chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose on 8-Nov-2021 and 2nd dose on 11-Apr-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 8-Nov-2021 and 2nd dose on 11-Apr-2022) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis). Concomitant products included ADALIMUMAB (HUMIRA) from an unknown date to 10-Jun-2022 for Rheumatoid arthritis.   On 08-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 8-Nov-2021 and 2nd dose on 11-Apr-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 8-Nov-2021 and 2nd dose on 11-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2022-627944 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough
Clinical narrative: SEVERE COUGH; JOINT PAIN FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (SEVERE COUGH) and ARTHRALGIA (JOINT PAIN FLARE UP) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Crohn's disease.    No Medical History information was reported.   On 13-May-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (SEVERE COUGH) and ARTHRALGIA (JOINT PAIN FLARE UP). At the time of the report, COUGH (SEVERE COUGH) outcome was unknown and ARTHRALGIA (JOINT PAIN FLARE UP) had not resolved.      No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 vaccine trial. No treatment medication was reported.   Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Fluid intake reduced, Hypophagia
Clinical narrative: Bedridden/experienced BED BOUND; Oral intake reduced/COULD NOT EAT; Fluid intake reduced/COULD NOT DRINK; Fatigue extreme/EXTREMELY FATIGUED; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (Bedridden/experienced BED BOUND), HYPOPHAGIA (Oral intake reduced/COULD NOT EAT), FLUID INTAKE REDUCED (Fluid intake reduced/COULD NOT DRINK) and FATIGUE (Fatigue extreme/EXTREMELY FATIGUED) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Previously administered products included for Product used for unknown indication: Humira (Patient was once on Humira few years ago and but stopped because it was not working as good). Past adverse reactions to the above products included No adverse event with Humira.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced BEDRIDDEN (Bedridden/experienced BED BOUND), HYPOPHAGIA (Oral intake reduced/COULD NOT EAT), FLUID INTAKE REDUCED (Fluid intake reduced/COULD NOT DRINK) and FATIGUE (Fatigue extreme/EXTREMELY FATIGUED). At the time of the report, BEDRIDDEN (Bedridden/experienced BED BOUND), HYPOPHAGIA (Oral intake reduced/COULD NOT EAT), FLUID INTAKE REDUCED (Fluid intake reduced/COULD NOT DRINK) and FATIGUE (Fatigue extreme/EXTREMELY FATIGUED) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality of co suspect SKYRIZI for the event(s) of BED BOUND, COULD NOT EAT OR DRINK onset in May 2021, COULD NOT EAT OR DRINK onset in May 2021 and EXTREMELY FATIGUED was not provided. No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Aphonia, Eye swelling, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Loss of voice; Swollen eyes; Fatigue extreme; Hair loss; 1st Dose on 13-Aug-2021 and 2nd Dose on 13-Oct-2021; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Loss of voice), EYE SWELLING (Swollen eyes), ALOPECIA (Hair loss), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 13-Aug-2021 and 2nd Dose on 13-Oct-2021) and FATIGUE (Fatigue extreme) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 13-Aug-2021 and 2nd Dose on 13-Oct-2021). In June 2022, the patient experienced ALOPECIA (Hair loss). On an unknown date, the patient experienced APHONIA (Loss of voice), EYE SWELLING (Swollen eyes) and FATIGUE (Fatigue extreme). At the time of the report, APHONIA (Loss of voice), EYE SWELLING (Swollen eyes) and ALOPECIA (Hair loss) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 13-Aug-2021 and 2nd Dose on 13-Oct-2021) and FATIGUE (Fatigue extreme) outcome was unknown. Not Provided          No concomitant medication was reported.  It was reported that patient experienced lost voice, very tired, swollen eyes or puffy eyes and hair loss with HUMIRA adalimumab Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of lost voice, swollen eyes or puffy eyes and hair loss with  humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of very tired was not provided.  No treatment medication was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Lip swelling, Skin discolouration
Clinical narrative: STILL HAD LITTLE DISCOLORATION IN SOME SPOTS; HAD REACTION TO COVID VACCINATION DUE TO ANTIBIOTICS; Swollen lips; 1st Dose on 15-Nov-2020 and 2nd dose on 15-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (STILL HAD LITTLE DISCOLORATION IN SOME SPOTS), IMMUNISATION REACTION (HAD REACTION TO COVID VACCINATION DUE TO ANTIBIOTICS), LIP SWELLING (Swollen lips) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-Nov-2020 and 2nd dose on 15-Mar-2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 15-Nov-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISCOLOURATION (STILL HAD LITTLE DISCOLORATION IN SOME SPOTS), IMMUNISATION REACTION (HAD REACTION TO COVID VACCINATION DUE TO ANTIBIOTICS), LIP SWELLING (Swollen lips) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-Nov-2020 and 2nd dose on 15-Mar-2021). At the time of the report, SKIN DISCOLOURATION (STILL HAD LITTLE DISCOLORATION IN SOME SPOTS) was resolving and IMMUNISATION REACTION (HAD REACTION TO COVID VACCINATION DUE TO ANTIBIOTICS), LIP SWELLING (Swollen lips) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-Nov-2020 and 2nd dose on 15-Mar-2021) outcome was unknown. Not Provided          No concomitant medications were reported. Humira: Solution for injection in pre-filled pen), Citrate free.  The reporter causality for the events of Still had little discoloration in some spots with HUMIRA was a reasonable possibility and had reaction to COVID vaccination due to antibiotics and swollen lips was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: NOT FEELING WELL; VACCINE CAUSED SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (NOT FEELING WELL) and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (NOT FEELING WELL) and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM). At the time of the report, MALAISE (NOT FEELING WELL) had not resolved and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) had resolved. Not Provided          No concomitant medications was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of NOT FEELING WELL and VACCINE CAUSED SORE ARM with HUMIRA was not provided for Humira.  No treatment drug details was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Inappropriate schedule of product administration, Pruritus
Clinical narrative: ITCHY FROM BEING OUTSIDE LITTLE BUG BITES; ITCHY FROM BEING OUTSIDE LITTLE BUG BITES; 1st dose on 4-jan-2021 and 2nd dose on 28-jan-2021; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD BITE (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES), PRURITUS (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 4-jan-2021 and 2nd dose on 28-jan-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC ).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Solution for injection in pre-filled pen). On 28-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 4-jan-2021 and 2nd dose on 28-jan-2021). On an unknown date, the patient experienced ARTHROPOD BITE (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES) and PRURITUS (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES). At the time of the report, ARTHROPOD BITE (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 4-jan-2021 and 2nd dose on 28-jan-2021) outcome was unknown and PRURITUS (ITCHY FROM BEING OUTSIDE LITTLE BUG BITES) was resolving.            Concomitant drugs not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Formulation for suspect HUMIRA given as Solution for injection in pre-filled pen. The reporter causality for the event Bug bite was reported as Not Reported and for the event Itchy was reported as (no reasonable possibility) Not Related. Treatment information was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to chemicals, Fatigue, Rash, Vaccination site pain
Clinical narrative: Allergic to wine; Flare up/occasional break out on face; Sore arm after vaccines; Fatigued after injection; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO CHEMICALS (Allergic to wine), RASH (Flare up/occasional break out on face), VACCINATION SITE PAIN (Sore arm after vaccines) and FATIGUE (Fatigued after injection) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ALLERGY TO CHEMICALS (Allergic to wine), RASH (Flare up/occasional break out on face), VACCINATION SITE PAIN (Sore arm after vaccines) and FATIGUE (Fatigued after injection). At the time of the report, ALLERGY TO CHEMICALS (Allergic to wine) and VACCINATION SITE PAIN (Sore arm after vaccines) outcome was unknown and RASH (Flare up/occasional break out on face) and FATIGUE (Fatigued after injection) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The patient did not agree to have physician contacted.  The reporter's causality for the event of flare up/ occasional break out on face and fatigued after injection with SKYRIZI was reported as reasonable possibility and for allergic to wine and sore arm after vaccines was no reasonable possibility.  No treatment medications were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Skin plaque
Clinical narrative: Skin plaque; Pain in arm; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Skin plaque), PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN PLAQUE (Skin plaque), PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (Joint pain). At the time of the report, SKIN PLAQUE (Skin plaque) had not resolved, PAIN IN EXTREMITY (Pain in arm) had resolved and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient received Moderna as Booster dose.  The reporter's causality for the events of plaque build up on hands and legs, pinching in arm painful to turn rotator cuff and synovial pain with Humira (adalimumab) was no reasonable possibility and with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was reasonable possibility.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Fully Vaccinated with Pfizer and Moderna plus Boosters but still caught the damm Virus; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Fully Vaccinated with Pfizer and Moderna plus Boosters but still caught the damm Virus) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Fully Vaccinated with Pfizer and Moderna plus Boosters but still caught the damm Virus). At the time of the report, COVID-19 (Fully Vaccinated with Pfizer and Moderna plus Boosters but still caught the damm Virus) outcome was unknown.            The patient was fully vaccinated with Pfizer and Moderna plus boosters too, still caught the virus.  No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  Company comment: This spontaneous case concerns a unspecified age and gender patient, who experienced the unexpected, nonserious AESI of Covid -19 (reported as Fully Vaccinated with Pfizer and Moderna plus Boosters but still caught the damm Virus). Latency cannot be assessed since exact onset date was not provided, event occurred after booster dose of mRNA-1273 vaccine.At the time of report outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Covid-19 pandemia remains as confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a unspecified age and gender patient, who experienced the unexpected, nonserious AESI of Covid -19 (reported as Fully Vaccinated with Pfizer and Moderna plus Boosters but still caught the damm Virus). Latency cannot be assessed since exact onset date was not provided, event occurred after booster dose of mRNA-1273 vaccine.At the time of report outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Covid-19 pandemia remains as confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Vaccination site pain
Clinical narrative: SORE ARM; FATIGUE; FELL; This spontaneous case was reported by a consumer and describes the occurrence of FALL (FELL), VACCINATION SITE PAIN (SORE ARM) and FATIGUE (FATIGUE) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free,Solution for injection in pre-filled pen. In 2022, the patient experienced FALL (FELL). On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM) and FATIGUE (FATIGUE). At the time of the report, FALL (FELL), VACCINATION SITE PAIN (SORE ARM) and FATIGUE (FATIGUE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach cramps; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Panuveitis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Known allergy. No relevant medical history.    On 23-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2022, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea) outcome was unknown.            Concomitant medications details were not reported.  The patient took Moderna vaccine as a booster dose. The patient received Humira (solution for injection in pre-filled pen) with the dosage citrate free (40 mg,1 in 2 week) for non-infectious intermediate, posterior and panuveitis.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the events of diarrhea and severe stomach cramps with Humira(adalimumab) and Janssen covid-19 vaccine was a  reasonable possibility.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; dry cough; high fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), COUGH (dry cough) and PYREXIA (high fever) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. it was unknow if the patient previously receive a COVID-19 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 OROPHARYNGEAL PAIN (sore throat), COUGH (dry cough) and PYREXIA (high fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), COUGH (dry cough) and PYREXIA (high fever) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.   The patient did not receive any treatment. Device Date  09-Jul-2022   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Unforeseen adverse medical side effects suffered as a result of my vaccination on 06/8/22; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Unforeseen adverse medical side effects suffered as a result of my vaccination on 06/8/22) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 037A22B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2021.    On 08-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Unforeseen adverse medical side effects suffered as a result of my vaccination on 06/8/22). At the time of the report, IMMUNISATION REACTION (Unforeseen adverse medical side effects suffered as a result of my vaccination on 06/8/22) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient's PCP advised him to hold any further vaccinations until all medical issues had resolved. Treatment information was not provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient administered first dose on 5-Mar-2021 and second dose 6-Dec-2021 then third dose on 19-Apr-2022; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 5-Mar-2021 and second dose 6-Dec-2021 then third dose on 19-Apr-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 0121421B and 0101A21A) for COVID-19 prophylaxis.     The patient's past medical history included Viral pneumonia (5 year ago.). Concurrent medical conditions included Rheumatoid arthritis since 02-Mar-2006, Fibromyalgia since 02-Mar-2006, Osteoarthritis since 02-Mar-2006, Immunocompromised and Acute gastritis (sever).   On 05-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 5-Mar-2021 and second dose 6-Dec-2021 then third dose on 19-Apr-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 5-Mar-2021 and second dose 6-Dec-2021 then third dose on 19-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2022, Blood test: Cholesterol little high, all other was great.         No concomitant medications were provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2022-628396 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction; patient inadvertently received 1st dose from an unauthorized age group (6-11) vial.; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient inadvertently received 1st dose from an unauthorized age group (6-11) vial.) and NO ADVERSE EVENT (No adverse reaction) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     The patient had no known allergies.     On 11-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 dosage form. On 11-Aug-2022, the patient experienced INCORRECT DOSE ADMINISTERED (patient inadvertently received 1st dose from an unauthorized age group (6-11) vial.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INCORRECT DOSE ADMINISTERED (patient inadvertently received 1st dose from an unauthorized age group (6-11) vial.) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (patient inadvertently received 1st dose from an unauthorized age group (6-11) vial.).    No concomitant medications were provided by the reporter.  Patient's height was reported as 44 7/8 inches.   No treatment medications were provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient administered with Moderna COVID-19 vaccine after the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with Moderna COVID-19 vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 Moderna for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with Moderna COVID-19 vaccine after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with Moderna COVID-19 vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with Moderna COVID-19 vaccine after the published expiration date).    Concomitant medication was not provided. Patient had not experienced any adverse event. Treatment information was not provided.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Fever up to 101.5 and rash at SQ injection site
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitis
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 26Dec2020 at 10:30 as dose 1, single (Lot number: EH9899), in left arm, on 16Jan2021 at 11:00 as dose 2, single (Lot number: EK9231), in left arm and on 16Oct2021 at 09:00 as dose 3 (booster), single (Lot number: 32030BD) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14May2022 at 11:00 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing), notes: seasonal allergies. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] oral, start date: 19Nov2017. Past drug history included: Finasteride, reaction(s): "Known allergies: Finasteride", notes: Known allergies: Finasteride. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included COVID-19 Treatment included PAXLOVID from 26Jul2022 to 01Aug2022.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events.
Age: 32.0
Sex: M
Vaccine: COVID19, 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 32-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 at 13:00 as dose 3 (booster), single (Lot number: EW0186) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no known allergies. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound, positive after negative; Positive, notes: Rebound, positive after negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient not received other medication in 2 weeks. The patient took anti-viral product Paxlovid for COVID 19 Treatment starting from 30Jul2022 to 04Aug2022.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid did actually spread to additional person who had all 4 series of the COVID Vaccine; Covid did actually spread to additional person who had all 4 series of the COVID Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid did actually spread to additional person who had all 4 series of the COVID Vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Fatigue, Heart rate
Clinical narrative: Increased heart rate; Fatigue when working out in heat; Diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID: (054550).  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant Concomitant medication(s) included: OMEPRAZOLE; LOSARTAN POTASSIUM; ROSUVASTATIN CALCIUM; LEFLUNOMIDE; XELJANZ XR (ongoing). Past drug history included: Aleve, reaction(s): "Allergies: Aleve", notes: Allergies: Aleve 220 mg Capsule; Methotrexate, reaction(s): "Allergies: Methotrexate", notes: Allergies: Methotrexate 2.5 mg tablet, Sulfasalazine 500 mg tablet; Sulfasalazine, reaction(s): "Allergies: Sulfasalazine", notes: Allergies: Sulfasalazine 500 mg tablet. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2022, outcome "unknown" and all described as "Diagnosed with Covid"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Increased heart rate"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue when working out in heat". It was reported that patient was diagnosed with Covid on 06Aug2022, states symptoms began 05Aug2022. Hes went to emergency room due to 102 fever, sore throat, and chest congestion, states prescriber unaware. He also experiences increased heart rate and fatigue when working out in the heat, states has mentioned this to prescriber. Patient states is still currently taking XELJANZ XR, started over 1 year ago. The reporter considered the events as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, SARS-CoV-2 test
Clinical narrative: Increased heart rate; Fatigue when working out in heat; Diagnosed with Covid; Diagnosed with Covid; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID: (054550).  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant Concomitant medication(s) included: OMEPRAZOLE; LOSARTAN POTASSIUM; ROSUVASTATIN CALCIUM; LEFLUNOMIDE; XELJANZ XR (ongoing). Past drug history included: Aleve, reaction(s): "Allergies: Aleve", notes: Allergies: Aleve 220 mg Capsule; Methotrexate, reaction(s): "Allergies: Methotrexate", notes: Allergies: Methotrexate 2.5 mg tablet, Sulfasalazine 500 mg tablet; Sulfasalazine, reaction(s): "Allergies: Sulfasalazine", notes: Allergies: Sulfasalazine 500 mg tablet. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2022, outcome "unknown" and all described as "Diagnosed with Covid"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Increased heart rate"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue when working out in heat". It was reported that patient was diagnosed with Covid on 06Aug2022, states symptoms began 05Aug2022. Hes went to emergency room due to 102 fever, sore throat, and chest congestion, states prescriber unaware. He also experiences increased heart rate and fatigue when working out in the heat, states has mentioned this to prescriber. Patient states is still currently taking XELJANZ XR, started over 1 year ago. The reporter considered the events as non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: Left arm has been aching; pain in the left arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Left arm has been aching; pain in the left arm". The event "left arm has been aching; pain in the left arm" required physician office visit. The patient underwent the following laboratory tests and procedures: X-ray: There is no problem there. Therapeutic measures were taken as a result of pain in extremity. Per clinical course, the patient and his wife had Pfizer shot for the COVID-19 two years ago and they were happier and had the shot in the right arm. Now, the left arm has been aching ever since the shot, they never had anything in the left arm, and they have pain now in the left arm. They had a reverse shoulder in the left arm (as reported) number one, and they had no trouble with the reverse shoulder. It has been fine, they had X-rays and everything else and there was no problem there. They have had pain in the left arm, and they believed it is the result of the Pfizer vaccine shot. The patient was calling, and his wife is right beside him wondering if there is anything they can take that Pfizer would recommend because none of their doctors know what to do with it. They had the booster shot also.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201050924 Same reporter, product, and event; different patient;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: left arm has been aching ever since the shot/ pain in the left arm; This is a spontaneous report received from a contactable reporter (consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "left arm has been aching ever since the shot/ pain in the left arm". The event "left arm has been aching ever since the shot/ pain in the left arm" required physician office visit. The patient underwent the following laboratory tests and procedures: X-ray: there is no problem there. Therapeutic measures were taken as a result of pain in extremity. Clinical course: The patient's husband reported that two years ago, they had the Pfizer shot for the COVID 19 and they were happier and had the shot in the right arm. Now, the left arm has been aching ever since the shot, they never had anything in the left arm, and they have pain now in the left arm. They had a reverse shoulder in the left arm (as reported) number one, and they had no trouble with the reverse shoulder. It has been fine, they had X-rays and everything else and there was no problem there. They have had pain in the left arm, and they believed it was the result of the Pfizer vaccine shot. They are wondering if there is anything they can take that Pfizer would recommend because none of their doctors know what to do with it. They had the booster shot also.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201050862 same reporter, product, and event; different patient;
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: D1620) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION; TURMERIC [CURCUMA LONGA]; SUMATRIPTAN; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". 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 received other medication in 2 weeks Product: Multivitamin. Patient received Paxlovid from 30Jul2022 to 03Aug2022 for treatment of COVID-19.; Sender's Comments: ~~~
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN60207), in left arm and on 09Apr2021 as dose 2, single (Lot number: EN60207) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 3, (booster), single (Lot number: Moderna/030H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Just nature" (unspecified if ongoing), notes: Known allergies: Just nature. Concomitant medication(s) included: ZYRTEC R. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive; (03Aug2022) Negative; (05Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had received other medication in 2 weeks. The patient had tested positive on 25Jul2022- took Paxlovid by 2pm for COVID 19 Treatment. Finished treatment on 29Jul2022. Tested negative on 03Aug2022. Symptoms resumed and tested positive on 05Aug2022.  Follow-up attempts are completed. No further information is expected.