chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUC4
Symptoms: Injection site swelling, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: A rash and redness on the arm and it's tender to the touch; A rash and redness on the arm and it's tender to the touch; A 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 202005389 (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: F
Vaccine: FLUC4
Symptoms: Dehydration, Diarrhoea, Fatigue, Tremor, Vomiting
Clinical narrative: Dehydrated; Tired; Shaking; Vomiting; Diarrhea; This spontaneous case was received on 22-Oct-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-04102) and concerned a female patient. Discrepant information about the age was provided. Date of birth was reporter as the patient was 69-year-old, but it was also reported that the patient was 59-years-old.  The patient's medical history included thyroidectomy. The patient's concomitant medications included Synthroid (levothyroxine sodium), Wellbutrin (bupropion hydrochloride), both used for unreported indication.   On 20-Oct-2020, at 11:55 am, 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 shoulder) for influenza prophylaxis. The batch number reported was 276557 and expiry date 30-Jun-2021.   On the same day, between 10:00 pm and 3:00 am, the patient experienced severe vomiting and diarrhea and shaking (three episodes), the patient contacted the pharmacy and reported that she never had a reaction to a flu vaccine.  On 21-Oct-2020, the patient felt tired and dehydrated.   On 22-Oct-2020, the patient recovered from the events felt tired and dehydrated.    The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A patient was administered Flucelvax QIV vaccine. On the same day, the patient experienced vomiting, diarrhoea and tremor. One day later, the patient developed fatigue and dehydration. The patient's medical history included thyroidectomy. The patient's concomitant medications included Synthroid (levothyroxine sodium), Wellbutrin (bupropion hydrochloride), both used for unreported indication. Concomitant medications may have contributed to development of the events. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related due to plausible chronology.; Sender's Comments: A patient was administered Flucelvax QIV vaccine. On the same day, the patient experienced vomiting, diarrhoea and tremor. One day later, the patient developed fatigue and dehydration. The patient's medical history included thyroidectomy. The patient's concomitant medications included Synthroid (levothyroxine sodium), Wellbutrin (bupropion hydrochloride), both used for unreported indication. Concomitant medications may have contributed to development of the events. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related due to plausible chronology.
Age: 12.0
Sex: U
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Pain in extremity, Skin warm, Urticaria
Clinical narrative: Half dollar sized welt, hot to touch/ the site is 2 degrees warmer than normal temperature; Pain down to elbow and near shouder blade; Half dollar sized welt; Pain down to elbow and near shouder blade; This spontaneous case was received on 22-Oct-2020 from pharmacist via Med Communications (reference number: SEQW20-04121) and concerned a 12-year-old patient of unspecified gender.   The patient's medical history and concomitant medications were not reported.   On 20-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration, anatomical location and indication: not reported). The batch number reported was 279827, expiry date: 18-Jun-2021.   On an unspecified date in Oct-2020, unknown amount of time after receiving Flucelvax QIV, the patient developed half dollar sized welt, hot to touch and pain down to elbow and near shoulder blade. The patient's mother scanned welts with a thermometer and the site was 2 degrees warmer than normal temperature. No treatment measures were used.  At the time of initial reporting on 22-Oct-2020, the patient had not recovered from events.    The reporter assessed the case as non-serious.  Company comment: The patient developed skin warm, pain in extremity, urticaria and musculoskeletal pain on an unspecified date within same month, 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).; Sender's Comments: The patient developed skin warm, pain in extremity, urticaria and musculoskeletal pain on an unspecified date within same month, 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: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; This spontaneous case was received on 22-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04125) and concerned a female child patient of unreported age. At the time of this report the patient was 10 years old.  The patient's medical history included pollen allergy. The patient's concomitant medications were not reported.   On an unspecified date in 2018, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.   On an unspecified date in 2018, the patient experienced redness, swelling, warmth, and severe itch on injection site.   The outcome of the events was not reported.  The reporter did not provide causality assessment.  This case is linked with cases 202005408, 202005409 (the same patient) and 202005414, 202005411 (the same reporter).  Company comment: The patient developed all events 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 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 and unknown amount of time after vaccination with the suspect product, Flucelvax QIV. 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: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; This spontaneous case  was received on 22-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04125) and concerned a female child patient of unreported age. At the time of this report the patient was 10-years-old.  The patient's medical history included pollen allergy. The patient's historical vaccines included Flucelvax QIV vaccines in 2018, with the same reaction of redness, swelling, warmth and severe itch on injection site. The patient 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; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.   On an unspecified date in 2019, the patient experienced redness, swelling, warmth, and severe itch on injection site.   The outcome of the events was not reported.  The reporter did not provide causality assessment.  This case is linked with cases 202005407, 202005409 (the same patient) and 202005414, 202005411 (the same reporter).  Company comment: A female child patient of unreported age was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A female child patient of unreported age was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. Causal role of the suspect vaccine is assessed as possibly related for all events.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: Redness, swelling, warmth and severe itch on injection site; Redness, swelling, warmth and severe itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and severe itch on injection site; This spontaneous case was received on 22-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04125) and concerned a 10-years-old, female patient.  The patient's current condition included pollen allergy. The patient's historical vaccines included two previous Flucelvax QIV vaccines in 2019 and 2018, with the same reaction of redness, swelling, warmth and severe itch on injection site. The patient was not taking any concomitant medications.   On 15-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 283847 and expiry date 30-Jun-2021.   On the same day, after vaccination with Flucelvax QIV, the patient experienced redness, swelling, warmth, and severe itch on injection site.   On 16-Oct-2020, the patient took ibuprofen as a treatment medication.   On 18-Oct-2020, the patient recovered from all the events.   The reporter did not provide causality assessment but reported this was third year in a row with the same reaction, same product (FLV QIV).  The reporter assessed the case as non-serious.  This case is linked with cases 202005407, 202005408 (the same patient) and 202005414, 202005411 (the same reporter).  Company comment: A 10-years-old, female patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. Causal role of the suspect vaccine is assessed as possibly related for all events.; Reporter's Comments: Third year in a row with the same reaction, same product (FLV QIV).; Sender's Comments: A 10-years-old, female patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. Causal role of the suspect vaccine is assessed as possibly related for all events.
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; This spontaneous case  was received on 22-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04125) and concerned a 67-year-old female patient.  The patient's concurrent conditions included allergies to pollen. The patient's concomitant medications included omeprazole, HCTZ and meloxicam, all used for unreported indications.  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 was 283847 and expiry date 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient experienced redness, swelling, warmth, and severe itch on injection site. The patient was treated with cetirizine and hydrocortisone cream for the events.  On 21-Oct-2020, the patient was recovering from the events, as reported symptoms were resolving, but still had symptoms.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed all the events as non-serious.  This case is linked to cases 202005407, 202005408, 202005409 and 202005414 due to the same reporter.  Company comment: A 67-year-old female patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. The patient's concurrent conditions included allergies to pollen. The patient's concomitant medications included omeprazole, HCTZ and meloxicam, all used for unreported indications. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A 67-year-old female patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. The patient's concurrent conditions included allergies to pollen. The patient's concomitant medications included omeprazole, HCTZ and meloxicam, all used for unreported indications. Causal role of the suspect vaccine is assessed as possibly related for all events.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; This spontaneous case was received on 22-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04125) and concerned a 51-year-old female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 15-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 was 283847 and expiry date 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient experienced redness, swelling, warmth, and severe itch on injection site. The patient did not receive any treatment for the events.  On 18-Oct-2020, the patient recovered from all the events.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed all the events as non-serious.  This case is linked to cases 202005407, 202005408, and 202005409, 202005411 due to the same reporter.  Company comment:The patient developed vaccination site warmth, vaccination site pruritus, vaccination site swelling and vaccination site erythema on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. 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 vaccination site warmth, vaccination site pruritus, vaccination site swelling and vaccination site erythema on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. 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: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Swollen red spots; Swollen red spots; Minor hives; Skin tingling and itching in both arms and hands; Skin tingling and itching in both arms and hands; This spontaneous case was received on 23-Oct-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-04198) and concerned a 35-year-old, female patient.   The patient historical conditions included reconstructive surgery at right wrist and anaphylactic reactions to jalapenos, chocolate, cucumber, pickles and bees. The patient's concurrent conditions included allergies to unspecified pain medications, oxytocin, prednisone and steroids. The patient's concomitant medications included unspecified prenatal vitamins, used for an unreported indication.  On 20-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: deltoid of left arm and indication: not reported). The batch number reported was 283849 and expiration date: 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed swollen red spots, minor hives, skin tingling and itching in both arms and hands. The patient was treated with unspecified pain killer and Benadryl (diphenhydramine hydrochloride).  At the time of initial reporting on 23-Oct-2020, the patient was recovering from the events.  The reporter did not provide causality assessment.  The reporter assessed this case as non-serious.  Company comment: All events were assessed as related to Flucelvax QIV.; Sender's Comments: All events were assessed as related to Flucelvax QIV.
Sex: F
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Rash all over her body; This spontaneous case was received on 23-Oct-2020 from other health professional via Med Communications (reference number: SEQW20-04173) and concerned a female patient of unreported age.   The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Fluad (TIV), the patient developed rash all over her body.  The outcome of rash was not reported.  The reporter did not provide a causality assessment.  Company comment: The event of 'rash all over' is assessed as related to Fluad (TIV).; Sender's Comments: The event of 'rash all over' is assessed as related to Fluad (TIV).
Sex: F
Vaccine: FLUC4
Symptoms: Lymphadenopathy, Weight decreased
Clinical narrative: Large lymph nodes in my right armpit and my neck; Lost 7 pounds; Still not myself; Diarrhea; This spontaneous case was received on 26-Oct-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-04239) and concerned a female patient of unreported age.  The patient's historical vaccine included unspecified influenza virus vaccine with unspecified adverse reaction. The patient's medical history and concomitant medications were not provided.  On 01-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; anatomical location: right arm, dose and route of administration: not reported) for flu prevention. The batch number reported was 276571 and expiration date: 30-Jun-2021.  On 02-Oct-2020, one day after vaccination with Flucelvax QIV, the patient experienced large lymph nodes in the right armpit and her neck.   On an unknown date in Oct-2020, the patient experienced severe diarrhoea for five days and was treated with unspecified antibiotics and probiotics. The patient also lost seven pounds and she was not herself, as reported.  On an unknown the in Oct-2020, the patient recovered from the event of diarrhoea.  At the time of initial reporting on 26-Oct-2020, the patient had not recovered from the event of 'feeling abnormal'.   The outcome of the events 'lymph nodes enlarged' and 'weight loss' was not reported.  The reporter assessed the case as non-serious.  This case is linked to the cases 202005553 (the same patient) and 202005556 (the same reporter).  Company comment: A female patient of unreported age, was vaccinated with Flucelvax QIV. One day after vaccination with Flucelvax QIV, the patient experienced lymphadenopathy. On an unknown date in Oct-2020, the patient experienced severe diarrhoea for five days and was treated with unspecified antibiotics and probiotics. The patient also lost seven pounds and she was not herself (feeling abnormal), as reported. Causality is assessed as possibly related for lymphadenopathy. Treating diarrhoea with antibiotics confounds causality, and weight loss was likely associated with it. Temporal relationship was unclear. For diarrhoea, weight loss and feeling abnormal, causality is also unassesable due to lack of information.; Sender's Comments: A female patient of unreported age, was vaccinated with Flucelvax QIV. One day after vaccination with Flucelvax QIV, the patient experienced lymphadenopathy. On an unknown date in Oct-2020, the patient experienced severe diarrhoea for five days and was treated with unspecified antibiotics and probiotics. The patient also lost seven pounds and she was not herself (feeling abnormal), as reported. Causality is assessed as possibly related for lymphadenopathy. Treating diarrhoea with antibiotics confounds causality, and weight loss was likely associated with it. Temporal relationship was unclear. For diarrhoea, weight loss and feeling abnormal, causality is also unassesable due to lack of information.
Sex: F
Vaccine: FLUC4
Symptoms: Gastrointestinal disorder, Hypoaesthesia
Clinical narrative: G.I. problems; Arm was numb; This spontaneous case was received on 26-Oct-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-04239) and concerned a female patient of unreported age.    The patient's medical history and concomitant medications were not reported.     On an unknown 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 flu prevention. The batch number reported was 276571, expiry date: 30-Jun-2021.   On an unknown date, an unknown amount of time after receiving Flucelvax QIV, the patient's arm was numb and she had gastrointestinal (G.I.) problems.   On an unspecified date, two days after the onset, the patient recovered from 'numbness localised'.   The outcome of event 'gastrointestinal disorder NOS' was not reported.   The reporter did not provide causality assessment.   The reporter assessed the case as non-serious.   This case is linked to cases 202005552 and 202005553 (the same reporter).  Company comment: A female patient of unreported age was vaccinated with Flucelvax QIV. An unknown amount of time after receiving Flucelvax QIV, the patient developed hypoaesthesia (arm was numb) and gastrointestinal disorder (gastrointestinal problems). Causality cannot be excluded and is assessed as possibly related for both events.; Sender's Comments: A female patient of unreported age was vaccinated with Flucelvax QIV. An unknown amount of time after receiving Flucelvax QIV, the patient developed hypoaesthesia (arm was numb) and gastrointestinal disorder (gastrointestinal problems). Causality cannot be excluded and is assessed as possibly related for both events.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Eye swelling, Injection site urticaria, Myalgia
Clinical narrative: Joint pain; Swelling around eyes; Myalgia; Hives on left arm; This spontaneous case was received on 26-Oct-2020 from a pharmacist via Med Communications (reference number: SEQW20-04290) and concerned a 60-year-old, female patient.  The patient's concurrent condition included allergy to Mycin (erythromycin). The patient's concomitant medications were not reported.  On 23-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml; route of administration: intramuscular and anatomical location: left arm) as influenza prophylaxis. The batch number was not reported, and expiry date was 30-Jun-2021.  On 24-Oct-2020, one day after receiving Afluria Quadrivalent, the patient felt joint pain, had myalgia, swelling around eyes and hives on left arm where the vaccine was administered. The patient had been receiving influenza vaccines for the last ten years and never felt this.   On an unknown date in Oct-2020, the patient was treated with Benadryl (diphenhydramine hydrochloride).  At the time of initial reporting on 26-Oct-2020, the patient was recovering from events. As reported, it was almost gone, and the patient was better.  The reporter did not provide a causality assessment.  The reporter assessed events as non-serious  Company comment: A 60-year-old, female patient was administered Afluria Quadrivalent vaccine. One day after receiving Afluria Quadrivalent, the patient felt arthralgia, myalgia, periorbital swelling and urticaria on left arm where the vaccine was administered. Chronology is plausible. Based on provided information, causality is assessed as possibly related for all events.; Sender's Comments: A 60-year-old, female patient was administered Afluria Quadrivalent vaccine. One day after receiving Afluria Quadrivalent, the patient felt arthralgia, myalgia, periorbital swelling and urticaria on left arm where the vaccine was administered. Chronology is plausible. Based on provided information, causality is assessed as possibly related for all events.
Sex: M
Vaccine: FLUC4
Symptoms: Accidental exposure to product, Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: A child pulled the arm away awhile being vaccinated and only got around 1/3 of the vaccine; 1/3 leaked to the arm; This spontaneous case was received on 26-Oct-2020 from pharmacist via Med Communications (reference number: SEQW20-04265) and concerned a male child patient. Discrepant information about the age was provided. Reporter stated that the patient was 5 years-old.  The patient had no relevant medical history and was not taking any concomitant medications.  On 25-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: unknown, route of administration: intramuscular, anatomical location: arm and indication: not reported) for flu prevention. The child pulled the arm away while being vaccinated and only got around 1/3 of the vaccine, 1/3 leaked to the arm and 1/3 was still inside of the syringe (explicitly coded as 'Incomplete dose administered' and 'Accidental exposure to product'). The batch number was reported as 279839 and expiry date was reported as 30-Jun-2021.  At the time of initial reporting on 26-Oct-2020, it was not reported if the patient experienced any adverse event after Flucelvax QIV administration.  The reporter assessed the events as non-serious.  Company comment: The child was vaccinated with Flucelvax QIV. Reportedly, the patient pulled the arm away while being vaccinated and only got around 1/3 of the vaccine, 1/3 leaked to the arm and 1/3 was still inside of the syringe. It was not reported whether the patient experience any adverse event. Incorrect dose administered and Accidental exposure to product are assessed as not related, per company's conventions.; Sender's Comments: The child was vaccinated with Flucelvax QIV. Reportedly, the patient pulled the arm away while being vaccinated and only got around 1/3 of the vaccine, 1/3 leaked to the arm and 1/3 was still inside of the syringe. It was not reported whether the patient experience any adverse event. Incorrect dose administered and Accidental exposure to product are assessed as not related, per company's conventions.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Arm pain that has progressed, she describes this as muscle pain, not joint pain; Arm pain that has progressed, she describes this as muscle pain, not joint pain; She is not using her arm much now; This spontaneous case was received on 27-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-04336) and concerned an 80-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 Afluria Quadrivalent vaccine (influenza vaccine; dose: 0.5ml, anatomical location: right deltoid and route of administration: not reported) for influenza prophylaxis. The batch number reported was P100261242 and expiration date: 30-Jun-2021.  On an unspecified day in Sep-2020, a week to ten days after receiving Afluria Quadrivalent vaccine, the patient developed arm pain that progressed. The patient described that pain as muscle pain and not as joint pain.   On an unspecified date in 2020, an unknown amount of time after receiving Afluria Quadrivalent, the patient was not using her arm much. The patient did not receive any treatment medication.   At the time of initial reporting on 27-Oct-2020, the patient had not recovered from events.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment:The patient developed mobility decreased, pain in extremity and myalgia several days after vaccination with the suspect product, Afluria Quadrivalent. Chronology seems plausible. The patient had no relevant medical history and was not taking any concomitant medications. 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 mobility decreased, pain in extremity and myalgia several days after vaccination with the suspect product, Afluria Quadrivalent. Chronology seems plausible. The patient had no relevant medical history and was not taking any concomitant medications. 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: FLUA3
Symptoms: Erythema, Inflammation
Clinical narrative: Inflammatory local reaction with erythema in her upper arm, below the injection site; Inflammatory local reaction with erythema in her upper arm, below the injection site; This spontaneous case was received on 27-Oct-2020 from a physician with additional information (being processed together) received on 28-Oct-2020 via Med Communications (reference number: SEQW20-04351) and concerned a female patient of unreported age.  The patient's historical condition included history of allergies in the childhood for which she received injection therapy. The patient's concurrent condition included allergy to cats, pecan, sulfa drugs and ampicillin. The patient's vaccination history included vaccine with a severe local reaction with swollen arm and induration, erythema in arm, a knot, that may had been an axillary node. It was also reported that the patient had ''it'' the time before that prior vaccination. The patient's concomitant medications were not reported.  On an unspecified date in Oct-2020, the patient was vaccinated with Fluad (TIV) (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: upper arm, dose: 0.5 ml and route of administration: intramuscular) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in Oct-2020, unknown amount of time after vaccination with Fluad (TIV), the patient had a severe inflammatory local reaction with erythema in her upper arm, below the injection site.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment:The patient developed inflammation and erythema on an unknown date after vaccination with the suspect product, Fluad (TIV). Although onset date was not provided, narrative suggested plausible temporal relationship. The patient's concurrent condition included allergy to cats, pecan, sulfa drugs and ampicillin. The patient's concomitant medications were not reported. Considering all above mentioned, 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 inflammation and erythema on an unknown date after vaccination with the suspect product, Fluad (TIV). Although onset date was not provided, narrative suggested plausible temporal relationship. The patient's concurrent condition included allergy to cats, pecan, sulfa drugs and ampicillin. The patient's concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Agitation, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling on the arm; Tenderness; Hot feeling; A 3 inch diameter red area located 1-2 inches below the injection site; Constant pain in left calf; Soreness; Grumpy; Itching; This spontaneous case was received on 28-Oct-2020 from pharmacist via Med Communications (reference number: SEQW20-04406) and concerned a 65-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 26-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: left arm) for influenza prophylaxis. The batch number reported was 283853, expiration date 30-Jun-2021.   On 27-Oct-2020, one day after vaccination, the patient experienced soreness, tenderness, hot feeling, itching and swelling on the arm. The patient had a 3-inch diameter red area located 1-2 inches below the injection site. She did not have fever. The patient felt grumpy and had constant pain in left calf. The patient did not receive any corrective treatment.  At the time of initial reporting on 28-Oct-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The patient developed all events one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. 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 all events one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. 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: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Swelling on the arm; Tenderness; Hot feeling; A 3 inch diameter red area located 1-2 inches below the injection site; Constant pain in left calf; Soreness; Grumpy; Itching; This spontaneous case was received on 28-Oct-2020 from pharmacist via Med Communications (reference number: SEQW20-04406) and concerned a 65-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 26-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: left arm) for influenza prophylaxis. The batch number reported was 283853, expiration date 30-Jun-2021.   On 27-Oct-2020, one day after vaccination, the patient experienced soreness, tenderness, hot feeling, itching and swelling on the arm. The patient had a 3-inch diameter red area located 1-2 inches below the injection site. She did not have fever. The patient felt grumpy and had constant pain in left calf. The patient did not receive any corrective treatment.  At the time of initial reporting on 28-Oct-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The patient developed all events one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. 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 all events one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient had no relevant medical history and was not taking any concomitant medications. 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: FLUC4
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat; Headache; Muscle aches; Fatigue; This spontaneous case was received on 28-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04433) and concerned a male patient of an unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 20-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location and route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On 23-Oct-2020, after receiving Flucelvax QIV vaccine, the patient developed headache, sore throat, muscle aches and fatigue.  At the time of initial reporting on 28-Oct-2020, the outcome of the events was recovering.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  Company comment: The patient developed all events three days after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient's relevant medical history and concomitant medications were not reported. 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 all events three days after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. The patient's relevant medical history and concomitant medications were not reported. 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: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain in injection site when moving arm upward; Pain in injection site when moving arm upward; This spontaneous case was received on 29-Oct-2020 from a pharmacist via Med Communications (reference number: SEQW20-04435) and concerned a 36-year-old, female patient.  The patient's medical history and concomitant medications were reported.  On 21-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; route of administration: intramuscular, anatomical location: not reported) for flu prevention. The batch number reported was P100270298 and expiry date reported was 30-Jun-2021. After batch mapping, these two Seqirus' batch numbers were identified as possible matches P100270294 and P100271298.   On 22-Oct-2020, one day after receiving Afluria Quadrivalent, the patient experienced pain in injection site when moving arm upward. The pain persisted even one week after getting the flu shot.  At the time of initial reporting on 29-Oct-2020, the patient had not recovered from the events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The patient developed pain and vaccination site pain one day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, 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 vaccination site pain one day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. The patient's relevant medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for both events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Headache, Pain in extremity
Clinical narrative: Arm sore; Headache; Pregnant patient received flu vaccine; This spontaneous case was received on 29-Oct-2020 from other non-health professional via Med Communication (reference number: SEQW20-04493) and concerned a 42-year-old, pregnant female patient.  The patient's relevant medical history included unspecified contraceptive, used for in vitro process (used with other pills). The patient's concomitant medications were low doses of ibuprofen and Prenatal DHA (docosahexaenoic acid), both used for unreported indications.  The patient's obstetrical history included two previous pregnancies, one successful and one miscarriage. The estimated delivery date was reported as 29-Jan-2021.  On 28-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, dose: 0.5 ml and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for influenza prophylaxis. The batch number was not reported.  On the same day, after received Flucelvax QIV vaccine, the patient experienced sore arm and headache.  The outcome of the events sore arm and headache was unknown.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  Company comment: A 42-year-old, pregnant patient was vaccinated with Flucelvax QIV. On the same day, after receiving vaccine, the patient experienced pain in extremity and headache. Causal role of the suspect vaccine is assessed as possibly related, considering plausible temporal relationship.  Vaccine exposure during pregnancy is assessed as not related, per company's conventions.; Sender's Comments: A 42-year-old, pregnant patient was vaccinated with Flucelvax QIV. On the same day, after receiving vaccine, the patient experienced pain in extremity and headache. Causal role of the suspect vaccine is assessed as possibly related, considering plausible temporal relationship.  Vaccine exposure during pregnancy is assessed as not related, per company's conventions.