chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Vaccination site warmth
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.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Influenza like illness, Pain, Pyrexia
Clinical narrative: Achy; Weak; Flu like symptoms; Temperature was 99.1 Farenheit; This spontaneous case was received on 28-Sep-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-02423) and concerned a 79-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included acyclovir occasionally and hormones, both used for unreported indication.  On 24-Sep-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) for flu prophylaxis. The batch number reported was 279809, expiry date: 30-Jun-2021.   On 25-Sep-2020, one day after receiving Fluad Quadrivalent, the patient started having flu like symptoms. The patient was feeling achy, weak but her temperature was 99.1 degrees Fahrenheit.  At the time of initial reporting on 28-Sep-2020, the patient did not recover from the events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: Pain, asthenia, fever and influenza-like illness were associated with the suspect product - Fluad Quadrivalent. One day after receiving the product all events emerged making chronology suggestive. The patient's medical history was not reported while concomitant medications included acyclovir occasionally and hormones, both used for unreported indication. Although influenza like illness developed within same day, it represents a body's normal immune response to the inactivated virus in the vaccine and therefore causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. Causal role for pain, asthenia, fever was also assessed as unlikely related to medicinal product. (''unlikely related'' defaults to ''relate'' in the safety database for reporting purposes); Sender's Comments: Pain, asthenia, fever and influenza-like illness were associated with the suspect product - Fluad Quadrivalent. One day after receiving the product all events emerged making chronology suggestive. The patient's medical history was not reported while concomitant medications included acyclovir occasionally and hormones, both used for unreported indication. Although influenza like illness developed within same day, it represents a body's normal immune response to the inactivated virus in the vaccine and therefore causal role of the suspect product cannot be totally excluded and is assessed as unlikely related. Causal role for pain, asthenia, fever was also assessed as unlikely related to medicinal product. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site; This spontaneous case was received on 28-Sep-2020 from other non-health professional via agency (reference number: SEQW20-02484) and concerned a 59-year old, female patient.   The patient's concurrent conditions included high blood pressure and high cholesterol. The patient's concomitant medications included doxycycline, losartan, atorvastatin, and escitalopram, all used for unreported indications.   On 26-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, expiry date, anatomical location and route of administration) for flu prophylaxis. The batch number reported was not reported.  On 27-Sep-2020, one day after vaccination, the patient experienced pain, redness and swelling at the injection site.   At the time of initial reporting on 28-Sep-2020, the patient had not recovered from events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: The events of 'vaccination site pain', 'vaccination site erythema' and 'vaccination site swelling' are considered as related to Flucelvax QIV.; Sender's Comments: The events of 'vaccination site pain', 'vaccination site erythema' and 'vaccination site swelling' are considered as related to Flucelvax QIV.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Vaccination site erythema, Vaccination site haemorrhage, Vaccination site inflammation
Clinical narrative: The site of injection bled for a second and then swelled immediately; The side of injection was also very red, inflamed and swollen; The site of injection bled for and then swelled immediately/ The side of injection was also very red, inflamed and and swollen; The side of injection was also very red, inflamed and and swollen; This spontaneous case  was received on 28-Sep-2020 from pharmacist via agency (reference number: SEQW20-02452) and concerned 57-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 28-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml; route of administration: intramuscular; anatomical location: not reported) for influenza prophylaxis. The batch number reported was P100253284 and expiry date 03-Jun-2021.  On the same day, immediately after receiving Afluria Quadrivalent the site of injection bled for a second and then swelled. The side of injection was also very red, inflamed and swollen for a while. Pharmacist used alcohol swabs and cotton balls to stop the bleeding, massaged a little bit, and put a band aid on it. It got better for a little while, but soon after it started swelling again and stayed swollen, red and large.  On the same day the patient recovered from the event of 'vaccination site bleeding'.   At the time of initial reporting on 28-Sep-2020, the patient had not recovered from the events 'vaccination site inflammation', 'vaccination site swelling' and 'vaccination site erythema'.  The reporter assessed the events as non-serious.   The reporter did not provide a causality assessment.  Company comment: Vaccination site reactions: haemorrhage, inflammation, swelling and erythema were associated with the use of the suspect product Afluria Quadrivalent. The events occurred immediately after vaccination making chronology highly suggestive. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events.; Sender's Comments: Vaccination site reactions: haemorrhage, inflammation, swelling and erythema were associated with the use of the suspect product Afluria Quadrivalent. The events occurred immediately after vaccination making chronology highly suggestive. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: The site of injection bled for a second and then swelled immediately; The side of injection was also very red, inflamed and swollen; The site of injection bled for and then swelled immediately/ The side of injection was also very red, inflamed and and swollen; The side of injection was also very red, inflamed and and swollen; This spontaneous case  was received on 28-Sep-2020 from pharmacist via agency (reference number: SEQW20-02452) and concerned 57-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 28-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml; route of administration: intramuscular; anatomical location: not reported) for influenza prophylaxis. The batch number reported was P100253284 and expiry date 03-Jun-2021.  On the same day, immediately after receiving Afluria Quadrivalent the site of injection bled for a second and then swelled. The side of injection was also very red, inflamed and swollen for a while. Pharmacist used alcohol swabs and cotton balls to stop the bleeding, massaged a little bit, and put a band aid on it. It got better for a little while, but soon after it started swelling again and stayed swollen, red and large.  On the same day the patient recovered from the event of 'vaccination site bleeding'.   At the time of initial reporting on 28-Sep-2020, the patient had not recovered from the events 'vaccination site inflammation', 'vaccination site swelling' and 'vaccination site erythema'.  The reporter assessed the events as non-serious.   The reporter did not provide a causality assessment.  Company comment: Vaccination site reactions: haemorrhage, inflammation, swelling and erythema were associated with the use of the suspect product Afluria Quadrivalent. The events occurred immediately after vaccination making chronology highly suggestive. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events.; Sender's Comments: Vaccination site reactions: haemorrhage, inflammation, swelling and erythema were associated with the use of the suspect product Afluria Quadrivalent. The events occurred immediately after vaccination making chronology highly suggestive. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events.
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity, Lethargy, Malaise
Clinical narrative: Lethargic; Allergic reaction; Sick; This spontaneous case was received on 29-Sep-2020 from a nurse via agency (reference number: SEQW20-02517) and concerned a female patient of an unreported age.  The patient's current condition included lots of preservative allergies. The patient's concomitant medications were not reported.  On 18-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: not reported) for influenza prophylaxis. The batch number reported was 276553, expiry date: 30-Jun-2021.   On the same day, the patient had an allergic reaction to the vaccine. In the evening, the patient felt sick.  On 19-Sep-2020, reported as on Saturday, the patient was lethargic.  At the time of initial reporting on 29-Sep-2020, the outcome of the events was unknown.  The reporter assessed the event of allergic reaction as related to Flucelvax QIV. The reporter did not provide a causality assessment for other events.  The reporter assessed the case as non-serious.  Company comment: A patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient developed hypersensitivity and malaise. One day after, the patient developed lethargy. The patient's current condition included lots of preservative allergies. The patient's concomitant medications were not reported. More information regarding experienced hypersensitivity reaction is needed. With information available, causality is assessed as possibly related for all events due to plausible temporal relationship.; Reporter's Comments: The patient had an allergic reaction to the vaccine.; Sender's Comments: A patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient developed hypersensitivity and malaise. One day after, the patient developed lethargy. The patient's current condition included lots of preservative allergies. The patient's concomitant medications were not reported. More information regarding experienced hypersensitivity reaction is needed. With information available, causality is assessed as possibly related for all events due to plausible temporal relationship.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Accidental exposure to product, Incorrect dose administered
Clinical narrative: The medication leaked out of the injection site and running down her arm, while the needle was still; The medication leaked out of the injection site and running down her arm, while the needle was still; The medication leaked out of the injection site and running down her arm, while the needle was still; This spontaneous case  was received on 29-Sep-2020 from a pharmacist via agency (reference number: SEQW20-02562) and concerned a 70-year-old, female patient.   The patient's medical history and concomitant medications were not reported.   On 29-Sep-2020, while the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose and anatomical location: not reported) for influenza prophylaxis, the medication leaked out of the injection site (explicitly coded as 'Incomplete dose administered'). The medication was running down the patient's arm while the needle was still in the injection site (explicitly coded as 'Accidental exposure to product'). The batch number reported was 279810, expiry date: 30-Jun-2021. According to the health professional, a good amount of vaccine was expelled out of the syringe.   At the time of initial reporting on 29-Sep-2020, the outcome of the event 'Vaccination site extravasation' was not reported. No side effects were reported by the patient.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A patient was administered incomplete dose of Fluad Quadrivalent. Reportedly, the medication leaked out of the injection site and was running down her arm, while the needle was still in the injection site. Vaccination site extravasation is assessed as not related to the vaccine substance. Incorrect dose administered and accidental exposure to product are assessed as not related, per company's conventions.; Sender's Comments: A patient was administered incomplete dose of Fluad Quadrivalent. Reportedly, the medication leaked out of the injection site and was running down her arm, while the needle was still in the injection site. Vaccination site extravasation is assessed as not related to the vaccine substance. Incorrect dose administered and accidental exposure to product are assessed as not related, per company's conventions.
Sex: U
Vaccine: UNK
Symptoms: Accidental exposure to product, Incorrect dose administered, Syringe issue
Clinical narrative: Vaccine leaked from the arm while administering; Vaccine leaked from the arm while administering; Vaccine leaked from the arm while administering; The pharmacist doesn't know if the leak was from the hub area of the syringe or the arm after the needle was withdrawn; This spontaneous case was received on 30-Sep-2020 from a pharmacist via agency (reference number SEQW20-02648) and concerned a patient of unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On an unknown date, while administering the Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration, dose, anatomical location and indication: not reported) some of a vaccine leaked from the arm (explicitly coded as 'Accidental exposure to product' and 'Incomplete dose administered'). The pharmacist doesn't know if the leak was from the hub area of the syringe or the arm after the needle was withdrawn (explicitly coded as 'Syringe leak'). The batch number was not reported.  The reporter assessed the case as non-serious.  Company comment: A patient was administered incomplete dose of Fluad Quadrivalent. Reportedly, some of a vaccine leaked from the arm. The pharmacist didn't know if the leak was from the hub area of the syringe or the arm after the needle was withdrawn. Vaccination site extravasation is assessed as not related to the vaccine substance. Syringe issue, incorrect dose administered and accidental exposure to product are assessed as not related, per company's conventions.; Sender's Comments: A patient was administered incomplete dose of Fluad Quadrivalent. Reportedly, some of a vaccine leaked from the arm. The pharmacist didn't know if the leak was from the hub area of the syringe or the arm after the needle was withdrawn. Vaccination site extravasation is assessed as not related to the vaccine substance. Syringe issue, incorrect dose administered and accidental exposure to product are assessed as not related, per company's conventions.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Nausea
Clinical narrative: The patient became very nauseous; This spontaneous case was received on 01-Oct-2020 from a pharmacist via  (reference number: SEQW20-02768) and concerned a 79-year-old, female patient.    The patient's medical history and concomitant medications were not reported.   On 01-Oct-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) for protection against seasonal influenza. The batch number reported was 279805, expiration date reported was 30-Jun-2021.   On the same day, one hour after receiving Fluad Quadrivalent vaccine, the patient became very nauseous. The patient did not receive any corrective treatment.  At the time of initial reporting on 01-Oct-2020, the outcome of event nauseous was not resolved.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: Event 'nausea' is assessed as related to Fluad Quadrivalent vaccine.; Sender's Comments: Event 'nausea' is assessed as related to Fluad Quadrivalent vaccine.
Sex: F
Vaccine: FLUC4
Symptoms: Adverse reaction, Erythema, Pain, Skin warm, Vaccination site pain
Clinical narrative: She developed redness, soreness, pain and hot to touch; She developed redness, soreness, pain and hot to touch; She developed redness, soreness, pain and hot to touch; It hurt a little when injected; This spontaneous case  was received on 29-Sep-2020 from a pharmacist via agency (reference number: SEQW20-02580) and concerned a female patient of unknown age.    The patient's medical history and concomitant medications were not reported.   On 18-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was 276569, expiry date: 30-Jun-2021. The patient stated the vaccine hurt a little when injected.  On 19-Sep-2020, one day after receiving Flucelvax QIV, the patient developed redness, soreness, pain and hot to touch.    The outcome of events was not reported.   The reporter assessed the events to be related to Flucelvax QIV. The pharmacist called to report adverse reactions to Flucelvax QIV.   The reporter assessed the case as non-serious.  Company comment: The patient developed skin warm, pain, erythema and vaccination site pain one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: The pharmacist called to report adverse reactions to Flucelvax QIV.; Sender's Comments: The patient developed skin warm, pain, erythema and vaccination site pain one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Sex: U
Vaccine: FLUC4
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Vaccination site swelling
Clinical narrative: Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; This spontaneous case was received on 30-Sep-2020 from other health professional via agency (reference number: SEQW20-02593) and concerned a patient of an unknown age and gender.   The patient's medical history and concomitant medications were not reported.    On an unknown date in Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 279838.     On the same day, a few hours after receiving Flucelvax QIV, the patient experienced warmth, pain and edema at injection site.   At the time of initial reporting on 30-Sep-2020, the outcome of the events was not reported.   The reporter did not provide a causality assessment.  This case is linked to cases 202004826, 202004882, 202004884 and 202004885 (the same reporter).  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, a few hours after receiving Flucelvax QIV, the patient experienced vaccination site pain, vaccination site swelling and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for all events. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, a few hours after receiving Flucelvax QIV, the patient experienced vaccination site pain, vaccination site swelling and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for all events. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.
Sex: U
Vaccine: FLUC4
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; This spontaneous case was received on 30-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02593) and concerned a patient of an unknown age and gender.   The patient's medical history and concomitant medications were not reported.    On an unknown date in Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 279838.     On the same day, a few hours after receiving Flucelvax QIV, the patient experienced warmth, pain and edema at injection site.   The outcome of events was not reported.   The reporter did not provide a causality assessment.  This case is linked to cases 202004826, 202004882, 202004883 and 202004885 (the same reporter).  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, a few hours after receiving Flucelvax QIV, the patient experienced vaccination site pain, vaccination site swelling and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for all events. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, a few hours after receiving Flucelvax QIV, the patient experienced vaccination site pain, vaccination site swelling and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for all events. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.
Sex: U
Vaccine: FLUC4
Symptoms: Vaccination site oedema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; This spontaneous case was received on 30-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02593) and concerned a patient of an unknown age and gender.   The patient's medical history and concomitant medications were not reported.    On an unknown date in Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 279838.     On the same day, a few hours after receiving Flucelvax QIV, the patient experienced warmth, pain and edema at injection site.   The outcome of events was not reported.   The reporter did not provide a causality assessment.  This case is linked to cases 202004826, 202004882, 202004883 and 202004884 (the same reporter).  Company comment: The patient developed vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this 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 vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Balance disorder, Disorientation, Dyspnoea, Electrocardiogram normal, Hypertension
Clinical narrative: High BP (systolic around 200mmHg); Loss of balance; Difficulty breathing/shortness of breath; Disorientation; This spontaneous case was received on 05-Oct-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-02933) and concerned a 76-year-old female patient.  The patient's concurrent conditions included hypertension, hypercholesterolemia and type 2 diabetes (T2D). The patient's concomitant medications included losartan, hydrochlorothiazide, Ozempic (semaglutide), metformin and ezetimibe, all used for unreported indications.  On 02-Oct-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 and anatomical location: left upper arm) for flu prevention. The batch number was 279812 and expiry date was 30-Jun-2021. It was the first time that the patient got vaccinated with Fluad Quadrivalent.  On 03-Oct-2020, one day after receiving Fluad Quadrivalent, the patient started feeling difficulty breathing, shortness of breath and developed high blood pressure (BP) (systolic around 200mmHg). In addition, the patient experienced disorientation and loss of balance. After, she went to the urgent care and started feeling better when she arrived there. Electrocardiogram (ECG) revealed that the patient had no abnormalities. The patient did not receive any treatment associated with the events.  On an unspecified date in Oct-2020, the patient visited her healthcare provider.  At the time of initial reporting on 05-Oct-2020, the patient was recovering from the events. The patient reported being better.  The reporter did not provide a causality assessment to Fluad Quadrivalent. The patient reported an adverse side effect she experienced after having her Fluad vaccine.   The reporter assessed the events as non-serious.  Company comment: Blood pressure systolic increased, balance disorder, dyspnoea and disorientation were associated with the use of the suspect product - Fluad Quadrivalent. Causality is assessed as unrelated for blood pressure systolic increased since the patient suffers from hypertension and for other reported events causality is assessed as unlikely related due to suggestive chronology and presence of confounding factors, concomitant medications. (unlikely related defaults to related for reporting purposes); Sender's Comments: Blood pressure systolic increased, balance disorder, dyspnoea and disorientation were associated with the use of the suspect product - Fluad Quadrivalent. Causality is assessed as unrelated for blood pressure systolic increased since the patient suffers from hypertension and for other reported events causality is assessed as unlikely related due to suggestive chronology and presence of confounding factors  concomitant medications. (unlikely related defaults to related for reporting purposes)
Sex: M
Vaccine: UNK
Symptoms: Emotional distress, Incorrect product formulation administered
Clinical narrative: Upset; Patient received Fluad Quadrivalent instead of 'high dose' influenza vaccine; This spontaneous case was received on 06-Oct-2020 from other non-health professional via agency (reference number: SEQW20-03031) and concerned an elderly male patient of an unknown age.   The patient's medical history and concomitant medications were not reported.  On an unknown date in 2020, nurse practitioner recommended to the patient to make sure that he got a high-dose influenza vaccine. The patient called several pharmacies in the area to see if they had a 'high-dose' influenza vaccine and was told that they did.  On 06-Oct-2020 before administration, the patient confirmed that he was receiving a 'high dose' influenza vaccine with pharmacist.  On the same day, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, route of administration, anatomical location and indication: not reported) instead of a 'high dose' influenza vaccine (explicitly coded as 'Wrong vaccine administered'). The batch number was not reported.  On the same day, when the patient got home and looked at the paperwork, however, patient saw that he received Fluad Quadrivalent. He did not experience any issues post vaccination, but he was very upset that he did not receive the vaccine that his healthcare provider had recommend he receive, despite he verified with pharmacist that this was what he received.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The reported assessed the case as non-serious.  Company comment: Anxiety was associated with the use of the suspect product - Fluad Quadrivalent. The patient's medical history and concomitant medications were not reported. According to the narrative wrong product was more likely a result of upset state than received vaccine therefore causality is assessed as unrelated to the product but more likely related to medication error. Wrong product administered is assessed as unrelated per company conventions.; Sender's Comments: Anxiety was associated with the use of the suspect product - Fluad Quadrivalent. The patient's medical history and concomitant medications were not reported. According to the narrative wrong product was more likely a result of upset state than received vaccine therefore causality is assessed as unrelated to the product but more likely related to medication error. Wrong product administered is assessed as unrelated per company conventions.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Musculoskeletal pain, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Sharp pain in the shoulder/When he raises the arm, the shoulder hurts a lot; Sharp pain in the arm; A 51-year-old patient received Fluad Quadrivalent; This spontaneous case was received on 06-Oct-2020 from a pharmacist via agency (reference number SEQW20-02977) and concerned a 51-year-old, male patient.   The patient's medical history and concomitant medications were not reported.   On 22-Sep-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 and anatomical location: not reported) for influenza prophylaxis (explicitly coded as 'Inappropriate age at vaccine administration'). The batch number reported was 279813, expiry date was 30-Jun-2021.    On the same day, after receiving Fluad Quadrivalent, the patient experienced sharp pain in the arm and sharp pain in the shoulder. When the patient raised the arm, the shoulder hurt a lot. The patient took ibuprofen and ice as a treatment.  At the time of initial reporting on 06-Oct-2020, the patient had not recovered from the events 'shoulder pain' and pain in arm'. As reported, the patient was not improving.   The reporter did not provide a causality assessment.  The reporter assessed these events as non-serious.  Company comment: Musculoskeletal pain and pain in extremity were associated with the use of the suspect product - Fluad Quadrivalent. The event occurred on the same day making chronology suggestive. The patient's medical history and concomitant medications were not reported. Causality is assessed as possibly related due to suggestive chronology and lack of another confounding factor. Information regarding anatomical location of administration is needed. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: Musculoskeletal pain and pain in extremity were associated with the use of the suspect product - Fluad Quadrivalent. The event occurred on the same day making chronology suggestive. The patient's medical history and concomitant medications were not reported. Causality is assessed as possibly related due to suggestive chronology and lack of another confounding factor. Information regarding anatomical location of administration is needed. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Dizziness, Nausea, Vision blurred
Clinical narrative: Blurred vision; Feeling dizzy; Hadn't eaten since a few hours; Nausea; This spontaneous case was received on 09-Oct-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-03268) and concerned a female patient of unknown age.   The patient's concurrent conditions included uric acid and hypertension. The patient's concomitant medications included potassium, omeprazole, unspecified vitamin D, allopurinol and amlodipine, all used for unreported indications.    On 04-Oct-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: not reported) for flu prevention. The batch number reported was 279813, expiry date: 30-Jun-2021.   On the same day, some hours after receiving Fluad Quadrivalent, the patient started feeling dizzy, had nausea and blurred vision. She also had to stop doing her shopping because of her symptoms and she hadn't eaten since a few hours. The patient did not receive any treatment for the events.   At the time of initial reporting on 09-Oct-2020, the patient was recovering from the events, as she started feeling better.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: Vision blurred, dizziness, decreased appetite and nausea were associated with the use of the suspect product - Fluad Quadrivalent. The events occurred on the same day, some hours after receiving the product making chronology suggestive. The patient's concurrent conditions included uric acid and hypertension while concomitant medications included potassium, omeprazole, unspecified vitamin D, allopurinol and amlodipine, all used for unreported indications. Causality is assessed as unlikely related for nausea and not related for all other events due to reported confounders - hypertension, reported nausea and provided confouners. (unlikely related defaults to related for reporting purposes); Sender's Comments: Vision blurred, dizziness, decreased appetite and nausea were associated with the use of the suspect product - Fluad Quadrivalent. The events occurred on the same day, some hours after receiving the product making chronology suggestive. The patient's concurrent conditions included uric acid and hypertension while concomitant medications included potassium, omeprazole, unspecified vitamin D, allopurinol and amlodipine, all used for unreported indications. Causality is assessed as unlikely related for nausea and not related for all other events due to reported confounders - hypertension, reported nausea and provided confouners. (unlikely related defaults to related for reporting purposes)
Age: 83.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, Memory impairment
Clinical narrative: A patient who got vaccinated with Fluad Quad got a second dose of Fluad Quad PFS; He didn't remember he was already vaccinated; This spontaneous case was received on 15-Oct-2020 from physician via agency (reference numbers: SEQW20-03706) and concerned an 83-year-old, male patient.  The patient's medical history included chronic kidney disease (CKD) stage 3, pre-diabetic, high cholesterol and prostate cancer. The patient's concomitant medications included Aspirin (acetylsalicylic acid), and Zocor (simvastatin), both used for unreported indication.  On 09-Oct-2020, the patient was vaccinated with the first Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was 279185.  On an unknown date in Oct-2020, the patient did not remember he was already vaccinated.  On 15-Oct-2020, six days after the first vaccine, the patient was vaccinated with the second Fluad Quadrivalent vaccine (dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) (explicitly coded as 'Extra dose administered') for flu prevention. The batch number reported was 279818.   The outcome of the event of 'forgetfulness' was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: On 09-Oct-2020, an 83-year-old, male patient was administered Fluad Quadrivalent vaccine. Six days after the first vaccine, the patient was vaccinated with the second Fluad Quadrivalent vaccine. The patient did not remember he was already vaccinated. The patient's medical history and concomitant medications were not reported. Regarding the event of memory impairment, causal role of the suspect vaccine is assessed as not related due to biological implausibility and strong confounder (advanced age). Extra dose administered is assessed as not related per company's conventions.; Sender's Comments: On 09-Oct-2020, an 83-year-old, male patient was administered Fluad Quadrivalent vaccine. Six days after the first vaccine, the patient was vaccinated with the second Fluad Quadrivalent vaccine. The patient did not remember he was already vaccinated. The patient's medical history and concomitant medications were not reported. Regarding the event of memory impairment, causal role of the suspect vaccine is assessed as not related due to biological implausibility and strong confounder (advanced age). Extra dose administered is assessed as not related per company's conventions.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain and hot to touch at injection site; Redness, swelling, pain and hot to touch at injection site; Redness, swelling, pain and hot to touch at injection site; Redness, swelling, pain and hot to touch at injection site; Headache; Fatigue; This spontaneous case  was received on 21-Oct-2020 from other non-health professional to agency (reference number: SEQW20-04048) with additional two documents (reference number: SEQW20-04055) received on the same day (being processed together) and concerned a 67-year-old, female patient.  The patient's concurrent conditions included diabetes type II and asthma. The patient's concomitant medications were not reported.  On 20-Oct-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 and anatomical location: deltoid) as influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Fluad Quadrivalent, the patient experienced redness, swelling, pain at the injection site which was hot to touch. Also, the patient started experiencing headache and fatigue.  At the time of initial reporting on 21-Oct-2020, the patient was recovering from all events. The symptoms started to wear off and the patient was doing better.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment:The patient developed all events on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's concomitant medications were not reported. No alternative aetiology 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 all events on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's concomitant medications were not reported. No alternative aetiology 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: 67.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth
Clinical narrative: Redness, swelling, pain and hot to touch at injection site; Redness, swelling, pain and hot to touch at injection site; Redness, swelling, pain and hot to touch at injection site; Redness, swelling, pain and hot to touch at injection site; Headache; Fatigue; This spontaneous case  was received on 21-Oct-2020 from other non-health professional to agency (reference number: SEQW20-04048) with additional two documents (reference number: SEQW20-04055) received on the same day (being processed together) and concerned a 67-year-old, female patient.  The patient's concurrent conditions included diabetes type II and asthma. The patient's concomitant medications were not reported.  On 20-Oct-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 and anatomical location: deltoid) as influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Fluad Quadrivalent, the patient experienced redness, swelling, pain at the injection site which was hot to touch. Also, the patient started experiencing headache and fatigue.  At the time of initial reporting on 21-Oct-2020, the patient was recovering from all events. The symptoms started to wear off and the patient was doing better.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment:The patient developed all events on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's concomitant medications were not reported. No alternative aetiology 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 all events on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's concomitant medications were not reported. No alternative aetiology 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: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in her right and left arm/leg; Tingling in upper lip; This spontaneous case from the  was received on 23-Oct-2020 from other non-health professional (consumer) via The Agency (reference number: SEQW20-04144) and concerned a 64-year-old, female patient.   The patient's past medical history included respiratory problem. The patient's concurrent conditions included migraines. The patient's concomitant medications included sumatriptan and Benadryl (diphenhydramine hydrochloride), both used for unreported indication.  On 20-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, anatomical location: left upper arm and route of administration: intramuscular) for influenza prophylaxis. The batch number was not reported.   On the same day, 10 to 15 minutes after receiving Afluria Quadrivalent, the patient started to feel tingling in upper lip. Later, the patient experienced tingling in her right and left arm/leg.  On an unspecified date in Oct-2020, the patient called doctor and was advised to wait and contact again if she felt worse.   At the time of initial report on 23-Oct-2020, the patient had not recovered from the events. The patient was still feeling tingling in her right and left arm/leg. The symptom was coming and going, and it was not improving.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: The events of 'tingling of extremity' and 'tingling lips' are considered as related to Afluria Quadrivalent.; Sender's Comments: The events of 'tingling of extremity' and 'tingling lips' are considered as related to Afluria Quadrivalent.