chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain in extremity, Sneezing
Clinical narrative: Arm was sore; Sore throat; Sneezing; Headache; Fatigue; This spontaneous case was received on 16-Sep-2020, from consumer via agency (reference number: SEQW20-01821) and concerned a female patient of an unknown age.  The patient's past medical history included bladder cancer. It was reported that the patient was in remission and healthy. The patient's concomitant medications were not reported.   On 15-Sep-2020, patient was vaccinated with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, indication, route of administration, anatomical location: not reported]. The batch number was not reported.  On an unspecified date in Sep-2020, unknown amount of time after vaccination with Fluad Quadrivalent, the patient's arm was sore. The patient had a sore throat, fatigue, headache and was sneezing. She was concerned about sore throat since she did not think this was side effect of the vaccine and she was wondering if she should get a COVID test.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  Company comment: The patient developed all events on an unknown date but within the same month after vaccination with the suspect product, Fluad Quadrivalent. Chronology is unclear. No information regarding concomitant medications 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 all events on an unknown date but within the same month after vaccination with the suspect product, Fluad Quadrivalent. Chronology is unclear. No information regarding concomitant medications 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: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin burning sensation, Skin warm
Clinical narrative: Red mark on her arm (half dollar in size)/it is burning and is hot to touch; Red mark on her arm (half dollar in size)/it is burning and is hot to touch; Red mark on her arm (half dollar in size)/it is burning and is hot to touch; Itching; This spontaneous case was received on 17-Sep-2020 from a pharmacist via agency (reference number: SEQW20-01866) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported.  On 14-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was P100240196 and expiry date was 19-May-2021.   On the same day, after vaccination, the patient developed a red mark on her arm which was half dollar in size. It was burning and hot to touch and the patient also experienced itching. The patient did not receive any treatment associated with events.  The outcome for the events was not reported.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: The developed erythema, skin burning sensation, skin warm and pruritus on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. No information about 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 developed erythema, skin burning sensation, skin warm and pruritus on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. No information about 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).
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Numbness in left arm; Tingling in left arm; This spontaneous case was received on 17-Sep-2020 from a pharmacist via agency [reference number: SEQW20-01846] and concerned a 48-year-old female patient.  The patient's medical history and concomitant medication were not reported.  On 16-Sep-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: left arm] for influenza prophylaxis. The batch number reported was 276534 and expiry date was 06-Jun-2021.  On an unspecified day in Sep-2020, after receiving Flucelvax QIV, the patient experienced tingling and numbness in the left arm where she had received the vaccine. No corrective treatment was given for the events.  At the time of initial reporting on 17-Sep-2020, the outcome of the events 'localised numbness' and 'tingling of extremity' was not reported.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  Additional information was received on 28-Sep-2020 from Group: Suspect vaccine was changed from Fluad Quadrivalent to Flucelvax QIV. The narrative was amended accordingly.  Company comment: On 16-Sep-2020, a 48-year-old female patient was administered Flucelvax QIV vaccine. On an unspecified day in Sep-2020, after receiving Flucelvax QIV, the patient experienced paraesthesia and hypoaesthesia in the left arm where she had received the vaccine. The patient's medical history and concomitant medication were not reported. Based on provided information, causality is assessed as possibly related for both events.; Sender's Comments: On 16-Sep-2020, a 48-year-old female patient was administered Flucelvax QIV vaccine. On an unspecified day in Sep-2020, after receiving Flucelvax QIV, the patient experienced paraesthesia and hypoaesthesia in the left arm where she had received the vaccine. The patient's medical history and concomitant medication were not reported. Based on provided information, causality is assessed as possibly related for both events.
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site; Administered a 2 mL dose of Flucelvax Quadrivalent in a patient's arm; This spontaneous case was received on 18-Sep-2020 from physician via agency (reference number: SEQW20-01987) and concerned an adult male patient in his 30s.  The patient's medical history and concomitant medications were not reported.   On 18-Sep-2020, in the morning, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 2 ml, route of administration and anatomical location: not reported) (explicitly coded as 'Overdose') for protection against seasonal influenza. The batch number reported was 283847 and expiry date was 30-Jun-2021.   On the same day, five or six hours after vaccination, the patient experienced soreness at the injection site. No treatment was used.  On an unspecified date in Sep-2020, the patient recovered from soreness at the injection site.  The reporter assessed the case as non-serious.  Company comment: The event of 'vaccination site pain' is considered as related, while the event of 'overdose' is considered as not related to Flucelvax QIV.; Sender's Comments: The event of 'vaccination site pain' is considered as related, while the event of 'overdose' is considered as not related to Flucelvax QIV.
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Pallor, Tremor, Vomiting projectile
Clinical narrative: The patinet got very pale; Shaky/shakiness; The patient started projectile vomiting; She was feeling queasy/queasiness; This spontaneous case was received on 18-Sep-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-01986) and concerned an adult, female patient.  The patient's medical history and concomitant medications were not reported.  On 18-Sep-2020 around noon, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right or left arm and route of administration: not reported) for protection against seasonal influenza. The batch reported was 276562 and expiry date was 30-Jun-2021.  On the same day, about five to seven minutes after receiving Flucelvax Quadrivalent, the patient got very pale, shaky, was feeling queasy, and started projectile vomiting. The vomiting episode only occurred once. The shakiness also went away.   On the same day, four hours after receiving Flucelvax Quadrivalent, the queasiness was still occurring. The patient was able to eat a piece of toast about four hours after the incident.   At the time of initial reporting on 18-Sep-2020, the patient was recovering from the event of 'feeling queasy' and 'pale'.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked with case 202004562 (the same patient).  Company comment: The patient developed pallor, tremor, vomiting projectile and nausea on the same day after receiving the suspect product, Flucelvax Quadrivalent. Chronology is suggestive. No information about concomitant medications and medical history was provided. Based on provided information, 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 pallor, tremor, vomiting projectile and nausea on the same day after receiving the suspect product, Flucelvax Quadrivalent. Chronology is suggestive. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship for all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash all over her chest; Rash is very itchy; This spontaneous case from the was received on 18-Sep-2020 from other non-health professional (consumer) to agency (reference number: SEQW20-01965) and concerned a 59-year-old, female patient.  The patient's concurrent conditions and concomitant medications were not reported. The patient's past medication included influenza vaccination without any issues.  On 16-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location and route of administration: not reported) for prevention of seasonal influenza. The batch number was not reported.  On 17-Sep-2020 in the morning, one day after receiving Flucelvax Quadrivalent, the patient developed a rash all over her chest. The reporter stated that the rash was very itchy. Treatment measure included calamine lotion on the rash.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  Company comment: The events of 'localized rash' and 'itchy rash' are considered as related to Flucelvax Quadrivalent vaccine.; Sender's Comments: The events of 'localized rash' and 'itchy rash' are considered as related to Flucelvax Quadrivalent vaccine.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Both hands are swollen; Rash in the face; Fever; This spontaneous case was received on 21-Sep-2020 from pharmacist via agency (reference number: SEQW20-02039) and being processed together with additional information received on 21-Sep-2020 and concerned a 32-year-old female patient.  The patient had no relevant medical history and did not use any concomitant medications.   On 19-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid and route of administration: intramuscular) for influenza prophylaxis. The batch number reported as 2765320 (Seqirus batch number possibly 276530 or 276532) and expiry date was 01-Jun-2021.  On 20-Sep-2020, one day after vaccination, the patient experienced rash in the face, both hands were swollen and mild fever on Sunday that went away with ibuprofen. She was not having difficulty breathing.  On 21-Sep-2020, patient's symptoms were getting worse, but she was not having difficulty breathing. The patient was referred to her treating medical doctor (MD) for medical assistance or to call 911 in case of emergency.   At the time of initial reporting on 21-Sep-2020, the patient had not recovered form 'facial rash' and 'hand swelling'.   The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: A 32-year-old female patient was administered Flucelvax QIV vaccine. One day after receiving Flucelvax QIV, the patient developed rash on face, peripheral swelling and pyrexia. More information regarding medical history and diagnostic findings is needed. However, with information available causal role of the suspect vaccine is assessed as possibly related due to plausible chronology.; Sender's Comments: A 32-year-old female patient was administered Flucelvax QIV vaccine. One day after receiving Flucelvax QIV, the patient developed rash on face, peripheral swelling and pyrexia. More information regarding medical history and diagnostic findings is needed. However, with information available causal role of the suspect vaccine is assessed as possibly related due to plausible chronology.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Tingling tongue; Itchy neck and chest; This spontaneous case reported was received on 22-Sep-2020 from other health professional (nurse) to Agency (reference number: SEQW20-02108) with additional document received on 23-Sep-2020 (being processed together) and concerned a 32-year-old, female patient.  The patient's concurrent conditions included thyroid disease. The patient's concomitant medications included levothyroxine for an unreported indication.  On 21-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 283848 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax Quadrivalent vaccine, the patient experienced tingling tongue and itchy neck and chest.  On the same day, the patient recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with cases 202004667, 202004665, 202004666, 202004663 and 202004664 (the same reporter).  Company comment: The events of 'tingling tongue' and 'localized itching' are assessed as related to Flucelvax Quadrivalent vaccine.; Sender's Comments: The events of 'tingling tongue' and 'localized itching' are assessed as related to Flucelvax Quadrivalent vaccine.
Sex: F
Vaccine: FLUA4
Symptoms: Injection site haemorrhage
Clinical narrative: Minor bleeding at the site of injection after taking the shot; This spontaneous case was received on 16-Sep-2020 from a pharmacist via Agency (reference number: SEQW20-01746) and concerned a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.  On 19-Aug-2020, the patient was vaccinated with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid] influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Fluad Quadrivalent, the patient had minor bleeding at the site of injection. There was no major bleeding, just the patient bled a little after taking the shot and put a band aid on.   On the same day, the patient recovered from the event.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  This case is linked with the case 202004506 (the same reporter).  Company comment:The patient developed vaccination site haemorrhage on the same day after receiving the suspect product, Fluad Quadrivalent. Chronology is suggestive. No information about concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site haemorrhage on the same day after receiving the suspect product, Fluad Quadrivalent. Chronology is suggestive. No information about concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Tenderness, Vaccination site pain, Yellow skin
Clinical narrative: Skin looks yellowish; Huge pain/ She describes her pain as 5 out 10; Tenderness and reddish skin after vaccinated; Tenderness and reddish skin after vaccinated; Arm sensitivity at site of injection; This spontaneous case was received on 22-Sep-2020 from a pharmacist via agency (reference number: SEQW20-02129) and concerned a female patient of unspecified age.  The medical history and concomitant medications of the patient were not reported. The historical vaccines included flu vaccines with no adverse reactions after their administration.  On an unspecified date, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, indication, dose, route of administration and anatomical location: not reported). The batch number and expiry date were not reported.   On the same day, after receiving Fluad Quadrivalent, the patient experienced huge pain. The patient did not take any pain killer.   On an unspecified date, after receiving Fluad Quadrivalent, the patient developed tenderness and reddish skin after getting vaccinated. The patient described the pain as 5 out 10.   On an unspecified date, four weeks after receiving Fluad Quadrivalent, the patient complained about arm sensitivity at site of the injection and skin which looked yellowish.    At the time of initial reporting on 22-Sep-2020, the outcome of the events was not reported.  The reporter did not provide a causality assessment.  Company comment: Yellow skin, pain, tenderness, erythema and vaccination site pain were associated with the use of the suspect product Fluad Quadrivalent. Chronology needs more clarification for all events. The medical history and concomitant medications of the patient were not reported and the historical vaccines included flu vaccines with no adverse reactions after their administration. With information presented, causality is assessed as possibly related for all events since narrative suggests that all event occurred on the vaccinted arm.; Sender's Comments: Yellow skin, pain, tenderness, erythema and vaccination site pain were associated with the use of the suspect product Fluad Quadrivalent. Chronology needs more clarification for all events. The medical history and concomitant medications of the patient were not reported and the historical vaccines included flu vaccines with no adverse reactions after their administration. With information presented, causality is assessed as possibly related for all events since narrative suggests that all event occurred on the vaccinted arm.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Malaise, Vomiting
Clinical narrative: Throwing up; Not feeling quite well; This spontaneous case was received on 22-Sep-2020 from pharmacist via agency (reference number: SEQW20-02125) and concerned a 45-year-old, male patient.  The patient had no relevant medical history. The patient's concomitant medications included Vitamin D (unspecified) for unreported indication.  On 18-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; indication: influenza prophylaxis, dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for influenza prophylaxis. The batch number reported was 276537 and expiry date was 10-Jun-2021.  On an unspecified date in Sep-2020, after receiving Flucelvax QIV, the patient was not feeling quite well.   On 19-Sep-2020, one day after receiving Flucelvax QIV, the patient started throwing up.  On 21-Sep-2020, the patient was still throwing up sporadically.   The outcome of the events 'vomiting' and 'malaise' was unknown.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: The events 'vomiting' and 'malaise' are considered as related to Flucelvax QIV.; Sender's Comments: The events vomiting' and malaise' are considered as related to Flucelvax QIV.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Rash pruritic, Vaccination site pain
Clinical narrative: Red and itchy rash at the site of the vaccine, occupying half of the left upper arm; Red and itchy rash at the site of the vaccine, occupying half of the left upper arm; Pain at the site of administration; This spontaneous case was received on 23-Sep-2020, from other non-health professional via agency (reference number: SEQW20-02193) and concerned a 76-year-old, female patient.     The patient's medical history included eczema, urticaria and allergy to dust and grass. The patient's concomitant medications were not reported.   On 19-Sep-2020, 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, anatomical location: left deltoid) for influenza prophylaxis. The batch number was not reported.  On the same date, after receiving Fluad (TIV), the patient experienced pain at the site of administration.   On the next day 20-Sep-2020, the patient developed a red and itchy rash at the site of the vaccine, occupying half of the left upper arm. Patient said that her doctor told her that some might be due to latex and wanted to know if there were latex in the vaccine.  On 23-Sep-2020, the patient recovered from all events.    The reporter did not provide causality assessment.  The reporter assessed these events as non-serious.  Company comment: The patient developed erythema, vaccination site pain and rash pruritic within one day after vaccination with the suspect product, Fluad (TIV). Chronology is plausible. No information about concomitant medications was provided. No alternative aetiology was provided. Considering all information above, 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 erythema, vaccination site pain and rash pruritic within one day after vaccination with the suspect product, Fluad (TIV). Chronology is plausible. No information about concomitant medications was provided. No alternative aetiology was provided. Considering all information above, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Sex: F
Vaccine: FLUC4
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This spontaneous case was received on 23-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02108) and concerned a 63-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-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) for influenza prophylaxis. The batch number reported was 283848 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed metallic taste.   On the same day, the patient recovered from the event.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the event as non-serious.  This case is linked to cases 202004666, 202004667, 202004665, 202004664 and 202004610 due to the same reporter.  Company comment: Dysgeusia (reported as 'metallic taste') was associated with the use of the suspect product Flucelvax QIV. The event occurred on the same after receiving the product making chronology suggstive.  The patient had no relevant medical history and was not taking any concomitant medications. With information presented, causality is assessed as possibly related due to lack of other confounding factors.; Sender's Comments: Dysgeusia (reported as 'metallic taste') was associated with the use of the suspect product Flucelvax QIV. The event occurred on the same after receiving the product making chronology suggstive.  The patient had no relevant medical history and was not taking any concomitant medications. With information presented, causality is assessed as possibly related due to lack of other confounding factors.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Dysgeusia, Hot flush, Nausea, Swollen tongue
Clinical narrative: Metalic taste; Swollen tongue; Hot flashes; Nausea; Joint pain in the hips and knees; This spontaneous case was received on 23-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02108) and concerned a 49-year-old male patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-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) for influenza prophylaxis. The batch number reported was 28384 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed metalic taste, swollen tongue, hot flashes, joint pain in the hips and knees and nausea. The patient was treated with Benadryl (diphenhydramine hydrochloride).  On 22-Sep-2020, 24 hours later, the patient still had symptoms.  At the time of this report on 23-Sep-2020, the patient did not recover from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  This case is linked to cases 202004667, 202004665, 202004666, 202004663 and 202004610 due to the same reporter.  Company comment: Metallic taste, swollen tongue, hot flush, nausea and arthralgia were associated with the use of the suspect product Flucelvax QIV. The events occurred on the same day after vaccination making chronology suggstive. The patient had no relevant medical history and was not taking any concomitant medications. With information presented, causality is assessed as possibly related for all events due to suggestive chronology and lack of other confounding factors.; Sender's Comments: Metallic taste, swollen tongue, hot flush, nausea and arthralgia were associated with the use of the suspect product Flucelvax QIV. The events occurred on the same day after vaccination making chronology suggstive. The patient had no relevant medical history and was not taking any concomitant medications. With information presented, causality is assessed as possibly related for all events due to suggestive chronology and lack of other confounding factors.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Pain
Clinical narrative: Body aches; Nausea; This spontaneous case was received on 23-Sep-2020 from other health professional via agency (reference number: SEQW20-02108) and concerned a 27-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-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) for influenza prophylaxis. The batch number reported was 283848 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed nausea and body aches. No corrective treatment was given for the event.   On the same day, the patient recovered from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  This case is linked with the cases 202004663, 202004664, 202004666, 202004667 and 202004610 (the same reporter).  Company comment: The patient developed pain and nausea on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all information above, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain and nausea on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all information above, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Feeling hot, Flushing, Skin warm
Clinical narrative: Hot ears; Heat and flushing; Heat and flushing; Diarrhea; This spontaneous case  was received on 23-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02108) and concerned a 30-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-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) for influenza prophylaxis. The batch number reported was 283848 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed hot ears, heat and flushing, then four hours later diarrhea that lasted for four hours.   On the same day, the patient recovered from the events.   The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  This case is linked to cases 202004667, 202004665, 202004663, 202004664 and 202004610 due to the same reporter.  Company comment: The patient developed skin warm, flushing, feeling hot and diarrhea on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all information above, 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 skin warm, flushing, feeling hot and diarrhea on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all information above, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Lymphadenopathy, Pain, Throat irritation
Clinical narrative: Swollen lymph nodes; Ache; Scratchy throat; Fatigue; This spontaneous case was received on 23-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02108) and concerned a 40-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-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) for influenza prophylaxis. The batch number reported was 283848 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed ache, fatigue, swollen lymph nodes and scratchy throat.  On 22-Sep-2020, the patient recovered from all the events.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  This case is linked to cases 202004666, 202004665, 202004663, 202004664 and 202004610 due to the same reporter.  Company comment: A 40-year-old, female patient was administered Flucelvax QIV. On the same day, after receiving Flucelvax QIV, the patient developed pain, fatigue, lymphadenopathy and throat irritation. The patient had no relevant medical history and was not taking any concomitant medications. Causality is assessed as possibly related for all events due to plausible chronology.; Sender's Comments: A 40-year-old, female patient was administered Flucelvax QIV. On the same day, after receiving Flucelvax QIV, the patient developed pain, fatigue, lymphadenopathy and throat irritation. The patient had no relevant medical history and was not taking any concomitant medications. Causality is assessed as possibly related for all events due to plausible chronology.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Headache, Hypoaesthesia, Nausea
Clinical narrative: Dizziness; Numbness of her left arm; Blurry vision; Nausea; Chills; Headache; This spontaneous case  was received on 23-Sep-2020, from pharmacist via agency (reference number: SEQW20-02191) and concerned a 49-year-old, female patient.     The patient had no relevant medical history and reported that she was healthy. The patient's concomitant medications included supplements such as calcium.  On 22-Sep-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: deltoid, left arm) for influenza prophylaxis. The batch number reported was 279828, expiry date: 20-Jun-2021.  On the same day, 15 minutes after receiving Flucelvax QIV the patient experienced side effects such as numbness of her left arm, headache, nausea, dizziness, chills, and she was at bed rest. The patient also had blurry vision. The patient was treated with Claritin (loratadine).   On 23-Sep-2020, side effects seemed to get worst.   At the time of initial reporting on 23-Sep-2020, the patient had not recovered from events.  The reporter assessed the events as non-serious.   The reporter did not provide causality assessment.  Company comment: A 49-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, 15 minutes after receiving Flucelvax QIV the patient experienced dizziness, hypoaesthesia, vision blurred, headache, nausea and chills. The patient had no relevant medical history and it was reported that she was healthy. Chronology is plausible. Causality is assessed as possibly related for all events.; Sender's Comments: A 49-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, 15 minutes after receiving Flucelvax QIV the patient experienced dizziness, hypoaesthesia, vision blurred, headache, nausea and chills. The patient had no relevant medical history and it was reported that she was healthy. Chronology is plausible. Causality is assessed as possibly related for all events.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Vision blurred
Clinical narrative: Dizziness; Numbness of her left arm; Blurry vision; Nausea; Chills; Headache; This spontaneous case  was received on 23-Sep-2020, from pharmacist via agency (reference number: SEQW20-02191) and concerned a 49-year-old, female patient.     The patient had no relevant medical history and reported that she was healthy. The patient's concomitant medications included supplements such as calcium.  On 22-Sep-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: deltoid, left arm) for influenza prophylaxis. The batch number reported was 279828, expiry date: 20-Jun-2021.  On the same day, 15 minutes after receiving Flucelvax QIV the patient experienced side effects such as numbness of her left arm, headache, nausea, dizziness, chills, and she was at bed rest. The patient also had blurry vision. The patient was treated with Claritin (loratadine).   On 23-Sep-2020, side effects seemed to get worst.   At the time of initial reporting on 23-Sep-2020, the patient had not recovered from events.  The reporter assessed the events as non-serious.   The reporter did not provide causality assessment.  Company comment: A 49-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, 15 minutes after receiving Flucelvax QIV the patient experienced dizziness, hypoaesthesia, vision blurred, headache, nausea and chills. The patient had no relevant medical history and it was reported that she was healthy. Chronology is plausible. Causality is assessed as possibly related for all events.; Sender's Comments: A 49-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, 15 minutes after receiving Flucelvax QIV the patient experienced dizziness, hypoaesthesia, vision blurred, headache, nausea and chills. The patient had no relevant medical history and it was reported that she was healthy. Chronology is plausible. Causality is assessed as possibly related for all events.
Sex: U
Vaccine: FLUC4
Symptoms: Vaccination site mass, Vaccination site rash
Clinical narrative: A bump at the site of administration of the vaccine; A 3 inch rash at the site of administration of the vaccine; This spontaneous case was received on 24-Sep-2020 from other non-health professional via agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-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: deltoid) for influenza prophylaxis. The batch number was 283849, expiry date: 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine. The patient did not receive any treatment measures associated with the events.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessmen to Flucelvax QIV.   The case was assessed as non-serious.  This case is linked to cases 202004696, 202004697, 202004698, 202004699, 202004700, 202004701, 202004702, 202004703, 202004704, 202004705 and 202004706 due to the same reporter.  Additional non-significant information received on 06-Jan-2021 from other non-health professional via agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional (reference number: SEQW21-00149) (being processed together): Two reporters were added. Reference numbers added. No changes in narrative.  Company comment: The patient developed vaccination site mass and vaccination site rash on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Considering all information above, causal relationship for both events is assessed as possibly related. (defaults to ''related''in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site mass and vaccination site rash on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Considering all information above, causal relationship for both events assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: Rash around her lips and chin/ having pain on that region since last night; Rash around her lips and chin/ having pain on that region since last night; This spontaneous case  was received on 24-Sep-2020 from a pharmacist via agency (reference number: SEQW20-02277) and concerned a 62-year-old, female patient.   The patient's concurrent conditions included psoriasis and allergy to latex. The patient's concomitant medications included unspecified steroid cream for psoriasis.   On 23-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, left arm) for flu prevention. The batch number reported was P100230210, expiry date: 22-Jun-2021.   On the same day at night, after receiving Afluria Quadrivalent, the patient developed rash around her lips and chin, and she stated having pain on that region.   The patient did not receive any treatment for the events.   At the time of initial reporting on 24-Sep-2020, the patient had not recovered from the events.    The reporter did not provide causality assessment. The pharmacist thought it could be related to patient's psoriasis.  The reporter assessed the events as non-serious.  Company comment: A 62-year-old, female patient was administered Afluria Quadrivalent vaccine. On the same day at night, after receiving Afluria Quadrivalent, the patient developed facial pain and rash. The patient's concurrent conditions included psoriasis and allergy to latex. The patient's concomitant medications included unspecified steroid cream for psoriasis. Causality is assessed as possibly related for both events, due to plausible temporal relationship.; Sender's Comments: A 62-year-old, female patient was administered Afluria Quadrivalent vaccine. On the same day at night, after receiving Afluria Quadrivalent, the patient developed facial pain and rash. The patient's concurrent conditions included psoriasis and allergy to latex. The patient's concomitant medications included unspecified steroid cream for psoriasis. Causality is assessed as possibly related for both events, due to plausible temporal relationship.
Sex: U
Vaccine: FLUC4
Symptoms: Vaccination site mass, Vaccination site rash
Clinical narrative: A bump  at the site of administration of the vaccine; A 3 inch rash at the site of administration of the vaccine; This spontaneous case was received on 24-Sep-2020 from other non-health professional via agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-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: deltoid) for influenza prophylaxis. The batch number reported was 283849, expiry date: 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked with cases: 202004697, 202004698, 202004699, 202004706, 202004701, 202004702, 202004703, 202004704, 202004705, 202004678 and 202004700 (same reporter).  Additional non-significant information received on 06-Jan-2021 from other non-health professional via agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional (reference number: SEQW21-00149) (being processed together): Two additional reporters added. Reference numbers added. No changes in narrative.  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site cellulitis, Skin warm, Vaccination site erythema, Vaccination site pain
Clinical narrative: Hotness at injection site; Redness at injection site; Pain at injection site; This spontaneous case was received on 25-Sep-2020 from pharmacist via agency (reference number: SEQW20-02361) and concerned a 57-year-old, female patient.  The patient's concurrent conditions included type 2 diabetes (T2D) and hypertension. The patient's concomitant medications included metformin, omeprazole and verapamil all used for an unreported indication.  On 23-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, route of administration: intramuscular, dose: 0.5 ml, anatomical location: some inches above the elbow as reported) for flu prevention. The batch number reported was 276575, expiry date: 30-Jun-2021. The used needle was 1 inch 25 gauge (g).   On 24-Sep-2020, one day after receiving Flucelvax QIV, the patient was having redness, hotness and pain at injection site. Only ice was used as a treatment, as reported.  At the time of initial reporting on 25-Sep-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.  Company comment: A 57-year-old, female patient was administered Flucelvax QIV vaccine. One day after receiving Flucelvax QIV, the patient developed vaccination site pain, vaccination site erythema and vaccination site warmth. Only ice was used as a treatment, as reported. Causality is assessed as possibly related. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.; Sender's Comments: A 57-year-old, female patient was administered Flucelvax QIV vaccine. One day after receiving Flucelvax QIV, the patient developed vaccination site pain, vaccination site erythema and vaccination site warmth. Only ice was used as a treatment, as reported. Causality is assessed as possibly related. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.