she got back to her old new self. The patient wanted to know whether the adverse reaction would go away in two weeks.  At the time of the initial reporting, the outcome of the events of feeling achey and tired was recovering/resolving.  The reporter assessed the case as non-serious but did not provide causality assessment.  Non-significant follow-up reported by Agency (reference number: SEQ19-04469) on 11-Oct-2019: Additional Agency reference number added. No changes in narrative.; Sender's Comments: A 76-year-old, female patient has experienced pain and fatigue associated with Fluad (TIV). Chronology seems plausible. The patient's relevant medical history, drug reactions or allergies were not reported. The patient's concomitant medications included amlodipine, latanoprost and escitalopram. Causality may be confounded with concomitant drugs however, information regarding starting date use and duration is needed in order to establish a proper casual relationship. Considering chronology, causality is assessed as possible related for both events.
Sex: M
Vaccine: FLUA3
Symptoms: Peripheral swelling
Clinical narrative: 3 to 4 inch of swelling on his arm; This is a spontaneous case, reported by pharmacist to Agency (case ID: SEQ19-03354) and initially received on 26-Sep-2019,  concernig a 65-year-old male patient.   The patient's relevant medical history and concomitant medications were not provided.  On an unknown date, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, anatomical location, route of administration, batch number and expiration date were not reported] for an unknown indication.  On an unknown date, after vaccination, the patient experienced 3 to 4 inch of swelling on his arm.  The outcome of the event was not reported.  The reporter did not provided causality and seriousness criteria.  Event was assessed as related per company.  Non-significant follow-up reported by Agency (reference number: SEQ19-04923) on 17-Oct-2019: Additional Agency reference number added. No changes in narrative.; Sender's Comments: Event was assessed as related per company.
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Exposure during pregnancy, Vaccination site bruising, Vaccination site pain
Clinical narrative: Pregnant women received a flu vaccine; It was sore and she had a bruise in the spot where she was given the injection for a week; It was sore and she had a bruise in the spot where she was given the injection for a week; This is a spontaneous case, initially received from other non-health professional via Med Communications (reference number: SEQ19-03642) on 01-Oct-2019, concerning 28-year-old pregnant female patient.  The patient's medical history included asthma.   The patient's concomitant medications were not provided.  The patient had no obstetrical history. The patient's last menstrual period date (LMP) was on May-2019 and the estimated date of delivery was reported as 17-Feb-2020.  The patient was unsure in regards to prenatal tests and did not have any performed (as reported).  On 01-Oct-2019, at 20 weeks of gestation, the patient was administered Afluria Quadrivalent [Influenza vaccine, batch number: P100118567, expiry date: 30-Jun-2019; dose: 0.5 ml; route of administration: intramuscular, anatomical location: upper right shoulder] (explicitly coded as Vaccine exposure during pregnancy') for an influenza prophylaxis.  On an unspecified date in Oct-2019, the spot where she was given the injection was sore and she developed bruise.   The outcome of events was resolved after a week.    The case was assessed as non-serious. The reporter did not provide causality assessment to Afluria Quadrivalent.   Follow-up received from other non-health professional on 15-Nov-2019: Classification-Special case with No AE and laboratory test removed, last menstrual period date, anatomical location, route of vaccination for Afluria and new events added. The narrative was amended accordingly.   Company Comment: The patient experienced vaccination site bruising and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Reportedly, vaccination occurred during pregnancy at 20 weeks of gestation. Chronology is possible. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and events vaccination site bruising and vaccination site pain is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site bruising and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Reportedly, vaccination occurred during pregnancy at 20 weeks of gestation. Chronology is possible. Vaccine exposure during pregnancy is assessed as not related per company's conventions. Causality between suspect product and events vaccination site bruising and vaccination site pain is assessed as possibly related.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising
Clinical narrative: Excessive multicolor bruising about 3 inches across  at the injection site; This is a spontaneous case, reported by pharmacist to Agency (reference number: SEQ19-03773) and initially received on 02-Oct-2019,  concernig a 62-year-old female patient.   The patient's relevant medical history included: type 2 diabetes, hypertension and concomitant medications included: Lisinopril, metformin, Aleve (for back ache).  On 25-Sep-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5ml , route of administration: intramuscular, anatomical location: deltoid right, batch number: 261204, expiration date: 26-Jun-2020] for influenza prophylaxis.  On the same day, several hours after vaccination, the patient developed injection site bruising.   On 02-Oct-2019 the pharmacist reported that the patient had excessive bruising at site that is healing. Multicolour bruising probably about 3 inches across. Could see spot of administration and it was in the correct location.  On 09-Sep-2019, 2 weeks after vaccine administration, the outcome of the event was resolved.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax QIV.  Follow up received from a pharmacist on 18-Oct-2019: Event expectedness, event start, stop date and outcome updated. The narrative was amended accordingly.  Company comment: The patient experienced injection site bruising after vaccination with the suspect product Flucelvax QIV. Chronology is plausible. Medical history of type 2 diabetes may have contributed to development of the event. Considering all the above mentioned, causal role of the suspect product is assessed as related.; Sender's Comments: Excessive multicolor bruising about 3 inches across  at the injection site considered as related to the Flucelvax.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Itching rash; This is a spontaneous case, initially received from other health professional via Med Communication (reference number: SEQ19-03751) on 02-Oct-2019, concerning a 61-year-old, male patient.   The patient's relevant medical history included high blood pressure, morbid obesity, testicular hypofunction and diabetes.  The patient's concomitant medications included amlodipine, losartan, testosterone, Flomax 0.4 (morniflumate) and citalopram.  On 20-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: P100110954 and expiration date: 22-May-2020] for influenza prophylaxis.   On the same day, an hour after vaccination as reported, the patient started breaking out in a rash, with was itching. The patient was treated with prednisone and Benadryl (diphenhydramine hydrochloride) as needed and was advised to avoid any other influenza vaccine in the future. It was reported that rash lasted for a few days. The patient did not visit clinic ever since. No further informations available.  The case was assessed as non-serious.   The reporter did not provide causality assessment to Afluria.  Follow up was received from other health Professional on 13-Nov-2019: The reporter could not reach out the patient for further informations. Narrative was amended accordingly.; Sender's Comments: Itching rash was considered as related to Afluria.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: Neck (and left arm) pain; (Neck and) left arm pain; This is a spontaneous case initially received from agency (case ID: SEQ19-04122) by pharmacist on 08-Oct-2019, concerning a 78-year-old, female patient.     The patient's current medical condition and concomitant medication were not provided.   On 03-Oct-2019, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscularly, batch number: P100110680, expiration date: 15-May-2020) for prevention of influenza.  On 04-Oct-2019, one day after the vaccination, the patient experienced neck and left arm pain.   The outcome for the events of neck and left arm pain were not reported.   The reporter did not provide seriousness and causality assessment.; Sender's Comments: The patient experienced neck pain and vaccination site pain, one day after administration of the suspect product, Afluria Quadrivalent. Chronology is plausible. Information regarding underlying medical history and concomitant drugs was not provided. Based on provided information, causal role of the suspect product is assessed as related for both events.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Skin warm
Clinical narrative: Tennis ball size reaction that is red and warm, 2 inches below injection site on left arm; Tennis ball size reaction that is red and warm, 2 inches below injection site on left arm; This is a spontaneous case, initially received from other health professional via Agency (reference number: SEQ19-04292) on 09-Oct-2019, concerning a 63-year-old, female patient.   The patient's relevant medical history and concomitant medications were not reported.  On 02-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route: intramuscular, anatomical location: left deltoid, batch number: 259808, and expiration date: 31-May-2020] for influenza prophylaxis.  On an unspecified date, the patient developed tennis ball size reaction, 2 inches below injection site on left arm, that was red and warm.  At the time of initial reporting, the outcome for the events of vaccination site warmth' and injection site redness' was not reported.  The reporter assessed the case as non-serious and did not provide causality assessment.  This case is linked to cases: 201905129, 201905130 (same reporter).  Non-significant follow up received via Agency (reference number: SEQ19-05262) on 22-Nov-2019: Additional reference numbers were added. No changes in the narrative.; Sender's Comments: The patient experienced vaccination site warmth and injection site erythema after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related for both events.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: [Reddened], warm raised area around injection site; Reddened, [warm] raised area around injection site; This is a spontaneous case from, initially received from other health professional via agency (reference number: SEQ19-04292) on 09-Oct-2019, concerning a 57-year-old, female patient.   The patient's relevant medical history and concomitant medications were not reported.  On 08-Oct-2019, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route: intramuscular, anatomical location: left deltoid, batch number: 259808, and expiration date: 31-May-2020] for an influenza prophylaxis.  On an unspecified date, the patient experienced reddened, warm raised area around injection site.  At the time of initial reporting, the outcome for the events of vaccination site warmth and injection site redness was not reported.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent.  This case is linked to cases 201905128 and 201905130 (the same reporter).  Non-significant follow up received via agency (reference number: SEQ19-05262) on 22-Nov-2019: Additional reference number were added. No changes in the narrative.; Sender's Comments: The patient experienced vaccination site warmth and injection site erythema after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, , causal role of the suspect product is assessed as related.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Skin warm
Clinical narrative: Tennis ball size reaction 2 inches below the injection site that was reddened and warm; Tennis ball size reaction 2 inches below the injection site that was reddened and warm; This is a spontaneous case, initially received from other health professional via Agency (reference number: SEQ19-04292) on 09-Oct-2019, concerning a 43-year-old, female patient.   The patient's relevant medical history and concomitant medications were not reported.  On 08-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route: intramuscular, anatomical location: left deltoid, batch number: 259808, and expiration date: 31-May-2020] for influenza prophylaxis.  On the same date, six hours after vaccination, the patient developed a tennis ball size reaction 2 inches below the injection site that was red and warm.  On an unspecified date in Oct-2019, the patient recovered from the events. The events were resolved within 24 hours, as reported.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent .  This case is linked to cases 201905128 and 201905129 (the same reporter).  Follow up was received from other health professional on 11-Nov-2019: Stop dates and updated outcomes for the events were provided. The narrative was amended accordingly.  Company Comment: The patient experienced vaccination site warmth and injection site erythema six hours after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible.  No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related for both events.; Sender's Comments: The patient experienced vaccination site warmth and injection site erythema six hours after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible.  No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related for both events.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Infection, Pain in extremity
Clinical narrative: Infection; This is a spontaneous case initially received from other health professional (pharmacist) via Med Communications (reference number: SEQ19-04307) on 09-Oct-2019, concerning a 65-year-old, female patient.   The patient's current condition included depression.  The patient's concomitant medications were not provided.  On 06-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 26200, expiration date: 31-May-2020] for an influenza prophylaxis.   On 08-Oct-2019, two days after vaccination, the patient experienced red and sore arm. The patient was advised to go in store clinic and it was found that the patient had an infection. The patient was treated with unspecified antibiotics.  At the time of initial reporting, the event of infection was not resolved.  The case was assessed as non-serious and the reporter did not provide causality criteria.  Non-significant follow-up reported by other non-health professional from Med Communications [reference number: SEQ19-07088]: Additional reference number added. No changes in narrative.; Sender's Comments: The patient developed the event of infection two days after Fluad (TIV) administration. Chronology is plausible. No information regarding concomitant medications was provided. Based on currently provided information, causality is assessed as possibly related.
Sex: F
Vaccine: FLUC4
Symptoms: Dysgeusia, Dyspnoea, Immediate post-injection reaction, Pruritus, Wheezing
Clinical narrative: The patient  could feel the taste of the vaccine in her mouth; Laboured breathing; Wheezing; The patient felt an itching; This is a spontaneous case from, reported by other health professional (Practice Administrator) via agency (reference number SEQ19-04325), initially received on 09-Oct-2019, concerning a 44-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 09-Oct-2019, the patient was administered Flucelvax (QIV) [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number:261210, expiry date: 30-Jun-2020] for influenza prophylaxis.  On the same date, immediately after vaccine administration, the patient experienced an itching, developed laboured breathing and wheezing. In addition, she stated that she could feel the taste of the vaccine in her mouth. The patient was brought to the emergency room, given the corrective treatment which included cocktail of drugs (including antihistamines) and sent home.  At the time of initial reporting, the outcome of the events 'itching', 'after taste', ' laboured breathing' and ' wheezing' was not recovered.  This reporter assessed the case as non-serious and did not provide causality assessment.  Non-significant follow-up reported by agency (reference number: SEQ19-05172) on 23-Oct-2019: Additional agency reference number added. No changes in narrative.; Sender's Comments: The patient developed pruritus, wheezing, dyspnoea and dysgeusia on the same date after Flucelvax (QIV) administration. Chronology is plausible. No information regarding patient's medical history and concomitant medications was provided. Based on currently provided information, causality is assessed as possibly related for all events.
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of product administration, Injection site pain, Injection site swelling
Clinical narrative: Tenderness at the site of injection; Swelling at the site of injection; Pateint felt it went not deep enought in the muscle; This is a spontaneous case, reported by other health professional to Med Communications (case ID: SEQ19-04349) and initially received on 09-Oct-2019, concerning a 45-years-old female patient.  The patient had no relevant medical history and concomitant medications were not provided.  On 03-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 261217 expiration date: 30-Jun-2020] for influenza prophylaxis.  On 06-Oct-2019, 3 days after vaccination, the patient developed tenderness and swelling at the site of injection. The patient stated that she felt that it did not go deep enough in the muscle (explicitly coded as ' Inappropriate route of administration'), and she was questioning whether she should receive a second dose.  The outcome of the event was resolved.  The reporter assessed the case as non-serious and did not provide causality criteria.; Sender's Comments: The patient experienced injection site pain and vaccination site swelling after incorrect route of administration with the suspect product Flucelvax QIV. Chronology is plausible. No diagnostic findings and concomitant medications were reported. Incorrect route of product administration is assessed as not related per company conventions. For all other events, causal role of the suspect product is assessed as related.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Axillary pain, Swelling
Clinical narrative: Significant pain (and swelling) in right armpit; (Significant pain) and swelling in right armpit; This is a spontaneous case, initially received from other health professional via Med Communications (reference number: SEQ19-04339) on 10-Oct-2019, concerning an 51-year-old male patient.   The patient's relevant medical history and concomitant medications were not provided.  On 08-Oct-2019, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: right deltoid, batch number reported as 260204 (Seqirus batch number: 261204), expiration date: 26-Jun-2020] for influenza prophylaxis.  On the same date, after vaccination, the patient developed significant pain and swelling in right armpit.  The outcome of the event significant pain and swelling in right armpit was unknown, at the time of report.  The reporter assessed the case as non-serious, but did not provide causality.; Sender's Comments: The patient developed axillary pain and axillary mass, on the same date after administration of the suspect vaccine, Flucelvax QIV. Chronology is plausible. More information regarding medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.
Age: 0.58
Sex: F
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Fever of 102F; Vaccine administered to a 7 month-old-child by mistake; This is a spontaneous case, initially received from other health professional (nurse) via Med Communications (reference number: SEQ19-04421) on 10-Oct-2019, concerning a 7-month-old female patient.  The patient's medical history and concomitant medications were not provided.  On 09-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261198 (also reported as 261199), expiration date: 18-Jun-2020 (also reported as 19-Jun-2020)] (explicitly coded as Inappropriate age at vaccine administration') for an influenza prophylaxis.  On 10-Oct-2019, one day after vaccination, the patient developed fever of 102F. As reported, the patient did not receive any treatment.  At the time of initial reporting, event of fever was not resolved.  The reporter assessed the case as non-serious and did not provide causality assessment.  Non-significant follow-up reported by Med Communications (reference number: SEQ19-05258) on 22-Oct-2019: Additional Med Communications reference number added. No changes in narrative.; Sender's Comments: The patient experienced pyrexia after administration of the suspect product Flucelvax QIV to patient of inappropriate age. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Causal relationship between the suspect product and product administered to patient of inappropriate age is assessed as not related per company conventions. For the event pyrexia, causal role of the suspect product is assessed as related.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Afluria Quadrivalent was administerd via subcutaneous route instead of intramuscular; Redness at injection site; This is a spontaneous case from initially reported by other health professional to agency (reference number: SEQ19-04419) on 10-Oct-2019, concerning 52-year old female patient.  The patient's medical history and concomitant medications were not reported.  On 10-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: subcutaneous, anatomical location: right arm; batch number: P100123050; expiration date: 30-Jun-2020] (explicitly coded as Inappropriate route of vaccination') for influenza prophylaxis.   On the same day, after vaccination, the patient experienced redness at injection site.  The reporter inquired what was needed to be done and was offering revaccination, but the patient was not revaccinated.  On an unknown date in Oct-2019, the redness at injection site was resolved.   This case is linked to: 201905179, 201905181, 201905182, 201905183, 201905184, 201905185, 201905186, 201905187, 201905189, 201905190, 201905191, 201905192, 201905193, 201905194, 201905195, 201905196, 201905180 due to same reporter.  Follow up received from other health professional on 22-Oct-2019: Classification 'Special case with no AE' removed. Anatomical location for vaccination added in product tab. New event added. No revaccination. Narrative amended accordingly.  Follow up received from other health professional via agency (reference number: SEQ19-06241) on 06-Nov-2019: Start date of event provided. Narrative amended accordingly.  Company comment: The patient experienced vaccination site erythema after incorrect route of the suspect product Afluria Quadrivalent administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Incorrect route of product administration is assessed as not related per company's conventions. Causality between suspect product and the event vaccination site erythema is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site erythema after incorrect route of the suspect product Afluria Quadrivalent administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Incorrect route of product administration is assessed as not related per company's conventions. Causality between suspect product and the event vaccination site erythema is assessed as possibly related.
Sex: F
Vaccine: FLUC4
Symptoms: Nerve injury, Paraesthesia
Clinical narrative: Hit a nerve when administering; Tingling down her arm and tingling in 3 fingers; This is a spontaneous case from initially received from pharmacist on 10-Oct-2019 via agency (reference number: SEQ19-04441), concerning a female patient of unknown age.  The patient's relevant medical history and concomitant medications were not provided.    On 10-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: deltoid left, dose, batch number and expiry date: not reported] for an influenza prophylaxis.  On the same day, approximately one hour after vaccination, the patient developed tingling down her arm and tingling in 3 fingers. Patient stated that she thought that they hit a nerve when administering.  At the time of this follow up, the patient she was fine and recovered.  The case was assessed as non-serious and the reporter did not provide causality assessment.  Follow up received from pharmacist on 23-Oct-2019: The outcome for the events was provided and changed to resolved. Route of administration and anatomical location for vaccine were added. The narrative was amended accordingly.  Company comment: The patient experienced paraesthesia and administration site nerve damage, approximately one hour after administration of the suspect product, Flucelvax QIV. Chronology is plausible. More information regarding underlying medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient experienced paraesthesia and administration site nerve damage, approximately one hour after administration of the suspect product, Flucelvax QIV. Chronology is plausible. More information regarding underlying medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.