chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID Disease & Sick months after 1st booster; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID Disease & Sick months after 1st booster) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient experienced COVID-19 (Tested positive for COVID Disease & Sick months after 1st booster). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID Disease & Sick months after 1st booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Company Comment: This is a spontaneous case concerning  a  93-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on May 9, 2022, after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on an unknown date.  Patient tested positive for SARS-CoV-2 test. Patient was treated with Nirmatrelvir/ritonavir at an unspecified dose and frequency. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-568684, MOD-2022-568296, MOD-2021-024069 (Patient Link).; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  93-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on May 9, 2022, after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on an unknown date.  Patient tested positive for SARS-CoV-2 test. Patient was treated with Nirmatrelvir/ritonavir at an unspecified dose and frequency. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose Number: 1 administered on 02-Nov-2021 and Dose Number: 2 administered on 17-Feb-2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number: 1 administered on 02-Nov-2021 and Dose Number: 2 administered on 17-Feb-2022) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number: 1 administered on 02-Nov-2021 and Dose Number: 2 administered on 17-Feb-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number: 1 administered on 02-Nov-2021 and Dose Number: 2 administered on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2022-568301, MOD-2022-568300 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion
Clinical narrative: COVID-19; nasal congestion and cough; nasal congestion and cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion and cough) and COUGH (nasal congestion and cough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031h21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Relevant past drug history: Allergy).    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2022, the patient experienced NASAL CONGESTION (nasal congestion and cough) and COUGH (nasal congestion and cough). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (nasal congestion and cough) and COUGH (nasal congestion and cough) outcome was unknown.            No concomitant medication were reported.  It was reported that 7 days after finishing treatment with Paxlovid ,Patient started having nasal congestion and a cough.He also tested positive again after having tested negative.  The device date was reported as 16-May-2022.  Company comment: This spontaneous case concerns a patient (unknown age and unknown gender) with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 5 months after mRNA-1273 vaccine, reported as third dose of the COVID  19 immunization schedules; no information about previous vaccination schedule was provided. The report stated that the patient received treatment with Paxlovid for COVID  19, and one week after finishing the treatment the patient started with nasal congestion and cough. It is also mentioned the patient tested positive after having tested negative, however, no further details regarding the type of test were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (unknown age and unknown gender) with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 5 months after mRNA-1273 vaccine, reported as third dose of the COVID  19 immunization schedules; no information about previous vaccination schedule was provided. The report stated that the patient received treatment with Paxlovid for COVID  19, and one week after finishing the treatment the patient started with nasal congestion and cough. It is also mentioned the patient tested positive after having tested negative, however, no further details regarding the type of test were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 57.0
Sex: M
Vaccine: COVID19, FLUX, FLUX
Symptoms: COVID-19
Clinical narrative: grade 1 covid-19 (Non-serious); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (grade 1 covid-19 (Non-serious)) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylaxis.  Co-suspect products included non-company products INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE POLYVAL.) for Prophylaxis and INFLUENZA VACCINE for Prophylaxis.  The patient's past medical history included Appendicitis in 1979 and Appendectomy in 1979. Concurrent medical conditions included Presbyopia since 2018. Concomitant products included COVID-19 VACCINE for an unknown indication.  On 22-Nov-2021 at 11:42 AM, the patient received first dose of INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE POLYVAL.) (Intramuscular) .5 milliliter. On 22-Nov-2021 at 11:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 05-Jan-2022 at 8:00 AM, the patient experienced COVID-19 (grade 1 covid-19 (Non-serious)). At the time of the report, COVID-19 (grade 1 covid-19 (Non-serious)) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (grade 1 covid-19 (Non-serious)) to be not related.   Patient received both Herpes Zoster subunit vaccine and influenza virus vaccine. Patient received both Flu Seasonal QIV Dresden and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. 44 days after receiving COVID-19 Vaccine Moderna and Flu Seasonal QIV Dresden, patient developed  grade 1 COVID-19. The patient experienced fever on 03-Jan-2022 and symptoms of runny nose and sore throat. The reporter considered that there was no reasonable possibility that the COVID-19 may have been caused by COVID-19 Vaccine Moderna and Flu Seasonal QIV Dresden. The patient did not taken any medication or treatment.  Company Comment: This is a spontaneous case concerning  a  57-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event Covid-19. The events occurred 44 days after the unspecified dose of mRNA-1273 COVID 19 Vaccine. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  57-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event Covid-19. The events occurred 44 days after the unspecified dose of mRNA-1273 COVID 19 Vaccine. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial stored in Refrigerator on 11-JAN-2022, Expired on 05-MAY-2022 and administered on 28-FEB-2022; patient was administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vial stored in Refrigerator on 11-JAN-2022, Expired on 05-MAY-2022 and administered on 28-FEB-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 044B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in Refrigerator on 11-JAN-2022, Expired on 05-MAY-2022 and administered on 28-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vial stored in Refrigerator on 11-JAN-2022, Expired on 05-MAY-2022 and administered on 28-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. On 28-Feb-2022, patient took first booster.  The vial was initially stored in the refrigerator on 11-Jan-2022 and vial did not undergo any temperature excursions, total number doses were 84 doses total administered to 82 patients total (2 of the patients received 2 doses from the same lot and their 1st and 2nd primary series dose from the same affected lot. Reportedly, the vial didn't undergo any temperature excursions. No treatment details were provided
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 28-Feb-2022/Patient received expired dose after the 30 day use by date; The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 28-Feb-2022/Patient received expired dose after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 28-Feb-2022/Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 28-Feb-2022/Patient received expired dose after the 30 day use by date) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 28-Feb-2022/Patient received expired dose after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 28-Feb-2022/Patient received expired dose after the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 28-Feb-2022/Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 28-Feb-2022/Patient received expired dose after the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial was initially stored in the refrigerator on 11-Jan-2022. The dose administered more than after 30 days. The vial did not undergo any temperature excursions. The patient had not reported adverse reaction to the HCP knowledge. No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was expired (more than 30 days it was in the fridge) and then stored in the fridge before administered; The patient administered dose that was more than 30 days after it was in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered dose that was more than 30 days after it was in the fridge) and PRODUCT STORAGE ERROR (The vaccine was expired (more than 30 days it was in the fridge) and then stored in the fridge before administered) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 084J21A and 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered dose that was more than 30 days after it was in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired (more than 30 days it was in the fridge) and then stored in the fridge before administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered dose that was more than 30 days after it was in the fridge) and PRODUCT STORAGE ERROR (The vaccine was expired (more than 30 days it was in the fridge) and then stored in the fridge before administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was stated that the reporter had identified an issue that staff were not dating the boxes of vaccine when placed them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which meant that all doses were administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA (Emergency Use Authorization). This includes 84 doses administered to 82 patients (as 2 patients received 2 doses from this lot more than 30 days after it was in the fridge). The reporter was further informed that the reporter team had accidentally administered expired Moderna COVID-19 vaccine to 18 patients: 9 patients on 09-May-2022 and 9 patients on 11-May-2022 (vaccine expired 05-May-2022). These patients were included in the spreadsheet. The vaccine in question had not experienced any temperature excursions. No reported adverse reaction of patient to the HCP (health care professional) knowledge. No treatment medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Oropharyngeal discomfort
Clinical narrative: Strong metallic or chemical taste and sensation in throat shortly after taking pills; sensation in throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Strong metallic or chemical taste and sensation in throat shortly after taking pills) and OROPHARYNGEAL DISCOMFORT (sensation in throat) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Migraine, Borderline hypertension and Anxiety. Concomitant products included LISINOPRIL, PROPRANOLOL, FREMANEZUMAB (AJOVY [FREMANEZUMAB]), MULTIVITAMINS [VITAMINS NOS], CALCIUM, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM;ERGOCALCIFEROL]) and FISH OIL for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 11-May-2022, the patient experienced DYSGEUSIA (Strong metallic or chemical taste and sensation in throat shortly after taking pills) and OROPHARYNGEAL DISCOMFORT (sensation in throat). At the time of the report, DYSGEUSIA (Strong metallic or chemical taste and sensation in throat shortly after taking pills) and OROPHARYNGEAL DISCOMFORT (sensation in throat) was resolving.            Patient had allergic reaction to Pain killers. Patient had Strong metallic or chemical taste and sensation in throat shortly after taking pills. Pills had a strong odor when opening package. The patient was taking any other medications within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Reaction to Moderna and Humira did not wotk; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Reaction to Moderna and Humira did not wotk) in a 65-year-old patient of an unknown gender 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-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 IMMUNISATION REACTION (Reaction to Moderna and Humira did not wotk). At the time of the report, IMMUNISATION REACTION (Reaction to Moderna and Humira did not wotk) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported It was unknown if patient was enrolled in a COVID-19 vaccine trial.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I had a return of symptoms and a positive rapid antigen test; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (I had a return of symptoms and a positive rapid antigen test) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     The patient's past medical history included Nephrotic syndrome. Concurrent medical conditions included Depression, Hypercholesterolemia and Penicillin allergy. Concomitant products included LEVOTHYROXINE from 01-May-2022 to 17-May-2022 for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I had a return of symptoms and a positive rapid antigen test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (I had a return of symptoms and a positive rapid antigen test) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16-May-2022, the patient had a return of symptoms and a positive rapid antigen test 8 days after stopping treatment with Paxlovid.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 56-year-old male patient with reported medical history of Nephrotic Syndrome, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, patient tested positive using rapid antigen test for COVID-19 8 days after stopping NIRMATRELVIR, RITONAVIR (PAXLOVID) which was his treatment for COVID-19 from 04-May-2022 to 08-May-2022 for COVID-19, no other clinical or treatment details were given. The medical history of Nephrotic Syndrome remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 56-year-old male patient with reported medical history of Nephrotic Syndrome, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, patient tested positive using rapid antigen test for COVID-19 8 days after stopping NIRMATRELVIR, RITONAVIR (PAXLOVID) which was his treatment for COVID-19 from 04-May-2022 to 08-May-2022 for COVID-19, no other clinical or treatment details were given. The medical history of Nephrotic Syndrome remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound of symptoms on day 11; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of symptoms on day 11) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    No Medical History information was reported.   On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022, the patient experienced COVID-19 (Rebound of symptoms on day 11). At the time of the report, COVID-19 (Rebound of symptoms on day 11) had not resolved.            No concomitant medication was reported. It was unknown that whether the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 41-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine and 11 days after receiving the co-suspect, non-company product Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 treatment. As reported, patient had rebound of symptoms on day 11, no other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 41-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine and 11 days after receiving the co-suspect, non-company product Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 treatment. As reported, patient had rebound of symptoms on day 11, no other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar numbers rocketed sky high/serious elevation of blood sugar; This spontaneous case was reported by a non-health professional and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar numbers rocketed sky high/serious elevation of blood sugar) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar numbers rocketed sky high/serious elevation of blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar numbers rocketed sky high/serious elevation of blood sugar) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose (Unknown-130): blood sugar levels have sky rocketed (High) Blood sugar levels have sky rocketed.         No concomitant medications reported.  It was reported that the reporter had a question concerning wife's second booster shot Madonna taken on May seven, roughly. About a week later, her blood sugar numbers rocketed sky high. Which normally were only around 130. She was slightly below seven A. One C. The question was had there been any clinical evidence of truly micrograms uh being administered in a way with the COVID-19 booster shot such that it lead to serious elevation of blood sugar.  No treatment information reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive rapid antigen test rebound on Day +4 after finishing the 5-day course of Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive rapid antigen test rebound on Day +4 after finishing the 5-day course of Paxlovid) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced COVID-19 (Positive rapid antigen test rebound on Day +4 after finishing the 5-day course of Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive rapid antigen test rebound on Day +4 after finishing the 5-day course of Paxlovid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative on day 5 of Paxlovid treatment and positive (Positive) Positive rapid antigen test rebound on Day 4 after finishing the 5 day course of Paxlovid treatment..         No concomitant medication information provided. No treatment medication information provided.  On 08-Dec-2021, the patient received booster dose of Moderna COVID-19 Vaccine.  Patient tested positive for COVID-19 on day 4th of Paxlovid treatment. After finishing the 5 days course symptoms were cough and congestion which was persisted steadily during that time. Rapid antigen test returned negative on the day 5 of paxlovid treatment.  Company Comment: This spontaneous case concerns a 26-year-old female patient, with Co-suspect drug Paxlovid, who experienced the unexpected ADR of COVID-19. The event occurred approximately 5 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with PAXLOVID for COVID-19, however the patient had persistent symptoms of cough and congestion and tested positive again after 4 days of treatment. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 26-year-old female patient, with Co-suspect drug Paxlovid, who experienced the unexpected ADR of COVID-19. The event occurred approximately 5 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with PAXLOVID for COVID-19, however the patient had persistent symptoms of cough and congestion and tested positive again after 4 days of treatment. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound Covid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound Covid symptoms) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Niaspan). Concomitant products included PREDNISONE, SALBUTAMOL (VENTOLIN [SALBUTAMOL]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT) for an unknown indication.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2022, the patient experienced COVID-19 (Rebound Covid symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound Covid symptoms) was resolving.            It was reported that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.   The device Date reported as 17-May-2022.  Company Comment: This spontaneous case concerns a 41-year-old male patient, with concomitant medications Symbicort and Combivent, who experienced the unexpected AESI of COVID-19. The event occurred approximately 5 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however the patient had Rebound COVID-19 symptoms 7 days after Paxlovid treatment. The outcome of the event was reported as resolving. The patient's treatment with Paxlovid and concomitant medications Symbicort and Combivent, remain as confounders for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old male patient, with concomitant medications Symbicort and Combivent, who experienced the unexpected AESI of COVID-19. The event occurred approximately 5 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however the patient had Rebound COVID-19 symptoms 7 days after Paxlovid treatment. The outcome of the event was reported as resolving. The patient's treatment with Paxlovid and concomitant medications Symbicort and Combivent, remain as confounders for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: I teasted positive for COVID; I'm gonna be down,goanna go lay down,Extremely tired; It was bad allergies; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I teasted positive for COVID), FATIGUE (I'm gonna be down,goanna go lay down,Extremely tired), HYPERSENSITIVITY (It was bad allergies) and HEADACHE (Headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I teasted positive for COVID), FATIGUE (I'm gonna be down,goanna go lay down,Extremely tired), HYPERSENSITIVITY (It was bad allergies) and HEADACHE (Headaches). At the time of the report, COVID-19 (I teasted positive for COVID), FATIGUE (I'm gonna be down,goanna go lay down,Extremely tired), HYPERSENSITIVITY (It was bad allergies) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested Positive for COVID-19.         No concomitant medication was reported. Patient had booster shot. No treatment medication was reported.  Company Comment: This spontaneous case concerns a  patient of an unknown age and gender, with a no medical history reported, who experienced the unexpected AESI of COVID-19, and the expected events of Fatigue, Hypersensitivity and Headache. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was also being treated with Pristiq. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a  patient of an unknown age and gender, with a no medical history reported, who experienced the unexpected AESI of COVID-19, and the expected events of Fatigue, Hypersensitivity and Headache. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was also being treated with Pristiq. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID rebound at day 8 (COVID-19 recurrent); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID rebound at day 8 (COVID-19 recurrent)) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced COVID-19 (COVID rebound at day 8 (COVID-19 recurrent)). At the time of the report, COVID-19 (COVID rebound at day 8 (COVID-19 recurrent)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Tested negative on day 7 on multiple rapid tests.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was reported that patient had unknown drug, start date of the drug was on 01-May-2022 and last administration on 05-May-2022 for COVID-Treatment as an indication.  No concomitant medication information was provided.  Company Comment: This spontaneous case concerns a 28-year-old male patient, with a no medical history reported, who experienced the unexpected AESI of COVID-19 recurrent. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was treated with an unspecified drug for COVID-19. However on day 8 of treatment, the patient had COVID rebound. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 28-year-old male patient, with a no medical history reported, who experienced the unexpected AESI of COVID-19 recurrent. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was treated with an unspecified drug for COVID-19. However on day 8 of treatment, the patient had COVID rebound. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: sulfa and keflex. Past adverse reactions to the above products included Allergy with keflex and sulfa. Concurrent medical conditions included Type 2 diabetes mellitus and Hypertension.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 11-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  On 16-May-2022, the patient had reemergence of symptoms after finishing 5-day course of Paxlovid.  Company Comment: This is a spontaneous case concerning a 73-year-old male patient with a medical history of Type 2 diabetes and hypertension, who experienced the unexpected non-serious ADR COVID-19 which occurred approximately 6 months after receiving a dose of mRNA-1273 Vaccine, dose 3 in vaccine series. There is no available information regarding the first 2 doses in the COVID-19 vaccine series. As reported, symptom reemerged 5 days after finishing 5-day course of Paxlovid (Nirmatrelvir/Ritonavir). The patient's age and medical history of diabetes and hypertension, all of which weaken the immune system, remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with a medical history of Type 2 diabetes and hypertension, who experienced the unexpected non-serious ADR COVID-19 which occurred approximately 6 months after receiving a dose of mRNA-1273 Vaccine, dose 3 in vaccine series. There is no available information regarding the first 2 doses in the COVID-19 vaccine series. As reported, symptom reemerged 5 days after finishing 5-day course of Paxlovid (Nirmatrelvir/Ritonavir). The patient's age and medical history of diabetes and hypertension, all of which weaken the immune system, remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Therapeutic product effect decreased
Clinical narrative: Drug effect decreased; Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022) in a 69-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 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2022, received second 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 01-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022). On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.  Company Comment: This is a Spontaneous case concerns a 81-year-old female patient, with no medical history reported, who experienced the non-serious unexpected event of Therapeutic product effect decreased unspecified days after the second dose of the mRNA-1273 vaccine. Inappropriate schedule of product administration is reported in this case as the Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerns a 81-year-old female patient, with no medical history reported, who experienced the non-serious unexpected event of Therapeutic product effect decreased unspecified days after the second dose of the mRNA-1273 vaccine. Inappropriate schedule of product administration is reported in this case as the Patient received first dose on 01-Jan-2021 and second dose on 01-Jan-2022. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Wrong technique in product usage process
Clinical narrative: possibility that my heart problems started/heart caught the virus; they hit the blood vessel instead of muscle; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (possibility that my heart problems started/heart caught the virus) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (they hit the blood vessel instead of muscle) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (possibility that my heart problems started/heart caught the virus) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (they hit the blood vessel instead of muscle). At the time of the report, CARDIAC DISORDER (possibility that my heart problems started/heart caught the virus) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (they hit the blood vessel instead of muscle) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient stated that there was a possibility that heart problems started when patient got second vaccine for COVID, they hit the blood vessel instead of muscle and heart caught the virus.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pharyngeal swelling
Clinical narrative: throat started to swell/went from having a double chin to a triple chin; arm is a little sore; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (throat started to swell/went from having a double chin to a triple chin) and PAIN IN EXTREMITY (arm is a little sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 025D21A, 140M20A and 012L20A) for COVID-19 vaccination.     The patient's medical history and history of allergies were reported as none. The patient did not have COVID positive test or diagnosis.  Concomitant products included LOSARTAN, AMLODIPINE, PRAVASTATIN and LEVOTHYROXINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced PAIN IN EXTREMITY (arm is a little sore). On 18-May-2022, the patient experienced PHARYNGEAL SWELLING (throat started to swell/went from having a double chin to a triple chin). At the time of the report, PHARYNGEAL SWELLING (throat started to swell/went from having a double chin to a triple chin) and PAIN IN EXTREMITY (arm is a little sore) outcome was unknown.            The patient had not received any treatment. It was reported that the patient had no issues with the previous 3 vaccinations.