chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient not had any drug allergy.  The patient's past medical history included Factor V Leiden mutation.    On 28-Oct-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 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 27-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 Concomitant medication reported.  It was reported that the COVID antigen test was negative by day 5 and symptoms resolved. Symptoms recurred 5 days later on 27-May-2022, increasing in severity, and strong positive antigen test recorded 3 days later.  No Treatment medication reported.  Company comment: This spontaneous case concerns a 40-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 23-May. Symptoms resolved after 5 days of treatment with Paxlovid, and patient tested negative for COVID 19. Symptoms recurred 5 days later with increased severity. Patient again tested positive 3 days later. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 40-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 23-May. Symptoms resolved after 5 days of treatment with Paxlovid, and patient tested negative for COVID 19. Symptoms recurred 5 days later with increased severity. Patient again tested positive 3 days later. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site infection, Vaccination site pain, Vaccination site warmth
Clinical narrative: a little sore left arm in the site of injection, not that bad; left arm a bit red in the site of injection; site of injection very hot to the touch; could be due to an infection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (a little sore left arm in the site of injection, not that bad), VACCINATION SITE ERYTHEMA (left arm a bit red in the site of injection), VACCINATION SITE WARMTH (site of injection very hot to the touch) and VACCINATION SITE INFECTION (could be due to an infection) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy, Blood pressure high, High cholesterol and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), VALSARTAN for Blood pressure high, SIMVASTATIN for High cholesterol.   On 28-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2022, the patient experienced VACCINATION SITE PAIN (a little sore left arm in the site of injection, not that bad), VACCINATION SITE ERYTHEMA (left arm a bit red in the site of injection), VACCINATION SITE WARMTH (site of injection very hot to the touch) and VACCINATION SITE INFECTION (could be due to an infection). At the time of the report, VACCINATION SITE PAIN (a little sore left arm in the site of injection, not that bad), VACCINATION SITE ERYTHEMA (left arm a bit red in the site of injection), VACCINATION SITE WARMTH (site of injection very hot to the touch) and VACCINATION SITE INFECTION (could be due to an infection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) very mild case.         No treatment was reported   This case was linked to MOD-2022-581141.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin discolouration, Vaccination site bruising
Clinical narrative: big bruise the size of a Nickle above where they got the needle, still gets the bruises; gets bruises on her arm,legs, knees, various places; start off pink or red and then get brown, sometimes they come in brown; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (big bruise the size of a Nickle above where they got the needle, still gets the bruises), CONTUSION (gets bruises on her arm,legs, knees, various places) and SKIN DISCOLOURATION (start off pink or red and then get brown, sometimes they come in brown) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Jansen (First dose). Past adverse reactions to the above products included No adverse event with Jansen. Concurrent medical conditions included Blood pressure high.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE BRUISING (big bruise the size of a Nickle above where they got the needle, still gets the bruises), CONTUSION (gets bruises on her arm,legs, knees, various places) and SKIN DISCOLOURATION (start off pink or red and then get brown, sometimes they come in brown). At the time of the report, VACCINATION SITE BRUISING (big bruise the size of a Nickle above where they got the needle, still gets the bruises) and CONTUSION (gets bruises on her arm,legs, knees, various places) had not resolved and SKIN DISCOLOURATION (start off pink or red and then get brown, sometimes they come in brown) outcome was unknown. Patient concomitant medications include high blood pressure medications before getting the vaccines. Patient did not taken any medications for reaction and declined for date of birth. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: got the two covid shots and  the other one, the booster.  ended up, just now, found out he probably got covid; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (got the two covid shots and  the other one, the booster.  ended up, just now, found out he probably got covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (got the two covid shots and  the other one, the booster.  ended up, just now, found out he probably got covid). At the time of the report, SUSPECTED COVID-19 (got the two covid shots and  the other one, the booster.  ended up, just now, found out he probably got covid) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company comment- This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Suspected covid. The caller stated that he got the two Covid vaccinations and  a booster but still probably got Covid. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Suspected covid. The caller stated that he got the two Covid vaccinations and  a booster but still probably got Covid. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: very mild COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (very mild COVID-19) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy, Blood pressure high (improving with medications), Hypercholesterolemia and Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (oesophageal), VALSARTAN for Blood pressure high, SIMVASTATIN for Hypercholesterolemia.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (very mild COVID-19). At the time of the report, COVID-19 (very mild COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive.         It was stated that the patient was not able to read the dates written in her vaccination card. After 1st, 2nd and 1st booster dose she did not experienced any symptoms.  It was not stated weather the patient received treatment for COVID-19 or not. Company comment: This spontaneous case concerns an 84-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no date; hence, latency to the primary schedule and to the third dose (first booster) of mRNA-1273 vaccine cannot be assessed. As per source document, she had a positive test, and she experienced a very mild case of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-580975 (Patient Link).; Sender's Comments: This spontaneous case concerns an 84-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no date; hence, latency to the primary schedule and to the third dose (first booster) of mRNA-1273 vaccine cannot be assessed. As per source document, she had a positive test, and she experienced a very mild case of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID 19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient do not have any allergies.    On 17-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative/ tested negative for 9 days. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive/ symptoms returned tested postive.         Concomitant medications were not reported.  The patient had reported had rebound of COVID-19 after completing 5 day course of Paxlovid. The patient had tested negative for 9 days then symptoms returned after 6 days and after completing course and patient had tested positive again.  Company comment: This spontaneous case concerns a 56-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. After the treatment with Paxlovid, patient tested negative for COVID 19 for 9 days. Symptoms returned 6 days later and patient again tested positive. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-581235 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. After the treatment with Paxlovid, patient tested negative for COVID 19 for 9 days. Symptoms returned 6 days later and patient again tested positive. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no known allergies.  Concurrent medical conditions included Multiple sclerosis. Concomitant products included DIMETHYL FUMARATE (TECFIDERA), ROSUVASTATIN CALCIUM (CRESTOR) and ENALAPRIL for an unknown indication.    On 04-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 20-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: negative (Negative) negative. On day-06 and positive (Positive) Positive tested positive from day 7 to 11.         Device Date : 31May2022 Paxlovid used for the treatment of Covid-19.  Company comment-This spontaneous case concerns a 45-year-old male patient with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 infection on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with paxlovid starting on 20th May-2022 for covid 19 treatment for 6 days. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. Patient had rebound covid, after completion of paxlovid with negative antigen test on day 6, followed by positive antigen test from day 7 to day 11. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns a 45-year-old male patient with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 infection on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated with paxlovid starting on 20th May-2022 for covid 19 treatment for 6 days. Details of the onset date, lab results and symptoms of this initial Covid 19 infection and its outcome was not reported. Patient had rebound covid, after completion of paxlovid with negative antigen test on day 6, followed by positive antigen test from day 7 to day 11. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 21-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Relapse of Covid infection symptoms were include sore throat, headache, cough and nasal congestion  No treatment medication were provided.  Device date was reported as 31-May-2022  Company comment: This spontaneous case concerns a 70-year-old female patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 21-May to 26-May. Symptoms relapsed 4 days after completion of treatment with Paxlovid and included sore throat, headache, cough and nasal congestion. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old female patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 21-May to 26-May. Symptoms relapsed 4 days after completion of treatment with Paxlovid and included sore throat, headache, cough and nasal congestion. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, COVID-19, Pyrexia, Sinus congestion
Clinical narrative: COVID-19; High temperature; sinus congestion; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19), PYREXIA (High temperature) and SINUS CONGESTION (sinus congestion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07f121A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient did not have any drug allergy.  The patient's past medical history included Overweight (BMI 28). Concurrent medical conditions included Asthma and Allergy. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19), PYREXIA (High temperature) and SINUS CONGESTION (sinus congestion). At the time of the report, COVID-19 (COVID-19) was resolving and PYREXIA (High temperature) and SINUS CONGESTION (sinus congestion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: up to 103 (High) up to 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that seven days after completing paxlovid symptoms returned on 28-May-2022, temperature was up to 103, sinus congestion. The event did not require hospitalization. Patient was required to quarantine again and miss additional days of work. COMPANY COMMENT: This is an spontaneous case concerning a 34-year-old female patient with medical history of Overweight,  (BMI 28), Asthma and Allergy, Concomitant products included PARACETAMOL (TYLENOL), PAXLOVID) (oral) from 17-May-2022 to 21-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI), PYREXIA and SINUS CONGESTION unknown days after 3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 34-year-old female patient with medical history of Overweight,  (BMI 28), Asthma and Allergy, Concomitant products included PARACETAMOL (TYLENOL), PAXLOVID) (oral) from 17-May-2022 to 21-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI), PYREXIA and SINUS CONGESTION unknown days after 3rd dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: Covid was before her daughter's 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Covid was before her daughter's 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine) in an 18-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Covid was before 1st dose).   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Covid was before her daughter's 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine). At the time of the report, ILLNESS (Covid was before her daughter's 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive - Before the 1st dose of Moderna vaccine.  mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.  Concomitant medications details were not reported by the reporter.  The patient had COVID and waited the recommended amount of time before she got the 1st dose of the Moderna vaccine. Covid was before her 1st dose but got sick after the 1st dose of the Moderna covid-19 vaccine. The patient also received the 2nd dose of the Moderna covid-19 vaccine, but was unable to provide any dates, lot numbers or expiration dates.  The patient had positive COVID test before the 1st dose of Moderna vaccine.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Person advised testing positive for COVID and similar mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Person advised testing positive for COVID and similar mild symptoms) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Person advised testing positive for COVID and similar mild symptoms). At the time of the report, COVID-19 (Person advised testing positive for COVID and similar mild symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. It was reported that patient had booster dose about 3 months prior to this report. Neither patient had a fever. Patient fully recovered within 10 days. No treatment medications were reported. COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old  patient with no medical history reported who experienced the unexpected event of COVID-19 (AESI) unknown days after 3rd dose of  mRNA-1273 vaccine. On an unknown date, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-561899 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old  patient with no medical history reported who experienced the unexpected event of COVID-19 (AESI) unknown days after 3rd dose of  mRNA-1273 vaccine. On an unknown date, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J221A) for COVID-19 vaccination.  Concurrent medical conditions included Neutropenia, Thrombocytopenia, Thyroiditis chronic and Drug allergy (unspecified drug allergy).  On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported. It was unknown whether the patient received any medications/products or not within 2 weeks of starting COVID-19 treatment. The patient had rebound COVID-19 after testing negative following Paxlovid treatment. The device date was 31-May-2022.  Company Comment: This spontaneous case concerns a 78-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid on 17-May-2022 to 21-May-2022 for Covid-19. She had rebound covid-19 after testing negative following Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 78-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid on 17-May-2022 to 21-May-2022 for Covid-19. She had rebound covid-19 after testing negative following Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Took Paxlovid for 5 days. 4 days after treatment negative covid test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Took Paxlovid for 5 days. 4 days after treatment negative covid test) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (Unspecified drug).    In March 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 (Took Paxlovid for 5 days. 4 days after treatment negative covid test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 23-May-2022, COVID-19 (Took Paxlovid for 5 days. 4 days after treatment negative covid test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative Negative. On 27-May-2022, SARS-CoV-2 test: positive Positive. On an unknown date, SARS-CoV-2 test: positive Positive.         Patient Race Native Hawaiian Other Pacific Islander. Patient date of birth was reported.  The patient did not take any other medications or products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine.  Company comment: This spontaneous case concerns a 55-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred approximately 2 months after the third dose of mRNA-1273 vaccine. The patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment for 5 days however; 4 days after treatment negative covid test and again positive on 5th day. SARS-CoV-2 test was positive as on 27-May-2022.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 55-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred approximately 2 months after the third dose of mRNA-1273 vaccine. The patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment for 5 days however; 4 days after treatment negative covid test and again positive on 5th day. SARS-CoV-2 test was positive as on 27-May-2022.  Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022 at 8:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022 at 8:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date vaccine removed from freezer to refrigerator 27-Apr-2022 1020. Date vaccine administered to patient 28-May-2022 0830. No adverse events have been reported by the 7 patients at the time of the call. No treatment information was reported.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.   On 13-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.   No concomitant medications were provided by the reporter.  No adverse events have been reported by the patient at the time of the call.  No treatment medications were provided by the reporter.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-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 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and administered on 28-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022. No adverse events have been reported by the 7 patients.  No information on treatment medications was reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date vaccine removed from freezer to refrigerator 27-Apr-2022 1020. Date vaccine administered to patient 28-May-2022 0830. No treatment information was reported. No adverse events have been reported by the 7 patients at the time of the call.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen on 29-Mar-2021 and Pfizer on 18-Dec-2021. Past adverse reactions to the above products included No adverse event with Janssen and Pfizer.    On 28-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022. No adverse events had been reported by patient at the time of the call. No treatment medications were reported.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.; Inadvertently administered dose of the Moderna Covid-19 vaccine which was 30 day beyond use date.; Dose 1 was administered on 09-Mar-2021 and dose 2 was administered on 26-Apr-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the Moderna Covid-19 vaccine which was 30 day beyond use date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 09-Mar-2021 and dose 2 was administered on 26-Apr-2021) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022 at 8:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 09-Mar-2021 and dose 2 was administered on 26-Apr-2021). On 28-May-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the Moderna Covid-19 vaccine which was 30 day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the Moderna Covid-19 vaccine which was 30 day beyond use date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 27-Apr-2022 and the doses were administered on 28-May-2022.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 09-Mar-2021 and dose 2 was administered on 26-Apr-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Patient was administered with Moderna Covid-19 vaccine which was 30 day beyond use date. No adverse events were reported by the patient at the time of this report.  Treatment information was not provided.