chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case from, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a male patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905319, 201950320, 201905321, 201905322, 201905323 and 201905324 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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 cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema 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 cannot be totally excluded and is assessed as possibly related.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: 3 ml of 5 ml vial was administered, arm is sore; 3 ml of 5 ml vial was administered, arm is sore; This is a spontaneous case, initially reported by other health professional (pharmacist) to Med Communications (reference number: SEQ19-05020) on 17-Oct-2019, concerning a 24-year-old, female patient.   The patient's medical history was not reported.  The patient's concomitant medications included unspecified antidepressant and anti-anxiety medicine.  On 17-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 3 ml, batch number: 259815, route of administration: intramuscular, anatomical location: right deltoid, expiration date: 30-Jun-2020] for influenza prophylaxis (explicitly coded as 'Overdose').  The pharmacist confused the Multi-Dose Vial (MDV) with a single dose vial, as reported.   On the same date, an unknown amount of time after vaccination, the patient's arm was sore.   On an unspecified date, the patient recovered.   The reporter assessed this case as non-serious. Causality was not provided.  Follow up received from pharmacist on 29-Oct-2019 (reference number: SEQ19-05759): Indication provided for flu vaccine, start date (17-Oct-2019) and outcome of the event (resolved) added in events tab. Narrative was amended accordingly.  Company comment:The patient was administered Flucelvax Quadrivalent. Reportedly, 3 ml of 5 ml vial was administered (explicitly coded as 'Overdose'). On the same date, the patient developed pain in extremity. Chronology is plausible. Causal role of the suspect product for the event of overdose is assessed as not related, while for the event of pain in extremity is assessed as possibly related.; Sender's Comments: The patient was administered Flucelvax Quadrivalent. Reportedly, 3 ml of 5 ml vial was administered (explicitly coded as 'Overdose'). On the same date, the patient developed pain in extremity. Chronology is plausible. Causal role of the suspect product for the event of overdose is assessed as not related, while for the event of pain in extremity is assessed as possibly related.
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Incorrect route of product administration, Injection site urticaria, Injection site warmth, Local reaction
Clinical narrative: Vaccine was administered subcutaneously; Local site reaction, singular hive which is raised but not painful and slightly warm; Malaise; Fatigue; This is a spontaneous case initially received from other health professional via agency (case ID: SEQ19-04956) on 17-Oct-2019, concerning an unspecific age male patient.   The patient's medical history was not reported and concomitant medication included Myrbetriq (mirabegron) for unknown indication.    On 16-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, batch number: 261197, expiration date: 15-Jun-2020, route of administration: subcutaneous] (explicitly coded as Inappropriate route of vaccination') for prevention of seasonal influenza.  On the same day, after vaccination, the patient developed local site reaction, singular hive which was raised but not painful and slightly warm. Also, the patient reported symptoms of malaise and fatigue.  On 17-Oct-2019, the patient visited nurse. The patient had been instructed to apply an ice pack on the injection site. The patient had also taken Zirtek as treatment. The patient had gone to work and seemed fine.  At the time of initial reporting, the outcome of the events was not reported.  The reporter assessed the case as non serious and did not provided causality criteria.  Non-significant follow-up reported by other non-health professional from agency [reference number: SEQ19-07093] on 12-Dec-2019: Additional reference number added. No changes in narrative.  Company comment: The patient was administered Flucelvax QIV, subcutaneously instead of intramuscular route. Reportedly, on the same day, after vaccination, the patient developed vaccination site urticaria, fatigue and malaise. Chronology is plausible. More information regarding patent's medical history is needed. Based on provided information, causal role of the suspect product is assessed as possibly related for all three events. Incorrect route of product administration is assessed as not related per company's conventions.
Sex: F
Vaccine: FLUC4
Symptoms: Malaise
Clinical narrative: Vaccine was administered subcutaneously; Local site reaction, singular hive which is raised but not painful and slightly warm; Malaise; Fatigue; This is a spontaneous case initially received from other health professional via agency (case ID: SEQ19-04956) on 17-Oct-2019, concerning an unspecific age male patient.   The patient's medical history was not reported and concomitant medication included Myrbetriq (mirabegron) for unknown indication.    On 16-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, batch number: 261197, expiration date: 15-Jun-2020, route of administration: subcutaneous] (explicitly coded as Inappropriate route of vaccination') for prevention of seasonal influenza.  On the same day, after vaccination, the patient developed local site reaction, singular hive which was raised but not painful and slightly warm. Also, the patient reported symptoms of malaise and fatigue.  On 17-Oct-2019, the patient visited nurse. The patient had been instructed to apply an ice pack on the injection site. The patient had also taken Zirtek as treatment. The patient had gone to work and seemed fine.  At the time of initial reporting, the outcome of the events was not reported.  The reporter assessed the case as non serious and did not provided causality criteria.  Non-significant follow-up reported by other non-health professional from agency [reference number: SEQ19-07093] on 12-Dec-2019: Additional reference number added. No changes in narrative.  Company comment: The patient was administered Flucelvax QIV, subcutaneously instead of intramuscular route. Reportedly, on the same day, after vaccination, the patient developed vaccination site urticaria, fatigue and malaise. Chronology is plausible. More information regarding patent's medical history is needed. Based on provided information, causal role of the suspect product is assessed as possibly related for all three events. Incorrect route of product administration is assessed as not related per company's conventions.
Sex: F
Vaccine: FLU4
Symptoms: Joint lock, Middle insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Joint locking; Worsening arm pain; Worsening arm pain, left shoulder; Pain waking patient up at night; This is a spontaneous case, reported by other health professional and initially received on 17-Oct-2019 from agency (SEQ19-05008), concerning a female patient of unspecified age.  The patients relevant medical history and concomitant medications were not provided.  On 06-Oct-2019, the patient was administered  Afluria Quadrivalent [influenza vaccine, dose, route of administration, anatomical location, batch number and expiration date: not reported] for influenza prophylaxis.   On an unspecified day in Oct-2019, after vaccination, the patient experienced worsening arm pain, left shoulder, waking up at night and joint locking.  The outcome of the event was reported as unknown.  The reporter assessed the case as non-serious and did not provide causality criteria.  Follow up received from the reporter on 23-Oct-2019: report type changed from invalid to spontaneous (patient gender provided), second reporter added (nurse). The narrative was amended accordingly.  Company comment: The patient developed joint lock, musculoskeletal pain, pain in extremity and sleep disorder after administration of Afluria Quadrivalent. Chronology is plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect vaccine cannot be excluded and it is assessed as possibly related for all events.; Reporter's Comments: The reporter assessed the case as non-serious.; Sender's Comments: The patient developed joint lock, musculoskeletal pain, pain in extremity and sleep disorder after administration of Afluria Quadrivalent. Chronology is plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect vaccine cannot be excluded and it is assessed as possibly related for all events.   .
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Tremor
Clinical narrative: Tremors in both of her hands; This is a spontaneous case reported by other health professional to Agency (reference number: SEQ19-05023) and initially retrieved on 17-Oct-2019, concerning a 31-year-old, female patient.  The patient had no relevant medical history.  The patient's concomitant medications were not provided.  On 17-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 259808, expiration date: 31-May-2020] for protection against seasonal influenza.  On the same day, about an hour after vaccination, the patient experienced tremors in both of her hands. Nurse stated that she was worried because the patient had no history of this occurring.   The outcome of the event was recovered after a couple of hours. As reported, during this time, patient's vitals were normal. Patient had no additional issues after tremors resolved.   The reporter assessed the case as non-serious. Causality assessment was not provided.  Follow up received from other health professional on 05-Nov-2019: Stop date and outcome of the event were updated. The narrative was amended accordingly.  Company comment: The patient developed tremor one the same day, about an hour after administration of suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history or concomitant medications. Reportedly, the event resolved after couple of hours. With information currently available, causal role of the suspect product is assessed as unlikely related.; Sender's Comments: The patient developed tremor one the same day, about an hour after administration of suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history or concomitant medications. Reportedly, the event resolved after couple of hours. With information currently available, causal role of the suspect product is assessed as unlikely related.
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Erythema, Incorrect route of product administration, Pruritus
Clinical narrative: Redness; Itching; The dose of vaccine was administered subcontaneously; This is a spontaneous case from, reported by other health professional to agency [reference number: SEQ19-05072] and initially received on 18-Oct-2019, concerning a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2019, reported as '16. and 17-oct-2019', the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: subcutaneous, anatomical location: deltoid, batch number: 259809, expiration date: 31-May-2020] (explicitly coded as 'Inappropriate route of vaccination') for prevention of seasonal influenza.  On an unspecified date in Oct-2019, unknown amount of time after vaccination, the patient experienced redness and itching. The patient was advised to use hydrocortisone cream, however, no corrective treatment was given for the events.  At the time of initial reporting, the outcome of the events was not reported.    The case was assessed as non-serious.  The reporter did not provide causality assessment.  This case is linked to cases 201905345 and 201905346 (same reporter).  Non-significant follow up received via agency (reference number: SEQ19-06325) on 06-Dec-2019: Additional numbers were added. No changes in narrative.  Company comment: The patient experienced erythema and pruritus after incorrect route of the suspect product Flucelvax QIV product administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Causal relationship between the suspect product and incorrect route of product administration is assessed as not related per company conventions. For the events erythema and pruritus, causal role of the suspect product is assessed as related.
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Erythema, Incorrect route of product administration, Pruritus
Clinical narrative: Redness; Itching; The dose of vaccine was administered subcontaneously; This is a spontaneous case, reported by other health professional to Agency [reference number: SEQ19-05072] and initially received on 18-Oct-2019, concerning a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2019, reported as '16. And 17-oct-2019', the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: subcutaneous, anatomical location: deltoid, batch number: 259809, expiration date: 31-May-2020] (explicitly coded as 'Inappropriate route of vaccination') for prevention of seasonal influenza.  On an unspecified date in Oct-2019, unknown amount of time after vaccination, the patient experienced redness and itching. The patient was advised to use hydrocortisone cream, however, no corrective treatment was given for the events.  At the time of initial reporting, the outcome of the events was not reported.    The case was assessed as non-serious.  The reporter did not provide causality assessment.  This case is linked to cases 201905344 and 201905346 (same reporter).  Non-significant follow-up reported by other non-health professional from Agency [reference numbers: SEQ19-06325, SEQ19-06355, SEQ19-06414] on 06-Dec-2019: Additional reference numbers added. No changes in narrative.  Company comment: The patient experienced erythema and pruritus after incorrect route of the suspect product Flucelvax QIV product administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Causal relationship between the suspect product and Incorrect route of product administration is assessed as not related per company conventions. For the events erythema and pruritus, causal role of the suspect product is assessed as related.; Sender's Comments: The patient experienced erythema and pruritus after incorrect route of the suspect product Flucelvax QIV product administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Causal relationship between the suspect product and Incorrect route of product administration is assessed as not related per company conventions. For the events erythema and pruritus, causal role of the suspect product is assessed as related.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: A week later her arm started hurting/pain at injection site; [A week later her arm started hurting /pain at injection site; This is a spontaneous case, reported by a pharmacist to Agency (reference number: SEQ19-05122) and initially received on 18-Oct-2019, concerning a 77-year-old female patient.  The patient's relevant medical history and concomitant medications were not provided.  On 11-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, anatomical location: right deltoid, route of administration: intramuscular, batch number: 260389, expiration date: 20-May-2020] for influenza prophylaxis.  On 18-Oct-2019, 7 days after vaccination, the patient reported pain at injection site but no redness or swelling. The patient's arm started hurting. The patient had no problems moving or lifting her arm.  The outcome of the event 'Injection site pain' and ' Pain in arm' was recovering.  The reporter assessed the case as non-serious and did not provide causality assessment to Fluad (TIV).  Follow up received from pharmacist on 29-Oct-2019: patient initials, start date and the outcome of the event 'Injection site pain 'Pain in arm' and were updated. The narrative was amended accordingly.  Company comment: The patient experienced injection site pain and pain in extremity after vaccination with the suspect product Fluad (TIV). 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 possibly related.; Sender's Comments: The patient experienced injection site pain and pain in extremity after vaccination with the suspect product Fluad (TIV). 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 possibly related.
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass
Clinical narrative: A lump swell up right next to the injection site; The area was now slightly red; This is a spontaneous case, reported by pharmacist to Agency (reference number: SEQ19-05124) and initially received on 18-Oct-2019, concerning a 76-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported. It was reported that the patient received Fluad vaccine last year and the year before without any issues.  On 18-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscular, batch number: 261280, expiration date: 30-Jun-2020] for protection against seasonal influenza.  On the same day, during vaccination, the pharmacist noticed a lump swell up right next to the injection site. After the pharmacist pulled the needle out of the patient's arm, she noticed that the swelling had gone down, however, the area was slightly red. Patient did not experience any additional issues.   At the time of initial reporting, the patient was recovering from the event of 'injection site redness'.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Non-significant follow-up reported by other non-health professional from Agency [reference number: SEQ19-05851] on 16-Jan-2020: Additional reference number added. No changes in narrative.  Company comment: The patient developed injection site mass and injection site erythema, associated with administration of the suspect product, Fluad (TIV). Chronology is plausible and causal role of the suspect vaccine is assessed as probably related.; Sender's Comments: The patient developed injection site mass and injection site erythema, associated with administration of the suspect product, Fluad (TIV). Chronology is plausible and causal role of the suspect vaccine is assessed as probably related.
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: He is now experiencing injection site reactions: lump, warmth and pain; He is now experiencing injection site reactions: lump, warmth and pain; He is now experiencing injection site reactions: lump, warmth and pain; This is a spontaneous case from, initially reported by other health professional to agency (reference number: SEQ19-05067) on 18-Oct-2019 and additional information received on 21-Oct-2019 (being processed together), concerning a male patient of unspecified age.  The patient's medical history and concomitant medications were not reported.  On 16-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose, batch number, expiration date, route of administration and anatomical location: not reported] for unknown indication.   On unspecified date at Oct-2019, the patient experienced injection site reactions: lump, warmth and pain. No further details were provided.  At the time of initial reporting, the patient had not recovered from the events.  The case was assessed as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient experienced vaccination site warmth, vaccination site mass and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site mass and vaccination site pain after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site induration
Clinical narrative: Cyst type induration on the injection arm/not on the deltoid; This is a spontaneous case from, initially reported by pharmacist via Agency (reference number: SEQ19-05212) on 21-Oct-2019, concerning a 56-year-old, female patient.  The patient's relevant medical history and concomitant medications were not provided.    On 20-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: left deltoid, batch number: 261201 and expiry date: 30-May-2020] for influenza prophylaxis.  On unspecified date, unknown period after vaccination, the patient developed cyst type induration on the injection arm. The reporter stated that the induration is on the arm but not on the deltoid like it is referred. Induration was distal to shoulder where vaccine was administered. The pharmacist confirmed the vaccine was given in the correct location, by checking the camera. Patient received no treatment for the event.  The outcome of the event was unknown.  The case was assessed as non-serious. The reporter did not provide causality assessment to Flucelvax QIV..  Follow up received on 31-Oct-2019 from pharmacist via Agency (reference number: SEQ19-05872): batch number and expiry date of vaccine provided, the outcome of the event updated. The narrative was amended accordingly.  Company comment: The patient experienced skin induration after vaccination with the suspect product, Flucelvax QIV. Chronology and anatomical description of the event is suggestive of causal role of vaccine. Considering all the above mentioned, causal role of the suspect product is assessed as related.; Sender's Comments: The patient experienced skin induration after vaccination with the suspect product, Flucelvax QIV. Chronology and anatomical description of  the event is suggestive of causal role of vaccine. Considering all the above mentioned, causal role of the suspect product is assessed as related.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint lock, Muscular weakness
Clinical narrative: Weakness in left arm; Locking of shoulder joint; Worsening pain in left arm at injection site; This is a spontaneous case reported by other health care professional to AGENCY (Case: SEQ19-05359) and initially received on 22-Oct-2019, concerning a female patient in her 30s.  The patient's medical history and concomitant medications were not reported.  On an unspecified day in Sep-2019, reported as last month at the time of the initial report, the patient was administered Afluria Quadrivalent [Influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, batch number: P100110239, anatomical location: left deltoid, expiration date: not reported) for influenza prophylaxis.  On 15-Oct-2019, three weeks after vaccination, the patient developed worsening pain in left arm at injection site with locking of shoulder joint and weakness in left arm. Patient's treatment measures included lab work and steroids.  The outcome of the events was not recovered/not resolved, at the time of reporting.  This case is linked to 201905416 (same reporter)   The reporter assessed the case as non-serious.  Non-significant follow-up reported by other non-health professional from Agency [reference number: SEQ19-06171] on 26-Nov-2019: Additional Agency reference numbers added. No changes in narrative.  Company comment: The patient developed muscular weakness, periarthritis and vaccination site pain, three weeks after administration of Afluria Quadrivalent. Chronology does not seem plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect vaccine cannot be excluded and it is assessed as possibly related for all events.; Sender's Comments: The patient developed muscular weakness, periarthritis and vaccination site pain, three weeks after administration of Afluria Quadrivalent. Chronology does not seem plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect vaccine cannot be excluded and it is assessed as possibly related for all events.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left arm pain at injection site for 2 months; This is a spontaneous case from initialy received from other health professional via agency (reference number: SEQ19-05359) on 22-Oct-2019, concerning a female patient in her 60s.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in Aug-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: P100110239 and expiration date: not reported] for influenza prophylaxis.   On the same day, after vaccination, the patient experienced pain at injection site that was not getting worse but remained the same for two months.  At the time of initial reporting, the patient had not recovered from the event.   The reporter assessed the case as non-serious but did not provide causality assessment.  This case is linked to companion case 201905415 due to same reporter.  Non-significant follow-up reported by other non-health professional from agency [reference number: SEQ19-06243] on 26-Nov-2019: Additional agency reference numbers added. No changes in narrative.   Company comment: Event was assessed as related.; Reporter's Comments: The reporter assessed the case as non-serious.; Sender's Comments: Event was assessed as related.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccine administration site became puffy and has continued to become puffier. It is about the size of golf ball, [itchy and burning].; Vaccine administration site became [puffy and has continued to become puffier. It is about the size of golf ball,] itchy [and burning].; Vaccine administration site became [puffy and has continued to become puffier. It is about the size of golf ball, itchy and] burning.; This is a spontaneous case, reported by other health professional via Agency (reference number: SEQ19-05374) and initially received on 23-Oct-2019, concerning a 48-year-old, female patient.  The patient's relevant medical history included diabetes and lupus. Concomitant medications were not reported.   On 23-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: right deltoid, batch number: 262637, expiration date: 30-Jun-2020] for influenza prophylaxis.   On the same day, unknown period after vaccination, the patient's vaccine administration site became puffy and has continued to become puffier. It was about the size of a golf ball, itchy and burning. The patient was treated with ice to the site.  At the time of the initial reporting, the outcome of all events was not recovered.  The case was assessed as non-serious. The reporter did not provide causality assessment to Flucelvax QIV.  Company comment: All events are considered related to Flucelvax QIV.; Sender's Comments: All events are considered related to Flucelvax QIV.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Influenza, Influenza virus test positive, Pain
Clinical narrative: Tested positive for flu; This is spontaneous case initially reported by consumer to Agency (reference number: SEQ19-05457) on 23-Oct-2019, concerning 31-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; batch number: P100110975; expiration date: 28-May-2020; dose: 0,5 ml; route of administration: intramuscular; anatomical location: deltoid] as influenza prophylaxis.  On an unspecified date in October the patient developed coughing, drainage, body aches, fever and chills. The patient advised she hurt all over.  On 23-Oct-2019, the patient went to physician and tested positive for flu.  On 27-Oct-2019, the patient recovered completely from the event flu.  The case was assessed as serious.  The reporter did not provide causality assessment.  Follow-up reported by other non-health professional to Agency [reference number: SEQ19-06012] on 01-Nov-2019: The event Flu was updated (stop date added; outcome changed from unknown to recovered). Additional Agency reference number added. Narrative amended accordingly.  Company Comment: The patient experienced influenza 13 days 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 related.; Sender's Comments: The patient experienced influenza 13 days 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 related.
Sex: F
Vaccine: FLU4
Symptoms: Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: Tested positive for flu; This is spontaneous case initially reported by consumer to Agency (reference number: SEQ19-05457) on 23-Oct-2019, concerning 31-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; batch number: P100110975; expiration date: 28-May-2020; dose: 0,5 ml; route of administration: intramuscular; anatomical location: deltoid] as influenza prophylaxis.  On an unspecified date in October the patient developed coughing, drainage, body aches, fever and chills. The patient advised she hurt all over.  On 23-Oct-2019, the patient went to physician and tested positive for flu.  On 27-Oct-2019, the patient recovered completely from the event flu.  The case was assessed as serious.  The reporter did not provide causality assessment.  Follow-up reported by other non-health professional to Agency [reference number: SEQ19-06012] on 01-Nov-2019: The event Flu was updated (stop date added; outcome changed from unknown to recovered). Additional Agency reference number added. Narrative amended accordingly.  Company Comment: The patient experienced influenza 13 days 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 related.; Sender's Comments: The patient experienced influenza 13 days 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 related.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Her arm was hard, had red circle and was real hot; Upset; Her arm was hard at the injection site; Her arm was hard, had red circle and was real hot; Injection site close to elbow; This is a spontaneous case reported by consumer via Agency (reference number: SEQ19-05563) and initially received on 24-Oct-2019, concerning a 46-year-old, female patient.  The patient had no relevant medical history her concomitant medications included stomach pill', as reported, for unknown indication.   On 22-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza vaccine polyvalent, dose: 0.5ml, route of administration, anatomical location, batch number and expiry date: not reported] for influenza prophylaxis.  On 24-Oct-2019, 2 days after vaccination, the patient went to scratch her arm and noticed a hard area at the injection site, that was close to her elbow, and red circle and the injection site was real hot (explicitly coded as 'Vaccine administered at inappropriate site').  Patient received no treatment for these events. On the same day, the pharmacist reported that the consumer was upset and hasn't come in to let her check the reaction site and location of injection. The pharmacist also noted that she always gives vaccines intramuscular in the deltoid.  The outcome of all the events was not recovered, at the time of this report.  The reporter assessed the case as non-serious and did not provide causality.  Company comment: The patient developed vaccination site warmth, emotional distress, vaccination site induration and vaccination site erythema two days after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. Reportedly, injection site was close to elbow (explicitly coded as 'Vaccine administered at inappropriate site').  Causality for the event of product administered at inappropriate site is assessed as not related, while for all other events as possibly related.; Sender's Comments: The patient developed vaccination site warmth, emotional distress, vaccination site induration and vaccination site erythema two days after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. Reportedly, injection site was close to elbow (explicitly coded as 'Vaccine administered at inappropriate site').  Causality for the event of product administered at inappropriate site is assessed as not related, while for all other events as possibly related.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Tinnitus
Clinical narrative: Annoying clanking noise in right ear; This is a spontaneous case, initially received from other non-health professional via Agency [reference number: SEQ19-05651] on 25-Oct-2019, concerning a 77-year-old, female patient.   The patient's relevant medical history included stent for brain aneurysm. It was reported that stent was put two weeks ago and will be needed another procedure in 3 weeks.    The patient's concomitant medications were not provided.  On 24-Oct-2019, the patient was administered Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen, egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiration date: not reported] for influenza prophylaxis.   On 25-Oct-2019, the patient noticed an annoying clanking noise in her right ear.  At the time of follow up reporting, the patient had not recovered from the event. It was reported that the patient was supposed to visit ear, nose and throat clinic (ENT) to receive second steroid shot in ear to attempt to relieve the tinnitus.  The reporter assessed the case as non-serious but did not provide causality.  Follow-up received from other non-health professional on 12-Nov-2019: Indication for vaccination added. It was confirmed that the event was ongoing, and the patient was supposed to receive second dose of steroids. The narrative was amended accordingly.  Company comment: The event developed day after administration of Fluad vaccine. Causality assessment is confounded by patient's medical history. Based on the available information the event of tinnitus was assessed as related to the suspect vaccine.; Sender's Comments: The event developed day after administration of Fluad vaccine. Causality assessment is confounded by patient's medical history. Based on the available information the event of tinnitus was assessed as related to the suspect vaccine.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia oral
Clinical narrative: Tongue and the back of her pallet tingled; This is a spontaneous case from, initially received from other non-health professional via agency (SEQ19-05696) on 28-Oct-2019, concerning an 66-year-old elderly, female patient.   The patient's medical history includes allergy's to eggs and peanuts, asthma and high blood pressure. The patient's concomitant medications include Claritine (loratadine), hydrochlorothiazide all for unknown indication.  On 22-Oct-2019, the patient was administrated Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine, polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, 5 minutes after receiving the vaccine, the patient experienced her tongue and the back of her pallet tingled. She took Albuterol (salbutamol) inhaler, and 2 Benadryl (diphenhydramine) later within 5 minutes. The symptoms then subsided, and she didn't experience any further problems.  The outcome of the event was recovered, on 22-Oct-2019.  The reporter assessed the case as non-serious but did not provide causality.  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.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; This is a spontaneous case from, reported by health professional to agency [reference number: SEQ19-05870] and initially received on 30-Oct-2019, concerning a 59-year-old male patient.  The patient's medical history was not reported. The patient's concomitant medications were not provided.  On 29-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: deltoid, batch number: 259808, expiration date: 31-May-2020] for prevention of seasonal influenza.  On the same day, after vaccination, the patient experienced injection site redness, itchiness, puffiness, swilling and the injection site was warm to the touch. The patient was advised to apply cold compress and Benadryl cream.   On 05-Nov-2019, one week after experienced events, the patient recovered.  The case was assessed as non-serious.  The reporter did not provide causality assessment.   This case is linked to case 201905790 (same reporter).  Follow-up received from other health professional via agency (reference number: SEQ19-06729) on 20-Nov-2019: Age of the patient added. Stop dates added for all events and the outcome changed from not reported to resolved. Additional numbers were added.The narrative was amendment accordingly.   Company comment: Temporal relationship and description of reported events are suggestive for the causal role of Flucelvax. No plausible alternative aetiology was provided. Based on the available information reported adverse events are assessed as related to the suspect vaccine.; Sender's Comments: Temporal relationship and description of reported events are suggestive for the causal role of Flucelvax. No plausible alternative aetiology was provided. Based on the available information reported adverse events are assessed as related to the suspect vaccine.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; Injection site is red, itchy, puffy, swollen and warm to the touch; This is a spontaneous case, reported by health professional to Agency [reference number: SEQ19-05870] and initially received on 30-Oct-2019, concerning a 7-year-old female patient.  The patient's medical history was not reported. The patient's concomitant medications were not provided.  On 29-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: 259808, expiration date: 31-May-2020] for prevention of seasonal influenza.  On the same day, after vaccination, the patient experienced injection site redness, itchiness, puffiness, swilling and the injection site was warm to the touch. The patient was treated with Benadryl cream (diphenhydramine). The patient was advised to apply cold compress.   On an unknown date in Nov-2019, four and five after experienced events, the patient recovered.  The case was assessed as non-serious.  The reporter did not provide causality assessment.   This case is linked to case 201905789 (same reporter).  Follow-up received from other health professional via Agency (reference number: SEQ19-06730) on 20-Nov-2019: Age of the patient added. Stop date for the events added and the outcome changed from not reported to resolved. Benadryl added as a treatment medication. Additional numbers added.The narrative was amended accordingly.   Company comment: Temporal relationship and description of reported events are suggestive for the causal role of Flucelvax. No plausible alternative aetiology was provided. Based on the available information reported adverse events are assessed as related to the suspect vaccine.; Sender's Comments: Temporal relationship and description of reported events are suggestive for the causal role of Flucelvax. No plausible alternative aetiology was provided. Based on the available information reported adverse events are assessed as related to the suspect vaccine.
Age: 26.0
Sex: F
Vaccine: FLUA3
Symptoms: Exposure via eye contact, Eye irritation, Occupational exposure to product
Clinical narrative: Eye irritation in the left eye; Fluad vaccine being splashed into her left eye; This is a spontaneous case, initially received from a pharmacist via Agency (reference number: SEQ19-05951) on 31-Oct-2019 and processed together with an additional source document received on 01-Nov-2019, concerning a 26-year-old pharmacist.   No medical history and concomitant medications were not provided.   On 25-Oct-2019, while was administered Fluad TIV to the patient [influenza vaccine, inactivated influenza virus surface antigen, egg-derived, MF59, batch number: 260397 and expiration date: 30-Jun-2020] and after retracting the needle, the pharmacist reported she thought some of the vaccine splashed into her left eye (explicitly coded as 'Occupational exposure to product via eye') . The pharmacist flushed the eye with water and stated it was ok.  On 29-Oct-2019, the pharmacist reported eye irritation in the left eye, but no redness. She did not see a physician.  On an unknown date in Nov-2019, at least a week after experienced eye irritation in the left eye, the pharmacist recovered.   The case was assessed as non-serious. The reporter did not provide causality assessment to Fluad (TIV).  Follow-up received from a pharmacist via Agency (reference number: SEQ19-06736) on 18-Nov-2019: The pharmacist's age were added. The outcome of the event eye irritation was changed from not resolved to resolved. The narrative was amended accordingly.   Company comment: The pharmacist experienced eye irritation after occupational exposure to suspect product Fluad TIV. Reportedly, some of the vaccine splashed into her left eye. Chronology is plausible. Occupational exposure to product is assessed as not related per company's conventions. For eye irritation, causality between suspect product and the event is assessed as possibly related.; Sender's Comments: The pharmacist experienced eye irritation after occupational exposure to suspect product Fluad TIV. Reportedly, some of the vaccine splashed into her left eye. Chronology is plausible. Occupational exposure to product is assessed as not related per company's conventions. For eye irritation, causality between suspect product and the event is assessed as possibly related.