chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 (COVID-19 infection); This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 (COVID-19 infection)) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Overweight. Concurrent medical conditions included Hypertension, Obstructive sleep apnea syndrome, Environmental allergy, Allergic to cats and Allergic to dogs. Concomitant products included LOSARTAN from 01-Jan-2021 to an unknown date for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19 (COVID-19 infection)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 12-May-2022 to 16-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19 (COVID-19 infection)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Had previously antigen tested negative after paxlovid.. On 25-May-2022, SARS-CoV-2 test: positive (Positive) tested positive again..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Return of symptoms 5/24/22, tested positive again on 5/25. Had previously antigen tested negative after paxlovid. Device Date : 27May2022  Company Comment:  This spontaneous case concerns a 44-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred approximately 6 months after receiving mRNA-1273 given as third dose in the COVID-19 vaccination series. Patient underwent a 5-day-course of Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment and subsequently tested negative.  Eight days later, patient presented with return of COVID-19 symptoms along with a positive SARS-CoV-2 test. No information was provided on the previous 2 doses of COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, that occurred approximately 6 months after receiving mRNA-1273 given as third dose in the COVID-19 vaccination series. Patient underwent a 5-day-course of Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment and subsequently tested negative.  Eight days later, patient presented with return of COVID-19 symptoms along with a positive SARS-CoV-2 test. No information was provided on the previous 2 doses of COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 26-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNODEFICIENCY (IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL) had not resolved.            No concomitant medications were reported.  The daily dose of Moderna COVID-19 Vaccine was given as (1 in 1 Once).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for the event of IMMUNE SYSTEM HAD FALLEN AND DID NOT RESPOND AS WELL with HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB)was not provided.  No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning an elderly female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Immunodeficiency, which occurred on an unknown date after a dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab (Humira) for unknown indication. Patient reported immune system had fallen and did not respond as well. At the time of the report, the event had not resolved.. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning an elderly female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Immunodeficiency, which occurred on an unknown date after a dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab (Humira) for unknown indication. Patient reported immune system had fallen and did not respond as well. At the time of the report, the event had not resolved.. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cough, Malaise, Pyrexia
Clinical narrative: Feeling unwell; a continued and worsening cough; low grade fever 100.2; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling unwell), COUGH (a continued and worsening cough) and PYREXIA (low grade fever 100.2) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient had no known drug allergy.  Concurrent medical conditions included Vitamin D deficiency and Allergy. Concomitant products included COLECALCIFEROL (NATURE MADE VITAMIN D3) from 01-Mar-2022 to 16-May-2022 for an unknown indication.   On 15-Apr-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022 at 6:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 27-May-2022 at 3:00 PM, the patient experienced MALAISE (Feeling unwell), COUGH (a continued and worsening cough) and PYREXIA (low grade fever 100.2). At the time of the report, MALAISE (Feeling unwell), COUGH (a continued and worsening cough) and PYREXIA (low grade fever 100.2) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, Body temperature: 100.2 Low grade fever of 100.2.         The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine.  It was reported that the patient four days after finishing the paxlovid course of treatment, started to feel unwell again, low grade fever 100.2 and a continued and worsening cough.  No treatment information was provided.  The device date reported as 27-May-2022.   This case was linked to MOD-2022-580186 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Feeling unwell; a continued and worsening cough; low grade fever 100.2; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling unwell), COUGH (a continued and worsening cough) and PYREXIA (low grade fever 100.2) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient had no known drug allergy.  Concurrent medical conditions included Vitamin D deficiency and Allergy. Concomitant products included COLECALCIFEROL (NATURE MADE VITAMIN D3) from 01-Mar-2022 to 16-May-2022 for an unknown indication.   On 15-Apr-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022 at 6:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 27-May-2022 at 3:00 PM, the patient experienced MALAISE (Feeling unwell), COUGH (a continued and worsening cough) and PYREXIA (low grade fever 100.2). At the time of the report, MALAISE (Feeling unwell), COUGH (a continued and worsening cough) and PYREXIA (low grade fever 100.2) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, Body temperature: 100.2 Low grade fever of 100.2.         The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine.  It was reported that the patient four days after finishing the paxlovid course of treatment, started to feel unwell again, low grade fever 100.2 and a continued and worsening cough.  No treatment information was provided.  The device date reported as 27-May-2022.   This case was linked to MOD-2022-580186 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Rectal haemorrhage
Clinical narrative: Rectal bleeding; Colitis ulcerative aggravated; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) and COLITIS ULCERATIVE (Colitis ulcerative aggravated) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On 10-Feb-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding) had not resolved and COLITIS ULCERATIVE (Colitis ulcerative aggravated) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant product was reported.   The reporters causality for the events of Rectal bleeding and ulcerative colitis flare with Humira (Adalimumab) was reported as reasonably possible.  No treatment information was provided.  Company comment-This spontaneous case concerns an elderly female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Rectal haemorrhage  and Colitis ulcerative (reported as Colitis ulcerative aggravated) on an unknown date after receiving a dose(dose number not specified) of mRNA-1273 vaccine. Patient had received 1st and 2nd dose of mRNA-1273 vaccine on unknown dates. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event Rectal haemorrhage was not resolved and Colitis ulcerative was not known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Rectal haemorrhage  and Colitis ulcerative (reported as Colitis ulcerative aggravated) on an unknown date after receiving a dose(dose number not specified) of mRNA-1273 vaccine. Patient had received 1st and 2nd dose of mRNA-1273 vaccine on unknown dates. No further details on clinical course, lab test results and treatment received were reported. Outcome of the event Rectal haemorrhage was not resolved and Colitis ulcerative was not known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.; administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.) and EXPIRED PRODUCT ADMINISTERED (administered with vaccine that is past beyond the 30 day use) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen on 24-Mar-2021 and Pfizer on 18-Dec-2021. Past adverse reactions to the above products included No adverse event with Janssen and Pfizer.    On 28-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.) and EXPIRED PRODUCT ADMINISTERED (administered with vaccine that is past beyond the 30 day use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022. No treatment medications were reported.   This case was linked to MOD-2022-581520 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2022: Follow up received on 01/Jun/2022: Upon follow up the case was upgraded to valid from invalid. added patient initials, date of birth, added historical vaccine, updated suspect coding and added event of product storage error which was missed in previous version.
Sex: F
Vaccine: COVID19
Symptoms: Colitis ischaemic
Clinical narrative: Diagnosed with Ischemic Colitis; This spontaneous case was reported by a patient and describes the occurrence of COLITIS ISCHAEMIC (Diagnosed with Ischemic Colitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Clot blood (10 days after the first booster patient got a blood clot in the lower abdomen/colon) on 01-Dec-2021.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLITIS ISCHAEMIC (Diagnosed with Ischemic Colitis) (seriousness criterion medically significant). At the time of the report, COLITIS ISCHAEMIC (Diagnosed with Ischemic Colitis) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported. Patient reported that 21Nov2021 the patient got her first booster and 10 days later the patient got a blood clot in the lower abdomen/colon. A few weeks ago the patient got her second booster and the day after the patient got another blood clot. The patient was diagnosed with Ischemic Colitis.  Company Comment: This spontaneous case concerns a female patient age not specified with no medical history reported, who experienced the unexpected serious (medically significant) event of Colitis ischaemic which occurred a day after receiving the fourth (second booster) dose of mRNA-1273 vaccine. It's reported that 10 days after the first booster patient got a blood clot in the lower abdomen/colon and few weeks later she had her second booster, and a day after the second booster she got another blood clot which was diagnosed as Ischemic colitis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.   This case was linked to MOD-2022-580272.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient age not specified with no medical history reported, who experienced the unexpected serious (medically significant) event of Colitis ischaemic which occurred a day after receiving the fourth (second booster) dose of mRNA-1273 vaccine. It's reported that 10 days after the first booster patient got a blood clot in the lower abdomen/colon and few weeks later she had her second booster, and a day after the second booster she got another blood clot which was diagnosed as Ischemic colitis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 diagnosed; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 diagnosed) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesteremia, Paroxysmal atrial fibrillation and Allergy. Concomitant products included METOPROLOL, APIXABAN (ELIQUIS), FAMOTIDINE and ATORVASTATIN from an unknown date to 18-May-2022 for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient experienced COVID-19 (COVID-19 diagnosed). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 diagnosed) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive with COVID-19 symptoms.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Pfizer oral formulation for treatment of COVID-19 on 14-May-2022 and end on 18-May-2022.  Device date was reported as 27-May-2022.  Company Comment: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown interval (vaccination date not provided) after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid (on 14-May-2022, the same day of the onset of COVID-19) for COVID-19 for 5 days and had Positive antigen test and COVID-19 symptoms 8 days after treatment with Paxlovid. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown interval (vaccination date not provided) after receiving the third dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid (on 14-May-2022, the same day of the onset of COVID-19) for COVID-19 for 5 days and had Positive antigen test and COVID-19 symptoms 8 days after treatment with Paxlovid. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Treatment of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Treatment of COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 030A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Contrast media allergy (Contrast dyes) and Drug allergy (Novacaine).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Treatment of COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (Treatment of COVID-19) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that the patient had rebound Covid Infection after paxlovid on 25-May-2022 with outcome recovering/resolving.  Company comment: This is a spontaneous case concerning a 67-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 which occurred 6 months after the third dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir, Ritonavir. Outcome of the event COVID-19 was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 67-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 which occurred 6 months after the third dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir, Ritonavir. Outcome of the event COVID-19 was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: After taking Paxlovid and finishing the course on Sunday, i tested positive again one week later; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (After taking Paxlovid and finishing the course on Sunday, i tested positive again one week later) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (unspecified drug) and Factor V Leiden mutation.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (After taking Paxlovid and finishing the course on Sunday, i tested positive again one week later). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (After taking Paxlovid and finishing the course on Sunday, i tested positive again one week later) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On 29-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Company comment: This is a spontaneous case concerning a 33-year-old female  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately two weeks after the fourth dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Paxlovid was prescribed for treatment; after taking it and finishing 5-days course patient tested positive one week later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   No concomitant medications were reported. The patient not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment medication given to the patient for recurrent COVID-19.; Sender's Comments: Company comment: This is a spontaneous case concerning a 33-year-old female  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately two weeks after the fourth dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Paxlovid was prescribed for treatment; after taking it and finishing 5-days course patient tested positive one week later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Asthma and Allergy (Name of Drug was not Reported).   On 22-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022 at 4:45 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medication was reported. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. The patient had sore throat returning 9 days later. Device date mentioned as 30-May-2022 No treatment medication was reported.  Company comment: This spontaneous case concerns a 60-year-old female patient, with concurrent asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving a dose of mRNA1273. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days. Patient reported sore throat returning 9 days later. Further details regarding the diagnostic test done and clinical course of the patient were not provided. The patient's elderly age and concurrent asthma may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient, with concurrent asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving a dose of mRNA1273. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days. Patient reported sore throat returning 9 days later. Further details regarding the diagnostic test done and clinical course of the patient were not provided. The patient's elderly age and concurrent asthma may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 prior to Pfizer treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19 prior to Pfizer treatment) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 036B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Previously dx w diabetes) and Allergy NOS. Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Pfizer treatment). At the time of the report, COVID-19 (covid-19 prior to Pfizer treatment) was resolving.            The race was reported. Unspecified pfizer medication having start date 18-May-2022 and end date as 22-May-2022 with indication as treatment of COVID-19 was reported The concomitant medication included daily vitamin once a day women's gummies. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date was reported as 30-May-2022  Company Comment: This spontaneous case concerns a 58-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Pfizer from 18 th to 22 nd May 2022 for Covid-19. After the treatment with Pfizer patient has Covid resurgence. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 58-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Pfizer from 18 th to 22 nd May 2022 for Covid-19. After the treatment with Pfizer patient has Covid resurgence. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: Reporter stated that Cosentyx was discontinued due to ineffectiveness that was noticed after taking vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of DRUG INTERACTION (Reporter stated that Cosentyx was discontinued due to ineffectiveness that was noticed after taking vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product SECUKINUMAB (COSENTYX) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and SECUKINUMAB (COSENTYX) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DRUG INTERACTION (Reporter stated that Cosentyx was discontinued due to ineffectiveness that was noticed after taking vaccine). At the time of the report, DRUG INTERACTION (Reporter stated that Cosentyx was discontinued due to ineffectiveness that was noticed after taking vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rosacea
Clinical narrative: BROKE OUT WITH ROSACE; This spontaneous case was reported by a consumer and describes the occurrence of ROSACEA (BROKE OUT WITH ROSACE) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and Psoriatic arthritis.    The patient's past medical history included Psoriasis.   On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 01-May-2022, the patient experienced ROSACEA (BROKE OUT WITH ROSACE). At the time of the report, ROSACEA (BROKE OUT WITH ROSACE) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. The patient had broke out with Rosacea. He had never had rosacea. He was perfect until received the Moderna vaccine where he received Moderna vaccine at work. The physician informed the vaccine must had ignited immune system. SKYRIZI was really working on Psoriasis. The patient was perfectly healthy until received Moderna. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. No treatment drug details was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID 19) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified. Previously administered products included for Product used for unknown indication: J and J (Dose number 1) in November 2020. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Allergy (Unspecified allergy). Concomitant products included ROSUVASTATIN from January 2017 to 19-May-2022 and ASPIRIN [ACETYLSALICYLIC ACID] from January 2017 to an unknown date for an unknown indication.   In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) tested positive on day 9.         It was reported that Symptoms was cleared after 2 days of Paxlovid but then returned 8 days later. Device date was given as 31-MAY-2022.  Company comment: This spontaneous case concerns a 64-year-old male patient with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. Symptoms cleared after 2 days of treatment with Paxlovid but then returned 8 days later. Patient again tested positive on day 9. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old male patient with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. Symptoms cleared after 2 days of treatment with Paxlovid but then returned 8 days later. Patient again tested positive on day 9. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for covid) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Type 1 diabetes mellitus, Sulfonamide allergy and Drug allergy (all stimulant-based drugs). Concomitant products included ISOTRETINOIN (ACCUTANE), IBUPROFEN, SPIRONOLACTONE and INSULIN ASPART (NOVOLOG) for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022 at 8:00 PM, the patient experienced COVID-19 (tested positive for covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for covid) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient was taking unspecified birth control as concomitant drug .   Event COVID-19 stop date reported as JUN-2022.  Device date reported as 31MAY2022.  Company comment: This spontaneous case concerns a 36-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. Details regarding primary doses and third dose of COVID 19 vaccination are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. Details regarding primary doses and third dose of COVID 19 vaccination are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: covid-19 prior to Paxlovid treatment; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient had allergy to unspecified drug.).   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 antibody test: positive (Positive) Positive(1st occurrence) and positive (Positive) Positive (after paxlovid treatment).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient previously received a COVID-19 vaccine. It was reported that patient received first dose on 08-Apr-2022. In 2022, patient tested Covid positive and received Paxlovid treatment. Patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient was again tested positive after treatment with Paxlovid. Device date was reported as 31-May-2022.  Company Comment: This spontaneous case concerns a 57-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. After the treatment with paxlovid patient tested positive again for covid-19. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. After the treatment with paxlovid patient tested positive again for covid-19. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Interstitial lung disease
Clinical narrative: interstitial lung disease (ILD) exacerbation; This literature-non-study case was reported in a literature article and describes the occurrence of INTERSTITIAL LUNG DISEASE (interstitial lung disease (ILD) exacerbation) in a 72-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       Concurrent medical conditions included Interstitial lung disease.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced INTERSTITIAL LUNG DISEASE (interstitial lung disease (ILD) exacerbation) (seriousness criterion medically significant). At the time of the report, INTERSTITIAL LUNG DISEASE (interstitial lung disease (ILD) exacerbation) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered INTERSTITIAL LUNG DISEASE (interstitial lung disease (ILD) exacerbation) to be related.    No concomitant and treatment medications were reported.  Company comment: This case concerns a 72-year-old male patient with medical history of interstitial lung disease, who experienced the unexpected, serious (medically significant) event of interstitial lung disease 5 days after the second dose of mRNA-1273. The patient experienced an exacerbation of his interstitial lung disease, which is a confounder. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 72-year-old male patient with medical history of interstitial lung disease, who experienced the unexpected, serious (medically significant) event of interstitial lung disease 5 days after the second dose of mRNA-1273. The patient experienced an exacerbation of his interstitial lung disease, which is a confounder. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed.  The benefit-risk relationship of mRNA-1273 is not affected by this report.