chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical details: Patient received Paxlovid for COVID-19 Treatment from 06Dec2022 to 11Dec2022. COVID reoccurred within 4 days of stopping Paxlovid worse than before.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Moderna; Dose Number:3 and 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6203), in right arm and on 19Mar2021 as dose 2, single (Lot number: ER2413) at the age of 67 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Nov2021 as dose 3 (booster), single (Lot number: 032F21A), in right arm and on 14Jul2022 as dose 4 (booster), single (Lot number: 016B22A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN, start date: 01Jun2022; CELEBREX, start date: 01Sep2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Nov2021, outcome "unknown", described as "Name of Drug as Reported: Moderna; Dose Number:3 and 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Positive, notes: Tested positive with at-home test and at Clinic  09Dec2022; (09Dec2022) Positive, notes: Tested positive with at-home test and at Clinic  09Dec2022; (16Dec2022) Negative, notes: Tested negative 16Dec2022; (19Dec2022) Positive, notes: Tested positive AGAIN 19Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti viral drug Paxlovid for COVID 19 Treatment from 09Dec2022 to 14Dec2022. Known allergies: Not that I am aware of. Other medical history: None.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.Treatment for COVID-19, Treatment start date: 08Dec2022, Treatment stop date: 12Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "bronchiecstasis" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, start date: 01Nov2021, stop date: 04Dec2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment start date was 05Dec2022, and treatment stop date was 09Dec2022, patient had no allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: my 43-year-old friend die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570).  A 43-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "my 43-year-old friend die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course details: Reporter had the following reports on the Pfizer BioNTech COVID-19 vaccine: The reporter sated that everyone taking the vaccines has had COVID once and twice and the reporter thinks they do not work. The reporter also stated that her cousin who is a nurse worked in operating room and had to go to the hospital she can't see she can't get in the highway to drive, and this is a side effect of the vaccine. She also reported that she saw her 43-year-old friend die. She also stated she don't have any confidence in the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: my 43-year-old friend die
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Had family members and friends that had miscarriages and lost their children, their actual children have died due to the Covid-19 shot/knows four people personally who have had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "Had family members and friends that had miscarriages and lost their children, their actual children have died due to the Covid-19 shot/knows four people personally who have had miscarriages". The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death.  Clinical course: Non-HCP general public is calling about the Pfizer BioNTech Covid 19 vaccine and how unsafe the vaccine is, as it has been attributed to 20 million deaths, stillbirths, miscarriages, infertility, spontaneous abortions. The reporter got the vaccine, he even states that there is a depopulation issue, and they have to bring in dreamers to help with jobs. Famous OB GYN has come out and stated that it has caused spontaneous abortions and fertility issues. There was no decrease in birth rate in 2020 so it can't be from just Covid, its attributed to the vaccine. It was a 10 minute video talking about the rises of spontaneous abortions, and due to "standard deviations"- he didn't understand what that meant, his wife had to explain it to him, his wife had to explain it to him. The miscarriages have been on the rise for the last year and a half. Early data is showing an enormous amount of miscarriages, and there could be people having trouble conceiving and delivering. Breastmilk could be dangerous to infants. They could be wiping out an entire generation that's needed to continue the human race. He knows four people personally who have had miscarriages, their children are dead. Their OB GYNs feel bad they recommended this. His wife is a psychologist who speaks with people who have vaccine remorse. People know they were lied to. Asked about data there is on miscarriages, pregnancy and infertility. He especially wants to see where Pfizer says its safe. Had family members and friends that had miscarriages and lost their children, their actual children have died due to the Covid-19 shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375068 same reporter/drug/AE, different patients;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 16:00 as dose 1, single (Lot number: EN6200), in left arm and on 31Mar2021 at 16:00 as dose 2, single (Lot number: ER2613) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given for COVID 19 treatment.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: caller might have taken the COVID-19 vaccine/she has COVID and and her whole family has COVID; caller might have taken the COVID-19 vaccine/she has COVID and and her whole family has COVID; The initial case was missing the following minimum criteria: no suspect drug was reported. Upon receipt of follow-up information on (19Dec2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "caller might have taken the COVID-19 vaccine/she has COVID and and her whole family has COVID".  Clinical course: Phone-Out 02:19 PM EST, 2nd attempt by phone to consumer to obtain mailing information. Phone answered by consumer who said that patient had the Pfizer covid vaccine and had three doses. Consumer did not want to provide mailing address, but agree to provide e-mail address instead.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Deafness, Hypokinesia, Vertigo, Vomiting
Clinical narrative: lost hearing; On the same evening I woke up vomiting and felt the whole living; On the same evening I woke up vomiting and felt the whole living; I couldn't move; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 05May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HYPOKINESIA (hospitalization) with onset 08May2021, outcome "unknown", described as "I couldn't move"; VOMITING (hospitalization), VERTIGO (hospitalization) all with onset 08May2021, outcome "unknown" and all described as "On the same evening I woke up vomiting and felt the whole living"; DEAFNESS (hospitalization) with onset 08May2021, outcome "unknown", described as "lost hearing". The events "lost hearing", "on the same evening i woke up vomiting and felt the whole living" and "i couldn't move" required emergency room visit. Therapeutic measures were taken as a result of deafness, vomiting, vertigo, hypokinesia.  Clinical course: Patient reported, "I was wondering if Pfizer offers any compensation regarding the Covid vaccine side effects. On the 3rd day, after taking the 2nd shot on 05May2021, I lost hearing on my right ear so I had to go to the emergency. On the same evening I woke up vomiting and felt the whole living room was spinning. I couldn't move so I called and was sent to a hospital for 8 days and to rehab. I asked the rehab to release me so I could see ENT. Four steroid shots didn't help."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Decreased activity, Hunger, Tachycardia
Clinical narrative: Tachycardia; I am unable to do marathons and be active as before; Hungry all the time; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TACHYCARDIA (non-serious), outcome "unknown"; DECREASED ACTIVITY (non-serious), outcome "unknown", described as "I am unable to do marathons and be active as before"; HUNGER (non-serious), outcome "unknown", described as "Hungry all the time". The event "tachycardia" required emergency room visit.  Additional information: The patient was nurse front of line in the pandemic. The patient took 4 doses of Pfizer, had few health problem end-up at the ER with tachycardia. The patient had a great healthy life as a Vegan, was unable to do marathons and be active as before plus was hungry all the time. The patient was not sure if will took the 5th dose. The patient should not had taken any dose at all. The patient need help now.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021800614 Same patient, product; different event;
Sex: U
Vaccine: PNC20
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Dry cough; Running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "Dry cough"; RHINORRHOEA (non-serious), outcome "not recovered", described as "Running nose".  Additional information: Patient just received Prevnar 20 vaccine. About 12 hours after, patient had a dry cough and running nose. This is still occurring; if it doesn't get better, the patient willl contact the doctor.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling hot, Pyrexia
Clinical narrative: brain fog; fever; chills; she's hot but not as often/she was feeling warm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Headaches" (ongoing); "Relapsing Remitting Multiple sclerosis" (ongoing); "Migraines" (ongoing); "Bladder issues" (ongoing); "heart palpitations" (ongoing); "Muscle spasms" (ongoing). Concomitant medication(s) included: METOPROLOL; OXYBUTYNIN; BACLOFEN; IMITREX. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization; Bnt162b2 (DOSE: 2), for COVID-19 Immunization; Bnt162b2 (DOSE: 3), for COVID-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 28Nov2022, outcome "recovered", described as "brain fog"; CHILLS (non-serious) with onset 28Nov2022, outcome "recovered"; PYREXIA (non-serious) with onset 28Nov2022, outcome "recovered", described as "fever"; FEELING HOT (non-serious) with onset 28Nov2022, outcome "recovered", described as "she's hot but not as often/she was feeling warm ".  Additional information: The patient stated there was fevers, chills, and brain fog from the vaccine. The patient stated from time to time she feels like she's hot but not as often, and it gradually tapered off. The patient stated she was feeling warm today and in the last couple days it has tapered off quite a bit.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: her arm is sore after getting her flu and COVID vaccines yesterday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US241636_NS. A 57-year-old female patient received BNT162b2 (BNT162B2), on 19Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Dec2022 as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Dec2022, outcome "unknown", described as "her arm is sore after getting her flu and COVID vaccines yesterday".  Additional information: patient shared that her arm was sore after getting her flu and COVID vaccines yesterday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She had COVID and she is still testing positive; She had COVID and she is still testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had COVID and she is still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She is still testing positive.  Clinical Course: Caller's concern was a caller said that she has an appointment scheduled for tomorrow. She had COVID and she is still testing positive and she is well over most of the symptoms and her doctor feels that she shouldn't get a booster right now. Her doctor said she should wait a few weeks. She shouldn't get a booster just so close to having COVID. She wants to know what our opinion is. Advised the caller I will transfer her to #. However when reading the # the caller interrupted and she said she wanted to know how she will cancel her appointment schedule. Provided the information from the Knowledge Article the caller then hung up. Creating AE Form since the caller had COVID and she is still testing positive and she is well over most of the symptoms and her doctor feels that she shouldn't get a booster right now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Haematochezia
Clinical narrative: Blood in stool; Abdominal cramping; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Not AVAILABLE). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4198471.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Intramuscular), administration date: 10Apr2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Intramuscular), administration date: 12May2021, for COVID-19 immunisation. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "recovered", described as "Blood in stool"; ABDOMINAL PAIN (non-serious), outcome "recovered", described as "Abdominal cramping". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "blood in stool" and "abdominal cramping" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: now day 11 with the flu. Horrible; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who was on day 11 with the flu  after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of now day 11 with the flu, horrible (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (now day 11 with the flu. Horrible).  Outcome: Unknown
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Malaise
Clinical narrative: patient had been feeling ill (malaise) due to getting a flu shot; fatigue; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves a 62 years old female patient (90.7 kg) had been feeling ill (malaise) due to getting a flu shot and fatigue after receiving Influenza Vaccine and while treated with Treprostinil Sodium.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included Amlodipine (amlodipine besilate).   On 23-May-2022, the patient started taking Treprostinil Sodium 54 µg (9 breaths) via inhalational route four times a day (QID) (lot number- 2102260, Expiry date:  30-Nov-2023) (with an unknown formulation, dose ) for Secondary pulmonary arterial hypertension.  On 00-000-2022, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown formulation, route, expiry date, lot number, administration site) for immunization.  In Nov-2022, the patient had been feeling ill (malaise) due to getting a flu shot (malaise) (latency: unknown) following the administration of Influenza Vaccine and first dose intake of Treprostinil Sodium.  In 2022, the patient developed an event of fatigue (latency: unknown) following the administration of Influenza Vaccine and first dose intake of Treprostinil Sodium.  Action taken with Influenza Vaccine not applicable and Treprostinil Sodium was unknown.  It was not reported if the patient received a corrective treatment for the events (fatigue, patient had been feeling ill (malaise) due to getting a flu).  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Adverse drug reaction
Clinical narrative: Starting to feel the side effects of the shot with no adverse event reported; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an adult patient with unknown age and gender who experienced starting to feel the side effects with no adverse event reported of the shot while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (Batch number, expiry date, frequency, formulation, strength was unknown) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious starting to feel the side effects of the shot with no adverse event reported (adverse drug reaction) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event starting to feel the side effects of the shot.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Mobility decreased
Clinical narrative: laying in bed as sick as ever for the past 3 days, with the flu; laying in bed as sick as ever for the past 3 days, with the flu; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced laying in bed as sick as ever for the past 3 days, with the flu and laying in bed as sick as ever for the past 3 days, with the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.  On an unknown date the patient developed laying in bed as sick as ever for the past 3 days, with the flu (illness) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious laying in bed as sick as ever for the past 3 days, with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (laying in bed as sick as ever for the past 3 days, with the flu, laying in bed as sick as ever for the past 3 days, with the flu).  At time of reporting, the outcome was Unknown for the event laying in bed as sick as ever for the past 3 days, with the flu and was Unknown for the event laying in bed as sick as ever for the past 3 days, with the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got flu; Initial information received on 15-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, lot number, expiry date, route, administration site: not reported) as Flu shot (Influenza immunisation).  On an unknown date the patient got flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event got flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who still got the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient had a non-serious event of still got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got my senior strength dose 1st week of November got a bad case of the flu day before holiday; Initial information was received on 18-Dec-2022 regarding an unsolicited valid Social Media case received via public post on the Not Today, Flu Social Media page non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who reported that got my senior strength dose 1st week of November got a bad case of the flu day before holiday after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization).  On an unknown date the patient  got my senior strength dose 1st week of November got a bad case of the flu day before holiday (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got my senior strength dose 1st week of November got a bad case of the flu day before holiday).  At time of reporting, the outcome was Unknown for the event got my senior strength dose 1st week of November got a bad case of the flu day before holiday.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: have the worst case of influenza A; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown gender who have the worst case of influenza a after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of have the worst case of influenza a (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  It was reported " This is a social media case received from public post on the Not Today, Flu Social Media page. Patient got the high dose flu vaccine, 2 months later and have the worst case of influenza A. "  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (have the worst case of influenza A).  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: still got sick; Initial information was received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (Patient)  This case involves an unknown age/gender patient who still got sick after being vaccinated with INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, route, administration site, formulation, expiry date: Unknown).  On an unknown date the patient developed a non-serious still got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (still got sick).  Outcome: Unknown for the event still got sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got my flu shot and still got the flu; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got Influenza vaccine flu shot and still got the flu.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received unknown dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, strength, route, formulation, expiry date and administration site unknown) for flu vaccination.  On an unknown date the patient developed a non-serious event "got my flu shot and still got the flu (influenza)" (unknown latency) following the administration of Influenza vaccine.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.    Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Influenza
Clinical narrative: got flu; fine now except for no energy; Initial information received on 15-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got flu and fine now except for no energy after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious got flu (influenza), fine now except for no energy (asthenia) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was unknown.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: Got flu shot in early November n been sick ever since n this weekend the worse; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got flu shot in early November n been sick ever since n this weekend the worse after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dose, expiration date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed got flu shot in early November n been sick ever since n this weekend the worse (illness).  Action taken was not applicable.  Corrective treatment was not reported for the event (Got flu shot in early November n been sick ever since n this weekend the worse).  Outcome was Unknown for the event got flu shot in early November n been sick ever since n this weekend the worse.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: got the flu and have been dealing with it for over a week now; tested positive for Influenza A twice; Initial information received on 18-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who got the flu and have been dealing with it for over a week now and tested positive for influenza a twice after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious events of got the flu and have been dealing with it for over a week now (influenza) and tested positive for influenza a twice (influenza a virus test positive) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, we get our flu shot yearly, this year included. I know every year is a different strain but this year, WHEW what a huge miss!!  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Relevant laboratory test results included: Influenza A virus test - On an unknown date: Positive  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  The patient was treated with PREDNISONE (PREDNISONE) for Influenza and Influenza A virus test positive, just to get a little relief.  At time of reporting, the outcome was Unknown for the event got the flu and have been dealing with it for over a week now and was Unknown for the event tested positive for influenza a twice.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu; Initial information received on 18-Dec-2022 regarding an unsolicited valid non-serious social media case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age male patient who still got the flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, not today, husband was vaccinated. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu).  At time of reporting, the outcome was Unknown for the event still got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: got the flu; positive for Influenza A; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got the flu and positive for influenza A after receiving vaccine Influenza Vaccine.   The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease, or risk factor.  On an unknown date, the patient received unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, route, formulation, batch number, expiry date and administration site unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got the flu (influenza)" and "positive for influenza a (influenza a virus test positive)" (unknown latency) following the administration of Influenza Vaccine. it was reported that the patient have been dealing with flu for over a week.   Relevant laboratory test results included: Influenza - On an unknown date: Positive.  Action taken: not applicable.  The patient was treated with PREDNISONE (PREDNISONE) for Influenza A virus test positive just to get a little relief.  Outcome: Unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got influenza; Initial information was received on 16-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got influenza after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  Concomitant medications included codeine and taking cough medicine with codeine and also have to take steroids.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of got influenza (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (got influenza).  At time of reporting, the outcome was Unknown for the event got influenza.