chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Papule
Clinical narrative: Papules on trunk and extremities, like chickenpox; This spontaneous case was received on 08-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-03165) and concerned a 19-year-old, female patient.  The patient's current condition included asthma. The patient's concomitant medications were not reported.  On 29-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: upper left arm) for flu prevention. The batch number reported was P100247215, expiration date: 30-Jun-2021.   On 30-Sep-2020, reported as the next day, one day after vaccination with Afluria Quadrivalent, the patient developed papules on trunk and extremities, like chickenpox. It was reported that the patient did not have any treatment associated with event.  The outcome of the event 'papule' was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: Papule were associated with the use of the suspect product Afluria Quadrivalent. One day after vaccination with vaccine, the patient developed papules on trunk and extremities, described as 'like chickenpox'. The patient's current condition included asthma. Concomitant medications were not reported. With information presented, causality is assessed as possibly related due to plausible chronology.; Sender's Comments: Papule were associated with the use of the suspect product Afluria Quadrivalent. One day after vaccination with vaccine, the patient developed papules on trunk and extremities, described as 'like chickenpox'. The patient's current condition included asthma. Concomitant medications were not reported. With information presented, causality is assessed as possibly related due to plausible chronology.
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: Itching on his head, arms and back; This spontaneous case was received on 09-Oct-2020 from a physician via Health Authority (reference number: SEQW20-03298) and concerned an adult, male patient. At time of this report, the patient was 46-years-old.  The patient's medical history and concomitant medications were not reported.    On an unspecified date in 2019, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 261198.   On the same day, one hour after receiving Flucelvax QIV, the patient started to have itching on his head, arms and back. There was no visible rash though.  The outcome of event was not reported.  The reporter did not provide a causality assessment.   Company comment: The event of 'itching' was considered as related to Flucelvax QIV.; Sender's Comments: The event of 'itching' was considered as related to Flucelvax QIV.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Hives located at the torso, back, buttocks, shoulder and bilaterally; This spontaneous case was received on 12-Oct-2020 from other non-health professional (consumer) via Health Authority (reference number: SEQW20-03369) and concerned a 50-year-old, male patient.  The patient had no relevant medical history. The patient's concomitant medications included Truvada (emtricitabine, tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).  On 03-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid-right arm) for influenza immunisation. The batch number was not reported.  On the same day, eight hours after receiving Flucelvax QIV, the patient developed hives located at the torso, back, buttocks, shoulder and bilaterally. The patient was treated with Benadryl for the event.  On 04-Oct-2020, the symptoms were resolved overnight, and the patient recovered from the event of hives.   The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment: The event of hives is assessed as related to Flucelvax QIV.; Sender's Comments: The event of hives is assessed as related to Flucelvax QIV.
Sex: U
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema that started in the injection site area and spread up to the shoulder; Swelling and erythema that started in the injection site area and spread up to the shoulder; Patient under 65 years of age received Fluad (TIV); This spontaneous case was received on 12-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03386) and concerned a patient of an unspecified age and gender, who was under the age of 65 at the time of this report.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml; route of administration: intramuscular and anatomical location: not reported) (explicitly coded as 'Inappropriate age at vaccine administration') as influenza prophylaxis. The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Fluad (TIV) vaccine, the patient experienced severe swelling and erythema that started in the injection site area and spread up to the shoulder.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202005145 and 202005146 (the same reporter).  Company comment: A patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: A patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Sex: U
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: Swelling and erythema that started in the injection site area and spread up to the shoulder; Swelling and erythema that started in the injection site area and spread up to the shoulder; Patient under 65 years of age was received Fluad (TIV); This spontaneous case was received on 12-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-03386) and concerned a patient of an unspecified age and gender, who was under the age of 65 at the time of this report.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml; route of administration: intramuscular and anatomical location: not reported) (explicitly coded as 'Inappropriate age at vaccine administration') as influenza prophylaxis. The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Fluad (TIV) vaccine, the patient experienced severe swelling and erythema that started in the injection site area and spread up to the shoulder.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202005144 and 202005146 (the same reporter).  Company comment: A patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: A patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: Swelling and erythema that started in the injection site area and spread up to the shoulder; Swelling and erythema that started in the injection site area and spread up to the shoulder; Patient under 65 years of age reecived Fluad (TIV); This spontaneous case was received on 12-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03386) and concerned a female patient of an unspecified age, who was under the age of 65 at the time of this report.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml; route of administration: intramuscular and anatomical location: not reported) (explicitly coded as 'Inappropriate age at vaccine administration') as influenza prophylaxis. The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Fluad (TIV) vaccine, the patient experienced severe swelling and erythema that started in the injection site area and spread up to the shoulder. The patient's arm was twice its normal size.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202005144 and 202005145 (the same reporter).  Company comment: The patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient's medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes). Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: The patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient's medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes). Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Delayed hypersensitive reaction of itchy hives all over my body; Delayed hypersensitive reaction of itchy hives all over my body; Delayed hypersensitive reaction of itchy hives all over my body; This spontaneous case was received on 19-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03840), processed together with additional information received on 20-Oct-2020 and concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included a flu vaccine in 2016 with delayed hypersensitive reaction of itchy hives all over the patient's body on it (reported as the exact same reaction which the patient experienced in 2020).  On an unspecified date 2020, the patient was vaccinated with Flucelvax QIV 2020-2021 (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration, anatomical location and indication: not reported). The batch number reported was 279844.  On an unspecified date in 2020, an unknown amount of time after receiving Flucelvax QIV, the patient experienced delayed hypersensitive reaction of itchy hives all over the body. The patient was advised and treated by a doctor.   The outcome of events was not reported.  The reporter assessed events as related to influenza virus vaccine polyvalent. The patient had the exact same reaction to the 2016 flu vaccine.  This case is linked to the case 202005291 (the same patient).  Company comment: A female patient of unreported age, was vaccinated with Flucelvax QIV vaccine. An unknown amount of time after receiving Flucelvax QIV, the patient experienced type IV hypersensitivity reaction, pruritus and urticaria. Reportedly, the patient had the exact same reaction to the 2016 flu vaccine. With information available, causality is assessed as possibly related for all events.; Reporter's Comments: The reporter stated: I had the exact same reaction to the 2016 flu vaccine.; Sender's Comments: A female patient of unreported age, was vaccinated with Flucelvax QIV vaccine. An unknown amount of time after receiving Flucelvax QIV, the patient experienced type IV hypersensitivity reaction, pruritus and urticaria. Reportedly, the patient had the exact same reaction to the 2016 flu vaccine. With information available, causality is assessed as possibly related for all events.
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Hives on the torso and then neck; This is a spontaneous case was received on 19-Oct-2020 from pharmacist via Health Authority (reference number: SEQW20-03881) and concerned an elderly female patient of an unspecified age.  The patient's concurrent conditions were not reported. The patient's historical vaccine included Afluria QIV vaccine (influenza vaccine). The patient's concomitant medications included several unspecified medications for an unreported indication.  On 08-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, and route of administration: intramuscular) as influenza prophylaxis. The batch number reported was 276539.  On the same day, immediately after receiving Flucelvax QIV, the patient developed hives on the torso and then neck.  On an unspecified date in Oct-2020, the patient recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The event 'urticaria localized' is considered as related to Flucelvax QIV vaccine.; Sender's Comments: The event 'urticaria localized' is considered as related to Flucelvax QIV vaccine.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Lot of pain on the neck/ it hurts a lot; Constrain muscle on the shoulder; Pain close to her neck; Pain in the arm; Difficulties moving her neck; The injection site is bruised, a little green in the injection site; This spontaneous case was received on 16-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03809) and concerned a 51-year-old female patient.  The patient had no relevant medical history. The patient's concomitant medications were not reported.  On 10-Oct-2020, the patient was vaccinated with Flucelvax QIV  (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml; route of administration: intramuscular; anatomical location: left arm) for influenza prophylaxis. The batch number reported was 279844 and expiry date: 30-Jun-2021.  On the same day, one hour after receiving Flucelvax QIV, the patient felt pain on the arm.    On 11-Oct-2020, one day after receiving Flucelvax QIV, patient felt constrain muscle on the shoulder and by afternoon she felt pain close to her neck.   On 12-Oct-2020, two days after receiving Flucelvax QIV, the patient felt a lot of pain on the neck.   On 13-Oct-2020, the patient waited 3 days, as advised by the pharmacy and symptoms got worse.  On an unknown date in Oct-2020, the patient had difficulties moving her neck, since it hurt a lot, also the injection site was bruised, a little green in the injection site. The patient took ibuprofen and Tylenol (paracetamol) as a treatment and also put heat cream for pain relief in the neck area. The patient scheduled an appointment for the doctor next Monday.   At the time of initial reporting on 16-Oct-2020, patient had not recovered from events and was getting worse, without improvement.   The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment:The patient developed pain in extremity, musculoskeletal stiffness, pain and neck pain within two days after vaccination with the suspect product, Flucelvax QIV. The events of movement disorder and injection site bruising occurred on an unknown date within same month. According to narrative, chronology seems plausible. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain in extremity, musculoskeletal stiffness, pain and neck pain within two days after vaccination with the suspect product, Flucelvax QIV. The events of movement disorder and injection site bruising occurred on an unknown date within same month. According to narrative, chronology seems plausible. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Mobility decreased, Pain in extremity
Clinical narrative: Feels like bursitis; Left elbow pain that radiates to forearm; Problems lifting his left arm; This spontaneous case was received on 20-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-03957) and concerned a male patient of unspecified age.  The patient's medical history and concomitant medications were not reported.   On 02-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: left deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was P100244639 and expiry date 23-Jun-2021.   On an unspecified date in Oct-2020, an unknown amount of time after vaccination with Afluria Quadrivalent, the patient experienced problems lifting his arm, left elbow pain that radiated to forearm and felt like bursitis. The patient was referred to healthcare professional.  At the time of initial reporting on 20-Oct-2020, the patient had not recovered from events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  This case is linked to cases 202005338 and 202005339 (the same reporter).  Company comment: A male patient of unspecified age was administered Afluria Quadrivalent vaccine. An unknown amount of time after receiving vaccine, the patient experienced bursitis, radiating pain and injected limb mobility decreased. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A male patient of unspecified age was administered Afluria Quadrivalent vaccine. An unknown amount of time after receiving vaccine, the patient experienced bursitis, radiating pain and injected limb mobility decreased. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Left arm pain that in her shoulder that radiated to her neck and down; Left arm pain that in her shoulder that radiated to her neck and down; Left arm pain that in her shoulder that radiated to her neck and down; Left arm pain that in her shoulder that radiated to her neck and down; This spontaneous case was received on 20-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03967) and concerned a female patient of unknown age.  The patient's medical history and concomitant medications were not reported.   On 02-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: left deltoid, route of administration not reported) for influenza prophylaxis. The batch number reported was P100244639 and expiry date 23-Jun-2021.   On unspecified date, an unknown amount of time after vaccination with Afluria Quadrivalent, the patient experienced left arm pain that from shoulder radiated to her neck and down to the forearm.   At the time of initial reporting on 20-Oct-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  This case is linked with cases 202005333 and 202005339 (the same reporter).  Company comment:The patient developed pain, neck pain, pain in extremity and musculoskeletal pain on an unspecified date after vaccination with Afluria Quadrivalent. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain, neck pain, pain in extremity and musculoskeletal pain on an unspecified date after vaccination with Afluria Quadrivalent. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Problems lifting her right arm/now is hurting again; Problems lifting her right arm/now is hurting again; This spontaneous case was received on 20-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-03968) and concerned a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported.   On 02-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: right deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was P100244639 and expiry date: 23-Jun-2021.   On an unspecified date in Oct-2020, an unknown amount of time after receiving Afluria Quadrivalent, the patient experienced problems when lifting her right arm. The patient was seen by her healthcare professional (HCP) and was given steroids. The patient reported it felt better but was hurting again now.   At the time of initial reporting on 20-Oct-2020, the patient had not recovered from events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  This case is linked to cases 202005333 and 202005338 (the same reporter).  Company comment: A female patient of unspecified age was administered Afluria Quadrivalent vaccine. An unknown amount of time after receiving Afluria Quadrivalent, the patient experienced pain in extremity and injected limb mobility decreased. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A female patient of unspecified age was administered Afluria Quadrivalent vaccine. An unknown amount of time after receiving Afluria Quadrivalent, the patient experienced pain in extremity and injected limb mobility decreased. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related.
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Upper arm swelling; Upper arm heat; Upper arm redness; This spontaneous case was received on 20-Oct-2020 from other non-health professional via Health Authority (reference number: SEQW20-03981) and concerned a 9-year-old, male patient.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 283850 and expiration date: 30-Jun-2021.  On an unspecified date, an unknown amount of time after receiving Flucelvax QIV, the patient developed upper arm swelling, heat and redness. It was not known whether the patient received any corrective treatment.  The outcome of events was unknown.  The reporter did not provide causality assessment.  This case was assessed as non-serious.  Company comment:The patient developed peripheral swelling, skin warm and erythema on an unknown date and unknown amount of time after vaccination with the suspect product, Flucelvax QIV. Chronology is unclear. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as unassessable, due to the lack of information regarding events onset date.; Sender's Comments: The patient developed peripheral swelling, skin warm and erythema on an unknown date and unknown amount of time after vaccination with the suspect product, Flucelvax QIV. Chronology is unclear. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as unassessable, due to the lack of information regarding events onset date.
Sex: U
Vaccine: FLUC4
Symptoms: Erythema
Clinical narrative: More redness than a normal post-vaccination reaction; This spontaneous case was received on 21-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-04056) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent;  dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number was 283847 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient was treated with Benadryl(diphenhydramine hydrochloride).  At the time of initial reporting on 21-Oct-2020, the patient had not recovered from the event of redness.  The reporter assessed the case as related to Flucelvax QIV.  The reporter assessed the case as non-serious.  This case is linked to cases 202005363, 202005385 and 202005386 (due to the same reporter).  Company comment: A patient of an unreported age was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed erythema. Reportedly, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology.; Reporter's Comments: They reported more redness than a normal post-vaccination reaction.; Sender's Comments: A patient of an unreported age was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed erythema. Reportedly, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology.
Sex: U
Vaccine: FLUC4
Symptoms: Erythema
Clinical narrative: More redness than a normal post-vaccination reaction; This spontaneous case was received on 21-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-04056) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number was 283847 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient was treated with Benadryl (diphenhydramine hydrochloride).  At the time of initial reporting on 21-Oct-2020, the patient had not recovered from the event of redness.  The reporter assessed the case as related to Flucelvax QIV.  The reporter assessed the case as non-serious.  This case is linked to cases 202005362, 202005385 and 202005386 (due to the same reporter).  Company comment: A patient of an unreported age was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed erythema. Reportedly, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology.; Reporter's Comments: They reported more redness than a normal post-vaccination reaction.; Sender's Comments: A patient of an unreported age was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed erythema. Reportedly, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation on the same arm as she got vaccinated; This spontaneous case was received on 21-Oct-2020 from pharmacist via Health Authority (reference number: SEQW20-04023) and concerned a 47-year-old, female patient.   The patient had no relevant medical history and was not taking any concomitant medications.  On 04-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: right arm) for flu prevention. The batch number reported was 276566 and expiration date: 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed tingling sensation on the same arm as she got vaccine. The patient did not receive any corrective treatment.  At the time of initial reporting on 21-Oct-2020, the patient had not recovered from event.  The reporter did not provide causality assessment.  The reporter assessed this case as non-serious.  Company comment: Event 'tingling of extremity' is assessed as related to Flucelvax QIV.; Sender's Comments: Event 'tingling of extremity' is assessed as related to Flucelvax QIV.
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: Allergy reaction; This spontaneous case was received on 21-Oct-2020 from other non-health professional (consumer) via Health Authority (reference number: SEQW20-04038) and concerned an elderly patient of unknown gender. At the time of this report, the patient was 77-year-old.  The patient's medical history and concomitant medications were not reported.   On unspecified date, the patient was vaccinated with Afluria Quadrivalent season 2018/2019 (influenza vaccine; dose: 0.5 ml, anatomical location and route of administration: not reported) for flu prevention. The batch number was not reported.   On unspecified date, after receiving Afluria Quadrivalent, the patient experienced allergy reaction.  The outcome of the event was not reported.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: The event of 'allergy reaction' is assessed as related to Afluria Quadrivalent vaccine.; Sender's Comments: The event of 'allergic reaction' is assessed as related to Afluria Quadrivalent vaccine.
Sex: U
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: High fever; This spontaneous case was received on 21-Oct-2020 from pharmacist via Med Communications (reference number: SEQW20-04071) and concerned a patient of an unspecified age and gender.  The patient's medical history and concomitant medications were not reported.  On 20-Oct-2020, the patient was vaccinated with Fluad ((unknown if trivalent or quadrivalent) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration, dose and anatomical location: not reported) for protection against seasonal influenza. The batch number reported was not reported.  On the same day, the patient was vaccination with non-company co-suspect "multiple" other vaccines (dose, route of administration, anatomical location and indication: not reported). The batch number reported was not reported.  On unknown date in Oct-2020, the patient experienced high fever. The reporter referred patient to their physician for guidance.  At the time of initial reporting on 21-Oct-2020, the patient did not recover from the event.  The reporter did not provide causality assessment. The reporter stated that "it probably wasn't a good idea" to received "multiple" other vaccines at the same time.  The case was assessed as non-serious.  Case updated on 30-Oct-2020: Correction made to information received on 21-Oct-2020: Narrative amended with co-suspect vaccines, treatment measures and causality statement.  Company Comment: The event of 'pyrexia' was assessed as related to Fluad.; Sender's Comments: The event of 'pyrexia' was assessed as related to Fluad.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: Redness; Tenderness; Itching; 2 small blisters at the site of injection; This spontaneous case was received on 21-Oct-2020 from other health professional via agency (reference number: SEQW20-04014) and concerned a 51-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283852 and expiration date: 30-Jun-2021.  On an unspecified day in Oct-2020, an unknown amount of time after receiving Flucelvax QIV, the patient experienced itching, redness, tenderness and developed two small blisters at the site of injection. The patient used the band aid after vaccination and blisters were noted after she removed band aid. After that, the blisters got better.  At the time of initial reporting on 21-Oct-2020, the patient was recovering from blisters at the site of injection.  The outcome of itching, redness and tenderness was not reported.  The reporter assessed blisters at the site of injection as not related to Flucelvax QIV and related to bend aid and did not provide causality assessment for other events.  The reporter assessed this case as non-serious.  Company comment: A 51-year-old patient was administered Flucelvax QIV vaccine. An unknown amount of time after receiving vaccine, the patient developed tenderness, erythema, pruritus and vaccination site vesicles. The patient used the band aid after vaccination and blisters were noted after she removed band aid. However, causality is assessed as possibly related for all events.; Reporter's Comments: The reporter thought that the blisters were a reaction to the Band Aid and not the vaccine.; Sender's Comments: A 51-year-old patient was administered Flucelvax QIV vaccine. An unknown amount of time after receiving vaccine, the patient developed tenderness, erythema, pruritus and vaccination site vesicles. The patient used the band aid after vaccination and blisters were noted after she removed band aid. However, causality is assessed as possibly related for all events.
Sex: U
Vaccine: FLUC4
Symptoms: Erythema, Injection site swelling, Rash, Tenderness
Clinical narrative: Rash and redness on the arm and it was tender to the touch; Rash and redness on the arm and it was tender to the touch; Rash and redness on the arm and it was tender to the touch; Golf ball size swelling at the injection site; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04047) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2020, reported as within the last week from initial reporting, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: not reported) for prevention of seasonal influenza. The batch number reported was 283852 and expiration date 30-Jun-2021.  On an unspecified date in Oct-2020, an unknown amount of time after receiving Flucelvax QIV, the patient developed a golf ball size swelling at the injection site on arm. The patient also developed a rash and redness on the arm, and it was tender to the touch. The reporter stated it was not life threatening.  The outcome of the events was unknown.  The reporter assessed the events to be related to Flucelvax QIV. Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.  This case is linked with cases 202005388, 202005389 and 202005390 (due to same reporter).  Additional information received on 05-Nov-2020 from pharmacist via Med Communications (SEQW20-04786): Reported provided causality. Causality changed from not reported to related. New reference number added. New reporter added. Narrative amended.  Company comment: A patient of an unreported age was administered Flucelvax QIV vaccine. The patient developed tenderness, erythema, rash and vaccination site swelling. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related for all events.; Reporter's Comments: Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.; Sender's Comments: A patient of an unreported age was administered Flucelvax QIV vaccine. The patient developed tenderness, erythema, rash and vaccination site swelling. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related for all events.
Sex: U
Vaccine: FLUC4
Symptoms: Erythema, Injection site swelling, Rash, Tenderness
Clinical narrative: Rash and and redness on the arm and it's tender to the touch; Rash and and redness on the arm and it's tender to the touch; Rash and and redness on the arm and it's tender to the touch; Golf ball size swelling at the injection site; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04047) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2020, reported as within the last week from initial reporting, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: not reported) for prevention of seasonal influenza. The batch number reported was 283852 and expiration date 30-Jun-2021.  On an unspecified date in Oct-2020, an unknown amount of time after receiving Flucelvax QIV, the patient developed a golf ball size swelling at the injection site on arm. The patient also developed a rash and redness on the arm, and it was tender to the touch. The reporter stated it was not life threatening.  The outcome of the events was unknown.  The reporter assessed the events to be related to Flucelvax QIV. Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.  This case is linked with cases 202005387, 202005389 and 202005390 (due to same reporter).  Additional information received on 05-Nov-2020 from pharmacist via Med Communications (SEQW20-04786): Reported provided causality. Causality changed from not reported to related. New reference number added. New reporter added. Narrative amended.  Company comment:The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.; Sender's Comments: The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Sex: U
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash and redness on the arm and it's tender to the touch; Rash and redness on the arm and it's tender to the touch; Rash and redness on the arm and it's tender to the touch; Golf ball size swelling at the injection site; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04047) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2020, reported as within the last week from initial reporting, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: not reported) for prevention of seasonal influenza. The batch number reported was 283852 and expiration date 30-Jun-2021.  On an unspecified date in Oct-2020, an unknown amount of time after receiving Flucelvax QIV, the patient developed a golf ball size swelling at the injection site on arm. The patient also developed a rash and redness on the arm, and it was tender to the touch. The reporter stated it was not life threatening.  The outcome of the events was unknown.  The reporter assessed the events to be related to Flucelvax QIV. Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.  This case is linked with cases 202005387, 202005388 and 202005390 (due to same reporter).  Additional information received on 05-Nov-2020 from pharmacist via Med Communications (SEQW20-04786): Reported provided causality. Causality changed from not reported to related. New reference number added. New reporter added. Narrative amended.  Company comment:The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.; Sender's Comments: The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).