chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Glossodynia, Tongue disorder
Clinical narrative: Pimples on her tongue; pimples on her tongue really hurt; cannot eat or drink; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Pimples on her tongue), GLOSSODYNIA (pimples on her tongue really hurt) and FEEDING DISORDER (cannot eat or drink) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Latex allergy, Seizures (since patient was little) and Disability (born with a disability and is wheelchair bound even before the 1st dose of moderna vaccine.).   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TONGUE DISORDER (Pimples on her tongue) and GLOSSODYNIA (pimples on her tongue really hurt). In May 2022, the patient experienced FEEDING DISORDER (cannot eat or drink). At the time of the report, TONGUE DISORDER (Pimples on her tongue), GLOSSODYNIA (pimples on her tongue really hurt) and FEEDING DISORDER (cannot eat or drink) outcome was unknown.            Concomitant medications includes seizure mediations and bunch of medications. No treatment medications was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported. On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient received 4th booster dose. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Vial did not undergo any temperature excursions. The Vial was not stored  in the refrigerator, they were directly thaw from the freezer before administration
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product preparation error
Clinical narrative: Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration; administered expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) and PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) and PRODUCT PREPARATION ERROR (Vial was not stored in the refrigerator, It was directly thawed from the freezer before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. The vial did not undergo any temperature excursions. No adverse events were reported by the patient. The vial was initially not stored in the refrigerator they directly thaw them from the freezer before administration. No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: They do not store them in the refrigerator, they directly thaw them from the freezer before administration; administered with expired vaccine on 29 Apr 2022 - 5 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine on 29 Apr 2022 - 5 doses) and PRODUCT STORAGE ERROR (They do not store them in the refrigerator, they directly thaw them from the freezer before administration) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (Received 3 doses). Past adverse reactions to the above products included No adverse event with Pfizer.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine on 29 Apr 2022 - 5 doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They do not store them in the refrigerator, they directly thaw them from the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine on 29 Apr 2022 - 5 doses) and PRODUCT STORAGE ERROR (They do not store them in the refrigerator, they directly thaw them from the freezer before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. A medical assistant reports that they administered an expired dose of the Moderna Covid-19 vaccine to 11 patients on different dates (15-Apr-2022 - 2 doses; 29-Apr-2022- 5 doses; 13-May-2022 - 4 doses). Lot number 066H21A; expiration date 04-Apr-2022. No patient adminstered with the vaccine had reported any event at the time of the call. Number of doses/vials: - 11 doses; probably 3 vials. The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. It was reported that the vials were not stored in the refrigerator, they directly thaw them  from the freezer before administration. Vial did not undergo temperature excursions. No treatment medications were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial did not undergo any temperature excursions.  The vial was initially not stored in the refrigerator they directly thaw them from the freezer before administration.  No treatment medication were provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were not stored in the refrigerator and directly thawed them from the freezer before administration. The vial did not undergo any temperature excursions. No treatment medications were reported
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
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 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ibuprofen). Concomitant products included FEXOFENADINE from 01-Apr-2022 to an unknown date for an unknown indication.    On 11-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) for COVID-19, 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 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive test result. In May 2022, SARS-CoV-2 test: negative (Negative) negative rapid antigen tests between finishing Paxlovid and Positive test result and positive (Positive) Postitive test on Rapid Antigen 6 days after completion of the 5-day course of Paxlovid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took treatment of COVID-19 from 03-May-2022 to 07-May-2022 with Paxlovid.It was reported that patient experirnced postitive test on rapid antigen 6 days after completion of the 5-day course of Paxlovid and 5 consecutive negative rapid antigen tests between finishing Paxlovid and Positive test result. On 13-May-2022 the outcome was reported as recovering/resolving. was reported that along with the treatment drug patient took FEXOFENADINE of unknown medicinal product name from  01-Apr-2022 to May-2022.  COMPANY COMMENT: This is a spontaneous case concerning a 30 -years-old male patient, with no relevant medical history, who experienced unexpected non serious AESI event of covid-19, which occurred 183 days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 13-May-2022. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report; Sender's Comments: This is a spontaneous case concerning a 30 -years-old male patient, with no relevant medical history, who experienced unexpected non serious AESI event of covid-19, which occurred 183 days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 13-May-2022. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Rebound of symptoms after completing Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of symptoms after completing Paxlovid) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L2A, 034F21a, 006B21A and 010A21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Lupus syndrome, Rheumatoid arthritis, Blood pressure high and Seasonal allergy. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), NIFEDIPINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and LISINOPRIL for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021 at 11:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022 at 11:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 10-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound of symptoms after completing Paxlovid). At the time of the report, COVID-19 (Rebound of symptoms after completing Paxlovid) had not resolved.            No concomitant medications was reported.  Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient was previously received a COVID-19 Vaccine.  No treatment medications were provided. Company comment: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 19 days after administration of fourth dose of mRNA-1273. The initial two doses of mRNA-1273 were administered 13 months prior, the interval between the two doses is 27 days, the third dose of mRNA-1273 was administered 5 months prior. Details of clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 19 days after administration of fourth dose of mRNA-1273. The initial two doses of mRNA-1273 were administered 13 months prior, the interval between the two doses is 27 days, the third dose of mRNA-1273 was administered 5 months prior. Details of clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Paranasal sinus discomfort, Sinus pain
Clinical narrative: Intense sinus pain and pressure; Intense sinus pain and pressure; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PAIN (Intense sinus pain and pressure), PARANASAL SINUS DISCOMFORT (Intense sinus pain and pressure) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Eustachian tube dysfunction. Concurrent medical conditions included Asthma, Drug allergy (Codeine allergy), Allergy to antibiotic (Flagyl allergy) and Anxiety. Concomitant products included ALBUTEROL [SALBUTAMOL], PARACETAMOL (TYLENOL) and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced SINUS PAIN (Intense sinus pain and pressure), PARANASAL SINUS DISCOMFORT (Intense sinus pain and pressure) and NAUSEA (Nausea). The patient was treated with ONDANSETRON HYDROCHLORIDE DIHYDRATE (ZOFRAN [ONDANSETRON HYDROCHLORIDE DIHYDRATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, SINUS PAIN (Intense sinus pain and pressure) and PARANASAL SINUS DISCOMFORT (Intense sinus pain and pressure) outcome was unknown and NAUSEA (Nausea) had not resolved.            It was reported that the patient started treatment with a co-suspect product on 03-May-2022 for COVID-19 treatment with the batch number FY8914 and stopped therapy on 07-May-2022.  The device date was reported as 14-May-2022.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment and the patient had also previously received a COVID-19 vaccine.  The event of nausea was not resolved by taking Zofran.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound of COVID-19 symptoms and positive antigen test on day 12; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of COVID-19 symptoms and positive antigen test on day 12) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient did not have any relevant medical history.  Concurrent medical conditions included Penicillin allergy and Sulfonamide allergy (Sulfa).   On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound of COVID-19 symptoms and positive antigen test on day 12). At the time of the report, COVID-19 (Rebound of COVID-19 symptoms and positive antigen test on day 12) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) positive antigen test.          It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient tested positive for COVID-19, 6 days after finishing Paxlovid five day treatment. The patient did not receive any treatment. Company comment: This spontaneous case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 170 days after receiving the third dose of mRNA-1273 Vaccine. There was no information regarding the initial two doses. On May 12, 2022, SARS-CoV-2 test was done which revealed a positive result. It was reported that patient tested positive for COVID-19 6 days after finishing Paxlovid five-day treatment. Details of clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 170 days after receiving the third dose of mRNA-1273 Vaccine. There was no information regarding the initial two doses. On May 12, 2022, SARS-CoV-2 test was done which revealed a positive result. It was reported that patient tested positive for COVID-19 6 days after finishing Paxlovid five-day treatment. Details of clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 14-Oct-2019, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient mentioned having a reaction like a flare up post her second booster dose. Felt the same way post her second vaccine as well, hence was not too concerned when it occurred again after first booster and second booster.  Reporter causality for event to Rinvoq was no reasonable possibility.  Company comment: This spontaneous case concerns a 65-year-old female patient, with relevant medical history of Rheumatoid arthritis on Upadacitinib, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) that occurred on an unspecified date (same month of vaccination) after receiving the 2nd dose of mRNA-1273 vaccine. Clinical course and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-568026, MOD-2022-568033 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old female patient, with relevant medical history of Rheumatoid arthritis on Upadacitinib, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) that occurred on an unspecified date (same month of vaccination) after receiving the 2nd dose of mRNA-1273 vaccine. Clinical course and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine headache; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Migraine headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Previously administered products included for Product used for unknown indication: valcyclovir. Past adverse reactions to the above products included Migraine with valcyclovir. Concurrent medical conditions included Coronary artery disease, Asthma and Drug allergy (No drugs were reported.). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 20-Nov-2019 to 07-May-2022, LISINOPRIL from 20-Nov-2019 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 20-Nov-2019 to an unknown date for an unknown indication.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 1:00 PM, the patient experienced MIGRAINE (Migraine headache). The patient was treated with PROMETHAZINE (PHENERGAN [PROMETHAZINE]) at an unspecified dose and frequency; SUMATRIPTAN (IMITREX [SUMATRIPTAN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine headache) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient previously receive a COVID-19 Vaccine.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: body ache; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LCOA) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy, Food allergy, Thyroid disorder and Palpitations (due to her thyroid problems). Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM SUPPLEMENT WITH VITAMIN D) 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. In 2021, the patient experienced MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever). At the time of the report, MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mentioned as Cilnidipine extended. No treatment information was provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: body ache; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LCOA) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy, Food allergy, Thyroid disorder and Palpitations (due to her thyroid problems). Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM SUPPLEMENT WITH VITAMIN D) 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. In 2021, the patient experienced MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever). At the time of the report, MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mentioned as Cilnidipine extended. No treatment information was provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Cardiac stress test, Decreased appetite, Electrocardiogram, Extrasystoles
Clinical narrative: body ache; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LCOA) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy, Food allergy, Thyroid disorder and Palpitations (due to her thyroid problems). Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM SUPPLEMENT WITH VITAMIN D) 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. In 2021, the patient experienced MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever). At the time of the report, MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mentioned as Cilnidipine extended. No treatment information was provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling of body temperature change, Influenza like illness, Myocardial necrosis marker
Clinical narrative: body ache; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LCOA) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy, Food allergy, Thyroid disorder and Palpitations (due to her thyroid problems). Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM SUPPLEMENT WITH VITAMIN D) 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. In 2021, the patient experienced MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever). At the time of the report, MYALGIA (body ache), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine/Pain and redness in the site of injection) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mentioned as Cilnidipine extended. No treatment information was provided by the reporter.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Began to have Covid symptoms again; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Began to have Covid symptoms again) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Psoriatic arthritis and Drug allergy. Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 04-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Began to have Covid symptoms again). At the time of the report, COVID-19 (Began to have Covid symptoms again) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient after finishing course of Paxlovid, I felt great for 2 days and then began to have COVID-19 symptoms again and symptoms include sinus pain, congestion and significant back pain and body aches. The patient took other medications/products within 2 weeks of starting COVID-19 treatment. No treatment medications were provided. Company comment: This spontaneous case concerns a 43-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred 222 days after administration of third dose of mRNA-1273. There was no information regarding the initial two doses. It has been reported that the patient's condition improved after finishing a course of Paxlovid and then began to have COVID-19 symptoms again and symptoms include sinus pain, congestion and significant back pain and body aches. Details of clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred 222 days after administration of third dose of mRNA-1273. There was no information regarding the initial two doses. It has been reported that the patient's condition improved after finishing a course of Paxlovid and then began to have COVID-19 symptoms again and symptoms include sinus pain, congestion and significant back pain and body aches. Details of clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: Did not feel good at all; Broke out in rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel good at all) and RASH (Broke out in rash) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Did not feel good at all) and RASH (Broke out in rash). At the time of the report, FEELING ABNORMAL (Did not feel good at all) and RASH (Broke out in rash) outcome was unknown. No concomitant medication information provided.  It was reported that, patient had not taken the fourth booster dose.  No treatment information provided.   This case was linked to MOD-2022-550427, MOD-2022-550512 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months) and VACCINATION SITE PAIN (had pain in his injection site left arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (had pain in his injection site left arm). On an unknown date, the patient experienced TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months). At the time of the report, TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months) and VACCINATION SITE PAIN (had pain in his injection site left arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2022-569012, MOD-2022-569013 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: had bouts of tinnitus after his Moderna Covid-19 vaccines, developed tinnitus over the past several months; painful left arm injection site.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines, developed tinnitus over the past several months) and VACCINATION SITE PAIN (painful left arm injection site.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (painful left arm injection site.). On an unknown date, the patient experienced TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines, developed tinnitus over the past several months). At the time of the report, TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines, developed tinnitus over the past several months) and VACCINATION SITE PAIN (painful left arm injection site.) outcome was unknown.            No concomitant medications were reported. No treatment details were reported. It was reported that the patient had developed Tinnitus over last several months.   This case was linked to MOD-2022-569010, MOD-2022-569013 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site inflammation, Vaccination site pain
Clinical narrative: had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months; Pain and inflammation at the site of the injection; Pain and inflammation at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months), VACCINATION SITE PAIN (Pain and inflammation at the site of the injection) and VACCINATION SITE INFLAMMATION (Pain and inflammation at the site of the injection) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 040B21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, the patient experienced VACCINATION SITE PAIN (Pain and inflammation at the site of the injection) and VACCINATION SITE INFLAMMATION (Pain and inflammation at the site of the injection). On an unknown date, the patient experienced TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months). At the time of the report, TINNITUS (had bouts of tinnitus after his Moderna Covid-19 vaccines / developed tinnitus over the past several months), VACCINATION SITE PAIN (Pain and inflammation at the site of the injection) and VACCINATION SITE INFLAMMATION (Pain and inflammation at the site of the injection) outcome was unknown.            No concomitant medication details was reported.  Patient received his booster dose on 26NOV2021.  No treatment medication details was reported.   This case was linked to MOD-2022-569010, MOD-2022-569012 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: had tinnitus from blood flow; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (had tinnitus from blood flow) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (preexisting health problems).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (had tinnitus from blood flow). At the time of the report, TINNITUS (had tinnitus from blood flow) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  It was told by doctor that event can occurred due to COVID-19 infection or the immunization.  No treatment medication was reported.