chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Diarrhoea, Muscle spasms
Clinical narrative: Sick stomach; Cramps; Diarrhea; Chills with a possible high temperature; Chills with a possible high temperature; Neck pain; This spontaneous case from the was received on 24-Oct-2020 from other non-health professional via The Agency (reference number: SEQW20-04206) and concerned a 73-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included influenza virus vaccine polyvalent (brand not specified) and shingles vaccine after which the patient was sick for four weeks.  On 22-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, anatomical location: left deltoid, route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On 23-Oct-2020, one day after receiving Fluad Quadrivalent, the patient developed neck pain.  On 24-Oct-2020, two days after receiving Fluad Quadrivalent, the patient experienced sick stomach, chills with a possible high temperature (not checked), cramps and diarrhoea.   At the time of initial reporting on 24-Oct-2020, the patient had not recovered from the events.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  This case is linked to the case 202005446 (same patient).  Company comment: A 73-year-old female patient was administered Fluad Quadrivalent vaccine. One day after receiving vaccine, the patient developed neck pain. Two days after receiving Fluad Quadrivalent, the patient experienced abdominal discomfort, chills, pyrexia, muscle spasms and diarrhoea. The patient's historical vaccine included influenza virus vaccine polyvalent (brand not specified) and shingles vaccine after which the patient was sick for four weeks. With information available, causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology.; Sender's Comments: A 73-year-old female patient was administered Fluad Quadrivalent vaccine. One day after receiving vaccine, the patient developed neck pain. Two days after receiving Fluad Quadrivalent, the patient experienced abdominal discomfort, chills, pyrexia, muscle spasms and diarrhoea. The patient's historical vaccine included influenza virus vaccine polyvalent (brand not specified) and shingles vaccine after which the patient was sick for four weeks. With information available, causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Neck pain
Clinical narrative: Sick stomach; Cramps; Diarrhea; Chills with a possible high temperature; Chills with a possible high temperature; Neck pain; This spontaneous case from the was received on 24-Oct-2020 from other non-health professional via The Agency (reference number: SEQW20-04206) and concerned a 73-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included influenza virus vaccine polyvalent (brand not specified) and shingles vaccine after which the patient was sick for four weeks.  On 22-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, anatomical location: left deltoid, route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On 23-Oct-2020, one day after receiving Fluad Quadrivalent, the patient developed neck pain.  On 24-Oct-2020, two days after receiving Fluad Quadrivalent, the patient experienced sick stomach, chills with a possible high temperature (not checked), cramps and diarrhoea.   At the time of initial reporting on 24-Oct-2020, the patient had not recovered from the events.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  This case is linked to the case 202005446 (same patient).  Company comment: A 73-year-old female patient was administered Fluad Quadrivalent vaccine. One day after receiving vaccine, the patient developed neck pain. Two days after receiving Fluad Quadrivalent, the patient experienced abdominal discomfort, chills, pyrexia, muscle spasms and diarrhoea. The patient's historical vaccine included influenza virus vaccine polyvalent (brand not specified) and shingles vaccine after which the patient was sick for four weeks. With information available, causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology.; Sender's Comments: A 73-year-old female patient was administered Fluad Quadrivalent vaccine. One day after receiving vaccine, the patient developed neck pain. Two days after receiving Fluad Quadrivalent, the patient experienced abdominal discomfort, chills, pyrexia, muscle spasms and diarrhoea. The patient's historical vaccine included influenza virus vaccine polyvalent (brand not specified) and shingles vaccine after which the patient was sick for four weeks. With information available, causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology.
Sex: F
Vaccine: FLUA4
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: Reactivation of VHS after being vaccinated with Fluad Quad; This spontaneous case from the  was received on 23-Oct-2020 from other non-health professional via The Agency (reference number: SEQW20-04156) and concerned a female patient of unreported age.   The patient's historical condition included Herpes simplex and reactivations of virus herpes simplex (VHS) as reaction of depressed immune system. The patient's concomitant medications were not reported.   On 19-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, route of administration and anatomical location: not reported) for flu prevention. The batch number was not reported.   On 21-Oct-2020, two days after receiving Fluad Quadrivalent, the patient had reactivation of virus herpes simplex (VHS). No treatment measures were used.   At the time of initial reporting on 23-Oct-2020, the patient had not recovered from event.  The reporter assessed the event as not related to Fluad Quadrivalent. The patient did not want to report this as an adverse event, as she had already had VHS reactivations, and this was a normal reaction when her immune system was depressed.   The reporter assessed the case as non-serious.  Case updated on 14-Dec-2020: Correction made to information received on 23-Oct-2020: Company comment amended.  Company comment: Herpes simplex reactivation was associated with the use of the suspect product, Fluad Quadrivalent. The event emerged after 2 days post vaccination. Chronology seems plausible however, due to biological implausibility and medical history of already acquired herpes viral infection and its pathophysiological characteristics, causality is assessed as not related to vaccine.; Sender's Comments: Herpes simplex reactivation was associated with the use of the suspect product, Fluad Quadrivalent. The event emerged after 2 days post vaccination. Chronology seems plausible however, due to biological implausibility and medical history of already acquired herpes viral infection and its pathophysiological characteristics, causality is assessed as not related to vaccine.
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Back pain, Bursitis, X-ray normal
Clinical narrative: Bursitis; This spontaneous case was received on 27-Oct-2020 from other non-health professional (consumer) via Health Authority (reference number: SEQW20-04322) and concerned a 73-year-old, male patient.   The patient's past medical history included two hip replacements, two heart attacks, clot bladder removal, heart failure and cardiac arrest. The patient's concurrent conditions included diabetes and prostate cancer. The patient concomitant medications included Eliquis (apixaban), Pravacol (pravastatin sodium), Jardiance (empagliflozin), atorvastatin, Aldactone (spironolactone), Aspirin (acetylsalicylic acid) and metformin, all used for an unreported indication.  On 25-Sep-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5ml, anatomical location: right arm and route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On 29-Sep-2020, in the morning, four days after receiving Fluad Quadrivalent, the patient started feeling pain in his lower back and pain moved to right hip. He visited his surgeon and X-ray revealed that everything was fine. The doctor diagnosed him with bursitis. The patient never had bursitis before. He was treated with cortisone and for about three to four weeks he got better and was fully recovered.  On an unspecified day in Oct-2020, the patient recovered from bursitis.   The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 73-year-old, male patient was administered Fluad Quadrivalent in right arm. Four days after receiving Fluad Quadrivalent, the patient started feeling pain in his lower back and pain moved to right hip. The doctor diagnosed him with bursitis. The patient's past medical history included two hip replacements, which confounds causality. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes); Sender's Comments: A 73-year-old, male patient was administered Fluad Quadrivalent in right arm. Four days after receiving Fluad Quadrivalent, the patient started feeling pain in his lower back and pain moved to right hip. The doctor diagnosed him with bursitis. The patient's past medical history included two hip replacements, which confounds causality. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes)
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Blood pressure decreased, Chills, Fatigue, Heart rate decreased
Clinical narrative: Blood pressure dropped; Pulse dropped; Became very weak; Sleeping most of the time; Chills; Fever; Nausea; Fatigue; This spontaneous case was received on 29-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-04448) and concerned a 74-year-old, male patient.   The patient's concurrent conditions included diabetic (not on medication) and renal cancer. The patient's past medical history included bypass surgery (two and a half years ago) and mini stroke one year ago. The patient's concomitant medications included Opdivo (nivolumab) used for renal cancer, metoprolol, lisinopril and Eliquis (apixaban), all used for an unreported indication. The patient's historical vaccine included unspecified influenza virus vaccine with no adverse reaction.  On 26-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 and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On the same day, four to five hours after receiving Fluad Quadrivalent, the patient became very weak. He developed chills, fever which was on and off for the next days, nausea and fatigue. His pulse and blood pressure dropped, and he was sleeping most of the time. He was treated with Tylenol (paracetamol) at unknown dosage regimen.   On an unspecified day in Oct-2020, the patient recovered from event fever.   At the time of initial reporting on 29-Oct-2020, the patient had not recovered from event 'weakness' and was recovering from all other events as it was reported that he was feeling better.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  The case is linked to 202005979 (due to same reporter).  Company comment: The patient experienced blood pressure decreased, heart rate decreased, asthenia, somnolence, chills, pyrexia, nausea and fatigue after administration of Fluad Quadrivalent. Causality is highly confounded with reported medical history (renal cancer) and chemotherapy with Opdivo even though temporal association is suggestive. Causality is assessed as not related for all events.; Sender's Comments: The patient experienced blood pressure decreased, heart rate decreased, asthenia, somnolence, chills, pyrexia, nausea and fatigue after administration of Fluad Quadrivalent. Causality is highly confounded with reported medical history (renal cancer) and chemotherapy with Opdivo even though temporal association is suggestive. Causality is assessed as not related for all events.
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: Blood pressure dropped; Pulse dropped; Became very weak; Sleeping most of the time; Chills; Fever; Nausea; Fatigue; This spontaneous case was received on 29-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-04448) and concerned a 74-year-old, male patient.   The patient's concurrent conditions included diabetic (not on medication) and renal cancer. The patient's past medical history included bypass surgery (two and a half years ago) and mini stroke one year ago. The patient's concomitant medications included Opdivo (nivolumab) used for renal cancer, metoprolol, lisinopril and Eliquis (apixaban), all used for an unreported indication. The patient's historical vaccine included unspecified influenza virus vaccine with no adverse reaction.  On 26-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 and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On the same day, four to five hours after receiving Fluad Quadrivalent, the patient became very weak. He developed chills, fever which was on and off for the next days, nausea and fatigue. His pulse and blood pressure dropped, and he was sleeping most of the time. He was treated with Tylenol (paracetamol) at unknown dosage regimen.   On an unspecified day in Oct-2020, the patient recovered from event fever.   At the time of initial reporting on 29-Oct-2020, the patient had not recovered from event 'weakness' and was recovering from all other events as it was reported that he was feeling better.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  The case is linked to 202005979 (due to same reporter).  Company comment: The patient experienced blood pressure decreased, heart rate decreased, asthenia, somnolence, chills, pyrexia, nausea and fatigue after administration of Fluad Quadrivalent. Causality is highly confounded with reported medical history (renal cancer) and chemotherapy with Opdivo even though temporal association is suggestive. Causality is assessed as not related for all events.; Sender's Comments: The patient experienced blood pressure decreased, heart rate decreased, asthenia, somnolence, chills, pyrexia, nausea and fatigue after administration of Fluad Quadrivalent. Causality is highly confounded with reported medical history (renal cancer) and chemotherapy with Opdivo even though temporal association is suggestive. Causality is assessed as not related for all events.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Oral disorder, Oral herpes, Oral pain
Clinical narrative: Large bump on the inside of his mouth/ Fever blister on the gum of his front teeth/ It's the size of a bean and it feels mushy/ It's not painful unless you touch it; Large bump on the inside of his mouth/ Fever blister on the gum of his front teeth/ It's the size of a bean and it feels mushy/ It's not painful unless you touch it; This spontaneous case was received on 29-Oct-2020 from other non-health professional via Health Authority (reference number: SEQW20-04487) and concerned a 69-year-old, male patient.  The patient's concurrent condition included high cholesterol. The patient's concomitant medications included atorvastatin.  On 19-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 arm) for influenza prophylaxis. The batch number was not reported.   On 20-Oct-2020, half day after receiving Fluad Quadrivalent, the patient developed a large bump on the inside of his mouth. The patient felt fever blister on the gum of his front teeth. It was not painful unless he touched it. It was the size of a bean and it felt mushy. The patient contacted the pharmacy and they told him it would probably go down in a few days. The patient stated it was the first time he had a flu shot.  At the time of initial reporting on 29-Oct-2020, the patient had not recovered from events. As reported, it was not improving and was getting larger.   The reporter did not provide a causality assessment.  The reporter assessed these events as non-serious.  Company comment: A 69-year-old, male patient was vaccinated with Fluad Quadrivalent. A half day after receiving vaccine, the patient developed a large painful bump inside his mouth. The patient felt fever blister on the gum of his front teeth. The event of oral herpes (fever blister) is assessed as not due to biological implausibility. However, it was not confirmed is it herpes aetiology, it could be response on disruption to the patient's immune system. With information available, oral pain is unassessable.; Sender's Comments: A 69-year-old, male patient was vaccinated with Fluad Quadrivalent. A half day after receiving vaccine, the patient developed a large painful bump inside his mouth. The patient felt fever blister on the gum of his front teeth. The event of oral herpes (fever blister) is assessed as not due to biological implausibility. However, it was not confirmed is it herpes aetiology, it could be response on disruption to the patient's immune system. With information available, oral pain is unassessable.
Age: 62.0
Sex: F
Vaccine: FLUA4
Symptoms: Feeling abnormal, Product administered to patient of inappropriate age
Clinical narrative: The patient was not feeling herself, but could not specify what was wrong; A 62-year-old female was vaccinated with Fluad Quadrivalent; This spontaneous case was received on 02-Nov-2020 from a pharmacist via Health Authority (reference number: SEQW20-04648) and concerned a 62-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 31-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: not reported) for flu prevention (explicitly coded as 'Inappropriate age at vaccine administration'). The batch number was not reported.  On the same day, after receiving Fluad Quadrivalent, the patient was not feeling herself, but could not specify what was wrong. No corrective treatment was applied.  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: A 62-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient was not feeling herself, but could not specify what was wrong. For feeling abnormal, causality is unassesable. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 62-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient was not feeling herself, but could not specify what was wrong. For feeling abnormal, causality is unassesable. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 68.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was received on 03-Nov-2020 from other non-health professional via agency (reference number: SEQW20-04730) and concerned a 68-year-old, female patient.  The patient's concurrent condition included alpha gal syndrome. The patient's concomitant included Zocor (simvastatin), simvastatin and Venlafaxin (venlafaxine hydrochloride), all for unreported indications.   On 21-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 and anatomical location: not reported) for flu prevention.The batch number was not reported.  On the same day, the patient was vaccinated with non-company co-suspect Shingrix (varicella zoster vaccine rge (cho); dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On 22-Sep-2020, one day after receiving Fluad Quadrivalent and Shingrix, the patient got diarrhea. No corrective treatment was applied.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the event as non-serious.  Company comment: The event of diarrhea is considered as related to Fluad Quadrivalent.; Sender's Comments: The event of diarrhea is considered as related to Fluad Quadrivalent.
Sex: M
Vaccine: UNK
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Fatigue, Nausea
Clinical narrative: Like an upset stomach; Tired/ Fatigued; Diarrhea; Joint pain in my knees; Nausea; This spontaneous case was received on 03-Nov-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-04689) and concerned an elderly male patient of an unknown age.  The patient had no relevant medical conditions. The patient's concomitant medications included magnesium, fish oil, chondroitin and B12 (cyanocobalamin) (store products), all for unreported indications.   On 03-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left arm; route of administration: not reported) for influenza prevention. The batch number reported was 279811, and expiry date: 30-Jun-2021.  On an unknown date in Oct-2020, two to four days after receiving Fluad Quadrivalent, the patient was tired, fatigued and had diarrhoea. He had no muscle aches and did not feel it. The patient had joint pain in his knees when he was going up and down the stairs and also had nausea when woke up in the morning like an upset stomach. The patient had no treatment associated with events.   The outcome of the events was unknown.   The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.   Company comment: An elderly male patient was vaccinated with Fluad Quadrivalent. Two to four days after receiving Fluad Quadrivalent, the patient developed fatigue, diarrhoea, arthralgia, nausea and abdominal discomfort. Reportedly, the patient had no relevant medical conditions. Causal role of the suspect vaccine is assessed as possibly for all events.; Sender's Comments: An elderly male patient was vaccinated with Fluad Quadrivalent. Two to four days after receiving Fluad Quadrivalent, the patient developed fatigue, diarrhoea, arthralgia, nausea and abdominal discomfort. Reportedly, the patient had no relevant medical conditions. Causal role of the suspect vaccine is assessed as possibly for all events.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Muscle tightness
Clinical narrative: Full body muscle tenseness; This spontaneous case from was received on 04-Nov-2020 from pharmacist via Agency (reference number: SEQW20-04773) and concerned a 71-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 16-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left arm, and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 279819 and expiry date was 30-Jun-2021.  On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed full body muscle tenseness.  At the time of initial reporting on 04-Nov-2020, the patient had not recovered from the event.  The reporter did not provide a causality assessment to Fluad Quadrivalent.  The reporter assessed the event as non-serious.  Company comment: A 71-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced full body muscle tenseness. More information regarding medical history, concomitant medications and temporal relationship is needed. With information available, causal role of the suspect vaccine is assessed as possibly.; Sender's Comments: A 71-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced full body muscle tenseness. More information regarding medical history, concomitant medications and temporal relationship is needed. With information available, causal role of the suspect vaccine is assessed as possibly.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Injection site pain, Neck pain, Pain in jaw, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 received Fluad QIV; Shoulder-neck-jaw pain; Shoulder-neck-jaw pain; Shoulder-neck-jaw pain; Injection site pain; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via agency (reference number: SEQW20-04804) and concerned a 26-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reprorted.   On 29-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) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced injection site pain and shoulder-neck-jaw pain. The patient was treated with Tylenol (paracetamol).   On an unknown date in 2020, three days after the onset, the patient recovered from the events.   The reporter did not provide causality assessment.   The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 26-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced vaccination site pain, arthralgia, neck pain and pain in jaw. Reportedly, the patient had no relevant medical history. Causal role of the suspect vaccine is assessed as possibly for all events. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 26-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced vaccination site pain, arthralgia, neck pain and pain in jaw. Reportedly, the patient had no relevant medical history. Causal role of the suspect vaccine is assessed as possibly for all events. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 31.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Product administered to patient of inappropriate age
Clinical narrative: Tenderness; Redness; Muscle aches; Edema at injection site; Patient under 65 received Fluad QIV; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04831) and concerned a 31-year-old, female patient.   The patient concurrent conditions included polycystic ovary syndrome (PCOS). The patient's concomitant medications were not reported.   On 29-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) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date, after receiving Fluad Quadrivalent, the patient experienced muscle aches, redness, tenderness, edema at injection site. The patient used Ibuprofen as treatment medication.   At the time of initial reporting on 05-Nov-2020, the outcome of the events was not reported.  The case was assessed as non-serious.  This case is linked to cases 202004845, 202006068, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006091, 202006092, 202006095, 202006097, 202006098, (the same reporter).  Company comment: The patient experienced tenderness, erythema, myalgia and vaccination site swelling on an unspecified date after administration of Fluad Quadrivalent. Causality is unassessable for tenderness, erythema and myalgia (unclarified chronology) and possibly related for vaccination site swelling (anatomically plausible). Patient under 65 received Fluad QIV - Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: The patient experienced tenderness, erythema, myalgia and vaccination site swelling on an unspecified date after administration of Fluad Quadrivalent. Causality is unassessable for tenderness, erythema and myalgia (unclarified chronology) and possibly related for vaccination site swelling (anatomically plausible). Patient under 65 received Fluad QIV - Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Age: 33.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Rash
Clinical narrative: Patient under 65 received Fluad QIV; Rash; Fatigue; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04823) and concerned a 33-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-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) (explicitly coded as 'Inappropriate age at vaccine administration') for influneza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed rash and fatigue. The patient did not receive any corrective treatment.   The outcome of events was not reported.  The case was assessed as non-serious.  The case is linked to 202004845, 202006068, 202006069, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (due to same reporter).  Company comment: The events of rash and fatigue are assesed as related to Fluad Quadrivalent , while the event of  'Inappropriate age at vaccine administration' is assessed as not related to Fluad Quadrivalent.; Sender's Comments: The events of rash and fatigue are assesed as related to Fluad Quadrivalent , while the event of  'Inappropriate age at vaccine administration' is assessed as not related to Fluad Quadrivalent.
Age: 31.0
Sex: F
Vaccine: FLUA4
Symptoms: Headache, Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Patient under 65 received Fluad QIV; Aches; Headache; Fever; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04839) and concerned a 31-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-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) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unknown date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced fever, aches and headache. The patient was treated with Tylenol (paracetamol).  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 31-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain, pyrexia and headache. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 31-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain, pyrexia and headache. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 46.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Injection site pain, Myalgia, Pain, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 received Fluad QIV; Aches; Injection site pain; Chills; Muscle soreness; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04830) and concerned a 46-year-old, male patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-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) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, unknown time after receiving Fluad Quadrivalent, the patient experienced injection site pain, muscle soreness, aches and chills. The patient's corrective treatment associated with the events included Tylenol (paracetamol), ibuprofen and Sudafed (xylometazoline hydrochloride).  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 46-year-old, male patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain, chills, myalgia and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 46-year-old, male patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain, chills, myalgia and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 33.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in extremity, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Patient under 65 received Fluad QIV; Soreness in the arm; Fever; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04815) and concerned a 33-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reprorted.   On 29-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) (explicitly coded as 'Inappropriate age at vaccine administration') for influneza prophylaxis. The batch number reported was 286592. .   On an unspecified date in 2020, unknown time after receiving Fluad Quadrivalent, the patient experienced soreness in the arm and fever. There was no corrective treatment  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 33-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and pyrexia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 33-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient experienced pain in extremity and pyrexia. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 41.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain, Vaccination site warmth
Clinical narrative: Very sore; Immediately hot at the injection site; Patient under 65 received Fluad QIV; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04783) and concerned a 41-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-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) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On the same day, immediately after receiving Fluad Quadrivalent, the patient felt very sore and hot at the injection site. The patient did not receive any corrective treatment.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 41-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, immediately after receiving Fluad Quadrivalent, the patient developed pain and vaccination site warmth. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 41-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, immediately after receiving Fluad Quadrivalent, the patient developed pain and vaccination site warmth. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 38.0
Sex: M
Vaccine: FLUA4
Symptoms: Headache, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient under 65 received Fluad QIV; Very sore arm; Headache; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04842) and concerned a 38-year-old, male patient.   The patient had no relevant medical history. The patient's concomitant medications were not reprorted.   On 29-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) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unknown date in 2020, an unspecified amount of time after receiving Fluad Quadrivalent, the patient experienced very sore arm and headache. The patient was treated with ibuprofen.   The outcome of events 'painful arm' and headache was not reported.   The reporter did not provide causality assessment.   The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 38-year-old, male patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain in extremity and headache. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 38-year-old, male patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain in extremity and headache. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Age: 40.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Pain in extremity, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Patient under 65 received Fluad QIV; Sore arm for 3 days; Chills; Low grade fever; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04805) and concerned a 40-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-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) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced low grade fever and chills, and she developed sore arm . The patient was treated with Tylenol (paracetamol).  On an unspecified date in 2020, three days after the onset, the patient recovered from the event of sore arm.  The outcome of the events fever and chills was not reported.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 40-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed chills, pyrexia and pain in extremity. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 40-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed chills, pyrexia and pain in extremity. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.