chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (a little bit of sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 4), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included Pain in arm with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Hypertension.    On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little bit of sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking medicine for hypertension. It was reported that patient had no other reaction after vaccination. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-725143 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725143:same reporter
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; More than 35 days between Moderna Primary Series vaccines in March to May 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Primary Series vaccines in March to May 2023) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-May-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Primary Series vaccines in March to May 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Primary Series vaccines in March to May 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Primary Series vaccines in March to May 2023).    No concomitant medications were provided. Patient received first Moderna COVID-19 vaccine on 01-Mar-2023 with lot number 071B22A, expiration date was 31-Mar-2023. Injection site arm was not known. No other adverse events reported. No treatment medication was provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023; No adverse event; HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number), PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 18-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number), PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18May2023 from the same lot number) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use by Date and Date the vial was initially stored in the refrigerator on 14Apr2023).    Concomitant medication was not reported. Vial size was 2.5 ml.  The vial did not undergo any temperature excursions. Treatment drug was not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-725148 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Significant follow up contains patient details and dose information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725148:Patient 1 out of 4 patients
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: called to report a TE for two different days FEB 9th and FEB 27th and she stated that she did not know if this vaccine had been given to anyone she said that it was possible because the vaccine was not discarded.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (called to report a TE for two different days FEB 9th and FEB 27th and she stated that she did not know if this vaccine had been given to anyone she said that it was possible because the vaccine was not discarded.) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (called to report a TE for two different days FEB 9th and FEB 27th and she stated that she did not know if this vaccine had been given to anyone she said that it was possible because the vaccine was not discarded.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (called to report a TE for two different days FEB 9th and FEB 27th and she stated that she did not know if this vaccine had been given to anyone she said that it was possible because the vaccine was not discarded.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (called to report a TE for two different days FEB 9th and FEB 27th and she stated that she did not know if this vaccine had been given to anyone she said that it was possible because the vaccine was not discarded.).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: We gave 2 doses of Moderna bivalent BUD; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of Moderna bivalent BUD) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of Moderna bivalent BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of Moderna bivalent BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of Moderna bivalent BUD).    No concomitant medications were provided. No treatment medication was provided.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 4yo child who received monovalent Moderna COVID19 vaccine on 4/20/23; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (4yo child who received monovalent Moderna COVID19 vaccine on 4/20/23) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (4yo child who received monovalent Moderna COVID19 vaccine on 4/20/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4yo child who received monovalent Moderna COVID19 vaccine on 4/20/23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4yo child who received monovalent Moderna COVID19 vaccine on 4/20/23).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Fatigue
Clinical narrative: Her husband has been having issues with tiredness and redness after the vaccine; Her husband has been having issues with tiredness and redness after the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (Her husband has been having issues with tiredness and redness after the vaccine) and FATIGUE (Her husband has been having issues with tiredness and redness after the vaccine) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Her husband has been having issues with tiredness and redness after the vaccine) and FATIGUE (Her husband has been having issues with tiredness and redness after the vaccine). At the time of the report, ERYTHEMA (Her husband has been having issues with tiredness and redness after the vaccine) and FATIGUE (Her husband has been having issues with tiredness and redness after the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Dosage text reported as unknown. No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Fatigue, Feeling abnormal, Influenza like illness, Respiratory symptom
Clinical narrative: Tested positive for COVID-19 after primary series with NVX vaccine; Tested positive for COVID-19 after primary series with NVX vaccine; Like [you have the flu];never went into chest or lungs, just upper respiratory; Felt [tired and] not myself; Like you have the flu;[never went into chest or lungs, just upper respiratory]; Felt tired; This non-serious initial spontaneous safety report was received by Novavax on 15-MAY-2023 from a consumer via the contact center.  A female of an unspecified age and race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 26-OCT-2022, intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 2 on 28-NOV-2022 in the arm.  No medical history was reported. It was reported that the individual had allergies, but th caller was unwilling to share any more details.   No concomitant medications were reported.  On 26-OCT-2022, the individual was vaccinated with dose 1 of Novavax COVID-19 vaccine and later experienced covid-19 (PT: Vaccination failure). On 06-MAR-2023, 4 months 8 days after vaccination, the individual experienced breakthrough covid-19 (PT: Breakthrough COVID-19), she tested positive for COVID-19 on 06-MAR-2023. It lasted about 7 days and her symptoms were described as like the flu, it never went into her chest or lungs, just upper respiratory(PT:Influenza like illness) (PT: Respiratory symptom). She felt tired (PT: Fatigue) and not herself exactly for maybe the next week to 10 days (PT: Feeling abnormal).  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 06-MAR-2023).  On 26-OCT-2022, the event outcome of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Breakthrough COVID-19, Respiratory symptom, Fatigue,Influenza like illness, and Feeling abnormal were recovered/resolved with unknow date in MAR-2023.  Lot number was requested but was unknown to the reporter.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 after primary series with NVX vaccine; Tested positive for COVID-19 after primary series with NVX vaccine; Like [you have the flu];never went into chest or lungs, just upper respiratory; Felt [tired and] not myself; Like you have the flu;[never went into chest or lungs, just upper respiratory]; Felt tired; This non-serious initial spontaneous safety report was received by Novavax on 15-MAY-2023 from a consumer via the contact center.  A female of an unspecified age and race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 26-OCT-2022, intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 2 on 28-NOV-2022 in the arm.  No medical history was reported. It was reported that the individual had allergies, but th caller was unwilling to share any more details.   No concomitant medications were reported.  On 26-OCT-2022, the individual was vaccinated with dose 1 of Novavax COVID-19 vaccine and later experienced covid-19 (PT: Vaccination failure). On 06-MAR-2023, 4 months 8 days after vaccination, the individual experienced breakthrough covid-19 (PT: Breakthrough COVID-19), she tested positive for COVID-19 on 06-MAR-2023. It lasted about 7 days and her symptoms were described as like the flu, it never went into her chest or lungs, just upper respiratory(PT:Influenza like illness) (PT: Respiratory symptom). She felt tired (PT: Fatigue) and not herself exactly for maybe the next week to 10 days (PT: Feeling abnormal).  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 06-MAR-2023).  On 26-OCT-2022, the event outcome of Vaccination failure was recovered/resolved. At the time of reporting, the event outcomes of Breakthrough COVID-19, Respiratory symptom, Fatigue,Influenza like illness, and Feeling abnormal were recovered/resolved with unknow date in MAR-2023.  Lot number was requested but was unknown to the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19, DTOX, TTOX, UNK
Symptoms: Body temperature, Investigation, Pyrexia
Clinical narrative: I seem to be running a little temperature/running a temperature of 100.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16May2023 as dose number unknown (booster), single (Lot number: GJ6743) at the age of 76 years for covid-19 immunisation; tetanus vaccine (TETANUS VACCINE), on 16May2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine (DIPHTHERIA VACCINE), on 16May2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pertussis vaccine (PERTUSSIS VACCINE), on 16May2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; manufacturer unknown), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 17May2023, outcome "unknown", described as "I seem to be running a little temperature/running a temperature of 100.5". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: Patient seem to be running a little temperature; running a temperature of 100.5. He had a Pfizer COVID-19 Shot (Pfizer COVID-19 Vaccine) yesterday (16May2023) and running about 100.5. All he wanted to know that he was running a temperature of 100.5. Should he be concerned with that? Also reported that running a low bit of the temperature; running about 100.5. He reported that with that shot (Pfizer COVID-19 Vaccine) he got a Tetanus Shot, A Diphtheria Shot, and a Pertussis Shot. He was taking a lot of medications (name of medications were not clarified further) but one thing he wanted to tell that had another hour, with that shot (Pfizer COVID-19 Vaccine) he got a Tetanus Shot, A Diphtheria Shot, and a Pertussis Shot. He stated that he did not have any clue regarding lot numbers of all other vaccines. He only got the name. Regarding anatomical site of administration he stated, "the COVID shot was done on my left shoulder and the other 3 were done on my right shoulder." Regarding route of administration he stated, "No I just took these, not intra veins."
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 3 (booster), single (Lot number: 6H9697) at the age of 33 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Lot number: EW0173), in left arm and on 07Jun2021 as dose 2, single (Lot number: EW0158), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cluster headaches" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "GERD" (unspecified if ongoing); "history of gallstones" (unspecified if ongoing); "history of gallbladder removed", start date: 2011, stop date: 2011; "fundoplocation for hiatal hernia and GERD in 1994", start date: 1994, stop date: 1994, notes: fundoplocation for hiatal hernia and GERD in 1994; "fundoplocation for hiatal hernia and GERD in 1994" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Dpt shot (anaphylaxis during infant DPT shot), for Immunisation, reaction(s): "anaphylaxis"; Dpt shot, for Immunisation, reaction(s): "Known allergies: Pertussis in DPT shot". The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) Positive, notes: indication: Treatment of COVID-19; (06May2023) Negative; (16May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 07May2023 to 11May2023.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5 (Moderna); Dose Number: 4 (Pfizer); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 60 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Sep2022 as dose 5 (booster), single (Lot number: A87146B), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Dose Number: 5 (Moderna); Dose Number: 4 (Pfizer)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with Paxlovid from 05May2023 to 09May2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9702), 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), 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's relevant medical history included: "Menieres Disease" (unspecified if ongoing), notes: Other medical history: Menieres Disease , high blood pressure; "high blood pressure" (unspecified if ongoing), notes: Other medical history: Menieres Disease , high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Started symptoms 7 days after full dose of paxlovid and tested positive again the next day. Horrible congestion and sinus/head pressure. Didn't have these symptoms with the original week of covid , which were extreme body aches and fatigue. No known allergy.  No follow-up attempts are possible. No further information is expected
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: EKG showed Afib and Flutter.; EKG showed Afib and Flutter.; Also basal heart rate has gone up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 51 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Lot number: 067H21A) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Diabetes Type II" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; METFORMIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8727), administration date: 25Mar2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Also basal heart rate has gone up"; ATRIAL FIBRILLATION (medically significant), ATRIAL FLUTTER (non-serious) all with onset 29Dec2021, outcome "not recovered" and all described as "EKG showed Afib and Flutter.". The events "ekg showed afib and flutter." and "also basal heart rate has gone up" required physician office visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (29Dec2021) showed Afib and Flutter; Heart rate: (unspecified date) around 80, notes: increased; SARS-CoV-2 test: (15Feb2022) Negative; (Mar2022) Negative; (May2022) Positive; (Aug2022) Negative; (Feb2023) Negative.  Clinical course: No other vaccine in four weeks. 29Dec2021 annual physical EKG showed Afib and Flutter. 2020 annual physical or any of the prior years did not show any cardiac rhythmic abnormalities. Also, basal heart rate has gone up (used to be around 60 till 2020) and these days it is around 80. No covid prior vaccination. covid tested post vaccination. No known allergies.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: EKG showed Afib and Flutter.; EKG showed Afib and Flutter.; Also basal heart rate has gone up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 51 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Lot number: 067H21A) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Diabetes Type II" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; METFORMIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8727), administration date: 25Mar2021, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Also basal heart rate has gone up"; ATRIAL FIBRILLATION (medically significant), ATRIAL FLUTTER (non-serious) all with onset 29Dec2021, outcome "not recovered" and all described as "EKG showed Afib and Flutter.". The events "ekg showed afib and flutter." and "also basal heart rate has gone up" required physician office visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (29Dec2021) showed Afib and Flutter; Heart rate: (unspecified date) around 80, notes: increased; SARS-CoV-2 test: (15Feb2022) Negative; (Mar2022) Negative; (May2022) Positive; (Aug2022) Negative; (Feb2023) Negative.  Clinical course: No other vaccine in four weeks. 29Dec2021 annual physical EKG showed Afib and Flutter. 2020 annual physical or any of the prior years did not show any cardiac rhythmic abnormalities. Also, basal heart rate has gone up (used to be around 60 till 2020) and these days it is around 80. No covid prior vaccination. covid tested post vaccination. No known allergies.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Electrocardiogram, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test positive; Covid test positive; Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8727) and on 15Apr2021 as dose 2, single (Lot number: EW0162) at the age of 51 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Lot number: 067H21A) for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "diabetes Type II" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; METFORMIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2021, outcome "unknown", described as "Dose 1: Pfizer/ Dose 2: Pfizer/ Dose 3: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "Covid test positive". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (29Dec2021) Afib and Flutter, notes: 29Dec2021 annual physical EKG showed Afib and Flutter; SARS-CoV-2 test: (15Feb2022) Negative; (Mar2022) Negative; (May2022) Positive; (Aug2022) Negative; (Feb2023) Negative.  Clinical course: No other vaccine in four weeks. 29Dec2021 annual physical EKG showed Afib and Flutter. 2020 annual physical or any of the prior years did not show any cardiac rhythmic abnormalities. Also, basal heart rate has gone up (used to be around 60 till 2020) and these days it is around 80. No covid prior vaccination. covid tested post vaccination. No known allergies.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Migraine with aura, Nausea, Occipital neuralgia
Clinical narrative: chronic headache; ocular/sensory migraine symptoms; Visual snow syndrome; tinnitus; nausea; occipital neuralgia; pain; migraines with aura; scalp is numb to touch; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ2524) at the age of 27 years 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; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "headache", "migraines and migraine symptoms"; Covid-19 vaccine (Dose 3 , Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "chronic headache"; OPHTHALMIC MIGRAINE (non-serious), outcome "not recovered", described as "ocular/sensory migraine symptoms"; VISUAL SNOW SYNDROME (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; OCCIPITAL NEURALGIA (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown"; MIGRAINE WITH AURA (non-serious), outcome "not recovered", described as "migraines with aura"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "scalp is numb to touch".  Additional information: Dealing with chronic headache and ongoing ocular/sensory migraine symptoms and migraines with aura. Visual snow syndrome and tinnitus being the most intense sensory symptom. With nausea, occipital neuralgia, and pain being the most intense physical symptoms. The pain has been chronic enough that scalp is numb to touch in certain areas. The migraine symptoms come and go, but the headache and occipital neuralgia has been chronic and consistent for about half a year. Noticed, after second dose of the COVID vaccine, headache within the hour and it induced a migraine within the same day. That migraine lasted a few days. Also noticed an increase in frequency and duration with my migraines and migraine symptoms since after receiving the second since after receiving the second dose, and all boosters of the COVID-19 vaccine. Supposed to get an MRI as soon as possible, but recently unable to continue seeing my out of network Neurologist who I was established with. So no EEG scripts until 05Nov.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic migraine, Pain, Tinnitus, Visual snow syndrome
Clinical narrative: chronic headache; ocular/sensory migraine symptoms; Visual snow syndrome; tinnitus; nausea; occipital neuralgia; pain; migraines with aura; scalp is numb to touch; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ2524) at the age of 27 years 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; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "headache", "migraines and migraine symptoms"; Covid-19 vaccine (Dose 3 , Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "chronic headache"; OPHTHALMIC MIGRAINE (non-serious), outcome "not recovered", described as "ocular/sensory migraine symptoms"; VISUAL SNOW SYNDROME (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; OCCIPITAL NEURALGIA (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown"; MIGRAINE WITH AURA (non-serious), outcome "not recovered", described as "migraines with aura"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "scalp is numb to touch".  Additional information: Dealing with chronic headache and ongoing ocular/sensory migraine symptoms and migraines with aura. Visual snow syndrome and tinnitus being the most intense sensory symptom. With nausea, occipital neuralgia, and pain being the most intense physical symptoms. The pain has been chronic enough that scalp is numb to touch in certain areas. The migraine symptoms come and go, but the headache and occipital neuralgia has been chronic and consistent for about half a year. Noticed, after second dose of the COVID vaccine, headache within the hour and it induced a migraine within the same day. That migraine lasted a few days. Also noticed an increase in frequency and duration with my migraines and migraine symptoms since after receiving the second since after receiving the second dose, and all boosters of the COVID-19 vaccine. Supposed to get an MRI as soon as possible, but recently unable to continue seeing my out of network Neurologist who I was established with. So no EEG scripts until 05Nov.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took 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 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: blood clot in my lung; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 30145RA) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Aorta aneurysm" (unspecified if ongoing), notes: other medical history: Aorta aneurysm. The patient took concomitant medications. Vaccination history included: BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, is bivalent: False, prev dose lot number: EN6207, prev dose lot unknown: False, prev dose administration date: 13Mar2021, prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 13Mar2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, is bivalent: False, prev dose lot number: EN6200, prev dose lot unknown: False, prev dose administration date: 20Feb2021, prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 20Feb2021, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: PULMONARY THROMBOSIS (medically significant) with onset Sep2022, outcome "recovered with sequelae", described as "blood clot in my lung". The event "blood clot in my lung" required physician office visit. Therapeutic measures were taken as a result of pulmonary thrombosis. Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other medications in two weeks. The patient had no known allergies. The patient was diagnosed with a blood clot in his lung. Treatment included Eliquis medicine.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Covid-19 treatment; Covid-19 treatment; Moderna Dose1, Dose 2, Dose 3, Dose 4/Pfizer Dose 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 at 12:30 as dose 5 (booster), single (Lot number: GJ6738), in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 19Mar2021 at 13:45 as dose 1, single (Lot number: 045A21A), in left arm, on 19Apr2021 at 14:30 as dose 2, single (Lot number: 044B21A), in left arm, on 05Nov2021 at 14:30 as dose 3 (booster), single (Lot number: 058F21A), in left arm and on 02Apr2022 at 13:45 as dose 4 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thalassemia minor" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Apr2022, outcome "unknown", described as "Moderna Dose1, Dose 2, Dose 3, Dose 4/Pfizer Dose 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antibody test, Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 46-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: "Alcohol use" (unspecified if ongoing), notes: 2-4 drinks/ per week; "Migraines" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "fever" (unspecified if ongoing); "fatigue" (unspecified if ongoing); "arthralgias" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for Covid-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 42 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; Alanine aminotransferase: 57 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: negative; Antinuclear antibody: negative; Aspartate aminotransferase: Return to baseline; Aspartate aminotransferase: 58 IU/l; Blood alkaline phosphatase: 147 IU/l; Blood bilirubin: 0.4 mg/dl; Body mass index: 27.4; ASMA: negative; Serum ferritin: 662 ng/ml.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event liver injury cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-PV202300089305 Same article;suspect;event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase, Blood bilirubin, Body mass index, Investigation, Liver injury
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 46-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: "Alcohol use" (unspecified if ongoing), notes: 2-4 drinks/ per week; "Migraines" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "fever" (unspecified if ongoing); "fatigue" (unspecified if ongoing); "arthralgias" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for Covid-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 42 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; Alanine aminotransferase: 57 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: negative; Antinuclear antibody: negative; Aspartate aminotransferase: Return to baseline; Aspartate aminotransferase: 58 IU/l; Blood alkaline phosphatase: 147 IU/l; Blood bilirubin: 0.4 mg/dl; Body mass index: 27.4; ASMA: negative; Serum ferritin: 662 ng/ml.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event liver injury cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-PV202300089305 Same article;suspect;event and different patient;