chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Rash, Throat irritation, Urticaria
Clinical narrative: Trouble breathing; Scratchy throat; Hives and rash on arm, neck and face; Hives and rash on arm, neck and face; This spontaneous case was retrieved on 15-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number 1632965-1), reported by other healthcare professional, and concerned a 38-year-old, female patient.  The patient's concurrent conditions included severe allergies, eczema, asthma, type 2 diabetes, high blood pressure, and allergy to fish, shellfish, and metformin. The patient's concomitant medications included duloxetine, cetirizine and albuterol, all used for unreported indication.  On 14-Oct-2020 the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: right arm (RA), dose and indication: not reported). The batch number reported was 276558.  On the same date, after receiving Flucelvax Quadrivalent, the patient developed hives and rash on arm, neck and face and experienced scratchy throat and had trouble breathing.  On unspecified date, the patient visited physician office, however further detail were not provided.   On unspecified date, the patient recovered from all events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 38-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed hives and rash on arm, neck and face and experienced scratchy throat and had trouble breathing. Information regarding the related diagnostic findings and whether treatment was required was not provided. Based on plausible time relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 38-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed hives and rash on arm, neck and face and experienced scratchy throat and had trouble breathing. Information regarding the related diagnostic findings and whether treatment was required was not provided. Based on plausible time relationship, causality for the reported events is assessed as possibly related.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm is no longer usefull; my arm is no longer usefull and always in pain; irregular chest pain and spasms; irregular chest pain and spasms; Arrhythmia; the one that harmed me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 07Aug2021 at 12:00 as dose 2, single (Lot number: FG4493) intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Single, Time (24 hr): 11:00, Site and route on injection: Anatomical site of injection: Left arm, Route of administration: intramuscular, Batch/Lot number: EW0196), administration date: 07Jul2021, for Covid-19 Immunization. The following information was reported: INJURY (disability, medically significant) with onset 10Aug2021 at 11:00, outcome "not recovered", described as "the one that harmed me"; ARRHYTHMIA (medically significant) with onset 15Apr2022, outcome "recovered"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "my arm is no longer usefull"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm is no longer usefull and always in pain"; CHEST PAIN (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "irregular chest pain and spasms". The event "the one that harmed me" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: (09Oct2021) irregular pain/event, notes: irregular pain/event; (15Dec2021) irregular pain/event, notes: irregular pain/event; (15Apr2022) Arrhythmia, notes: New Arrhythmia. Therapeutic measures were taken as a result of injury.  Clinical Course: My left arm is no longer useful and always in pain. I have regular episodes of irregular chest pain and spasms, I have now been diagnosed with Arrhythmia and no longer approved for competitive sport, as failed Eco cardio sport stress test (which passed 1 month prior to vaccine with no arrhythmia). Before and after my dose of FG4493 VAERS shows. FG4493 killed and disabled many!.  Follow-up (06Sep2022): This is a spontaneous follow-up report from a contactable consumer. This Consumer (patient) reported in response to Non-HCP letter sent via follow-up letter which included that: Updated information: 'PC' of reporter slider#01 was unchecked, Patient's age at vaccination was added. RMH and historical vaccine coding was updated, start and stop date was added, notes were updated, lab data was added, start and stop date, patient route of administration, anatomical location of dosage regimen slider#01 of suspect product was added, Vaccine facility information was added, Event onset date, outcome, treatment received was added and 'Physician Office visit' checked for event 'Injury', new events 'Arrhythmia', 'Arm discomfort', 'Pain in arm', 'Chest pain' and 'Spasms' with event onset date were added. Concomitant therapy captured.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: my arm is no longer usefull; my arm is no longer usefull and always in pain; irregular chest pain and spasms; irregular chest pain and spasms; Arrhythmia; the one that harmed me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 07Aug2021 at 12:00 as dose 2, single (Lot number: FG4493) intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Single, Time (24 hr): 11:00, Site and route on injection: Anatomical site of injection: Left arm, Route of administration: intramuscular, Batch/Lot number: EW0196), administration date: 07Jul2021, for Covid-19 Immunization. The following information was reported: INJURY (disability, medically significant) with onset 10Aug2021 at 11:00, outcome "not recovered", described as "the one that harmed me"; ARRHYTHMIA (medically significant) with onset 15Apr2022, outcome "recovered"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "my arm is no longer usefull"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm is no longer usefull and always in pain"; CHEST PAIN (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "irregular chest pain and spasms". The event "the one that harmed me" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: (09Oct2021) irregular pain/event, notes: irregular pain/event; (15Dec2021) irregular pain/event, notes: irregular pain/event; (15Apr2022) Arrhythmia, notes: New Arrhythmia. Therapeutic measures were taken as a result of injury.  Clinical Course: My left arm is no longer useful and always in pain. I have regular episodes of irregular chest pain and spasms, I have now been diagnosed with Arrhythmia and no longer approved for competitive sport, as failed Eco cardio sport stress test (which passed 1 month prior to vaccine with no arrhythmia). Before and after my dose of FG4493 VAERS shows. FG4493 killed and disabled many!.  Follow-up (06Sep2022): This is a spontaneous follow-up report from a contactable consumer. This Consumer (patient) reported in response to Non-HCP letter sent via follow-up letter which included that: Updated information: 'PC' of reporter slider#01 was unchecked, Patient's age at vaccination was added. RMH and historical vaccine coding was updated, start and stop date was added, notes were updated, lab data was added, start and stop date, patient route of administration, anatomical location of dosage regimen slider#01 of suspect product was added, Vaccine facility information was added, Event onset date, outcome, treatment received was added and 'Physician Office visit' checked for event 'Injury', new events 'Arrhythmia', 'Arm discomfort', 'Pain in arm', 'Chest pain' and 'Spasms' with event onset date were added. Concomitant therapy captured.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Wrong product administered
Clinical narrative: Nurse reports that a pregnant patient was accidently administered GARDASIL 9 on Aug 16, 2022.; No additional AE reported; This spontaneous prospective pregnancy case has been received from a registered nurse concerning to a 31-year-old pregnant female patient.  The patient's medical history included abnormal Papanicolaou (pap) smear and anemia. Concomitant therapies included prenatal vitamin (unspecified). None previous drug reactions and allergies were reported.  At the time of the report, she was at 27 weeks and 6 days of her pregnancy. The last menstrual period (LMP) was estimated on 04-FEB-2022.  On 16-AUG-2022, the patient was accidently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (mL), administered intramuscularly (IM) for prophylaxis (strength, vaccination scheme frequency, route of administration, anatomical site of application, lot number, and expiration date were not provided) (exposure during pregnancy). It was reported that the patient was fine, and nothing has happened.  The estimate due date would be on 11-NOV-2022.   No additional adverse event (AE) was reported. By the reporting time, the outcome of the event exposure during pregnancy was unknown per internal guidelines; the patient did not seek for medical attention, and no treatment was provided for the event.   The pregnancy outcome was pending, and the fetal outcome was unknown.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Nurse reports that a pregnant patient was accidently administered GARDASIL 9 on Aug 16, 2022.; No additional AE reported; This spontaneous prospective pregnancy case has been received from a registered nurse concerning to a 31-year-old pregnant female patient.  The patient's medical history included abnormal Papanicolaou (pap) smear and anemia. Concomitant therapies included prenatal vitamin (unspecified). None previous drug reactions and allergies were reported.  At the time of the report, she was at 27 weeks and 6 days of her pregnancy. The last menstrual period (LMP) was estimated on 04-FEB-2022.  On 16-AUG-2022, the patient was accidently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (mL), administered intramuscularly (IM) for prophylaxis (strength, vaccination scheme frequency, route of administration, anatomical site of application, lot number, and expiration date were not provided) (exposure during pregnancy). It was reported that the patient was fine, and nothing has happened.  The estimate due date would be on 11-NOV-2022.   No additional adverse event (AE) was reported. By the reporting time, the outcome of the event exposure during pregnancy was unknown per internal guidelines; the patient did not seek for medical attention, and no treatment was provided for the event.   The pregnancy outcome was pending, and the fetal outcome was unknown.
Age: 31.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: Nurse reports that a pregnant patient was accidently administered GARDASIL 9 on Aug 16, 2022.; No additional AE reported; This spontaneous prospective pregnancy case has been received from a registered nurse concerning to a 31-year-old pregnant female patient.  The patient's medical history included abnormal Papanicolaou (pap) smear and anemia. Concomitant therapies included prenatal vitamin (unspecified). None previous drug reactions and allergies were reported.  At the time of the report, she was at 27 weeks and 6 days of her pregnancy. The last menstrual period (LMP) was estimated on 04-FEB-2022.  On 16-AUG-2022, the patient was accidently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (mL), administered intramuscularly (IM) for prophylaxis (strength, vaccination scheme frequency, route of administration, anatomical site of application, lot number, and expiration date were not provided) (exposure during pregnancy). It was reported that the patient was fine, and nothing has happened.  The estimate due date would be on 11-NOV-2022.   No additional adverse event (AE) was reported. By the reporting time, the outcome of the event exposure during pregnancy was unknown per internal guidelines; the patient did not seek for medical attention, and no treatment was provided for the event.   The pregnancy outcome was pending, and the fetal outcome was unknown.
Age: 21.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Asthenia, Back pain, Headache, Lymphadenopathy, Neck pain
Clinical narrative: fEVER 104.5 I've been able to slightly get it under control through the use of Advil and Tylenol. But once that wears off I skyrocket back up to at least 102. All other symptoms besides swollen neck lymph nodes have subsided.
Age: 21.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Pyrexia
Clinical narrative: fEVER 104.5 I've been able to slightly get it under control through the use of Advil and Tylenol. But once that wears off I skyrocket back up to at least 102. All other symptoms besides swollen neck lymph nodes have subsided.
Age: 21.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: General symptom, Lymphadenopathy, Pyrexia
Clinical narrative: fEVER 104.5 I've been able to slightly get it under control through the use of Advil and Tylenol. But once that wears off I skyrocket back up to at least 102. All other symptoms besides swollen neck lymph nodes have subsided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; Caller reported vaccines administered after temperature excursion.  Caller also unable to provide information on prior temperature excursions.  During data collection- Caller reported the vaccines were administered IM (instead of SQ).  No additional; Vaccines were administered IM (instead of SQ); This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.  On 16-AUG-2022,  the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)at a dose of 0.5 ml lot #U028164, expiration date: 09-SEP-2023, administered intramuscularly instead of subcutaneously (incorrect route of administration) for prophylaxis following a temperature excursion of 32.9 degrees Fahrenheit for 28 hours and 39 minutes (product storage error), it was stated that previous temperature excursions did occurred. No additional adverse event was reported.  This is one of several case from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA010122: US-009507513-2208USA008558:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccines administered after temperature excursion.  Caller also unable to provide information on prior temperature excursions.  During data collection- Caller reported the vaccines were administered IM (instead of SQ).  No additional; Vaccines were administered IM (instead of SQ); This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.  On 16-AUG-2022,  the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)at a dose of 0.5 ml lot #U028164, expiration date: 09-SEP-2023, administered intramuscularly instead of subcutaneously (incorrect route of administration) for prophylaxis following a temperature excursion of 32.9 degrees Fahrenheit for 28 hours and 39 minutes (product storage error), it was stated that previous temperature excursions did occurred. No additional adverse event was reported.  This is one of several case from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA010122: US-009507513-2208USA008558:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Deafness
Clinical narrative: Test: COVID - positive; Test: COVID - positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), on 29Jan2021 at 10:30 as dose 1, single (Lot number: EL9262), in left arm, on 19Feb2021 at 11:30 as dose 2, single (Lot number: EN6203), in left arm, on 31Oct2021 at 15:30 as dose 3 (booster), single (Lot number: FE4525), in left arm and on 04Jun2022 at 11:30 as dose 4 (booster), single (Lot number: FM7553), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation", start date: 2005 (ongoing), notes: 5 cardioversions 3 ablations; "Hypothyroid" (ongoing). Concomitant medication(s) included: SOTALOL oral taken for atrial fibrillation (ongoing); SYNTHROID oral taken for hypothyroidism (ongoing); XARELTO oral taken for atrial fibrillation (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Test: COVID - positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: Relevant test; (28Jul2022) Positive, notes: Relevant test; (30Aug2022) Negative, notes: Relevant test.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test: COVID - positive; Test: COVID - positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2 (BNT162B2), on 29Jan2021 at 10:30 as dose 1, single (Lot number: EL9262), in left arm, on 19Feb2021 at 11:30 as dose 2, single (Lot number: EN6203), in left arm, on 31Oct2021 at 15:30 as dose 3 (booster), single (Lot number: FE4525), in left arm and on 04Jun2022 at 11:30 as dose 4 (booster), single (Lot number: FM7553), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation", start date: 2005 (ongoing), notes: 5 cardioversions 3 ablations; "Hypothyroid" (ongoing). Concomitant medication(s) included: SOTALOL oral taken for atrial fibrillation (ongoing); SYNTHROID oral taken for hypothyroidism (ongoing); XARELTO oral taken for atrial fibrillation (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Test: COVID - positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: Relevant test; (28Jul2022) Positive, notes: Relevant test; (30Aug2022) Negative, notes: Relevant test.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Blood test normal, Urticaria
Clinical narrative: the patient been tested positive for COVID; the patient been tested positive for COVID; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 09Apr2021 as dose 2, single (Lot number: ER8733) and on 19Nov2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "the patient been tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2022) Positive.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2  to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Chronic spontaneous urticaria, Emotional distress, Pruritus, Urticaria
Clinical narrative: the patient been tested positive for COVID; the patient been tested positive for COVID; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 09Apr2021 as dose 2, single (Lot number: ER8733) and on 19Nov2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "the patient been tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2022) Positive.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2  to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: the patient been tested positive for COVID; the patient been tested positive for COVID; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 09Apr2021 as dose 2, single (Lot number: ER8733) and on 19Nov2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "the patient been tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2022) Positive.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2  to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lupus syndrome. Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated). At the time of the report, URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: High temperature. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2022-638961, MOD-2022-638963, MOD-2022-638962 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lupus syndrome. Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated). At the time of the report, URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: High temperature. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2022-638961, MOD-2022-638963, MOD-2022-638962 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urinary incontinence
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lupus syndrome. Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated). At the time of the report, URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: High temperature. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2022-638961, MOD-2022-638963, MOD-2022-638962 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lupus syndrome. Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated). At the time of the report, URINARY INCONTINENCE (incontinent of urine), PAIN IN EXTREMITY (Patient had sore arm), PYREXIA (high temperature/high fever), FATIGUE (fatigued) and NAUSEA (nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: High temperature. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2022-638961, MOD-2022-638963, MOD-2022-638962 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Magnetic resonance imaging, Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: BNT162b2 (Dose 1, Single, Lot No.: Unable to locate or read the details, Arm Left), administration date: 17Sep2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: TRIGEMINAL NEURALGIA (non-serious) with onset 21Apr2022, outcome "not recovered". The event "trigeminal neuralgia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of trigeminal neuralgia. Additional Information: The patient had no other vaccines in four weeks. The patient received multiple medications with no relief in response to event. The patient had no COVID prior vaccination and not tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: BNT162b2 (Dose 1, Single, Lot No.: Unable to locate or read the details, Arm Left), administration date: 17Sep2021, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: TRIGEMINAL NEURALGIA (non-serious) with onset 21Apr2022, outcome "not recovered". The event "trigeminal neuralgia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of trigeminal neuralgia. Additional Information: The patient had no other vaccines in four weeks. The patient received multiple medications with no relief in response to event. The patient had no COVID prior vaccination and not tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Extra dose administered, Tinnitus
Clinical narrative: Approximately 70 minutes after vaccine I had our ringing in my ears (Tinnitus); Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 04:15 as dose 5 (booster), single (Lot number: GH9644) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Prev dose administration time=01:00 PM; Prev dose lot number=EL3246; Prev dose lot unknown=False), administration date: 07Jan2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Prev dose administration time=10:00 AM; Prev dose lot number=EL9263; Prev dose lot unknown=False; Prev dose vaccine location=Left arm), administration date: 28Jan2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3, SINGLE; Prev dose administration time=01:00 PM; Prev dose lot number=FD8448; Prev dose lot unknown=False; Prev dose vaccine location=Left arm), administration date: 17Aug2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4, SINGLE; Prev dose administration time=01:00 AM; Prev dose lot number=FC3209; Prev dose lot unknown=False; Prev dose vaccine location=Left arm), administration date: 02Mar2022, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Sep2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 07Sep2022, outcome "unknown"; TINNITUS (non-serious) with onset 07Sep2022 at 17:30, outcome "not recovered", described as "Approximately 70 minutes after vaccine I had our ringing in my ears (Tinnitus)". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not received any other vaccine in four weeks. No COVID prior vaccination and not tested for COVID post vaccination. No known allergies.
Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Immunisation, Off label use, Tinnitus
Clinical narrative: Approximately 70 minutes after vaccine I had our ringing in my ears (Tinnitus); Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 04:15 as dose 5 (booster), single (Lot number: GH9644) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Prev dose administration time=01:00 PM; Prev dose lot number=EL3246; Prev dose lot unknown=False), administration date: 07Jan2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Prev dose administration time=10:00 AM; Prev dose lot number=EL9263; Prev dose lot unknown=False; Prev dose vaccine location=Left arm), administration date: 28Jan2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3, SINGLE; Prev dose administration time=01:00 PM; Prev dose lot number=FD8448; Prev dose lot unknown=False; Prev dose vaccine location=Left arm), administration date: 17Aug2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4, SINGLE; Prev dose administration time=01:00 AM; Prev dose lot number=FC3209; Prev dose lot unknown=False; Prev dose vaccine location=Left arm), administration date: 02Mar2022, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Sep2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 07Sep2022, outcome "unknown"; TINNITUS (non-serious) with onset 07Sep2022 at 17:30, outcome "not recovered", described as "Approximately 70 minutes after vaccine I had our ringing in my ears (Tinnitus)". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not received any other vaccine in four weeks. No COVID prior vaccination and not tested for COVID post vaccination. No known allergies.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Agitation, Ammonia increased, Ascites, Asthenia, Asymptomatic COVID-19
Clinical narrative: Admitted to hospital.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Culture negative, Enema administration, Hepatic cirrhosis, Hepatic encephalopathy
Clinical narrative: Admitted to hospital.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pancytopenia, Paracentesis
Clinical narrative: Admitted to hospital.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Admitted to hospital.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Pityriasis rosea, Rash
Clinical narrative: Pityriasis Rosea. Onset 1 week after vaccination. Full rash peaked 1mo after vaccination and lasted for another 1.5 months from peak. 3mo back to normal.
Age: 15.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered
Clinical narrative: Patient received incorrect dose. Correct dose was 0.5 mL subcutaneous. Per documentation, patient was given 0.1 mL subcutaneous (potential documentation error regarding route).
Age: 17.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered
Clinical narrative: Patient received incorrect dose. Correct dose was 0.5 mL subcutaneous. Per documentation, patient was given 0.1 mL subcutaneous (potential documentation error regarding route).
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Injection site discharge, Injection site haemorrhage, Myalgia, Somnolence
Clinical narrative: Very small amount of blood and liquid drained at injection.  Could not go back to show and tell them at that time.  Also muscle pain, sleepy, little fatigued
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Dyspnoea, Rash, Tremor
Clinical narrative: At 12:00am on 09/04/2022, about twelve hours after receiving my bivalent booster, I was suddenly hit with extreme chills that caused me to violently shake. After two hours they went away, I fell asleep, and woke up around 2:30am unable to breathe. It did not feel like I was congested, but I did not have any decongestants to take on hand so I couldn't test the theory. I got some breathing ability back after about three hours, but I had marked difficulty breathing until around 11:00am on 09/04/2022. I also developed a red pinpoint rash along the tops of both my left and right thigh. I noticed it first on 09/04/2022 in the early afternoon, but it is possible it appeared overnight. It has taken approximately six days for the rash to dissipate: it is mostly gone as of today, 09/10/22. The rash was not itchy or painful, and there were no other symptoms of an allergic reaction.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Itchiness and achiness.
Age: 48.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: The following AM I had a large bruise and swollen injection site.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Laboratory test, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal, Optic neuritis
Clinical narrative: Attack of bilateral optic neuritis with accompanying permanent loss of vision.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Flushing
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Severe
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Syncope, Tinnitus, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Severe
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Severe
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Nausea, Palpitations, Syncope
Clinical narrative: Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild. Additional details: About 5-10 minutes after vaccine given, patient fainted and fell. She complained of nausea and heart racing. We called the EMTs. They took her to ER.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Tachycardia-Mild. Additional details: About 5-10 minutes after vaccine given, patient fainted and fell. She complained of nausea and heart racing. We called the EMTs. They took her to ER.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient came to pharmacy on tuesday 09/09/2022 presenting with redness, swelling and warmth on her left forearem.  I sent patient to see her MD. MD diagnosis with cellulitis and  prescribed Bactrim DS 1 tablet twice a day for 14 days. Patient picked up medication day of.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 94.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Dizziness, Fatigue, Injection site pain, Lethargy
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Additional Details: Patient called pharmacy to report an adverse reaction to the high dose flu vaccine, does not typically have a reaction this severe. Reported feeling extremely fatigued and dizzy for 3 days starting approx. 12 hrs after vaccine was administered. She said she is feeling better today but was concerned because of the severity of her reaction and that it lasted beyond one day
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Joint injury, Limb injury
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.).
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Injection Site-
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysphagia, Fatigue, Lethargy, Pruritus
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: Gave patient 5ml of liquid benadryl, pt was not having any adverse effects within the 15 minute time frame but came back around 20 min after vaccine and stated she was experiencing tightness when swallowing and very weak feeling.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: Gave patient 5ml of liquid benadryl, pt was not having any adverse effects within the 15 minute time frame but came back around 20 min after vaccine and stated she was experiencing tightness when swallowing and very weak feeling.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: Severe watery diarrhea for beginning day 2 after vaccine and continues into day 4.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Error: Leak from syringe.
Age: 38.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blindness transient, Chills, Confusional state, Dizziness, Pyrexia
Clinical narrative: Severe chills Fever Dizziness Confusion Temporary loss of vision- lasted approximately 10 minutes following a dizzy spell. Complete loss of vision in both eyes. Happened about 15 hours post vaccination in the middle of the night.  Severe enough we almost called 911
Age: 38.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blindness transient, Body temperature, Chills, Dizziness, Pain
Clinical narrative: Severe chills Fever Dizziness Confusion Temporary loss of vision- lasted approximately 10 minutes following a dizzy spell. Complete loss of vision in both eyes. Happened about 15 hours post vaccination in the middle of the night.  Severe enough we almost called 911
Age: 38.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pyrexia
Clinical narrative: Severe chills Fever Dizziness Confusion Temporary loss of vision- lasted approximately 10 minutes following a dizzy spell. Complete loss of vision in both eyes. Happened about 15 hours post vaccination in the middle of the night.  Severe enough we almost called 911