chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 1 day after refrigerator shelf life.; vaccine given 1 day after refrigerator shelf life.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life.) and PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life.) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 0271L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included LEVOTHYROXINE and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 14-Apr-2022 at 3:42 PM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Apr-2022 at 3:42 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life.) and PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included one touch delica plus lancet 33 gauge and OneTouch Verio test strips
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine given 1 day after refrigerator shelf life.; vaccine given 1 day after refrigerator shelf life.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life.) and PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life.) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 0271L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included LEVOTHYROXINE and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 14-Apr-2022 at 3:42 PM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Apr-2022 at 3:42 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life.) and PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included one touch delica plus lancet 33 gauge and OneTouch Verio test strips
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 1 day after refrigerator shelf life; vaccine given 1 day after refrigerator shelf life; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life) and PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concomitant products included AZATHIOPRINE, PREDNISONE, TAMSULOSIN and URSODIOL for an unknown indication.    On 04-Apr-2022 at 4:23 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022 at 4:23 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life) and PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine given 1 day after refrigerator shelf life; vaccine given 1 day after refrigerator shelf life; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life) and PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concomitant products included AZATHIOPRINE, PREDNISONE, TAMSULOSIN and URSODIOL for an unknown indication.    On 04-Apr-2022 at 4:23 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022 at 4:23 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life) and PRODUCT STORAGE ERROR (vaccine given 1 day after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product use issue
Clinical narrative: vaccine given 1 day after refrigerator shelf life; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included ESOMEPRAZOLE, FERROUS SULFATE, LEVOTHYROXINE and OXYBUTYNIN HYDROCHLORIDE (OXYBUTYNIN CHLORIDE ER) for an unknown indication.    On 14-Apr-2022 at 10:19 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2022 at 10:19 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given 1 day after refrigerator shelf life; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included ESOMEPRAZOLE, FERROUS SULFATE, LEVOTHYROXINE and OXYBUTYNIN HYDROCHLORIDE (OXYBUTYNIN CHLORIDE ER) for an unknown indication.    On 14-Apr-2022 at 10:19 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2022 at 10:19 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given 1 day after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine given 23 days after refrigerator shelf life; Vaccine given 23 days after refrigerator shelf life; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life) and PRODUCT STORAGE ERROR (Vaccine given 23 days after refrigerator shelf life) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine allergy) and Drug allergy (Symbicort allergy). Concomitant products included ALBUTEROL SULFATE, FLUTICASONE PROPIONATE, MONTELUKAST and ETONOGESTREL (NEXPLANON) for an unknown indication.    On 06-May-2022 at 5:07 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-May-2022 at 5:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine given 23 days after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life) and PRODUCT STORAGE ERROR (Vaccine given 23 days after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine given 23 days after refrigerator shelf life; Vaccine given 23 days after refrigerator shelf life; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life) and PRODUCT STORAGE ERROR (Vaccine given 23 days after refrigerator shelf life) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine allergy) and Drug allergy (Symbicort allergy). Concomitant products included ALBUTEROL SULFATE, FLUTICASONE PROPIONATE, MONTELUKAST and ETONOGESTREL (NEXPLANON) for an unknown indication.    On 06-May-2022 at 5:07 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-May-2022 at 5:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine given 23 days after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 23 days after refrigerator shelf life) and PRODUCT STORAGE ERROR (Vaccine given 23 days after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate irregular, Myocarditis
Clinical narrative: I may have myocarditis as a result of my 4th Pfizer, my second booster; substantial orthostatic hypertension; great deal of lightheadedness almost dizziness; substantial shortness of breath; irregular heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 81 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; Lot#: (First Shot): ER8732), administration date: 27Mar2021, for COVID-19 immunization; BNT162b2 (Dose 2), administration date: 17Apr2021, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster)), administration date: 17Nov2021, for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "I may have myocarditis as a result of my 4th Pfizer, my second booster"; ORTHOSTATIC HYPERTENSION (non-serious), outcome "unknown", described as "substantial orthostatic hypertension"; DIZZINESS (non-serious), outcome "unknown", described as "great deal of lightheadedness almost dizziness"; DYSPNOEA (non-serious), outcome "unknown", described as "substantial shortness of breath"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "irregular heartbeat". Therapeutic measures were not taken as a result of myocarditis, orthostatic hypertension, dizziness, dyspnoea, heart rate irregular.  Clinical course: The patient reported that he may have myocarditis as a result of his 4th Pfizer, second booster. The first 3 Pfizer were a piece of cake and he had almost no reactions but the fourth one, about 5 days after the injection, he began with a lot of side effects roughly. The patient reported that events started about 5 days after the 4th injection. He stated that he understands that in rare cases myocarditis exists, but very rare. He understood that it tends to resolve itself in about 90 days. The patient had very often substantial orthostatic hypertension, both pre and post (as reported), accompanied by a great deal of lightheadedness almost dizziness, substantial shortness of breath, and then noticeable irregular heartbeat. The patient had no prior Vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Orthostatic hypotension
Clinical narrative: I may have myocarditis as a result of my 4th Pfizer, my second booster; substantial orthostatic hypertension; great deal of lightheadedness almost dizziness; substantial shortness of breath; irregular heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 81 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; Lot#: (First Shot): ER8732), administration date: 27Mar2021, for COVID-19 immunization; BNT162b2 (Dose 2), administration date: 17Apr2021, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster)), administration date: 17Nov2021, for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "I may have myocarditis as a result of my 4th Pfizer, my second booster"; ORTHOSTATIC HYPERTENSION (non-serious), outcome "unknown", described as "substantial orthostatic hypertension"; DIZZINESS (non-serious), outcome "unknown", described as "great deal of lightheadedness almost dizziness"; DYSPNOEA (non-serious), outcome "unknown", described as "substantial shortness of breath"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "irregular heartbeat". Therapeutic measures were not taken as a result of myocarditis, orthostatic hypertension, dizziness, dyspnoea, heart rate irregular.  Clinical course: The patient reported that he may have myocarditis as a result of his 4th Pfizer, second booster. The first 3 Pfizer were a piece of cake and he had almost no reactions but the fourth one, about 5 days after the injection, he began with a lot of side effects roughly. The patient reported that events started about 5 days after the 4th injection. He stated that he understands that in rare cases myocarditis exists, but very rare. He understood that it tends to resolve itself in about 90 days. The patient had very often substantial orthostatic hypertension, both pre and post (as reported), accompanied by a great deal of lightheadedness almost dizziness, substantial shortness of breath, and then noticeable irregular heartbeat. The patient had no prior Vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate irregular, Myocarditis, Orthostatic hypertension
Clinical narrative: I may have myocarditis as a result of my 4th Pfizer, my second booster; substantial orthostatic hypertension; great deal of lightheadedness almost dizziness; substantial shortness of breath; irregular heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 81 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; Lot#: (First Shot): ER8732), administration date: 27Mar2021, for COVID-19 immunization; BNT162b2 (Dose 2), administration date: 17Apr2021, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster)), administration date: 17Nov2021, for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "I may have myocarditis as a result of my 4th Pfizer, my second booster"; ORTHOSTATIC HYPERTENSION (non-serious), outcome "unknown", described as "substantial orthostatic hypertension"; DIZZINESS (non-serious), outcome "unknown", described as "great deal of lightheadedness almost dizziness"; DYSPNOEA (non-serious), outcome "unknown", described as "substantial shortness of breath"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "irregular heartbeat". Therapeutic measures were not taken as a result of myocarditis, orthostatic hypertension, dizziness, dyspnoea, heart rate irregular.  Clinical course: The patient reported that he may have myocarditis as a result of his 4th Pfizer, second booster. The first 3 Pfizer were a piece of cake and he had almost no reactions but the fourth one, about 5 days after the injection, he began with a lot of side effects roughly. The patient reported that events started about 5 days after the 4th injection. He stated that he understands that in rare cases myocarditis exists, but very rare. He understood that it tends to resolve itself in about 90 days. The patient had very often substantial orthostatic hypertension, both pre and post (as reported), accompanied by a great deal of lightheadedness almost dizziness, substantial shortness of breath, and then noticeable irregular heartbeat. The patient had no prior Vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Myelitis transverse, Neurological examination
Clinical narrative: Transverse Myelitis; Muscle pain/weakness; Muscle pain/weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2021 at 15:00 as dose 2, single (Lot number: EW0176) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: BNT162b2 (Dose 1, Single,, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 01Apr2021, when the patient was 58-year-old, for COVID-19 Immunization. The following information was reported: MYALGIA (hospitalization), MUSCULAR WEAKNESS (hospitalization) all with onset May2021, outcome "not recovered" and all described as "Muscle pain/weakness"; MYELITIS TRANSVERSE (hospitalization) with onset 2021, outcome "not recovered", described as "Transverse Myelitis". The patient was hospitalized for myalgia, muscular weakness (hospitalization duration: 2 day(s)). The events "transverse myelitis" and "muscle pain/weakness" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Tests done: (Jul2021) Unknown results, notes: More tests; (Aug2021) diagnosed with Transverse Myelitis; SARS-CoV-2 test: (Jun2021) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of myelitis transverse. Therapeutic measures were taken as a result of myalgia, muscular weakness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Investigation, Muscular weakness, Myalgia, Myelitis transverse, SARS-CoV-2 test
Clinical narrative: Transverse Myelitis; Muscle pain/weakness; Muscle pain/weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2021 at 15:00 as dose 2, single (Lot number: EW0176) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: BNT162b2 (Dose 1, Single,, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 01Apr2021, when the patient was 58-year-old, for COVID-19 Immunization. The following information was reported: MYALGIA (hospitalization), MUSCULAR WEAKNESS (hospitalization) all with onset May2021, outcome "not recovered" and all described as "Muscle pain/weakness"; MYELITIS TRANSVERSE (hospitalization) with onset 2021, outcome "not recovered", described as "Transverse Myelitis". The patient was hospitalized for myalgia, muscular weakness (hospitalization duration: 2 day(s)). The events "transverse myelitis" and "muscle pain/weakness" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Tests done: (Jul2021) Unknown results, notes: More tests; (Aug2021) diagnosed with Transverse Myelitis; SARS-CoV-2 test: (Jun2021) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of myelitis transverse. Therapeutic measures were taken as a result of myalgia, muscular weakness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Tested positive for Covid-19 on the RT-PCR Test April of 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid-19 on the RT-PCR Test April of 2022) in a 59-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient has no known allergies to food, medications or any products.  Concurrent medical conditions included Diabetes (Started about 10 years ago) since 2010.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Tested positive for Covid-19 on the RT-PCR Test April of 2022). In May 2022, COVID-19 (Tested positive for Covid-19 on the RT-PCR Test April of 2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication were reported.  Vaccine had no effect on patient's medical condition.   The patient had mentioned that he did not received any other vaccine 1 month prior to getting the Moderna Covid-19 Vaccine. He did not seek medical help. This was the first time that the patient experience the symptoms. Patient tested negative after one and half month.  No treatment medication were reported.  Company Comment: This spontaneous case concerns a 59 year-old male patient, with no relevant history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the first and second dose of mRNA-1273 vaccine administration. Patient tested negative after one and half months. No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-591982 (Patient Link). Sender's Comments: This spontaneous case concerns a 59 year-old male patient, with no relevant history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the first and second dose of mRNA-1273 vaccine administration. Patient tested negative after one and half months. No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19 on the RT-PCR Test April of 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid-19 on the RT-PCR Test April of 2022) in a 59-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Patient has no known allergies to food, medications or any products.  Concurrent medical conditions included Diabetes (Started about 10 years ago) since 2010.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Tested positive for Covid-19 on the RT-PCR Test April of 2022). In May 2022, COVID-19 (Tested positive for Covid-19 on the RT-PCR Test April of 2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication were reported.  Vaccine had no effect on patient's medical condition.   The patient had mentioned that he did not received any other vaccine 1 month prior to getting the Moderna Covid-19 Vaccine. He did not seek medical help. This was the first time that the patient experience the symptoms. Patient tested negative after one and half month.  No treatment medication were reported.  Company Comment: This spontaneous case concerns a 59 year-old male patient, with no relevant history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the first and second dose of mRNA-1273 vaccine administration. Patient tested negative after one and half months. No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-591982 (Patient Link). Sender's Comments: This spontaneous case concerns a 59 year-old male patient, with no relevant history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the first and second dose of mRNA-1273 vaccine administration. Patient tested negative after one and half months. No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: This spontaneous report received from a health care professional concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2022 for prophylactic vaccination. The drug was associated with Medication error. Age at time of vaccination 72 years old. No concomitant medications were reported. On 21-JUN-2022, the patient experienced partial dose (0.25ml) administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose (0.25ml) administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220647247.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: This spontaneous report received from a health care professional concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2022 for prophylactic vaccination. The drug was associated with Medication error. Age at time of vaccination 72 years old. No concomitant medications were reported. On 21-JUN-2022, the patient experienced partial dose (0.25ml) administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose (0.25ml) administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220647247.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report received from a health care professional concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) .25 ml, administered on 21-JUN-2022 for prophylactic vaccination. The drug was associated with medication error. Age at time of vaccination 64 years old. No concomitant medications were reported. On 21-JUN-2022, the patient experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220646742.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: This spontaneous report received from a health care professional concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) .25 ml, administered on 21-JUN-2022 for prophylactic vaccination. The drug was associated with medication error. Age at time of vaccination 64 years old. No concomitant medications were reported. On 21-JUN-2022, the patient experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220646742.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Ear swelling, Eye swelling, Nerve injury, Pain
Clinical narrative: painful rash on face; whole body nerve pain; pain at injection site; diarrhea; vomiting; body pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st April 2022, immediately after receiving Shingrix, the patient experienced injection site pain. On 2nd April 2022, the patient experienced diarrhea, vomiting and general body pain. On an unknown date, the patient experienced painful rash and nerve pain. The patient was treated with steroids nos (Steroids) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the injection site pain, diarrhea, vomiting and general body pain were recovered/resolved and the outcome of the painful rash and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, diarrhea, vomiting, general body pain, painful rash and nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received first dose of Shingrix and immediately after vaccine patient started with pain at injection site. This pain had resolved. The day following the vaccine, patient reported having diarrhea, vomiting, and body pain that lasted for two days. The week following her vaccine, patient reported that she broke out in a painful rash on face that had gotten worse and whole-body nerve pain.  The patient's doctor prescribed an Antiviral and Steroid but had not helped. These symptoms were ongoing.  The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: painful rash on face; whole body nerve pain; pain at injection site; diarrhea; vomiting; body pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st April 2022, immediately after receiving Shingrix, the patient experienced injection site pain. On 2nd April 2022, the patient experienced diarrhea, vomiting and general body pain. On an unknown date, the patient experienced painful rash and nerve pain. The patient was treated with steroids nos (Steroids) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the injection site pain, diarrhea, vomiting and general body pain were recovered/resolved and the outcome of the painful rash and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, diarrhea, vomiting, general body pain, painful rash and nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received first dose of Shingrix and immediately after vaccine patient started with pain at injection site. This pain had resolved. The day following the vaccine, patient reported having diarrhea, vomiting, and body pain that lasted for two days. The week following her vaccine, patient reported that she broke out in a painful rash on face that had gotten worse and whole-body nerve pain.  The patient's doctor prescribed an Antiviral and Steroid but had not helped. These symptoms were ongoing.  The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Injection site pain, Neuralgia, Pain, Rash
Clinical narrative: painful rash on face; whole body nerve pain; pain at injection site; diarrhea; vomiting; body pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st April 2022, immediately after receiving Shingrix, the patient experienced injection site pain. On 2nd April 2022, the patient experienced diarrhea, vomiting and general body pain. On an unknown date, the patient experienced painful rash and nerve pain. The patient was treated with steroids nos (Steroids) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the injection site pain, diarrhea, vomiting and general body pain were recovered/resolved and the outcome of the painful rash and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, diarrhea, vomiting, general body pain, painful rash and nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received first dose of Shingrix and immediately after vaccine patient started with pain at injection site. This pain had resolved. The day following the vaccine, patient reported having diarrhea, vomiting, and body pain that lasted for two days. The week following her vaccine, patient reported that she broke out in a painful rash on face that had gotten worse and whole-body nerve pain.  The patient's doctor prescribed an Antiviral and Steroid but had not helped. These symptoms were ongoing.  The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: painful rash on face; whole body nerve pain; pain at injection site; diarrhea; vomiting; body pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st April 2022, immediately after receiving Shingrix, the patient experienced injection site pain. On 2nd April 2022, the patient experienced diarrhea, vomiting and general body pain. On an unknown date, the patient experienced painful rash and nerve pain. The patient was treated with steroids nos (Steroids) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the injection site pain, diarrhea, vomiting and general body pain were recovered/resolved and the outcome of the painful rash and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, diarrhea, vomiting, general body pain, painful rash and nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received first dose of Shingrix and immediately after vaccine patient started with pain at injection site. This pain had resolved. The day following the vaccine, patient reported having diarrhea, vomiting, and body pain that lasted for two days. The week following her vaccine, patient reported that she broke out in a painful rash on face that had gotten worse and whole-body nerve pain.  The patient's doctor prescribed an Antiviral and Steroid but had not helped. These symptoms were ongoing.  The reporter consented to follow up.
Age: 36.0
Sex: M
Vaccine: PNC20
Symptoms: Discomfort, Erythema, Product administered at inappropriate site, Skin warm, Swelling
Clinical narrative: Given too low, red, hot to touch, swelling, discomfort
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Drug hypersensitivity, Food allergy, Loss of personal independence in daily activities
Clinical narrative: 2 days after my booster shot, my arm became very painful.  My first 2 vaccines were pain free.  My arm became so sore I could not extend it and I could not sleep on my right side.  Pain extended into shoulder blade and into my collarbone.  It has been almost 6 months and it is still affecting my daily life and sleep.  Pain is in my arm.  I can pinpoint exactly when injection was given.  Painful rotator cuff, shoulder and pain sometimes goes into my elbow and down to my wrist.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lupus-like syndrome, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: 2 days after my booster shot, my arm became very painful.  My first 2 vaccines were pain free.  My arm became so sore I could not extend it and I could not sleep on my right side.  Pain extended into shoulder blade and into my collarbone.  It has been almost 6 months and it is still affecting my daily life and sleep.  Pain is in my arm.  I can pinpoint exactly when injection was given.  Painful rotator cuff, shoulder and pain sometimes goes into my elbow and down to my wrist.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Rash, Skin discolouration, Sleep disorder
Clinical narrative: 2 days after my booster shot, my arm became very painful.  My first 2 vaccines were pain free.  My arm became so sore I could not extend it and I could not sleep on my right side.  Pain extended into shoulder blade and into my collarbone.  It has been almost 6 months and it is still affecting my daily life and sleep.  Pain is in my arm.  I can pinpoint exactly when injection was given.  Painful rotator cuff, shoulder and pain sometimes goes into my elbow and down to my wrist.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Bacterial test, Blood immunoglobulin M increased, Chromaturia, Glomerulonephritis
Clinical narrative: It's glomerulonephritis. Inflammation of the kidneys, such as proteinuria, hematuria, and bacteria. It started a few days after the booster shot. It is still under way. It has also become a lifelong condition to be treated. My daughter is only 13 years old. She needs to get vaccinated and take medicine for life.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Inflammation, Laboratory test normal, Proteinuria, Red blood cells urine
Clinical narrative: It's glomerulonephritis. Inflammation of the kidneys, such as proteinuria, hematuria, and bacteria. It started a few days after the booster shot. It is still under way. It has also become a lifelong condition to be treated. My daughter is only 13 years old. She needs to get vaccinated and take medicine for life.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary occult blood, Urine abnormality, Urine leukocyte esterase positive, White blood cells urine positive
Clinical narrative: It's glomerulonephritis. Inflammation of the kidneys, such as proteinuria, hematuria, and bacteria. It started a few days after the booster shot. It is still under way. It has also become a lifelong condition to be treated. My daughter is only 13 years old. She needs to get vaccinated and take medicine for life.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site induration, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Error: Wrong Route (SC, IM, etc.)-, Additional Details: Patient is a RN states she thinks it might be SQ insted of IM due to no systemic reactions and due to swelling and hardness of deltoid area post vaccination. Informed her to have MD check it out. Will reassess with her in a couple days after speaking to MD.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Lymph node and armpit swelling-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Pt had hx of lymph nodes and armpit swelling with Pfizer COVID vaccine, pt stated MD approved her to receive booster. Was aware of the chance of reoccurence and was counseled on which steps to take if a reaction occured. Pt reported reswelling of lymph nodes and armpit and wanted us to report the event again.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient was dehydrated. Once she drank a bottle of water, she was fine
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain
Clinical narrative: Chest pain in entire chest cavity.    The evening of the shot the pain was isolated to the heart, now the entire chest pain region hurts.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Decreased appetite, Dysgeusia, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: About a week after my 2nd vaccine, the first week in Sept,  I developed the first symptoms of Parosmia and Disgeusia. I began smelling smoke that wasn't there. Then slowly, foods started tasting horrible. Things I love, like coffee and chocolate suddenly smelled horrible, and tasted putrid. Then on Halloween, all the candy tasted and smelled awful. From there this thing took a fast downward spiral. I didn't know what I could eat, or where I could "safely" breathe. Nearly all smells and tastes made me vomit. I dropped weight rapidly. There were about 12 "safe" foods left for me by the time this thing stopped getting worse. Everything, in the beginning, that was bad, had the same exact smell and taste/flavor, regardless of what it was. Chocolate, Lettuce, meat, rice, (and nearly everything else I used to eat) all tasted exactly the same, and it was horrible. I'm almost 10 months into this and I still have about 12-15 foods. I cant go out to eat anywhere. I can't eat with my family. No family BBQs. I can't enjoy a walk outside in the spring, or go shopping in the mall, or even many grocery stores because the smells are so bad. I'm isolated. There is no known treatment that's guaranteed to work. Most doctors have never even heard of this. It's taken away so much of my livelihood.