chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 Blood pressure high, Drug allergy (unspecified drug) and Single functional kidney. Concomitant products included LISINOPRIL and CHLORTHALIDONE for an unknown indication.    On 03-May-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 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient reported had rebound headache starting on 24-May-2022, symptom were  worse toild cold. Device Date was reported as 29-May-2022.  Company Comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred after receiving the fourth dose of mRNA-1273 vaccine. There was no information regarding the first three doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however it was reported that headache recurred, and cold symptoms worsened 2 days after completion of anti-viral treatment. Patient also tested positive for COVID-19 four days later. The clinical course, diagnostic investigations, and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred after receiving the fourth dose of mRNA-1273 vaccine. There was no information regarding the first three doses of COVID-19 vaccine. Patient developed COVID-19 on unspecified date and was treated with 5-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however it was reported that headache recurred, and cold symptoms worsened 2 days after completion of anti-viral treatment. Patient also tested positive for COVID-19 four days later. The clinical course, diagnostic investigations, and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 prior to Paxlovid treatment) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Penicillin since an unknown date. Past adverse reactions to the above products included Allergy with Penicillin. Concomitant products included ALLOPURINOL for an unknown indication.    On 05-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 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 prior to Paxlovid treatment) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient previously received a COVID-19 Vaccine. It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Device Date : 29-May-2022.  Company Comment: This spontaneous case concerns a 51-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 the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19. After the treatment with Paxlovid patient had rebound covid symptoms and was tested positive for covid-19 as on 29-May-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 a 51-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 the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for COVID-19. After the treatment with Paxlovid patient had rebound covid symptoms and was tested positive for covid-19 as on 29-May-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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive/COVID-19/Rhinorrhea/Throat irritation; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive/COVID-19/Rhinorrhea/Throat irritation) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2022, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022 at 3:00 PM, the patient experienced COVID-19 (COVID-19 virus test positive/COVID-19/Rhinorrhea/Throat irritation). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 virus test positive/COVID-19/Rhinorrhea/Throat irritation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: tested negative one time (Negative) Tested negative one time. On 27-May-2022, SARS-CoV-2 test: strong positives (Positive) Strong positives. On an unknown date, SARS-CoV-2 test: tested negative three times on at home test (Negative) Tested negative three times on at home test, tested negative three times on at home test (Negative) Tested negative three times on at home test and tested negative three times on at home test (Negative) Tested negative three times on at home test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient previously received a COVID-19 Vaccine.  The indication for Paxlovid was reported as Treatment of COVID-19.  Company Comment: This spontaneous case concerns a 62-year-old male patient, with no medical history reported, who experienced the unexpected AESI of COVID-19. The event occurred approximately 42 days after receiving the fourth dose of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for 5 days, however 4 days later, the patient had tested positive again for COVID-19. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old male patient, with no medical history reported, who experienced the unexpected AESI of COVID-19. The event occurred approximately 42 days after receiving the fourth dose of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for 5 days, however 4 days later, the patient had tested positive again for COVID-19. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Taste disorder
Clinical narrative: Terrible taste in my mouth that does not go away; Upset stomach; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Terrible taste in my mouth that does not go away), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 042B21A and 021B21A-1) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Penicillin allergy and RA. Concomitant products included ADALIMUMAB from 20-May-2022 to an unknown date, METHOTREXATE from 19-May-2022 to an unknown date, GUAIFENESIN from 24-May-2022 to an unknown date, TRAZODONE from 23-May-2022 to an unknown date, FOLIC ACID from 22-May-2022 to an unknown date, CALCIUM CITRATE from 22-May-2022 to an unknown date and MULTIVITAMIN [VITAMINS NOS] from 18-May-2022 to an unknown date for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022, the patient experienced TASTE DISORDER (Terrible taste in my mouth that does not go away), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea). At the time of the report, TASTE DISORDER (Terrible taste in my mouth that does not go away), ABDOMINAL DISCOMFORT (Upset stomach) and DIARRHOEA (Diarrhea) outcome was unknown.            No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue/was in bed basically for a day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/was in bed basically for a day) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue/was in bed basically for a day). At the time of the report, FATIGUE (Fatigue/was in bed basically for a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on concomitant medication was reported. No information on treatment medications was reported.   This case was linked to MOD-2022-579941 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive again for COVID on 05/11/2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive again for COVID on 05/11/2022.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Autologous haematopoietic stem cell transplant. Concurrent medical conditions included Diabetes. Concomitant products included ACYCLOVIR [ACICLOVIR], ATORVASTATIN, METFORMIN and PIOGLITAZONE for an unknown indication.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 05-May-2022, the patient experienced COVID-19 (Tested positive again for COVID on 05/11/2022.). On 16-May-2022, COVID-19 (Tested positive again for COVID on 05/11/2022.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that concomitant drug METFORMIN included Active Drug substance JARDIANCE 25 MG.  Treatment medication included Bebtelovimab.  Device Date reported as 26May2022.  Company comment- This spontaneous case concerns a 54-year-old male patient with relevant medical history of autologous stem cell transplant and Diabetes, who experienced unexpected, non-serious adverse event of special interest Covid-19 3 months and 29 days after vaccination with a third dose of mRNA-1273. The patient tested positive again for Covid-19 6 days after his initial diagnosis. The outcome of the event was reported as resolved. The relevant medical history of autologous stem cell transplant and diabetes can be a contributory factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old male patient with relevant medical history of autologous stem cell transplant and Diabetes, who experienced unexpected, non-serious adverse event of special interest Covid-19 3 months and 29 days after vaccination with a third dose of mRNA-1273. The patient tested positive again for Covid-19 6 days after his initial diagnosis. The outcome of the event was reported as resolved. The relevant medical history of autologous stem cell transplant and diabetes can be a contributory factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) 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 (Drug was not specified).    On 20-Oct-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 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient did not received any treatment for Rebound COVID after paxlovid.  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 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 experienced rebound symptoms and was tested positive for covid-19 as on 23-May-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 a patient of unknown age and gender 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 experienced rebound symptoms and was tested positive for covid-19 as on 23-May-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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid rebound/Treatment of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid rebound/Treatment of COVID-19) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: keflex and Penicillin. Past adverse reactions to the above products included Allergy with Penicillin and keflex. Concurrent medical conditions included Ventricular tachycardia, Prediabetes and Obesity.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced COVID-19 (Covid rebound/Treatment of COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-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 rebound/Treatment of COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's historical drug mentioned as sulfas, had reaction of allergy with sulfas.  No concomitant medications were reported.  It was reported that patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The event reported was Covid rebound with Device Date as 26-May-2022.  Company Comment: This is a Spontaneous case concerning a 44-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 2 months after a dose of mRNA-1273 vaccine. Patient completed 5 days treatment with nirmatrelvir, ritonavir (Paxlovid) for COVID-19. 5 days after treatment finished, COVID-19 started again. No information about diagnostic tests was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 44-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 2 months after a dose of mRNA-1273 vaccine. Patient completed 5 days treatment with nirmatrelvir, ritonavir (Paxlovid) for COVID-19. 5 days after treatment finished, COVID-19 started again. No information about diagnostic tests was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Eructation, Flatulence, Gastrointestinal pain, Headache
Clinical narrative: Altered taste (stomach acid or bile taste); Painful bowel movements (product not act); Indigestion; Increased flatulence; Increased eructation; Headache/light sensitivity; Headache/light sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Altered taste (stomach acid or bile taste)), GASTROINTESTINAL PAIN (Painful bowel movements (product not act)), DYSPEPSIA (Indigestion), FLATULENCE (Increased flatulence) and ERUCTATION (Increased eructation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Previously administered products included for Drug use for unknown indication: Septra/Suprax (Septra/Suprax) and Septra/Suprax (Septra/Suprax). Past adverse reactions to the above products included Allergy with Septra/Suprax and Septra/Suprax.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced TASTE DISORDER (Altered taste (stomach acid or bile taste)), GASTROINTESTINAL PAIN (Painful bowel movements (product not act)), DYSPEPSIA (Indigestion), FLATULENCE (Increased flatulence), ERUCTATION (Increased eructation), PHOTOPHOBIA (Headache/light sensitivity) and HEADACHE (Headache/light sensitivity). At the time of the report, TASTE DISORDER (Altered taste (stomach acid or bile taste)), GASTROINTESTINAL PAIN (Painful bowel movements (product not act)), DYSPEPSIA (Indigestion), FLATULENCE (Increased flatulence), ERUCTATION (Increased eructation), PHOTOPHOBIA (Headache/light sensitivity) and HEADACHE (Headache/light sensitivity) was resolving.            Concomitant medication was not reported.  Device date was reported as 29-May-2022.
Sex: U
Vaccine: COVID19
Symptoms: Photophobia, Taste disorder
Clinical narrative: Altered taste (stomach acid or bile taste); Painful bowel movements (product not act); Indigestion; Increased flatulence; Increased eructation; Headache/light sensitivity; Headache/light sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Altered taste (stomach acid or bile taste)), GASTROINTESTINAL PAIN (Painful bowel movements (product not act)), DYSPEPSIA (Indigestion), FLATULENCE (Increased flatulence) and ERUCTATION (Increased eructation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Previously administered products included for Drug use for unknown indication: Septra/Suprax (Septra/Suprax) and Septra/Suprax (Septra/Suprax). Past adverse reactions to the above products included Allergy with Septra/Suprax and Septra/Suprax.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced TASTE DISORDER (Altered taste (stomach acid or bile taste)), GASTROINTESTINAL PAIN (Painful bowel movements (product not act)), DYSPEPSIA (Indigestion), FLATULENCE (Increased flatulence), ERUCTATION (Increased eructation), PHOTOPHOBIA (Headache/light sensitivity) and HEADACHE (Headache/light sensitivity). At the time of the report, TASTE DISORDER (Altered taste (stomach acid or bile taste)), GASTROINTESTINAL PAIN (Painful bowel movements (product not act)), DYSPEPSIA (Indigestion), FLATULENCE (Increased flatulence), ERUCTATION (Increased eructation), PHOTOPHOBIA (Headache/light sensitivity) and HEADACHE (Headache/light sensitivity) was resolving.            Concomitant medication was not reported.  Device date was reported as 29-May-2022.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo with vomiting; Vertigo with vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo with vomiting) and VOMITING (Vertigo with vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057MZHA) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 2 Batch (EL9265) and anatomical  location: Left Arm) on 08-Feb-2021, Pfizer (Dose Number: 1 Batch (EL3246) and anatomical location: Left arm) on 18-Jun-2021 and Pfizer (Dose Number: 3 Batch (EW0168) and anatomical  location: Left Arm) on 06-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Addison's disease, Hypothyroidism, Hypercholesterolemia, Type 2 diabetes mellitus and Allergy to antibiotic (Allergy to cipro). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Feb-2015 to an unknown date, HYDROCORTISONE from 01-Feb-2015 to an unknown date, FLUDROCORTISONE from 01-Feb-2015 to an unknown date and ATORVASTATIN CALCIUM (LIPITOR) from 01-Feb-2015 to an unknown date for an unknown indication.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022 at 11:00 PM, the patient experienced VERTIGO (Vertigo with vomiting) and VOMITING (Vertigo with vomiting). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo with vomiting) and VOMITING (Vertigo with vomiting) was resolving.            Anatomical location for suspect product given as left leg.  Patient received motion sickness medication as a treatment medication for the adverse event Vertigo with vomiting.  Pfizer dose not have permission to contact about this report and does not have permission to contact the patient's healthcare provider.  The device date was 26-May-2022.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: The full dose of Paxlovid taken three days from starting the symptoms; Symptoms came back after 8 days from the last dose taken.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (The full dose of Paxlovid taken three days from starting the symptoms; Symptoms came back after 8 days from the last dose taken.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment.  Concurrent medical conditions included Allergy (Allergy to unspecified drug.).   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (The full dose of Paxlovid taken three days from starting the symptoms; Symptoms came back after 8 days from the last dose taken.). The last dose administered for NIRMATRELVIR, RITONAVIR (PAXLOVID) was on 16-May-2022. At the time of the report, COVID-19 (The full dose of Paxlovid taken three days from starting the symptoms; Symptoms came back after 8 days from the last dose taken.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient's symptom started on 09-May-2022 and 3 days after the patient started COVID-19 treatment. On 25-May-2022 at 12:00 the patient's symptoms came back after 8 days from the last dose taken.  It was unknown if patient received any treatment for recurrence of COVID-19. COMPANY COMMENT: This is an spontaneous case concerning a 38-years-old male patient with medical history of allergy and PAXLOVID from 10-May-2022 to 16-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) 194 days after 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 38-years-old male patient with medical history of allergy and PAXLOVID from 10-May-2022 to 16-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) 194 days after 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-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) from 17-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) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. Patent had a rebound COVID on 26May2022. Device Date : 27-May-2022. Treatment medication was not reported.  Company comment-This spontaneous case concerns a 67-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 17th to 21st May2022. Patient had rebound covid-19 five days after completion of Paxlovid. 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 67-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 17th to 21st May2022. Patient had rebound covid-19 five days after completion of Paxlovid. 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: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st Dose of Moderna on 30-Mar-2021 and 2nd Dose on 27-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose of Moderna on 30-Mar-2021 and 2nd Dose on 27-May-2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037b21a and 016b21a) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol (Use meds), Blood pressure high (Use meds) and Penicillin allergy.   On 30-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose of Moderna on 30-Mar-2021 and 2nd Dose on 27-May-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose of Moderna on 30-Mar-2021 and 2nd Dose on 27-May-2021) outcome was unknown. Not Provided          Patient was taking medications for High cholesterol and blood pressure. It was reported that the patient previously received a COVID-19 Vaccine. Treatment information was not provided.   This case was linked to MOD-2022-579897 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo with vomiting; Vertigo with vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of VERTIGO (Vertigo with vomiting) and VOMITING (Vertigo with vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057MZHA) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EL3246 Location of injection: Arm Left) on 18-Jan-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EL9265 Location of injection: Arm Left) on 08-Feb-2021 and Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: EW0168 Location of injection: Arm Left) on 06-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Addison's disease, Hypothyroidism, High cholesterol, Type 2 diabetes mellitus and Allergy to antibiotic (Cipro). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Feb-2015 to an unknown date, HYDROCORTISONE from 01-Feb-2015 to an unknown date, FLUDROCORTISONE from 01-Feb-2015 to an unknown date and ATORVASTATIN CALCIUM (LIPITOR) from 01-Feb-2015 to an unknown date for an unknown indication.   On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022 at 11:00 PM, the patient experienced VERTIGO (Vertigo with vomiting) and VOMITING (Vertigo with vomiting). At the time of the report, VERTIGO (Vertigo with vomiting) and VOMITING (Vertigo with vomiting) was resolving.            It was reported that patient took Motion sickness medicines for the adverse event. The patient previously received a COVID-19 Vaccine. It was reported that he patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: couldn't lift it and next day it was gone; Her arm was sore; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (couldn't lift it and next day it was gone) and PAIN IN EXTREMITY (Her arm was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included GERD and Anxiety. Previously administered products included for Product used for unknown indication: Pneumonia shot and Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot and Pneumonia shot. Concurrent medical conditions included Thyroid disorder and Blood pressure high.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MOBILITY DECREASED (couldn't lift it and next day it was gone) and PAIN IN EXTREMITY (Her arm was sore). In February 2021, MOBILITY DECREASED (couldn't lift it and next day it was gone) and PAIN IN EXTREMITY (Her arm was sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided No treatment details were provided   This case was linked to MOD-2022-579922 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Weight
Clinical narrative: couldn't lift it and next day it was gone; Her arm was sore; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (couldn't lift it and next day it was gone) and PAIN IN EXTREMITY (Her arm was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included GERD and Anxiety. Previously administered products included for Product used for unknown indication: Pneumonia shot and Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot and Pneumonia shot. Concurrent medical conditions included Thyroid disorder and Blood pressure high.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MOBILITY DECREASED (couldn't lift it and next day it was gone) and PAIN IN EXTREMITY (Her arm was sore). In February 2021, MOBILITY DECREASED (couldn't lift it and next day it was gone) and PAIN IN EXTREMITY (Her arm was sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided No treatment details were provided   This case was linked to MOD-2022-579922 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: couldn't lift it and next day it was gone; Her arm was sore; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (couldn't lift it and next day it was gone) and PAIN IN EXTREMITY (Her arm was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included GERD and Anxiety. Previously administered products included for Product used for unknown indication: Pneumonia shot and Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot and Pneumonia shot. Concurrent medical conditions included Thyroid disorder and Blood pressure high.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MOBILITY DECREASED (couldn't lift it and next day it was gone) and PAIN IN EXTREMITY (Her arm was sore). In February 2021, MOBILITY DECREASED (couldn't lift it and next day it was gone) and PAIN IN EXTREMITY (Her arm was sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided No treatment details were provided   This case was linked to MOD-2022-579922 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Paxlovid Rebound; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Paxlovid Rebound) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced IMMUNISATION REACTION (Paxlovid Rebound) (seriousness criterion life threatening). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, IMMUNISATION REACTION (Paxlovid Rebound) was resolving.            No concomitant medication information was reported.  Unknown if any treatment medication was provided.  It was unknown whether the patient took any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine.  Paxlovid Rebound device date was 28-May-2022  Company comment: This is a spontaneous case concerning a 27-year-old male patient with no reported medical history, who experienced the unexpected serious (seriousness criterion life threatening) event of immunization reaction. It was reported that immunization reaction described as Paxlovid Rebound which occurred 6 days after the patient completed a 5-day course of Paxlovid. The patient had received a third dose of mRNA-1273 (Spikevax) 6 month 20 days before the event of immunization reaction. Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 27-year-old male patient with no reported medical history, who experienced the unexpected serious (seriousness criterion life threatening) event of immunization reaction. It was reported that immunization reaction described as Paxlovid Rebound which occurred 6 days after the patient completed a 5-day course of Paxlovid. The patient had received a third dose of mRNA-1273 (Spikevax) 6 month 20 days before the event of immunization reaction. Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Dysgeusia
Clinical narrative: Very bitter taste in mouth, altered sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Very bitter taste in mouth, altered sense of taste) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy (sulfa drugs).   On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 19-May-2022, the patient experienced DYSGEUSIA (Very bitter taste in mouth, altered sense of taste). At the time of the report, DYSGEUSIA (Very bitter taste in mouth, altered sense of taste) had not resolved.            The was patient not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The concomitant medication was not reported. The treatment medication was reported.
Age: 73.0
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 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.   Previously administered products included for Product used for unknown indication: omeprazole. Past adverse reactions to the above products included Allergy with omeprazole. Concurrent medical conditions included Chronic kidney disease (mild). Concomitant products included EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) from January 2022 to an unknown date and EZETIMIBE from October 2021 to an unknown date for an unknown indication.    On 05-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 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 23-May-2022, the patient had rebound COVID symptoms and positive test 8 days after completing Paxlovid.  The patient did not receive any treatment for the rebound COVID symptoms.  Company comment: This case concerns a 73-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the fourth dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 73-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the fourth dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.