chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction; Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021) and NO ADVERSE EVENT (No adverse reaction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteopenia, Arthritis, Rosacea and Diarrhea predominant irritable bowel syndrome.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021).    Patient's ethnicity was reported.  No concomitant medication was reported.  Reportedly, patient further received Pfizer / BioNTech vaccine as a 3rd dose on 06-Oct-2021 and Pfizer / BioNTech vaccine as a 4th dose on 08-Mar-2022 and Bivalent dose as a dose 5 on 21-SEP-2022.  No treatment information was provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Autoimmune disorder
Clinical narrative: An autoimmune disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AUTOIMMUNE DISORDER (An autoimmune disease) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (An autoimmune disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (An autoimmune disease) outcome was unknown.            No concomitant medication information was reported. It was reported that grandfather, the patient, had been vaccinated multiple times and had been in and out of the hospital. Also stated that grandfather at the time of report had an autoimmune disease. Now that there was overwhelming evidence that Moderna vaccine was killing people and harming people. The reporter did not see why it would be a problem to get money through the court system. No treatment medication information was reported.  Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of autoimmune disorder. The event occurred on an unknown date after a dose of mRNA-1273 bivalent BA.4/BA.5. As reported, the patient had been vaccinated multiple times and had been in and out of the hospital and now (at the time of the report) has an autoimmune disease. No further information about the event (including diagnostic findings, final diagnosis, clinical course, laboratory results etc.) was provided. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-707866, US-MODERNATX, INC.-MOD-2023-707867 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707866:case for mother US-MODERNATX, INC.-MOD-2023-707867:case for father
Sex: M
Vaccine: COVID19-2
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.            Concomitant product information was not provided by the reporter.   The reporter's father had been vaccinated multiple times and had been in and out of the hospital. The reporter's father had a heart attack. Now that there was overwhelming evidence that Moderna vaccine was killing people and harming people. The reporter did not see why it would be a problem to get money through the court system.  Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-707862, US-MODERNATX, INC.-MOD-2023-707866 (E2B Linked Report).; Reporter's Comments: This spontaneous case concerns an unknown-years-old male patient, with no medical history related who experienced the medically significant expected AESI of myocardial infarction unknown days after a  dose of  mRNA- 1273 bivalent vaccine. The outcome was unknown.    The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707862:case for grandfather US-MODERNATX, INC.-MOD-2023-707866:case for mother
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 doses which were beyond the manufacturer expiration date and the 30 BUD were administered on 01Feb2023; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses which were beyond the manufacturer expiration date and the 30 BUD were administered on 01Feb2023) and NO ADVERSE EVENT (no adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051C22a) for COVID-19 prophylaxis.     No Medical History information was reported.  On 01-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses which were beyond the manufacturer expiration date and the 30 BUD were administered on 01Feb2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses which were beyond the manufacturer expiration date and the 30 BUD were administered on 01Feb2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses which were beyond the manufacturer expiration date and the 30 BUD were administered on 01Feb2023).    Concomitant product use was not provided by the reporter.  Nurse at facility gave primary to customer on 01-Feb-2023 it was discovered as expired 13-Jan-2023.  It was reported that the 2 doses which were beyond the manufacturer expiration date and the 30 BUD were administered on 01-Feb-2023. Lot number 051C22A, manufacturer expiration date 13-Jan-2023 and the initial date the vaccine was placed in the refrigerator was on 09-Nov-2022.  No adverse reactions were reported by the patients.  Treatment information was not provided.  This case contains information for the 1st patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-707259 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707259:
Age: 37.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.) and NO ADVERSE EVENT (no adverse event) in a 37-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 06-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (they inadvertently administered the the 6-11 year old bivalent booster dose to a 37 year old patient today, 06Feb2023.).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: I suffered heart damage from the vaccine; This spontaneous case was reported by a paramedic and describes the occurrence of CARDIAC DISORDER (I suffered heart damage from the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (I suffered heart damage from the vaccine). At the time of the report, CARDIAC DISORDER (I suffered heart damage from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with a Moderna Covid 19 vaccine after 30 Day use by date.).    It was unknown patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.    No treatment information was reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose administered after manufacturer date of expiry; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No relevant medical history or conditions, allergy, concomitant diseases and risk factor were reported. No other vaccines in the 4 weeks prior to COVID-19 vaccine were reported.  No concomitant medication was reported. No treatment information was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Abnormal dreams
Clinical narrative: developed extremely vivid dreams; This spontaneous case was reported by a physician and describes the occurrence of ABNORMAL DREAMS (developed extremely vivid dreams) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 and Vivid dreams (when he was ill with COVID. Those dreams had resolved had comeback with each dose of vaccine.).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (developed extremely vivid dreams). At the time of the report, ABNORMAL DREAMS (developed extremely vivid dreams) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient developed extremely vivid dreams where patient was ill with COVID and that the dreams had resolved have comeback briefly with each dose of vaccine. After receiving the bivalent vaccine patient had three or four nights of vivid dreams that awoke from the sleep. They were extremely detailed.  No treatment medications were reported.   This case was linked to MOD-2023-708149 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: vivid dreams with each dose of vaccine; This spontaneous case was reported by a physician and describes the occurrence of ABNORMAL DREAMS (vivid dreams with each dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 and Vivid dreams (developed extremely vivid dreams during COVID, but it was resolved and again came back with each dose of vaccine).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (vivid dreams with each dose of vaccine). At the time of the report, ABNORMAL DREAMS (vivid dreams with each dose of vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient was an entomologist. The vivid dreams which were developed by the patient during COVID was resolved, but comeback briefly with each dose of vaccine.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-708066 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708066:Bivalent booster
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle twitching
Clinical narrative: Muscle twitching; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (Muscle twitching) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu shot (Flu shot one week before bivalent booster); for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Flu shot and Moderna COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Muscle twitching). At the time of the report, MUSCLE TWITCHING (Muscle twitching) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient states that took the Moderna bivalent booster last fall. After 4-5 weeks. patient noticed muscle twitching. It got worse. Patient took the bivalent COVID booster a week after getting FluZone (flu shot). patient was not sure if it was too close together. Patient does not think a flu shot could do that because patient had so many flu shots over the years. The patient states that took 5 Moderna shots before getting the Moderna bivalent booster. patient got the Moderna bivalent booster on the same day.  No treatment medications were reported.   This case was linked to MOD-2023-707976 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (light headed) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033E21-2A, 002A21A, 006B21A and 939906) for COVID-19 prophylaxis.     Concurrent medical conditions included Prostate cancer stage IV (using Lupron Injection every 6 months and casodex twice daily.) since 2005, Hypertension (taking Metoprolol , Lisinopril, Norvasc, and Eliquis) since 2010, High cholesterol (taking Simvastatin) since 2010 and Gastroesophageal reflux (taking Famotidine) since 2010. Concomitant products included FAMOTIDINE for Gastroesophageal reflux, SIMVASTATIN for High cholesterol, METOPROLOL, LISINOPRIL, AMLODIPINE BESILATE (NORVASC) and APIXABAN (ELIQUIS) for Hypertension, LEUPRORELIN ACETATE (LUPRON) and BICALUTAMIDE (CASODEX) for Prostate cancer stage IV.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that about 10 days after the 2nd primary dose, patient started feeling very very light headed. About 10 days after the 3rd shot, and 10 days after the 4th shot. Patient did not had any other vaccines within 4 weeks of any of his COVID shots.   Treatment medications were not reported.   This case was linked to MOD-2023-707708 (Patient Link).
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; 11-year-old patient received an adult dose (0.5 ml) of Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (11-year-old patient received an adult dose (0.5 ml) of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2) in May 2022 and PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE for an unknown indication.    On 06-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL OVERDOSE (11-year-old patient received an adult dose (0.5 ml) of Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (11-year-old patient received an adult dose (0.5 ml) of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (11-year-old patient received an adult dose (0.5 ml) of Bivalent Moderna COVID-19 vaccine).    Treatment medication were not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Psoriasis
Clinical narrative: got COVID; This rash then progressed to her hands and feet/saw her general practitioner who stated it looked like psoriasis; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got COVID) and PSORIASIS (This rash then progressed to her hands and feet/saw her general practitioner who stated it looked like psoriasis) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 047AZ1A, 046B21A and 012H21B) for COVID-19 prophylaxis.     Previously administered products included for Vaccination: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII.   On 20-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID) and PSORIASIS (This rash then progressed to her hands and feet/saw her general practitioner who stated it looked like psoriasis). The patient was treated with CLOBETASOL ongoing since an unknown date for Psoriasis, at an unspecified dose and frequency. At the time of the report, COVID-19 (got COVID) and PSORIASIS (This rash then progressed to her hands and feet/saw her general practitioner who stated it looked like psoriasis) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  It was reported that by the middle of June patient gradually started to notice her elbows were red and her hands were itchy. She thought she had poison ivy. She tried using poison ivy medication with no changes. This rash then progressed to her hands and feet. She saw her general practitioner who stated it looked like psoriasis and prescribed Clobetasol (a steroid). If she uses the steroid it goes away, but the second she stops using it the symptoms return. Had an appointment with a dermatologist but got COVID before that appointment, and so was unable to make her appointment.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain in extremity
Clinical narrative: horrible left arm pain/ pain is killing her/ it is super painful; she cannot sleep at night; The pain is located around the shoulder; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (horrible left arm pain/ pain is killing her/ it is super painful), INSOMNIA (she cannot sleep at night) and ARTHRALGIA (The pain is located around the shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In June 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (horrible left arm pain/ pain is killing her/ it is super painful), INSOMNIA (she cannot sleep at night) and ARTHRALGIA (The pain is located around the shoulder). At the time of the report, PAIN IN EXTREMITY (horrible left arm pain/ pain is killing her/ it is super painful), INSOMNIA (she cannot sleep at night) and ARTHRALGIA (The pain is located around the shoulder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that since patient had the 2 Moderna and one booster dose in Jun2022, she started to have horrible left arm pain. She initially thought that it would go away but it did not. The pain was killing her, it was super painful, was unbearable that she cannot sleep at night. Patient went to see her doctor but could not tell what was happening. They do not know if it coming from the muscles or the joints. The pain was located around the shoulder and the upper arm. She wants to know what was happening with her arm. Patient states that she knows a lot of people who have the same complaint - pain on the arm after getting the Moderna Covid-19 vaccine.   Treatment medications were not reported.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyskinesia, Muscle twitching
Clinical narrative: muscle twitching; He still jerks quite a bit; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCLE TWITCHING (muscle twitching) and DYSKINESIA (He still jerks quite a bit) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: FLUZONE [INFLUENZA VACCINE] (Flu shot one week before bivalent booster); for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with FLUZONE [INFLUENZA VACCINE] and Moderna COVID-19 Vaccine.    On 28-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (muscle twitching) and DYSKINESIA (He still jerks quite a bit). At the time of the report, MUSCLE TWITCHING (muscle twitching) had not resolved and DYSKINESIA (He still jerks quite a bit) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient states that took the Moderna bivalent booster last fall. After 4-5 weeks. patient noticed muscle twitching. It got worse and was more noticeable.  Patient had so many flu shots over the years.  The patient states that took 5 Moderna shots before getting the Moderna bivalent booster. patient got the Moderna bivalent booster on the same day.  No treatment medications were reported.   This case was linked to MOD-2023-708150 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator; Vaccine was stored at room temperature for 31 hours; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator), PRODUCT STORAGE ERROR (Vaccine was stored at room temperature for 31 hours) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator), PRODUCT STORAGE ERROR (Vaccine was stored at room temperature for 31 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator), PRODUCT STORAGE ERROR (Vaccine was stored at room temperature for 31 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administer to 1 patient (immuno-competent) 31 hrs after removed from refrigerator) and PRODUCT STORAGE ERROR (Vaccine was stored at room temperature for 31 hours).    No concomitant medication information was provided.  It was reported that patient was administer with vaccine 31 hrs after removed from refrigerator (recommended time is 12hr).  No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: He had COVID disease 1 week ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He had COVID disease 1 week ago) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (He had COVID disease 1 week ago). At the time of the report, COVID-19 (He had COVID disease 1 week ago) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient had COVID disease 1 week ago (14 months after the last shot).  Patient had an appointment last week to receive the Bivalent shot, but patient was canceled it. No treatment information was reported.   Reporter did not allow further contact
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; patient received a bivalent booster vaccine on January 8, 2023 instead of a first dose of the monovalent Primary Series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a bivalent booster vaccine on January 8, 2023 instead of a first dose of the monovalent Primary Series) and NO ADVERSE EVENT (no adverse event) in a 9-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a bivalent booster vaccine on January 8, 2023 instead of a first dose of the monovalent Primary Series). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a bivalent booster vaccine on January 8, 2023 instead of a first dose of the monovalent Primary Series) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a bivalent booster vaccine on January 8, 2023 instead of a first dose of the monovalent Primary Series).    No Concomitant medication was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; On 07-FEB-2023, this serious, initial non-interventional study safety report was received from a consumer was received by Regulatory Authority on 07-FEB-2023.  An individual of an unspecified race, age and sex was vaccinated with intramuscular Covid-19 Vaccine (Recombinant and Adjuvanted) 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual experienced headache (PT: Headache) (Serious: Hospitalization). It was reported the individual was admitted to an intensive care unit (ICU) because of symptoms related to the COVID-19 vaccine for 2 nights.   At the time of reporting, the event outcome of Headache was unknown.  The reporter assessed the causality between vaccine and reported events: Headache as not reported.  Lot number was not provided in the report.; Sender's Comments: This individual of an unspecified age and sex experienced: Headache after vaccination with Covid-19 Vaccine (Recombinant, Adjuvanted) 10 ug/mL. The event Headache was reported as serious. Considering the current knowledge of the vaccine, the causal relationship between Covid-19 Vaccine (Recombinant and Adjuvanted) and Headache was assessed as related.
Sex: U
Vaccine: PNC13
Symptoms: Product contamination
Clinical narrative: Looked like a white substance, like a floating piece of cotton. Reporter would shake and shake the syringe, but this substance wouldn't go away (NO PATIENT); The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse) from medical information team and product quality group. A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: FW0032, Expiration Date: Nov2024) for immunisation, Device Lot Number: FW0032, Device Expiration Date: Nov2024. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONTAMINATION (non-serious), outcome "unknown", described as "Looked like a white substance, like a floating piece of cotton. Reporter would shake and shake the syringe, but this substance wouldn't go away (NO PATIENT)".  Additional information: The sample of the product was not available to be returned.
Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: first broken syringe/broke in half; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 27Jan2023, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, 0.5ml single (Lot number: FY2475, Expiration Date: Dec2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious) with onset 10Jan2023, outcome "unknown", described as "first broken syringe/broke in half". Additional information: When one of the nurses went to give the vaccine, it broke in half. She doesn't know about patient or not, they said it broke when they went to administer it. No patient got the broken vaccines.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna/Vaccine administration date: 01Apr2022/Vaccine dose number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 68 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), on 13Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 22Jun2021 at 14:00 as dose 3 (booster), single (Lot number: OGIE21A), in right arm and on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: 027L2iA), in right arm for covid-19 immunisation. The patient's relevant medical history included: "2 small aneurysm's" (unspecified if ongoing), notes: 2 small aneurysm's,1 in left carotid artery 1 in Aorta. Both are small and under medical observation. The patient's concomitant medications were not reported. Past drug history included: Pseudoephedrine, reaction(s): "known allergies: Pseudoephedrine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022 at 14:00, outcome "unknown", described as "Vaccine brand other: Moderna/Vaccine administration date: 01Apr2022/Vaccine dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was Unknown. The patient previously receive a COVID-19 vaccine. Patient received Paxlovid for COVID 19 treatment from 20Jan2023 to 24Jan2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: SLE" (unspecified if ongoing), notes: Other medical history: SLE; "Other medical history: RA" (unspecified if ongoing), notes: Other medical history: RA; "Anemia" (unspecified if ongoing); "adrenal insufficiency" (unspecified if ongoing); "Other medical history: immunosuppressive" (unspecified if ongoing), notes: Other medical history: immunosuppressive. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid as treatment. Treatment start date 25Jan2023, Treatment stop date 01Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 11:30 as dose 5 (booster), single (Lot number: GH9402) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 at 10:30 as dose 1, single (Lot number: EL9264), on 24Feb2021 at 10:30 as dose 2, single (Lot number: EN6203), on 14Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 07Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 20Jan2023, stop date: 24Jan2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 1 year 11 months 28 days 13 hrs 30 min after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Negative; (01Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was received Paxlovid as treatment from 22Jan2023 to 27Jan2023. Medication received within 2 weeks is Tylenol from 20Jan2023 to 24Jan2023.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 19Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included paxlovid from 25Jan2023 to 29Jan2023. The patient had received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: medical contrast" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes. Paxlovid Treatment for COVID 19 from 25Jan2023 to 29Jan2023.