chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for coronavirus; lack of drug effect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for coronavirus) and DRUG INEFFECTIVE (lack of drug effect) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A-B, 013A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2022, the patient experienced COVID-19 (tested positive for coronavirus) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (tested positive for coronavirus) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  It was reported that patient received two doses and one booster dose from Moderna. pharmacist asked when she can receive her 2nd booster dose of the Moderna COVID-19 vaccine if she has coronavirus.  No treatment information were provided.  Comp[any comment: This spontaneous case concerns 71 years old female, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred approximately 7 months after receiving third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive On 05-Jun-2022. 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 71 years old female, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred approximately 7 months after receiving third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive On 05-Jun-2022. 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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: patient felt like she was having flu; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Migraine, Allergy to antibiotic (cephalosporines) and Contrast media allergy (IV contrast). Concomitant products included GABAPENTIN for Migraine, ATORVASTATIN CALCIUM (LIPITOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.  On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills). On 04-Feb-2021, INFLUENZA LIKE ILLNESS (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   It was reported that After 1st dose patient experienced the symptoms as she felt like she was having flu, with fever and chills for about 2 days. No treatment medication was reported   This case was linked to MOD-2022-584154, MOD-2022-584155, MOD-2022-584156 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Influenza, Pyrexia
Clinical narrative: patient felt like she was having flu; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Migraine, Allergy to antibiotic (cephalosporines) and Contrast media allergy (IV contrast). Concomitant products included GABAPENTIN for Migraine, ATORVASTATIN CALCIUM (LIPITOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.  On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills). On 04-Feb-2021, INFLUENZA LIKE ILLNESS (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   It was reported that After 1st dose patient experienced the symptoms as she felt like she was having flu, with fever and chills for about 2 days. No treatment medication was reported   This case was linked to MOD-2022-584154, MOD-2022-584155, MOD-2022-584156 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: patient felt like she was having flu; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 007M20A) for COVID-19 vaccination.     Has patient ever had COVID + test or diagnosis was given as no.  Concurrent medical conditions included Allergy to antibiotic (cephalosporines), Contrast media allergy (IV contrast) and Migraine. Concomitant products included GABAPENTIN for Migraine, ATORVASTATIN CALCIUM (LIPITOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills). On 06-Mar-2021, INFLUENZA (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills) had resolved.            After 1st and 2nd dose patient experienced the same symptoms: she felt like she was having flu, with fever and chills for about 2 days. Treatment information was not provided.   This case was linked to MOD-2022-584152, MOD-2022-584155, MOD-2022-584156 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Influenza, Pyrexia
Clinical narrative: patient felt like she was having flu; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 007M20A) for COVID-19 vaccination.     Has patient ever had COVID + test or diagnosis was given as no.  Concurrent medical conditions included Allergy to antibiotic (cephalosporines), Contrast media allergy (IV contrast) and Migraine. Concomitant products included GABAPENTIN for Migraine, ATORVASTATIN CALCIUM (LIPITOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills). On 06-Mar-2021, INFLUENZA (patient felt like she was having flu), PYREXIA (fever) and CHILLS (chills) had resolved.            After 1st and 2nd dose patient experienced the same symptoms: she felt like she was having flu, with fever and chills for about 2 days. Treatment information was not provided.   This case was linked to MOD-2022-584152, MOD-2022-584155, MOD-2022-584156 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 12-May-2022 to 17-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): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive, negative (Negative) Negative, negative (Negative) Negative and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was unknown if the patient taken other medications/products within 2 weeks of starting COVID-19 treatment. The patient reported possible rebound of COVID-19 , 11 days after completing paxlovid he felt well for 1 week and tested negative twice and then felt sick again and tested positive again Device Date was reported as 03-Jun-2022  Company comment: This spontaneous case concerns a 34-year-old male patient with no  medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-may-2022 to 17-may-2022. She was tested positive 11 days after the treatment with Paxlovid. It is reported that patient felt well for 1 week and tested negative twice and got sick again and tested positive again. 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 34-year-old male patient with no  medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 12-may-2022 to 17-may-2022. She was tested positive 11 days after the treatment with Paxlovid. It is reported that patient felt well for 1 week and tested negative twice and got sick again and tested positive again. 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: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Jan-2021 and 2nd dose on 20-Feb-2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Allergy (No drug reported). Concomitant products included METFORMIN, DULAGLUTIDE (TRULICITY), LOSARTAN, GLIMEPIRIDE and ATORVASTATIN for an unknown indication.  4 On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Jan-2021 and 2nd dose on 20-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Jan-2021 and 2nd dose on 20-Feb-2021) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-584173 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Jan-2021 and 2nd dose on 20-Feb-2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Allergy (No drug reported). Concomitant products included METFORMIN, DULAGLUTIDE (TRULICITY), LOSARTAN, GLIMEPIRIDE and ATORVASTATIN for an unknown indication.  4 On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Jan-2021 and 2nd dose on 20-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Jan-2021 and 2nd dose on 20-Feb-2021) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-584173 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound infection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included LEVOTHYROXINE from 02-Jan-2012 to an unknown date for an unknown indication.    On 04-May-2022 at 11:00 AM, 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 (Rebound infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound infection) had not resolved.            Patient took other medications or products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 vaccine. On 02-Jun-2022, the patient had rebound infection.  Company Comment: This is a Spontaneous case concerning a 73-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 in an unknown date in the context of the administration of the 4th dose of the mRNA-1273 vaccine (in the covid 19 vaccination series of an unknown schedule of administration). It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) starting on 24-May-2022 for covid 19 treatment for 5 days. Very limited information is available regarding diagnostic work-up to support the current diagnosis of COVID-19, severity and treatment received. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement; Sender's Comments: This is a Spontaneous case concerning a 73-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 in an unknown date in the context of the administration of the 4th dose of the mRNA-1273 vaccine (in the covid 19 vaccination series of an unknown schedule of administration). It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) starting on 24-May-2022 for covid 19 treatment for 5 days. Very limited information is available regarding diagnostic work-up to support the current diagnosis of COVID-19, severity and treatment received. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/ Rebound of COVID symptoms and positive antigen test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19/ Rebound of COVID symptoms and positive antigen test) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to unspecified drug).    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19/ Rebound of COVID symptoms and positive antigen test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/ Rebound of COVID symptoms and positive antigen test) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported. From 25-May-2022 to 29-May-2022, other medication Zithromax was administered. From 25-May-2022 to 31-May-2022, other medication Prednisone was administered. On 03-Jun-2022, the COVID symptoms was rebound and positive antigen test. Device Date was reported as 04-Jun-2022.  Company comment: This spontaneous case concerns a 45-year-old female patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 30-May-2022  for COVID-19 treatment. It was reported 25-May-2022 to 29-May-2022, Zithromax and 25-May-2022 to 31-May-2022 Prednisone was administered. COVID symptoms was rebound and positive antigen test ( SARS-CoV-2 test) as on 03-Jun-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 45-year-old female patient with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after the third dose of mRNA-1273 vaccine The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 30-May-2022  for COVID-19 treatment. It was reported 25-May-2022 to 29-May-2022, Zithromax and 25-May-2022 to 31-May-2022 Prednisone was administered. COVID symptoms was rebound and positive antigen test ( SARS-CoV-2 test) as on 03-Jun-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 50.0
Sex: F
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 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Asthma and Allergy to antibiotic (Erythromyecin). Concomitant products included LOSARTAN POTASSIUM (COZAAR) from 01-May-2022 to 05-Jun-2022 for an unknown indication.    On 29-Oct-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine. It was reported that patient had positive rapid test results after a week of negative, with respiratory symptoms including sneezing and difficulty breathing, coughing.  Device Date: 05-Jun-2022  Company comment: This spontaneous case concerns a 50-years-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 19-may-2022 to 24-may-2022. After a week patient was positive. 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 50-years-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 19-may-2022 to 24-may-2022. After a week patient was positive. 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: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. 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 information provided. Patient took COVID-19 treatment medication on 03-Jun-2022.  On 03-Jun-2022 at 21.00 , patient reported nasty taste in mouth about 5 hours after taking first dose of COVID-19 Treatment.  Device date was reported as 03-Jun-2022.  Company comment: This spontaneous case concerns unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It is reported that patient had nasty taste in mouth about 5 hours after taking first dose. Patient started on unspecified covid-19 treatment. 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 unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious event of COVID-19 unspecified days after receiving third dose of mRNA-1273 vaccine. It is reported that patient had nasty taste in mouth about 5 hours after taking first dose. Patient started on unspecified covid-19 treatment. 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: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypertension, Pyrexia
Clinical narrative: High blood pressure; Felt miserable; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), FEELING ABNORMAL (felt miserable), PYREXIA (fever) and FATIGUE (tired, She just wanted to go to bed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure), FEELING ABNORMAL (felt miserable), PYREXIA (fever) and FATIGUE (tired, She just wanted to go to bed). At the time of the report, HYPERTENSION (high blood pressure), FEELING ABNORMAL (felt miserable), PYREXIA (fever) and FATIGUE (tired, She just wanted to go to bed) had resolved.            No concomitant medication reported.   Patient experienced side effects from all the three doses of Moderna vaccine.  No treatment medication reported.  It was reported that her symptoms lasted for one and a half days.   This case was linked to MOD-2022-584186, MOD-2022-584194 (Patient Link).   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease, Epstein-Barr virus infection, ADHD and Drug allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE and LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-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 16-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Further concomitant medication includes Vitamin supplement.  It was reported that the patient taken other medications/products within 2 weeks of starting COVID-19 treatment. Patient has previously received a COVID-19 Vaccine.  It was reported that unintended positive therapeutic benefit-Epstein Barr virus fatigue, energy and brain fog improvement experienced by patient after taking Paxlovid on 26-May-2022.  Device Date : 06Jun2022  Company comment: This spontaneous case concerns a 44-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 third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19 from 16-May to 22-May. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-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 third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19 from 16-May to 22-May. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested negative on 5/31/22 but tested positive again on 6/6/22; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested negative on 5/31/22 but tested positive again on 6/6/22) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (No drug reported.).    On 19-Jan-2021 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested negative on 5/31/22 but tested positive again on 6/6/22). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 31-May-2022, COVID-19 (Tested negative on 5/31/22 but tested positive again on 6/6/22) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 06-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient did not take any medications within 2 weeks of starting COVID-19 treatment.  Company Comment:  This spontaneous case concerns a 70-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 on an unknown date after receiving an unspecified dose of mRNA-1273. Patient started Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment approximately 4 months and 5 days after mRNA-1273 vaccination. Patient tested negative for COVID-19 two days after completion of Paxlovid treatment and subsequently tested positive 6 days later. No information was provided on any other COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-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 on an unknown date after receiving an unspecified dose of mRNA-1273. Patient started Nirmatrelvir, Ritonavir (Paxlovid) COVID-19 treatment approximately 4 months and 5 days after mRNA-1273 vaccination. Patient tested negative for COVID-19 two days after completion of Paxlovid treatment and subsequently tested positive 6 days later. No information was provided on any other COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 22-Apr-2022 at 1:00 PM, 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 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medication was not reported.  It was reported patient had rebound of COVID-19, 4 days later with mild symptoms. Patient had a positive test after negative for 4 days on 03-Jun-2022 and was not recovered. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient was treated with Pfizer from  26-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency.  Device Date  was reported as 04-Jun-2022.  Company comment-This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 4th dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Phizer drug from 26th May 2022 to 30th May 2022 for 5 days. COVID-19 test done on an unknown date was negative. Patient reported rebound 4 days later with mild symptoms. Positive test after negative 4 days. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 4th dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Phizer drug from 26th May 2022 to 30th May 2022 for 5 days. COVID-19 test done on an unknown date was negative. Patient reported rebound 4 days later with mild symptoms. Positive test after negative 4 days. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022)and gave 1 shot; We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.) and PRODUCT STORAGE ERROR (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022)and gave 1 shot) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2022 at 10:20 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2022 at 10:20 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022)and gave 1 shot). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.) and PRODUCT STORAGE ERROR (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022)and gave 1 shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was unknown if patient had the ever been diagnosed with Covid-19. It was unknown if patient had acute illness at the time of vaccination as well as unknown  for chronic health conditions. It was unknown if patient experienced similar adverse event in the past. Treatment information was not provided.   This case was linked to MOD-2022-584257 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19 Treatment/COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), BUPROPION HYDROCHLORIDE (WELLBUTRIN), LOSARTANUM KALIUM, MELATONIN and FISH OIL for an unknown indication.   On 20-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021 at 10:00 AM, 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 Treatment/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. On 24-May-2022, COVID-19 (COVID 19 Treatment/COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 03-Jun-2022, SARS-CoV-2 test: positive (Positive) positive.         Device Date was reported as 05-Jun-2022.  Patient had the disgusting taste in my mouth for the entire five days.  Company comment: This spontaneous case concerns a 60-year-old female 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) for the treatment of COVID-19 from 19-May to 24-May. Patient tested negative for COVID 19 on 23-May and then tested positive on 03-Jun with mild symptoms. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female 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) for the treatment of COVID-19 from 19-May to 24-May. Patient tested negative for COVID 19 on 23-May and then tested positive on 03-Jun with mild symptoms. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Lung fibrosis, Pulmonary hypertension and Drug allergy (Codeine). Concomitant products included GABAPENTIN from 04-May-2022 to an unknown date for an unknown indication.  On 20-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-Jun-2022 to 04-Jun-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. On 02-Jun-2022, the patient also experienced abdominal pain, nausea, diarrhea, vision changes, dizziness, headaches, insomnia and hoarseness and it was recovered on 06-Jun-2022. The device date was reported as 06-Jun-2022.  Company comment: This spontaneous case concerns a 37-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 an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 37-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 an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 29.0
Sex: F
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 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Allergic reaction was reported for unspecified drug.     On 08-Nov-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 27-May-2022 to 31-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medication included Birth Control Pills. Patient previously received a COVID-19 Vaccine. It was reported that on 05-JUN-2022  at 07:00, five days after taking Paxlovid, patient had higher viral load of Covid again. It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 06-Jun-2022.  Company comment-This spontaneous case concerns a female patient aged 29 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Paxlovid from 27th May 2022 to 31st May 2022 for 5 days. Patient reported five days after Paxlovid she had higher viral load of covid again. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 29 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Paxlovid from 27th May 2022 to 31st May 2022 for 5 days. Patient reported five days after Paxlovid she had higher viral load of covid again. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeding disorder, Illness, Immunisation reaction, Muscle strength abnormal
Clinical narrative: Is weak; Is sick; Can't keep food down; Has no muscle strength; Having a reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Is weak), ILLNESS (Is sick), FEEDING DISORDER (Can't keep food down), MUSCLE STRENGTH ABNORMAL (Has no muscle strength) and IMMUNISATION REACTION (Having a reaction to the vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 017F21A, 038K20A and 026L20A) for COVID-19 vaccination.     patient had  not tested Positive to Covid-19test or diagnosis.  Concurrent medical conditions included Pollen allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Is weak), ILLNESS (Is sick), FEEDING DISORDER (Can't keep food down), MUSCLE STRENGTH ABNORMAL (Has no muscle strength) and IMMUNISATION REACTION (Having a reaction to the vaccine). At the time of the report, ASTHENIA (Is weak), ILLNESS (Is sick), FEEDING DISORDER (Can't keep food down), MUSCLE STRENGTH ABNORMAL (Has no muscle strength) and IMMUNISATION REACTION (Having a reaction to the vaccine) outcome was unknown.            Concomitant blood pressure medication provided by the reporter. The caller was a consumed who stated that he is calling on behalf of his wife who is a 80 year old patient who was vaccinated 26 hours ago. Treatment information was not provided.   This case was linked to MOD-2022-584926 (Patient Link).