chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: ER8734), on 01May2021 as dose 2, single (Lot number: ER8736) and on 15Jan2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (Nov2022) Result unknown; Oxygen saturation: (Nov2022) Result unknown; SARS-CoV-2 test: (13Nov2022) Positive; Vital signs measurement: (unspecified date) Unknown.  Clinical course: Reporter States that he took his mom to the hospital on Saturday, 12Nov2022, and found out that she was positive for Covid. Saturday night he had a sore throat and a cough. He did a self test on Sunday, 13Nov2022 and it was positive for COVID-19. He called his transplant team and he went in for monoclonal antibodies yesterday. His symptoms are mild. He has a runny nose and today his body hurts. States that he monitors his vital signs 4 times a day anyway and sends his temperature and oxygen levels to the hospital via an app on his phone. His mom is normally his caretaker, so he is doing a lot more activity than he would normally due, so he is having hip issues which is probably from using different muscles to hold himself up with a walker. He thinks his body aches are because he is being more active.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to Polyethylene glycol (PEG)" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Patient Age: Almost 85 years old. The patient mentioned that she called like year and a half ago regarding the ingredients of the vaccine. She was allergic to Polyethylene glycol (PEG) and remembered that when she called, someone told her that it contains 53 mg. However, she stated that she never had an adverse event when she received her first doses of the Pfizer-BioNTech COVID 19 Vaccine. Later, she mentioned that she only had a sore arm but that was all. She was allergic to PEG on quantities greater than 1000mg. She waited between 4 to 5 months to receive her next dose of the COVID Vaccine, but in her area, someone told her that the new formulation is only available. She wanted to know if the amount of PEG is still the 53 mg. After hearing the response, patient complained that that it was a small quantity of PEG and it should contain more. The patient who was in her 80s took three shots of the COVID-19 vaccine and would like to know more regarding the new booster vaccine because she had an allergic reaction with one of the ingredients in it. She got information and found out it was safe for her to take the vaccines which she had. She didn't have any problem with the vaccines she took. She also mentioned she was allergic to high doses.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201304036 Same reporter/patient/vaccine/events, different dose;
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Vaccine brand = Pfizer / BioNTech; Vaccine administration date = 28Feb2022; Vaccine brand other = Moderna; Vaccine administration date = 07Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: er2613), on 08Apr2021 as dose 2, single (Lot number: er8737), on 27Aug2021 as dose 3 (booster), single (Lot number: fc3183) and on 28Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Sep2022 as dose 5 (booster), single (Lot number: as7140c) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: Other medical history: Cancer; "PE" (unspecified if ongoing), notes: Other medical history: PE; "PVC's" (unspecified if ongoing), notes: Other medical history: PVC's. Concomitant medication(s) included: WARFARIN; TOPROL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "not recovered", described as "Vaccine brand = Pfizer / BioNTech; Vaccine administration date = 28Feb2022; Vaccine brand other = Moderna; Vaccine administration date = 07Sep2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: It was reported, the patient had no known allergies. Patient received other medication in 2 weeks. Anti-viral PAXLOVID was given from 02Nov2022 to 07Nov2022 for COVID 19 Treatment.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Pain in extremity, Pruritus
Clinical narrative: Very large lymph nodes in armpit with swelling, pain and itching  over lymph nodes. Pain was 8/10 with Advil and alternating with Tylenol.  Pain radiated down arm/radiculopathy.
Age: 48.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Radiculopathy
Clinical narrative: Very large lymph nodes in armpit with swelling, pain and itching  over lymph nodes. Pain was 8/10 with Advil and alternating with Tylenol.  Pain radiated down arm/radiculopathy.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive. The patient got sick within 18 hours of getting the booster vaccine. The patient and her daughter have had this; tested positive. The patient got sick within 18 hours of getting the booster vaccine. The patient and her daughter have had this; This is a spontaneous report received from non-contactable reporter (Nurse). Other Case identifiers: MOD22-029141 on behalf of Moderna).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (batch/lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. 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 "tested positive. The patient got sick within 18 hours of getting the booster vaccine. The patient and her daughter have had this". The patient underwent the following laboratory tests and procedures: COVID-19 test: (unspecified date) positive; (08Nov2022) unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The reporter informed that the patient was still tested positive. The patient got sick within 18 hours of getting the booster vaccine. The patient and her daughter have had this, they live together. They both tested Tuesday 08Nov2022, but they didn't get the result until today 10Nov2022. The patient wanted to know if she was still contagious. She was still holding on to a little bit of the cough, but she didn't feel sick. The patient informed that her daughter feels good. The patient stated that her daughter got the Pfizer on the same exact day that the patient got her Moderna vaccines. The patient informed that she was told by her doctor that if she was testing positive, then that means she was still shedding virus. She was told by another nurse that she could have the virus up to 3 months in her body, but she was not contagious.  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.; Sender's Comments: A contributory role of BNT162B2 to event tested positive/ The patient got sick within 18 hours of getting the booster vaccine/The patient and her daughter have had this cannot be excluded based on temporal association and available information.
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Hypersensitivity, Inflammation, Interchange of vaccine products, Swelling
Clinical narrative: Interchange of vaccine product; minor redness; swelling; local inflammatory story; allergies and drug reactions; This is a spontaneous report received from contactable reporter(s) (Physician and Pharmacist). Other Case identifier(s): MOD22-029002 (Moderna).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, unknown manufacturer), for COVID-19 immunization; Moderna (DOSE 1, SINGLE), for COVID-19 immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine product"; ERYTHEMA (non-serious), outcome "unknown", described as "minor redness"; SWELLING (non-serious), outcome "recovering"; INFLAMMATION (non-serious), outcome "unknown", described as "local inflammatory story"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies and drug reactions".  Additional information: I am a retired physician and called Moderna to get some background info on inert ingredients as my wife had a minor redness and swelling to the new bivalent Pfizer covid vaccine, but had no such reaction to Moderna in the past-although did have some moderate symptoms with the first dose of Modema. The symptoms she had and mine are well known, minor and fairly common with many other vaccines especially flu vaccine. As a courtesy, I provided the requested information for what I would not normally consider a reportable condition-common mild symptom written in the literature. I called Moderna after my wife received a bivalent booster. My wife has a lot of allergies and drug reactions, and she had a local inflammatory story issue with the Pfizer bivalent And just to give you a kind of reference point. She was recently given a generic Statin drug. And she had a allergic reaction to it. And I feel that in that case, and her allergic reaction was not to the statin because shes now on another statin. But theres something you know one of the in their ingredients and that particular manufacturer So I was just trying to compare the ingredients and the Pfizer bivalent versus the Moderna bivalent because we have had Moderna before. Alright, But this time we were only able to get the Pfizer so we took it. But I do not consider fatigue, mild aches and pains and mild, feverish reaction, which are well reported with many vaccines. To be side effects. Yes, I know they are sort of effects. It just happened that I had to be a physician calling and it happened to be in my family.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocardial fibrosis
Clinical narrative: severe chest pain; scaring of heart muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the parent.  A 17-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: after having Covid in 2020; "myocarditis" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: MYOCARDIAL FIBROSIS (hospitalization) with onset Oct2022, outcome "unknown", described as "scaring of heart muscle"; CHEST PAIN (hospitalization, medically significant) with onset Oct2022, outcome "unknown", described as "severe chest pain". The patient was hospitalized for chest pain (start date: Oct2022).  Clinical course: It was reported that patient had myocarditis after having covid in 2020 and vaccine in summer 2021, he was admitted with severe chest pain Oct2022. The reporter wanted the patient to be part of the study for any long-term risks he had scaring of heart muscle and was in hospital for week.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Electroencephalogram, Investigation, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: New Onset Mania With Psychotic Features; The initial case was missing the following minimum criteria: Invalid due to ICH-Unspecified product. Upon receipt of follow-up information on 16Nov202 this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s):  A 66-year-old female patient received BNT162b2 (BNT162B2), 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: MANIA (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovered", described as "New Onset Mania With Psychotic Features". The patient underwent the following laboratory tests and procedures: Angiogram: with out acute findings; Electroencephalogram: mild cortical dysfunction in the left temporallobe, notes: without evidence of epileptiform discharges or seizures; Labs: unremarkeable; Lumbar puncture: Negative, notes: for an infectious cause of symptoms; Magnetic resonance imaging head: without acute findings; Polymerase chain reaction: Negative. Therapeutic measures were taken as a result of mania.; Sender's Comments: Based on the available information in the case, the causal association between the event 'mania' and the 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: F
Vaccine: COVID19
Symptoms: Mania, Polymerase chain reaction
Clinical narrative: New Onset Mania With Psychotic Features; The initial case was missing the following minimum criteria: Invalid due to ICH-Unspecified product. Upon receipt of follow-up information on 16Nov202 this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s):  A 66-year-old female patient received BNT162b2 (BNT162B2), 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: MANIA (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovered", described as "New Onset Mania With Psychotic Features". The patient underwent the following laboratory tests and procedures: Angiogram: with out acute findings; Electroencephalogram: mild cortical dysfunction in the left temporallobe, notes: without evidence of epileptiform discharges or seizures; Labs: unremarkeable; Lumbar puncture: Negative, notes: for an infectious cause of symptoms; Magnetic resonance imaging head: without acute findings; Polymerase chain reaction: Negative. Therapeutic measures were taken as a result of mania.; Sender's Comments: Based on the available information in the case, the causal association between the event 'mania' and the 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: COVID19-2
Symptoms: Immune system disorder
Clinical narrative: other immune symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in Sep2022 as dose number unknown, single. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious) with onset 2022, outcome "unknown", described as "other immune symptoms".  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: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: He has seen a  case of stroke for a patient; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown" described as "He has seen a case of stroke for a patient."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Cerebrovascular accident and the suspect drug BNT162b2 cannot be excluded. The case will be reassessed once new information is available. 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: incurable chronic blindness disease; This is a spontaneous report received from contactable reporter(s) (Nurse). Other Case identifier(s): 2022MED00439 (Medexus Pharma, Inc.).  A 64-year-old female patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "incurable chronic blindness disease".  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 available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Blindness. 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: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal
Clinical narrative: Foggy head/ she is experiencing this for a long time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), 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 (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Foggy head/ she is experiencing this for a long time".  Additional information: Patient mentioned that she read about the listed side effects of this and one of it was foggy head, she mentioned she was experiencing this for a long time and she confirmed that she got the Pfizer booster vaccine and wants to know more about it.  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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; 26Dec2020-Pfizer (DOSE 01); 15Jan2021-Pfizer (Dose 02); 03Sep2021-Moderna (Dose 03); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 26Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 15Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 26Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Is the patient a smoker/former smoker? No" (unspecified if ongoing), notes: Is the patient a smoker/former smoker? No. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2021, outcome "unknown", described as "26Dec2020-Pfizer (DOSE 01); 15Jan2021-Pfizer (Dose 02); 03Sep2021-Moderna (Dose 03)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient contracted COVID-19 after initial Comirnaty vaccine series; Patient contracted COVID-19 after initial Comirnaty vaccine series; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "recovered" and all described as "Patient contracted COVID-19 after initial Comirnaty vaccine series".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Patient contracted COVID-19 after initial Comirnaty vaccine series; Patient contracted COVID-19 after initial Comirnaty vaccine series; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2,  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 "recovered" and all described as "Patient contracted COVID-19 after initial Comirnaty vaccine series".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pericardial effusion, Pericarditis, Pleural effusion
Clinical narrative: pericarditis; fluid around my heart; fluid around my lung; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: PERICARDITIS (medically significant), outcome "unknown"; PERICARDIAL EFFUSION (medically significant), outcome "unknown", described as "fluid around my heart"; PLEURAL EFFUSION (non-serious), outcome "unknown", described as "fluid around my lung". Clinical course: The covid vaccine gave pericarditis, fluid around heart and lung. It almost killed the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 14.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Pain
Clinical narrative: muscle pain and aches; muscle pain and aches; Initial information was received on 31-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via specialty pharmacy .  This case is linked to case 2022SA453284(CLUSTER).  This case involves a 14 years old male patient who experienced muscle pain and aches 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) (with unknown strength, dose, form, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient had muscle pain and aches (myalgia) (pain)(unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient have always gotten the flu; Initial information received on 10-Nov-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 have always gotten 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, route, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of have always gotten the flu (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 (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient have always gotten the flu).  At time of reporting, the outcome was Unknown for the event patient have always gotten the flu.
Sex: U
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: was sick for 2 days; chills; headache; joint pain; muscle pain; Initial information was received on 10-Nov-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 was sick for 2 days, chills, headache, joint pain and muscle pain 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 suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (strength, form, dosage, frequency, expiry date: unknown) for Immunization.  On an unknown date the patient developed non-serious events of was sick for 2 days (illness), chills, headache, joint pain (arthralgia) and muscle pain (myalgia) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: had the flu shot and had a reaction,from her shoulder to her elbow were red; had the flu shot and had a reaction,from her shoulder to her elbow were red AND HOT; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves Adult female patient (64.41 kg) who had the flu shot and had a reaction, from her shoulder to her elbow were red and hot after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Cefdinir for Sinus infection.  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 had the flu shot and had a reaction, from her shoulder to her elbow were red (erythema) and hot (feeling hot) (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 (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for both events.  At time of reporting, the outcome was Unknown for both events.
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 20 month old female was given fluzone hd with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 20-month-old female patient who was given influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 04-Nov-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.5 ml once (lot UT8817BA, expiry date: 30-Jun-2023) via intramuscular route in the left thigh for immunization.  On 04-Nov-2022, 20-month-old female was given fluzone hd with no reported adverse event (product administered to patient of inappropriate age, same day latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: patient was administered ACTHIB that was reconstituted with sterile water instead of the recommended ACTHIB 0.4% sodium chloride diluent with no reported adverse event; Initial information was received on 10-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered hib (prp/t) vaccine [ACT-HIB] that was reconstituted with sterile water instead of the recommended acthib 0.4% sodium chloride diluent with no reported adverse event.  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 hib (prp/t) vaccine powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site (strength, dosage, frequency, expiry date: unknown) for Immunization.  On an unknown date the patient was administered hib (prp/t) vaccine that was reconstituted with sterile water instead of the recommended acthib 0.4% sodium chloride diluent with no reported adverse event (product preparation error) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product use issue
Clinical narrative: 4-month old patient was accidentally given Fluzone Quadrivalent WIth no reported adverse event; Initial information received on 10-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 4 months old female patient who was accidentally given fluzone quadrivalent with no reported adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR).  On 10-Nov-2022, the patient received a dose of suspect influenza quadrival A-B vaccine Suspension for injection at a dose of 0.5 ml with lot UT7683KA and expiry date- 30-Jun-2023 via unknown route in unknown administration site for influenza.  On 10-Nov-2022, 4-month old patient was accidentally given fluzone quadrivalent with no reported adverse event (product use issue) following the administration of influenza quadrival A-B vaccine (latency unknown).  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event   Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental exposure to product
Clinical narrative: medication ran down the consumer's arm with no reported adverse event; Initial information was received on 11-Nov-2022 regarding an unsolicited valid  non-serious case received from a healthcare professional.  This case involves a 36 years old male patient and reporter reported that medication ran down the consumer's arm with no reported adverse event while receiving vaccine Influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2022, the Influenza quadrival A-B vaccine suspension for injection (intramuscular route in the left arm) (lot UT7716JA and expiration date: 30-Jun-2023) ran down the consumer's arm with no reported adverse event (accidental exposure to product).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: COVID-19, Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: covid 19; injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful; injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful; injection site became itchy; body aches for a day or two; low grade fever; Initial information received from on 11-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had experienced injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful,  body aches for a day or two, low grade fever after receiving Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent]   The patient's past medical history included Skin peeling.  The patient's past medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing Drug allergy.  The patient had allergy with Benadryl, which includes topical formulation found in Caladryl lotion, which makes her skin peel off, diclofenac sodium and Ceclor.  The concomitant vaccine administered was the Pfizer pneumonia vaccine in the left arm and medication included Asfotase alfa (Strensiq).   On an unknown date in 2021, the patient had body aches for a day or two (pain) and low grade fever (pyrexia) after a dose of suspect Influenza quadrival A-B high dose HV vaccine (lot number- not reported) in the arm nos. for Immunization with unknown form, strength, dose, frequency, route, expiry date.  On an unknown date the patient had developed covid 19 (covid-19) (unknown latency).  On 08-Nov-2022 at around 4:00 or 5:00 pm, the patient had injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful (injection site pain), (injection site swelling) and (injection site pruritus) after she received a 0.7 ml dose of the Influenza quadrival A-B high dose HV vaccine (lot- UJ924AD) via intramuscular route in the right arm for Immunization with unknown form, strength, frequency, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events except for for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid).  Outcome: Recovering / Resolving on 11-Nov-2022 for the events- injection site pain, injection site swelling and injection site pruritus and Recovered / Resolved in 2021 for pain and pyrexia and recovered/resolved for Covid-19 in 2 months.  Additional information was received on 11-Nov-2022: patient past history of drug allergy is updated (Benadryl, diclofenac sodium and Ceclor), concomitant medication is updated (Strensiq), event of Covid-19 is added. Text amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: covid 19; injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful; injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful; injection site became itchy; body aches for a day or two; low grade fever; Initial information received from on 11-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had experienced injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful,  body aches for a day or two, low grade fever after receiving Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent]   The patient's past medical history included Skin peeling.  The patient's past medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing Drug allergy.  The patient had allergy with Benadryl, which includes topical formulation found in Caladryl lotion, which makes her skin peel off, diclofenac sodium and Ceclor.  The concomitant vaccine administered was the Pfizer pneumonia vaccine in the left arm and medication included Asfotase alfa (Strensiq).   On an unknown date in 2021, the patient had body aches for a day or two (pain) and low grade fever (pyrexia) after a dose of suspect Influenza quadrival A-B high dose HV vaccine (lot number- not reported) in the arm nos. for Immunization with unknown form, strength, dose, frequency, route, expiry date.  On an unknown date the patient had developed covid 19 (covid-19) (unknown latency).  On 08-Nov-2022 at around 4:00 or 5:00 pm, the patient had injection site became itchy, and then it started to swell up, and it eventually swelled up larger than a baseball, and was sore and painful (injection site pain), (injection site swelling) and (injection site pruritus) after she received a 0.7 ml dose of the Influenza quadrival A-B high dose HV vaccine (lot- UJ924AD) via intramuscular route in the right arm for Immunization with unknown form, strength, frequency, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events except for for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid).  Outcome: Recovering / Resolving on 11-Nov-2022 for the events- injection site pain, injection site swelling and injection site pruritus and Recovered / Resolved in 2021 for pain and pyrexia and recovered/resolved for Covid-19 in 2 months.  Additional information was received on 11-Nov-2022: patient past history of drug allergy is updated (Benadryl, diclofenac sodium and Ceclor), concomitant medication is updated (Strensiq), event of Covid-19 is added. Text amended accordingly.
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Administration site pain, Administration site rash, Diarrhoea, Injection site erythema, Nausea
Clinical narrative: Intense diarrhea; Soreness in the area of administration; Rash in the area of administration; Redness in the area of administration; Nauseas; Lost 10 pounds; This spontaneous case was received on 25-Oct-2022 from pharmacist via Communications (reference number: SEQW22-05019) and concerned a 54-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 13-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 350379 and expiry date: 30-Jun-23.   On 14-Oct-2022, one day after receiving Flucelvax Quadrivalent the patient experienced soreness, rash and redness in the area of administration, and also experienced intense diarrhea and nausea.   On an unspecified day in Oct-2022, the patient stated that had lost 10 pounds.  On an unspecified day in Oct-2022, the patient visited physician's office, however, further details were not reported.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 54-year-old female patient experienced pain, rash, and erythema at vaccination site, intense diarrhea and nausea one day after being vaccinated with the suspect Flucelvax Quadrivalent vaccine. As reported, the patient also had lost 10 pounds. Information regarding the underlying medical history and concomitant medications has not been provided. Based on  information provided causality for the event of weight decreased is not related. Causality for the remaining events is assessed as possibly related. The reported events meet level 2 of diagnostic certainty for Brighton Collaboration criteria for cellulitis.; Sender's Comments: A 54-year-old female patient experienced pain, rash, and erythema at vaccination site, intense diarrhea and nausea one day after being vaccinated with the suspect Flucelvax Quadrivalent vaccine. As reported, the patient also had lost 10 pounds. Information regarding the underlying medical history and concomitant medications has not been provided. Based on  information provided causality for the event of weight decreased is not related. Causality for the remaining events is assessed as possibly related. The reported events meet level 2 of diagnostic certainty for Brighton Collaboration criteria for cellulitis.