chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: 04-FEB-2022) dose was not reported, 1 total, administered to right arm on 06-APR-2021 for prophylactic vaccination. Age at time of vaccination 55 years old. No concomitant medications were reported.  On 25-MAY-2022, the patient had a stuffy nose and a cough.  On 27-MAY-2022, tested positive for covid-19 with an antigen self test (suspected clinical vaccination failure and suspected covid-19) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint; Sender's Comments: V0.20220600585-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE NOT STORED IN REFRIGERATOR GIVEN  TO 80 PATIENTS; PRODUCT STORAGE ERROR; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine not stored in refrigerator given to 80 subjects, and product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine not stored in refrigerator given to 80 patients and product storage error was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISES; This spontaneous report received from a patient concerned a 61 year old female of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included: heart attack (heart attack in 2020 because of blood clots) and stomach upset because of Aspirin and concurrent conditions included: seasonal allergies and acid reflux.  The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: unknown) dose was not reported, 1 total administered at left arm on 04-FEB-2022 for prophylactic vaccination. No adverse events reported following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient was ok until she got the booster.  The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 and expiry: unknown) dose was not reported, 1 total administered at left arm on 05-APR-2022 for prophylactic vaccination.  Concomitant medications included acetylsalicylic acid for blood clots. The patient stated that, she had stopped taking her medications, she stopped taking the aspirin too soon in 2018 because it was upsetting her stomach. She stopped it for a couple of years. Then again restarted on an unspecified date JUN-2020. On an unspecified date in APR-2022 started a couple of days after vaccine, the patient experienced bruises (Dose number in series 2). The patient reported, she looked like somebody had beaten her. She had bruises that were humongous. She had a bruise right up her hand and one two inches from her wrist, one in the middle of the arm, and then there were six on her right leg, three on her left leg and got one on her elbow and one on wrist on her left arm. When they show up they were almost black, that's how dark they were. It took two and half weeks for that bruise to go. The patient used Vaseline for the bruise. She stated that, she was on other medications at the time of reporting but not wanted to provide the information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bruises. This report was non-serious. This case, from the same reporter is linked to 20220600703.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Burning sensation, Discharge, Illness, Rash pruritic
Clinical narrative: CLEAR FLUID COMES OUT; SCRATCH IT BURNS; RASH THAT ITCHES; SICK; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. Age at time of vaccination 56 years old. No concomitant medications were reported.  On APR-2021, the patient experienced sick. On an unspecified date, the patient experienced clear fluid comes out, scratch it burns, and rash that itches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the sick, clear fluid comes out, scratch it burns and rash that itches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a health care professional and describes the occurrence of DEATH (Death) 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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  Company comment This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the Fatal unexpected, event of death, which occurred on an unknown date, thus latency between vaccination and the event cannot be assessed. The patient received the second dose of mRNA-1273. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information regarding the course of events, lab tests, imaging studies and treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Upon internal Review on 01-Jun-2022, significant correction was made to update report type, suspect product and narrative.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the Fatal unexpected, event of death, which occurred on an unknown date, thus latency between vaccination and the event cannot be assessed. The patient received the second dose of mRNA-1273. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information regarding the course of events, lab tests, imaging studies and treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered to multiple patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered to multiple patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered to multiple patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses administered to multiple patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. The vial was punctured for more than 12 hours, the vial was initially stored in the refrigerator on 09-May-2022 and vial was first punctured on 23-May-2022 at 8:30 AM and Product administered to patient on 24-may-2022 at 11:00 AM for one patient and 10:00 AM for one patient. The vial was stored in room temperature and did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F was about 27 hours. No treatment details were provided
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after Moderna booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID after Moderna booster) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient experienced COVID-19 (Tested positive for COVID after Moderna booster). At the time of the report, COVID-19 (Tested positive for COVID after Moderna booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case concerns a 68-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred after administration of third dose of mRNA-1273, the exact date of administration of third dose of mRNA-1273 was not provided, the initial two doses of mRNA-1273 were given unknown dates. On May 24, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred after administration of third dose of mRNA-1273, the exact date of administration of third dose of mRNA-1273 was not provided, the initial two doses of mRNA-1273 were given unknown dates. On May 24, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis, Large intestine perforation
Clinical narrative: acute diverticulitis; micro-perforation of the colon; This literature-non-study case was reported in a literature article and describes the occurrence of DIVERTICULITIS (acute diverticulitis) and LARGE INTESTINE PERFORATION (micro-perforation of the colon) in a 41-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, the patient experienced DIVERTICULITIS (acute diverticulitis) (seriousness criterion medically significant) and LARGE INTESTINE PERFORATION (micro-perforation of the colon) (seriousness criterion medically significant). At the time of the report, DIVERTICULITIS (acute diverticulitis) and LARGE INTESTINE PERFORATION (micro-perforation of the colon) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIVERTICULITIS (acute diverticulitis) and LARGE INTESTINE PERFORATION (micro-perforation of the colon) to be related.    No concomitant and treatment medication were reported. COMPANY COMMENT: This is a literature non-study case concerning a 41-years-old male patient with no medical history who experienced the unexpected (seriousness criterion medically significant) events of DIVERTICULITIS and LARGE INTESTINE PERFORATION 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 a literature non-study case concerning a 41-years-old male patient with no medical history who experienced the unexpected (seriousness criterion medically significant) events of DIVERTICULITIS and LARGE INTESTINE PERFORATION unknown days after  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Symptoms went away after completion of therapy,tested negative on day 14; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Symptoms went away after completion of therapy,tested negative on day 14) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included LISINOPRIL, OMEPRAZOLE (OMPRAZOLE) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 10-May-2022 at 4:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Symptoms went away after completion of therapy,tested negative on day 14). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 16-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Symptoms went away after completion of therapy,tested negative on day 14) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Symptoms went away after completion of therapy, tested negative on day 11, mild symptoms returned and positive test on day 14  Device Date was reported as 24-May-2022  Company comment: This spontaneous case concerns a 61 year old male patient, with no relevant medical history, who experienced the unexpected non serious of COVID-19, unknown days after receiving the fourth dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Patient started taking Paxlovid for COVID-19 for 5 days. Symptoms disappeared after completion of therapy. He tested negative for COVID-19 on day 11. However, mild symptoms returned and he tested positive on day 14. The event was resolving. No further details about the previous doses of vaccination were available in the report. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61 year old male patient, with no relevant medical history, who experienced the unexpected non serious of COVID-19, unknown days after receiving the fourth dose with mRNA-1273 vaccine in the COVID-19 vaccination series. Patient started taking Paxlovid for COVID-19 for 5 days. Symptoms disappeared after completion of therapy. He tested negative for COVID-19 on day 11. However, mild symptoms returned and he tested positive on day 14. The event was resolving. No further details about the previous doses of vaccination were available in the report. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Took paxlovid on my first day of covid test and symptoms, and tested negative on day 9 and felt fine day 11 started feeling like a had a head cold, and tired today I tested and i'm POSITIVE again; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Took paxlovid on my first day of covid test and symptoms, and tested negative on day 9 and felt fine day 11 started feeling like a had a head cold, and tired today I tested and i'm POSITIVE again) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 081B21A and 048B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Overweight (just overweight and over 50) and Drug allergy (Unknown drug allergy).   On 26-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021 at 12:00 PM, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced COVID-19 (Took paxlovid on my first day of covid test and symptoms, and tested negative on day 9 and felt fine day 11 started feeling like a had a head cold, and tired today I tested and i'm POSITIVE again). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Took paxlovid on my first day of covid test and symptoms, and tested negative on day 9 and felt fine day 11 started feeling like a had a head cold, and tired today I tested and i'm POSITIVE again) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive again. On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative on day 9 and positive (Positive) took paxlovid on first day of covid test and symptoms.         No Concomitant medication was reported.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The device date was reported as 23-May-2022.  Patient took paxlovid on first day of covid test and symptoms, and tested negative on day 9 and felt fineday 11 started feeling like patient had a head cold, and tired, today patient tested and is positive again.  No treatment medication was reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Completed a full course of Paxlovid and on day 8 COVID symptoms began to re-appear; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Completed a full course of Paxlovid and on day 8 COVID symptoms began to re-appear) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Name of drug not reported).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2022 at 8:00 PM, the patient experienced COVID-19 (Completed a full course of Paxlovid and on day 8 COVID symptoms began to re-appear). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Completed a full course of Paxlovid and on day 8 COVID symptoms began to re-appear) had not resolved.            Concomitant product use was not provided by the reporter.  Device date was reported as 24-May-2022. Company comment: This spontaneous case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The exact date of administration of third dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. It has been reported that patient completed the treatment regimen of Paxlovid but the symptoms recurred after 8 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The exact date of administration of third dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. It has been reported that patient completed the treatment regimen of Paxlovid but the symptoms recurred after 8 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I am reporting that I had a Rebound and retested positive) in a 72-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 Drug allergy. Concomitant products included ATORVASTATIN for an unknown indication. On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (I am reporting that I had a Rebound and retested positive). At the time of the report, COVID-19 (I am reporting that I had a Rebound and retested positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative, Tested negative on two antigen tests on 2 consecutive days around day 10, negative (Negative) Negative, Tested negative on two antigen tests on 2 consecutive days around day 10, positive (Positive) Retested positive and negative (Negative) Negative, also negative PCR test A few days later. The birth date of patient was reported as unknown of JUN-1949. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 25-May-2022. Company comment: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date on the next month after the 4th dose of mRNA-1273. It was reported that the patient had a Rebound. Tested negative on two antigen tests on 2 consecutive days around day 10 and also negative PCR test. A few days later she had mild sneeze symptoms, and retested positive. The patient had completed 5 days treatment with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date on the next month after the 4th dose of mRNA-1273. It was reported that the patient had a Rebound. Tested negative on two antigen tests on 2 consecutive days around day 10 and also negative PCR test. A few days later she had mild sneeze symptoms, and retested positive. The patient had completed 5 days treatment with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I am reporting that I had a Rebound and retested positive) in a 72-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 Drug allergy. Concomitant products included ATORVASTATIN for an unknown indication. On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced COVID-19 (I am reporting that I had a Rebound and retested positive). At the time of the report, COVID-19 (I am reporting that I had a Rebound and retested positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative, Tested negative on two antigen tests on 2 consecutive days around day 10, negative (Negative) Negative, Tested negative on two antigen tests on 2 consecutive days around day 10, positive (Positive) Retested positive and negative (Negative) Negative, also negative PCR test A few days later. The birth date of patient was reported as unknown of JUN-1949. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 25-May-2022. Company comment: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date on the next month after the 4th dose of mRNA-1273. It was reported that the patient had a Rebound. Tested negative on two antigen tests on 2 consecutive days around day 10 and also negative PCR test. A few days later she had mild sneeze symptoms, and retested positive. The patient had completed 5 days treatment with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 72-year-old female patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date on the next month after the 4th dose of mRNA-1273. It was reported that the patient had a Rebound. Tested negative on two antigen tests on 2 consecutive days around day 10 and also negative PCR test. A few days later she had mild sneeze symptoms, and retested positive. The patient had completed 5 days treatment with Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative on two antigen tests on 2 consecutive days; (May2022) Negative, notes: Tested negative on two antigen tests on 2 consecutive days; (May2022) Negative; (May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included patient had a Rebound. Tested negative on two antigen tests on 2 consecutive days around day 10. and also negative PCR test. A few days later I had mild sneeze symptoms, and retested positive.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative on two antigen tests on 2 consecutive days; (May2022) Negative, notes: Tested negative on two antigen tests on 2 consecutive days; (May2022) Negative; (May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included patient had a Rebound. Tested negative on two antigen tests on 2 consecutive days around day 10. and also negative PCR test. A few days later I had mild sneeze symptoms, and retested positive.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive Covid test after a negative result; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive Covid test after a negative result) in a 71-year-old female 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 an unknown date, the patient experienced COVID-19 (Positive Covid test after a negative result). At the time of the report, COVID-19 (Positive Covid test after a negative result) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive COVID test after a negative result. On an unknown date, SARS-CoV-2 test: negative (Negative) Positive COVID test after a negative result.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided.  It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Unspecified Pfizer medication was reported with start date 13-May-2022 and stop date 17-May-2022, with active substance information as COVID-19 Treatment.  Device date: 25-May-2022.  Company comment: This spontaneous case concerns a 71-year-old, female patient with no reported medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19, which occurred at an unspecified date after receiving a dose of mRNA-1273.  The patient was diagnosed with COVID-19 at an unknown date and started treatment with an unspecified drug on 13-May-2022 and completed the course for 4 days. On an unknown date the patient tested positive again for COVID-19 after a prior negative result. Further details on the clinical course and diagnostic test were not provided in the case.  The patient's advanced age may be considered as a risk factor for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old, female patient with no reported medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19, which occurred at an unspecified date after receiving a dose of mRNA-1273.  The patient was diagnosed with COVID-19 at an unknown date and started treatment with an unspecified drug on 13-May-2022 and completed the course for 4 days. On an unknown date the patient tested positive again for COVID-19 after a prior negative result. Further details on the clinical course and diagnostic test were not provided in the case.  The patient's advanced age may be considered as a risk factor for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Neuralgia, Psoriasis
Clinical narrative: Psoriasis of scalp; NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG; ARTHRITIS; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis of scalp), NEURALGIA (NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG) and ARTHRITIS (ARTHRITIS) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included COVID-19 in January 2021.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis of scalp), NEURALGIA (NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG) and ARTHRITIS (ARTHRITIS). At the time of the report, PSORIASIS (Psoriasis of scalp) and ARTHRITIS (ARTHRITIS) outcome was unknown and NEURALGIA (NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG) had not resolved.            No concomitant medication information provided.  The reporter's causality for the event(s) of COVID, PSORIASIS ON SCALP and NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event(s) of ARTHRITIS was not provided.  No treatment medication information provided.  Company Comment: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the non-serious of Arthritis and non-serious events of Psoriasis (Psoriasis of scalp) and Neuralgia (nerve pain was generating from back to left leg) unspecified days after receiving the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the non-serious of Arthritis and non-serious events of Psoriasis (Psoriasis of scalp) and Neuralgia (nerve pain was generating from back to left leg) unspecified days after receiving the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound 5 days after full course of Paxlovid) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No allergy were reported. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment. On 04-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-May-2022, after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Rebound 5 days after full course of Paxlovid). At the time of the report, COVID-19 (Rebound 5 days after full course of Paxlovid) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications information was not reported. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. No treatment medications were provided. Company comment: This spontaneous case concerns a 58-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19, approximately a week after receiving a dose of mRNA-1273 vaccine. Initially, the patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for COVID-19; however, patient again tested positive for COVID-19 five days after completing treatment with Paxlovid. Outcome of the event was reported as resolving. Details of symptoms, clinical course, concurrent conditions, investigation reports, previous COVID-19 vaccination doses, and further treatment was not provided. The current pandemic situation of COVID-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 58-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19, approximately a week after receiving a dose of mRNA-1273 vaccine. Initially, the patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for COVID-19; however, patient again tested positive for COVID-19 five days after completing treatment with Paxlovid. Outcome of the event was reported as resolving. Details of symptoms, clinical course, concurrent conditions, investigation reports, previous COVID-19 vaccination doses, and further treatment was not provided. The current pandemic situation of COVID-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 28.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Furuncle, Headache, Hidradenitis
Clinical narrative: Hidradenitis suppurativa Flare up; Boils on inner thigh; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (Headache), HIDRADENITIS (Hidradenitis suppurativa Flare up) and FURUNCLE (Boils on inner thigh) in a 28-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) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced CHILLS (chills) and HEADACHE (Headache). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa Flare up) and FURUNCLE (Boils on inner thigh). In December 2021, CHILLS (chills) and HEADACHE (Headache) had resolved. At the time of the report, HIDRADENITIS (Hidradenitis suppurativa Flare up) had not resolved and FURUNCLE (Boils on inner thigh) outcome was unknown.            Concomitant information was not provided.  In dec 2021, Patient had Moderna covid booster vaccine which caused headache and chills for 48 hrs. In May 2022, the patient had surgery on boils under arms. It was healing and draining slowely. Patient had flare up of Hidradenitis suppurativa. Patient had bolis on inner thigh. The reporters causality for event Hidradenitis suppurativa with Humira was reasonable possibility and with chills and headache no reasonable possibility.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Illness, Mental status changes, Weight decreased
Clinical narrative: Losing weight and is down to 106 pounds; Patient is very ill; mental changes; skin on her rectum and thighs is beet red; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (Losing weight and is down to 106 pounds), ILLNESS (Patient is very ill), MENTAL STATUS CHANGES (mental changes) and ERYTHEMA (skin on her rectum and thighs is beet red) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and first dose of DUPILUMAB (DUPIXENT) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (Losing weight and is down to 106 pounds), ILLNESS (Patient is very ill), MENTAL STATUS CHANGES (mental changes) and ERYTHEMA (skin on her rectum and thighs is beet red). At the time of the report, WEIGHT DECREASED (Losing weight and is down to 106 pounds), ILLNESS (Patient is very ill), MENTAL STATUS CHANGES (mental changes) and ERYTHEMA (skin on her rectum and thighs is beet red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: losing weight losing weight and was down to 106 pounds.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered WEIGHT DECREASED (Losing weight and is down to 106 pounds), ILLNESS (Patient is very ill), MENTAL STATUS CHANGES (mental changes) and ERYTHEMA (skin on her rectum and thighs is beet red) to be related.    No concomitant drug information was provided. On 09-May-2022, Nurse had recieved the report from patient's spouse and stated that the patient is very ill. It was reported that the patient is still losing weight and is down to 106 pounds, as well as having mental changes and the skin on her rectum and thighs is beet red. The patient had been seen for a second opinion for the symptoms and was reported that the doctor felt that the symptoms were related to Moderna Covid Vaccine. Patient had received a corrective treatment for the events.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID rebound after Paxlovid. 7 days after completion; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID rebound after Paxlovid. 7 days after completion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient previously received a COVID-19 Vaccine.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced COVID-19 (COVID rebound after Paxlovid. 7 days after completion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID rebound after Paxlovid. 7 days after completion) outcome was unknown.            The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.   No concomitant medications were reported.  Device Date was 26-May-2022.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. The event was described as, on unknown date patient experienced Covid-19. Patient took Nirmatrelvir + Ritonavir (Paxlovid) as treatment for Covid-19. It was reported that the patient experienced rebound Covid, 7 days after completion of Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. 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 is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. The event was described as, on unknown date patient experienced Covid-19. Patient took Nirmatrelvir + Ritonavir (Paxlovid) as treatment for Covid-19. It was reported that the patient experienced rebound Covid, 7 days after completion of Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.